{
 "title": "GB-115 / Ranquilon Evidence Card: census of the literature, human studies, registries and regulatory status",
 "version": "1.4",
 "cut_off": "2026-10-25",
 "license": "CC BY 4.0",
 "creator": "Condor Research Editorial",
 "dictionary": {
  "evidence_type": "H human data; A animal; C chemistry/analytical; R review or methods; K congress abstract without human data; P patent; O other",
  "origin": "Z Zakusov Institute / FRC OPBPT author, no Valenta; ZV both; V Valenta Pharm without Zakusov; I neither",
  "compound": "L GB-115 (L-Trp); D D-GB-115; M mention/example only",
  "unit": "one row per record; duplicate_of marks a duplicate publication counted once"
 },
 "queries": {
  "pubmed": [
   {
    "q": "\"GB-115\"",
    "n": 23
   },
   {
    "q": "GB-115[tiab]",
    "n": 23
   },
   {
    "q": "GB115[tiab]",
    "n": 22
   },
   {
    "q": "Ranquilon[tiab] OR \"ranquilon\"[All Fields]",
    "n": 1
   },
   {
    "q": "\"N-(6-phenylhexanoyl)glycyl-L-tryptophan amide\"",
    "n": 1
   },
   {
    "q": "phenylhexanoylglycyltryptophan",
    "n": 1
   },
   {
    "q": "GB-115 anxiolytic",
    "n": 17
   },
   {
    "q": "GB-115 dipeptide",
    "n": 21
   },
   {
    "q": "GB-115 cholecystokinin",
    "n": 16
   },
   {
    "q": "GB-115 anxiety",
    "n": 14
   },
   {
    "q": "GB-115[tiab] AND Zakusov",
    "n": 11
   },
   {
    "q": "GB-115 alcohol",
    "n": 2
   },
   {
    "q": "ГБ-115",
    "n": "invalid (261236 noise hits)"
   },
   {
    "q": "Ранквилон",
    "n": 0
   },
   {
    "q": "GB-115 sigma / mitochondria / neuroprotective / nootropic",
    "n": 0
   }
  ],
  "europepmc": [
   {
    "q": "\"GB-115\"",
    "n": 60,
    "note": "incl. noise; adds PMC9564032 and PMC9563656 (Eur Psychiatry 2022) and patent RU2429874"
   },
   {
    "q": "ranquilon",
    "n": 1
   },
   {
    "q": "Ранквилон",
    "n": 0
   },
   {
    "q": "\"phenylhexanoyl\" AND tryptophan",
    "n": 12,
    "note": "no new GB-115 record"
   },
   {
    "q": "Seredenin AND cholecystokinin",
    "n": 16,
    "note": "adds patent RU2227144"
   }
  ],
  "cyberleninka": [
   {
    "q": "Ранквилон (2 hits)"
   },
   {
    "q": "ГБ-115 / GB-115 / ГБ 115 (1000 noisy hits; filtered by text match)"
   },
   {
    "q": "дипептидный анксиолитик"
   },
   {
    "q": "N-(6-фенилгексаноил)глицил-L-триптофана"
   },
   {
    "q": "блокатор холецистокининовых рецепторов"
   },
   {
    "q": "аналог холецистокинина-4 дипептид"
   },
   {
    "q": "ГБ-115 + 12 modifier queries"
   }
  ],
  "elibrary": [
   {
    "q": "Ранквилон",
    "n": 6,
    "note": "page 1, complete"
   },
   {
    "q": "ГБ-115",
    "n": ">=25 titles seen (page 1, truncated); CAPTCHA appeared on re-query, not circumvented"
   }
  ],
  "google_scholar": [
   {
    "q": "\"GB-115\" cholecystokinin (0 results rendered)"
   },
   {
    "q": "\"GB-115\" anxiolytic dipeptide (9)"
   },
   {
    "q": "Ranquilon (4)"
   },
   {
    "q": "\"Ранквилон\" (3)"
   },
   {
    "q": "\"ГБ-115\" (18)"
   },
   {
    "q": "GB-115 Kolik Seredenin Gudasheva (10)"
   },
   {
    "q": "\"ГБ-115\" Колик (9)"
   },
   {
    "q": "\"ГБ-115\" Незнамов (3)"
   },
   {
    "q": "\"GB-115\" CCK1 antagonist (2)"
   }
  ],
  "clinicaltrials_gov": [
   {
    "q": "GB-115",
    "n": 3
   },
   {
    "q": "GB115",
    "n": 3
   },
   {
    "q": "ranquilon",
    "n": 2
   },
   {
    "q": "Ranquilon",
    "n": 2
   },
   {
    "q": "N-(6-phenylhexanoyl)glycyl-L-tryptophan amide",
    "n": 0
   }
  ],
  "ema_dataset": "medicines JSON 2026-10-24T18:22:32Z, 2754 records: no match for gb-115, ranquilon, phenylhexanoyl, cholecystokinin",
  "openfda_drugsfda": [
   "openfda.brand_name:ranquilon",
   "products.active_ingredients.name:tryptophan",
   "openfda.substance_name:\"GB-115\""
  ],
  "wada": "2026 Prohibited List (valid 2026-01-01) PDF text: no hit for cholecystokinin, GB-115, ranquilon, phenylhexanoyl, dipeptide"
 },
 "identity": {
  "pubchem_cid": 11281948,
  "cas": "678996-63-9",
  "unii": "G5YT2F7SG8",
  "formula": "C25H30N4O3",
  "mw": 434.5,
  "inchikey": "ZBIQNIJICMOVKN-QFIPXVFZSA-N",
  "smiles": "C1=CC=C(C=C1)CCCCCC(=O)NCC(=O)N[C@@H](CC2=CNC3=CC=CC=C32)C(=O)N",
  "iupac": "N-[2-[[(2S)-1-amino-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-2-oxoethyl]-6-phenylhexanamide",
  "ru_inn_style": "амид N-(6-фенилгексаноил)глицил-L-триптофана"
 },
 "records": [
  {
   "id": "PMID:12910281",
   "pmid": "12910281",
   "doi": "10.1023/a:1024907207370",
   "title": "Pharmacogenetic study of anxiolytic effects of new cholecystokinin receptor antagonists in animals with different levels of emotionality.",
   "year": 2003,
   "journal": "Bulletin of experimental biology and medicine",
   "lang": "ru",
   "first_author": "Kolik LG",
   "n_authors": 3,
   "in_pubmed": true,
   "study_type": "behavioural pharmacology (inbred strains, rats)",
   "species": "mouse, rat",
   "n_participants": null,
   "affiliation": "Institute of Pharmacology RAMS (Zakusov)",
   "affiliation_source": "pubmed",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:17886432",
   "pmid": "17886432",
   "doi": "10.1134/s1068162007040036",
   "title": "[Design and synthesis of cholecystokinin-4 dipeptide analogues with anxiolytic and anxiogenic activities].",
   "year": 2007,
   "journal": "Bioorganicheskaia khimiia",
   "lang": "ru",
   "first_author": "Gudasheva TA",
   "n_authors": 5,
   "in_pubmed": true,
   "study_type": "design/synthesis + SAR + in vivo screen",
   "species": "rat",
   "n_participants": null,
   "affiliation": "Zakusov Institute (inferred: Gudasheva, Kolik, Seredenin)",
   "affiliation_source": "inferred_from_authors (PubMed gives no affiliation)",
   "duplicate_of": null,
   "note": " Full text read (v1.3).",
   "evidence_type": "C",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:17523442",
   "pmid": "17523442",
   "doi": null,
   "title": "[Manifestations of the antinociceptive and anxiolytic properties of the compound GB-115: interactions of cholecystokinin and opioid systems].",
   "year": 2007,
   "journal": "Eksperimental'naia i klinicheskaia farmakologiia",
   "lang": "ru",
   "first_author": "Kolik LG",
   "n_authors": 3,
   "in_pubmed": true,
   "study_type": "behavioural pharmacology (nociception/anxiety, CCK interaction)",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute (inferred: Kolik, Seredenin)",
   "affiliation_source": "inferred_from_authors (PubMed gives no affiliation)",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:18239806",
   "pmid": "18239806",
   "doi": "10.1007/s10517-007-0219-3",
   "title": "Effect of compound GB-115 on morphine-induced analgesia.",
   "year": 2007,
   "journal": "Bulletin of experimental biology and medicine",
   "lang": "ru",
   "first_author": "Kolik LG",
   "n_authors": 3,
   "in_pubmed": true,
   "study_type": "pharmacology (morphine analgesia)",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute, Dept Pharmacogenetics",
   "affiliation_source": "pubmed",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:18457023",
   "pmid": "18457023",
   "doi": "10.1007/s10517-007-0319-0",
   "title": "Experimental study of the pharmacokinetics of a tryptophan-containing dipeptide GB-115.",
   "year": 2007,
   "journal": "Bulletin of experimental biology and medicine",
   "lang": "ru",
   "first_author": "Boyko SS",
   "n_authors": 6,
   "in_pubmed": true,
   "study_type": "pharmacokinetics",
   "species": "rat",
   "n_participants": null,
   "affiliation": "Zakusov Institute",
   "affiliation_source": "pubmed",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:19145294",
   "pmid": "19145294",
   "doi": "10.1007/s10517-008-0153-z",
   "title": "Immunocorrecting properties of GB-115 dipeptide.",
   "year": 2008,
   "journal": "Bulletin of experimental biology and medicine",
   "lang": "ru",
   "first_author": "Shipaeva EV",
   "n_authors": 7,
   "in_pubmed": true,
   "study_type": "immunopharmacology",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute",
   "affiliation_source": "pubmed",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:20726348",
   "pmid": "20726348",
   "doi": null,
   "title": "[Preclinical safety investigation of GB-115 dipeptide].",
   "year": 2010,
   "journal": "Eksperimental'naia i klinicheskaia farmakologiia",
   "lang": "ru",
   "first_author": "Sorokina AV",
   "n_authors": 14,
   "in_pubmed": true,
   "study_type": "preclinical toxicology (acute, 6-month, genotox, reprotox)",
   "species": "mouse, rat, rabbit",
   "n_participants": null,
   "affiliation": "Zakusov Institute (inferred: Kolik, Durnev, Seredenin)",
   "affiliation_source": "inferred_from_authors (PubMed gives no affiliation)",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:21476266",
   "pmid": "21476266",
   "doi": null,
   "title": "[Experimental study of antidepressant effects of GB-115 dipeptide].",
   "year": 2011,
   "journal": "Eksperimental'naia i klinicheskaia farmakologiia",
   "lang": "ru",
   "first_author": "Kolik LG",
   "n_authors": 1,
   "in_pubmed": true,
   "study_type": "behavioural pharmacology (antidepressant-like)",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute (inferred: Kolik)",
   "affiliation_source": "inferred_from_authors (PubMed gives no affiliation)",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:21899085",
   "pmid": "21899085",
   "doi": null,
   "title": "[Strategy for the development of dipeptide drugs].",
   "year": 2011,
   "journal": "Vestnik Rossiiskoi akademii meditsinskikh nauk",
   "lang": "ru",
   "first_author": "Gudasheva TA",
   "n_authors": 1,
   "in_pubmed": true,
   "study_type": "narrative review of dipeptide drug design",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute (inferred: Gudasheva)",
   "affiliation_source": "inferred_from_authors (PubMed gives no affiliation)",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "R",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:21899090",
   "pmid": "21899090",
   "doi": null,
   "title": "[The absence of tolerance and withdrawal syndrome after the treatment with the new L-tryptophane-containing dipeptide anxiolytic GB-115].",
   "year": 2011,
   "journal": "Vestnik Rossiiskoi akademii meditsinskikh nauk",
   "lang": "ru",
   "first_author": "Kolik LG",
   "n_authors": 10,
   "in_pubmed": true,
   "study_type": "behavioural pharmacology (tolerance/withdrawal vs diazepam)",
   "species": "rat",
   "n_participants": null,
   "affiliation": "Zakusov Institute (inferred: Kolik, Gudasheva, Seredenin)",
   "affiliation_source": "inferred_from_authors (PubMed gives no affiliation)",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:22235394",
   "pmid": "22235394",
   "doi": "10.1007/s10517-011-1200-8",
   "title": "Study of anti-inflammatory effects of GB-115, a glycine-containing retropeptide cholecystokinin analog.",
   "year": 2011,
   "journal": "Bulletin of experimental biology and medicine",
   "lang": "ru",
   "first_author": "Shipaeva EV",
   "n_authors": 9,
   "in_pubmed": true,
   "study_type": "pharmacology (anti-inflammatory)",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute",
   "affiliation_source": "pubmed",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:22238979",
   "pmid": "22238979",
   "doi": null,
   "title": "[Effect of GB-115 dipeptide on anxiety in rats with model benzodiazepine withdrawal syndrome].",
   "year": 2011,
   "journal": "Eksperimental'naia i klinicheskaia farmakologiia",
   "lang": "ru",
   "first_author": "Kolik LG",
   "n_authors": 5,
   "in_pubmed": true,
   "study_type": "behavioural pharmacology (benzodiazepine-withdrawal anxiety model)",
   "species": "rat",
   "n_participants": null,
   "affiliation": "Zakusov Institute (inferred: Kolik, Gudasheva, Seredenin)",
   "affiliation_source": "inferred_from_authors (PubMed gives no affiliation)",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:22977846",
   "pmid": "22977846",
   "doi": "10.1007/s10517-012-1742-4",
   "title": "Experimental study of antinociceptive potency of dipeptide GB-115 during chemical and thermal stimulation.",
   "year": 2012,
   "journal": "Bulletin of experimental biology and medicine",
   "lang": "ru",
   "first_author": "Kolik LG",
   "n_authors": 4,
   "in_pubmed": true,
   "study_type": "pharmacology (antinociception)",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute",
   "affiliation_source": "pubmed",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
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  {
   "id": "PMID:23113301",
   "pmid": "23113301",
   "doi": "10.1007/s10517-012-1842-1",
   "title": "Role of the cholecystokinin system in anxiolytic activity of dipeptide GB-115.",
   "year": 2012,
   "journal": "Bulletin of experimental biology and medicine",
   "lang": "ru",
   "first_author": "Kolik LG",
   "n_authors": 3,
   "in_pubmed": true,
   "study_type": "behavioural pharmacology (mechanism: CCK system)",
   "species": "rat, mouse",
   "n_participants": null,
   "affiliation": "Zakusov Institute",
   "affiliation_source": "pubmed",
   "duplicate_of": null,
   "note": " Full text read (v1.3).",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:24130989",
   "pmid": "24130989",
   "doi": "10.1007/s10517-013-2112-6",
   "title": "Anxiolytic activity of dipeptide GB-115 after oral administration.",
   "year": 2013,
   "journal": "Bulletin of experimental biology and medicine",
   "lang": "ru",
   "first_author": "Kolik LG",
   "n_authors": 6,
   "in_pubmed": true,
   "study_type": "behavioural pharmacology (oral anxiolytic activity)",
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   "affiliation": "Zakusov Institute",
   "affiliation_source": "pubmed",
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  {
   "id": "PMID:24397028",
   "pmid": "24397028",
   "doi": "10.1134/s1068162013030060",
   "title": "[The study of biologically active conformation of cholecystokinin-4 dipeptide analog GB-115].",
   "year": 2013,
   "journal": "Bioorganicheskaia khimiia",
   "lang": "ru",
   "first_author": "Gudasheva TA",
   "n_authors": 6,
   "in_pubmed": true,
   "study_type": "NMR conformational analysis + SAR + in vivo screen",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute (inferred: Gudasheva, Kolik, Seredenin)",
   "affiliation_source": "inferred_from_authors (PubMed gives no affiliation)",
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   "note": "",
   "evidence_type": "C",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:25322652",
   "pmid": "25322652",
   "doi": null,
   "title": "[Pharmacokinetics of three peroral dosage forms of new dipeptide anxiolytic drug GB-115].",
   "year": 2014,
   "journal": "Eksperimental'naia i klinicheskaia farmakologiia",
   "lang": "ru",
   "first_author": "Ivannikova EV",
   "n_authors": 7,
   "in_pubmed": true,
   "study_type": "pharmacokinetics / formulation bioequivalence (species not stated in abstract)",
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   "n_participants": null,
   "affiliation": "Zakusov Institute (abstract: developed at Institute of Pharmacology RAMS)",
   "affiliation_source": "inferred_from_authors (PubMed gives no affiliation)",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:27017703",
   "pmid": "27017703",
   "doi": null,
   "title": "[EXPERIMENTAL PHARMACOKINETICS AND PHARMACODYNAMICS OF GB-115 DIPEPTIDE ANXIOLYTIC SUBSTANCES].",
   "year": 2015,
   "journal": "Eksperimental'naia i klinicheskaia farmakologiia",
   "lang": "ru",
   "first_author": "Kolik LG",
   "n_authors": 8,
   "in_pubmed": true,
   "study_type": "pharmacokinetics + behavioural pharmacology (micronized vs crystalline)",
   "species": "rat",
   "n_participants": null,
   "affiliation": "Zakusov Institute (inferred: Kolik, Zherdev, Gudasheva, Seredenin)",
   "affiliation_source": "inferred_from_authors (PubMed gives no affiliation)",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:27590755",
   "pmid": "27590755",
   "doi": "10.1007/s10517-016-3449-4",
   "title": "Pharmacological Correction of Alcohol Motivation Depends on the Phenotype of the Response to Emotional Stress.",
   "year": 2016,
   "journal": "Bulletin of experimental biology and medicine",
   "lang": "ru",
   "first_author": "Kolik LG",
   "n_authors": 4,
   "in_pubmed": true,
   "study_type": "behavioural pharmacology (alcohol motivation)",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute",
   "affiliation_source": "pubmed",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:30295186",
   "pmid": "30295186",
   "doi": "10.2174/1381612824666181008105641",
   "title": "Novel Technologies for Dipeptide Drugs Design and their Implantation.",
   "year": 2018,
   "journal": "Current pharmaceutical design",
   "lang": "ru",
   "first_author": "Gudasheva TA",
   "n_authors": 3,
   "in_pubmed": true,
   "study_type": "narrative review of the Zakusov dipeptide programme",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute",
   "affiliation_source": "pubmed",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "R",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:31626171",
   "pmid": "31626171",
   "doi": "10.17116/jnevro201911908153",
   "title": "[Results of a clinical study of a new anxiolytic, a blocker of central cholecystokinin receptors].",
   "year": 2019,
   "journal": "Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova",
   "lang": "ru",
   "first_author": "Neznamov GG",
   "n_authors": 8,
   "in_pubmed": true,
   "study_type": "open-label, single-arm pilot, GAD, n=31, 21 days",
   "species": null,
   "n_participants": 31,
   "affiliation": "Zakusov Institute (PubMed lists only this)",
   "affiliation_source": "pubmed",
   "duplicate_of": null,
   "note": "Full text read (v1.3): open phase IIa pilot, dose-finding stage; 31 enrolled, 1 withdrew, 25 analysed at selected level (same 25 as Eur Psychiatry 2022 abstracts); permit No. 616 of 2016-08-31; no COI declared.",
   "evidence_type": "H",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:37582869",
   "pmid": "37582869",
   "doi": "10.1134/S1607672923700175",
   "title": "The Effect of the Agonist Cholecystokinin-4 D-GB-115 On the Character of Motor Activity of Paramecium caudatum.",
   "year": 2023,
   "journal": "Doklady. Biochemistry and biophysics",
   "lang": "en",
   "first_author": "Gruzdev GA",
   "n_authors": 3,
   "in_pubmed": true,
   "study_type": "non-mammalian organism (Paramecium caudatum); compound is D-GB-115 (D-Trp enantiomer), not GB-115",
   "species": null,
   "n_participants": null,
   "affiliation": "Moscow State University",
   "affiliation_source": "pubmed",
   "duplicate_of": null,
   "note": "IDENTITY: D-GB-115 is the D-tryptophan enantiomer designated an anxiogenic CCK-4 agonist in the original SAR paper (PMID 17886432). Not evidence about GB-115 (L-form).",
   "evidence_type": "O",
   "origin": "I",
   "compound": "D"
  },
  {
   "id": "PMID:39847298",
   "pmid": "39847298",
   "doi": "10.1134/S1607672924701254",
   "title": "Influence of Retrodipeptide Analogue of Cholecystokinin Tetrapeptide (GB-115) and Phenazepam on the Behavior of Rhesus Monkeys under Isolation Conditions.",
   "year": 2025,
   "journal": "Doklady. Biochemistry and biophysics",
   "lang": "en",
   "first_author": "Panchenko AV",
   "n_authors": 7,
   "in_pubmed": true,
   "study_type": "behavioural + endocrine (cortisol/DHEA-S), rhesus, n=4",
   "species": "rhesus macaque (n=4)",
   "n_participants": null,
   "affiliation": "FRC OPBPT (ex-Zakusov) + Kurchatov Complex of Medical Primatology (Sochi) + Petrov Oncology Centre",
   "affiliation_source": "pubmed",
   "duplicate_of": null,
   "note": "Senior authors Kolik, Seredenin (originators). Same dataset as Mol Med 2023 (Russian).",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMID:42565399",
   "pmid": "42565399",
   "doi": "10.17116/jnevro202612607151",
   "title": "[Comparative study of the efficacy and safety of Ranquilon and Afobazol in the treatment of patients with anxiety associated with neurasthenia and adjustment disorders. (Results of an open, randomized, multicenter, phase IV clinical study)].",
   "year": 2026,
   "journal": "Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova",
   "lang": "ru",
   "first_author": "Karavayeva TA",
   "n_authors": 5,
   "in_pubmed": true,
   "study_type": "randomised comparative vs fabomotizole, n=200, 28 days (probably NCT06843044, phase IV)",
   "species": null,
   "n_participants": 200,
   "affiliation": "Institute of Integrative Family Therapy + JSC Valenta Pharm + Petrov Oncology Centre",
   "affiliation_source": "pubmed",
   "duplicate_of": null,
   "note": "Sponsor employees among authors. Link to NCT06843044 inferred from arms/duration; enrolment differs (200 vs 250 estimated). v1.3: publisher page (abstract + references) read; cites NCT06843044 and CSR dated 2025-09-30; full text not obtained.",
   "evidence_type": "H",
   "origin": "V",
   "compound": "L"
  },
  {
   "id": "PMC9564032",
   "pmid": null,
   "doi": "10.1192/j.eurpsy.2022.981",
   "title": "Clinical effects of central antagonist of cholecystokinin-1 receptors GB-115 in patients with Generalized Anxiety Disorder",
   "year": 2022,
   "journal": "Eur Psychiatry 65(S1):S388",
   "lang": "en",
   "first_author": "Dorofeeva",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "conference abstract, post-hoc of open pilot, n=25",
   "species": null,
   "n_participants": 25,
   "affiliation": "Zakusov Institute, Dept Pharmacological Genetics",
   "affiliation_source": "full text read",
   "duplicate_of": null,
   "note": "CC BY 4.0 (PMC OA). Not in PubMed index.",
   "evidence_type": "H",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PMC9563656",
   "pmid": null,
   "doi": "10.1192/j.eurpsy.2022.490",
   "title": "Impact of central antagonist of cholecystokinin-1 receptors GB-115 on cognitive functions in patients with Generalized Anxiety Disorder",
   "year": 2022,
   "journal": "Eur Psychiatry 65(S1):S186",
   "lang": "en",
   "first_author": "Dorofeeva",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "conference abstract, uncontrolled, n=25",
   "species": null,
   "n_participants": 25,
   "affiliation": "Zakusov Institute + Lomonosov MSU (co-author)",
   "affiliation_source": "full text read",
   "duplicate_of": null,
   "note": "CC BY 4.0 (PMC OA).",
   "evidence_type": "H",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "DOI:10.29296/24999490-2023-06-03",
   "pmid": null,
   "doi": "10.29296/24999490-2023-06-03",
   "title": "Влияние дипептидного ретро-аналога тетрапептида холецистокинина (ГБ-115) на поведение макак-резус в условиях изоляции",
   "year": 2023,
   "journal": "Molekulyarnaya meditsina 21(6)",
   "lang": "ru",
   "first_author": "Panchenko A.V.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "behavioural + endocrine, rhesus n=4 (Russian version; likely same dataset as PMID 39847298)",
   "species": null,
   "n_participants": null,
   "affiliation": "Medical Primatology Research Institute (Sochi) + Zakusov Institute",
   "affiliation_source": "full text read",
   "duplicate_of": "PMID:39847298",
   "note": "DUPLICATE_OF PMID:39847298 (count once)"
  },
  {
   "id": "DOI:ZherdevKolik2015",
   "pmid": null,
   "doi": null,
   "title": "Доклиническое изучение фармакокинетики нового анксиолитика дипептидной структуры ГБ-115",
   "year": 2015,
   "journal": "Farmakokinetika i Farmakodinamika",
   "lang": "ru",
   "first_author": "Zherdev V.P.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "preclinical PK (review-like synthesis of Zakusov PK data)",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute",
   "affiliation_source": "full text read",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "DOI:Konstantinopolsky2016",
   "pmid": null,
   "doi": null,
   "title": "Экспериментальная оценка влияния ладастена и ГБ-115 на развитие толерантности к анальгетическому действию морфина",
   "year": 2016,
   "journal": "Farmakokinetika i Farmakodinamika",
   "lang": "ru",
   "first_author": "Konstantinopolsky M.A.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "behavioural pharmacology (morphine tolerance)",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute",
   "affiliation_source": "full text read",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "DOI:Raskin2017",
   "pmid": null,
   "doi": null,
   "title": "Фармакокинетика дипептидного анксиолитика ГБ-115 после перорального введения у различных видов животных и человека",
   "year": 2017,
   "journal": "Farmakokinetika i Farmakodinamika",
   "lang": "ru",
   "first_author": "Raskin S.Yu.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "PK in rat, rabbit, healthy volunteers (cross-species)",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute + Sechenov Univ + Institute of Immunology FMBA + Maluna-Farm",
   "affiliation_source": "full text read",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "H",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "DOI:Kolik2017",
   "pmid": null,
   "doi": null,
   "title": "Дипептидный аналог холецистокинина-4 ослабляет тревожную реакцию у «высокоэмоциональных» мышей BALB/c и при моделировании алкогольной абстиненции",
   "year": 2017,
   "journal": "Farmakokinetika i Farmakodinamika",
   "lang": "ru",
   "first_author": "Kolik L.G.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "behavioural pharmacology (BALB/c, alcohol withdrawal model)",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute",
   "affiliation_source": "full text read",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "DOI:Zherdev2017",
   "pmid": null,
   "doi": null,
   "title": "Клиническая фармакокинетика оригинального дипептидного анксиолитика ГБ-115",
   "year": 2017,
   "journal": "Farmakokinetika i Farmakodinamika",
   "lang": "ru",
   "first_author": "Zherdev V.P.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "phase I, healthy volunteers, single ascending doses (PK)",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute + Sechenov Univ + Maluna-Farm",
   "affiliation_source": "full text read",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "H",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "DOI:10.37489/2587-7836-2019-4-37-44",
   "pmid": null,
   "doi": "10.37489/2587-7836-2019-4-37-44",
   "title": "Исследование хронической токсичности готовой лекарственной формы ГБ-115",
   "year": 2019,
   "journal": "Farmakokinetika i Farmakodinamika",
   "lang": "ru",
   "first_author": "Sorokina A.V.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "chronic toxicity of finished dosage form",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute",
   "affiliation_source": "full text read",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "DOI:ClinPharmTher2023-1",
   "pmid": null,
   "doi": null,
   "title": "Оценка фармакокинетики, безопасности и переносимости препарата Ранквилон® у здоровых добровольцев: результаты клинического исследования I фазы",
   "year": 2023,
   "journal": "Klinicheskaya farmakologiya i terapiya 32(1):49-55",
   "lang": "ru",
   "first_author": "Dorofeeva O.A.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "phase I, open, randomised 3-period crossover, food effect, n=26 healthy (Minzdrav permit No 623, 11-10-2021)",
   "species": null,
   "n_participants": 26,
   "affiliation": "Zakusov Institute + CRO (Eco-Bezopasnost, Sechenov-linked sites) + Valenta Pharm",
   "affiliation_source": "full text read",
   "duplicate_of": null,
   "note": "Sponsor: Valenta Pharm (authors are employees). Not registered on ClinicalTrials.gov.",
   "evidence_type": "H",
   "origin": "ZV",
   "compound": "L"
  },
  {
   "id": "DOI:ClinPharmTher2023-4",
   "pmid": null,
   "doi": null,
   "title": "Оптимальный режим дозирования препарата Ранквилон® ... клиническое исследование II фазы",
   "year": 2023,
   "journal": "Klinicheskaya farmakologiya i terapiya 32(4):36-40",
   "lang": "ru",
   "first_author": "Goncharov O.V.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "phase II, double-blind, placebo-controlled, 4 arms, n=168, 4 weeks (Minzdrav permit No 208, 15-04-2021)",
   "species": null,
   "n_participants": 168,
   "affiliation": "Multi-site Russian clinics + Valenta Pharm (authors employees)",
   "affiliation_source": "full text read",
   "duplicate_of": null,
   "note": "Not on ClinicalTrials.gov. Primary endpoint CGI-I responders day 29; one active arm separated from placebo (p=0.0148); placebo response 28.6%.",
   "evidence_type": "H",
   "origin": "V",
   "compound": "L"
  },
  {
   "id": "DOI:10.31363/2313-7053-2024-1047",
   "pmid": null,
   "doi": "10.31363/2313-7053-2024-1047",
   "title": "Эффективность и безопасность препарата Ранквилон® в терапии пациентов с тревожными состояниями при неврастении и расстройстве адаптации: фаза III",
   "year": 2024,
   "journal": "Obozrenie psikhiatrii i meditsinskoi psikhologii im. Bekhtereva 58(4-2):78-99",
   "lang": "ru",
   "first_author": "Karavaeva T.A.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "phase III, double-blind, placebo-controlled, multicentre, n=220, 28 days (NCT05586789)",
   "species": null,
   "n_participants": 220,
   "affiliation": "Bekhterev NMRC + Petrov + Pavlov Univ + Medsi + FRC OPBPT (Kolik) + Valenta Pharm",
   "affiliation_source": "full text read",
   "duplicate_of": null,
   "note": "Paper states sponsorship by Valenta Pharm; two authors are journal editors (declared). Primary: HARS>=50% responders 70.0% vs 24.5% (p<0.0001). AEs 25.5% vs 14.6% of patients (p=0.063); no serious AEs.",
   "evidence_type": "H",
   "origin": "ZV",
   "compound": "L"
  },
  {
   "id": "DOI:10.37489/2587-7836-2025-4-96-104",
   "pmid": null,
   "doi": "10.37489/2587-7836-2025-4-96-104",
   "title": "Сравнительная оценка фармакокинетики и безопасности двух дозировок препарата Ранквилон® в исследовании биоэквивалентности",
   "year": 2025,
   "journal": "Farmakokinetika i Farmakodinamika",
   "lang": "ru",
   "first_author": "Vasilyuk V.B.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "bioequivalence, 2-period crossover, n=36 healthy",
   "species": null,
   "n_participants": 36,
   "affiliation": "CRO Eco-Bezopasnost + Valenta Pharm",
   "affiliation_source": "full text read",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "H",
   "origin": "V",
   "compound": "L"
  },
  {
   "id": "DOI:Ivannikova2013",
   "pmid": null,
   "doi": null,
   "title": "Исследование фармакокинетики и биодоступности в создании новых оригинальных лекарственных средств пептидной структуры",
   "year": 2013,
   "journal": "Farmakokinetika i Farmakodinamika",
   "lang": "ru",
   "first_author": "Ivannikova E.V.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "review (GB-115 is one of the examples; 8 mentions)",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute",
   "affiliation_source": "full text read",
   "duplicate_of": null,
   "note": "peripheral",
   "evidence_type": "R",
   "origin": "Z",
   "compound": "M"
  },
  {
   "id": "DOI:10.24411/2587-7836-2019-10037",
   "pmid": null,
   "doi": "10.24411/2587-7836-2019-10037",
   "title": "Изучение особенностей проницаемости ГЭБ для новых нейротропных пептидных лекарственных препаратов",
   "year": 2019,
   "journal": "Farmakokinetika i Farmakodinamika",
   "lang": "ru",
   "first_author": "Zherdev V.P.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "review/experimental (BBB; GB-115 14 mentions)",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute",
   "affiliation_source": "full text read",
   "duplicate_of": null,
   "note": "peripheral",
   "evidence_type": "R",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "DOI:10.24411/2587-7836-2018-10001",
   "pmid": null,
   "doi": "10.24411/2587-7836-2018-10001",
   "title": "Роль исследований межвидовых особенностей фармакокинетики в создании новых пептидных лекарственных средств",
   "year": 2018,
   "journal": "Farmakokinetika i Farmakodinamika",
   "lang": "ru",
   "first_author": "Zherdev V.P.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "review (GB-115 61 mentions)",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute",
   "affiliation_source": "full text read",
   "duplicate_of": null,
   "note": "peripheral; cites rat/rabbit/human PK of GB-115",
   "evidence_type": "R",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "DOI:10.37489/2587-7836-2023-3-19-27",
   "pmid": null,
   "doi": "10.37489/2587-7836-2023-3-19-27",
   "title": "Сопоставление приёмов расчёта фармакокинетических параметров в исследованиях с дизайном «животное-точка»",
   "year": 2023,
   "journal": "Farmakokinetika i Farmakodinamika",
   "lang": "ru",
   "first_author": "Kosman V.M.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "methodology paper; GB-115 used as an example (4 mentions)",
   "species": null,
   "n_participants": null,
   "affiliation": "NPO Dom Farmatsii (Leningrad Oblast)",
   "affiliation_source": "full text read",
   "duplicate_of": null,
   "note": "peripheral; excluded from empirical denominators",
   "evidence_type": "R",
   "origin": "I",
   "compound": "M"
  },
  {
   "id": "DOI:Alekseev2014",
   "pmid": null,
   "doi": null,
   "title": "Создание и фармакологическое исследование пеллет с ГБ-115 анксиолитического действия",
   "year": 2014,
   "journal": "Fundamental Research 12(5)",
   "lang": "ru",
   "first_author": "Alekseev K.V.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "pharmaceutics + behavioural pharmacology (pellets, rats n=530)",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute / Experimental technology dept",
   "affiliation_source": "full text read",
   "duplicate_of": null,
   "note": "Journal listing; page numbers not captured. OA.",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "ELIB:63621640",
   "pmid": null,
   "doi": null,
   "title": "Доклиническая разработка дипептидного анксиолитика Ранквилон, сконструированного на основе эндогенного тетрапептида холецистокинина",
   "year": 2023,
   "journal": "Eksp Klin Farmakol 86(11S):76b",
   "lang": "ru",
   "first_author": "Kolik L.G.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "congress abstract (Russian pharmacology congress), review of preclinical programme",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov lineage (Kolik, Gudasheva, Seredenin)",
   "affiliation_source": "eLibrary/Scholar listing",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "K",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "SCHOLAR:Zherdev2016",
   "pmid": null,
   "doi": null,
   "title": "Фармакокинетика и фармакодинамика фармацевтических композиций дипептидного анксиолитика ГБ-115",
   "year": 2016,
   "journal": "Khimiko-Farmatsevticheskii Zhurnal",
   "lang": "ru",
   "first_author": "Zherdev V.P.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "PK/PD of formulations",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute",
   "affiliation_source": "eLibrary/Scholar listing",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "A",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "SCHOLAR:Klumova2011",
   "pmid": null,
   "doi": null,
   "title": "Разработка методик анализа твердой дозированной лекарственной формы ГБ-115",
   "year": 2011,
   "journal": "Khimiko-Farmatsevticheskii Zhurnal",
   "lang": "ru",
   "first_author": "Klumova V.S.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "analytical methods (dosage form)",
   "species": null,
   "n_participants": null,
   "affiliation": "Sechenov Univ / Zakusov (Klumova, Grushevskaya)",
   "affiliation_source": "eLibrary/Scholar listing",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "C",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "SCHOLAR:Klumova2012",
   "pmid": null,
   "doi": null,
   "title": "Developing analytical techniques for GB-115 determination in solid dosage form (tablets)",
   "year": 2012,
   "journal": "Pharmaceutical Chemistry Journal (Springer)",
   "lang": "ru",
   "first_author": "Klumova V.S.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "analytical methods (tablets)",
   "species": null,
   "n_participants": null,
   "affiliation": "Sechenov Univ / Zakusov",
   "affiliation_source": "eLibrary/Scholar listing",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "C",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "SCHOLAR:Ivannikova2014",
   "pmid": null,
   "doi": null,
   "title": "Методика количественного определения ГБ-115 в биоматериале с использованием ВЭЖХ",
   "year": 2014,
   "journal": "Khimiko-Farmatsevticheskii Zhurnal",
   "lang": "ru",
   "first_author": "Ivannikova E.V.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "bioanalytical HPLC method",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute",
   "affiliation_source": "eLibrary/Scholar listing",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "C",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "SCHOLAR:Gudasheva2015",
   "pmid": null,
   "doi": null,
   "title": "Theoretical grounds and technologies for dipeptide drug development",
   "year": 2015,
   "journal": "Russian Chemical Bulletin (Springer)",
   "lang": "ru",
   "first_author": "Gudasheva T.A.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "review",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute",
   "affiliation_source": "eLibrary/Scholar listing",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "R",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "SCHOLAR:Kolik2011ECNP",
   "pmid": null,
   "doi": "10.1016/s0924-977x(11)70177-8",
   "title": "P.4.004 Dipeptide anxiolytic GB-115: new receptor targets",
   "year": 2011,
   "journal": "Eur Neuropsychopharmacol (ECNP abstract)",
   "lang": "ru",
   "first_author": "Kolik L.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "congress abstract (mechanism)",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute",
   "affiliation_source": "eLibrary/Scholar listing",
   "duplicate_of": null,
   "note": "Full abstract read (v1.3): 45-receptor binding/functional screen; CCK1 Ki 6.1e-5 M, KOP Ki 1.0e-5 M, BB3 Ki 9.7e-6 M; no CCK2 affinity. DOI 10.1016/s0924-977x(11)70177-8.",
   "evidence_type": "K",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "ELIB:23152784",
   "pmid": null,
   "doi": null,
   "title": "Синтез замещённого дипептида ГБ-115, потенциального селективного анксиолитика",
   "year": null,
   "journal": "(eLibrary listing, details not captured)",
   "lang": "ru",
   "first_author": "?",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "synthesis",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov lineage (inferred)",
   "affiliation_source": "eLibrary listing (truncated)",
   "duplicate_of": null,
   "note": "Title seen in a truncated eLibrary listing before CAPTCHA; verify.",
   "evidence_type": "C",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PATENT:RU2227144",
   "pmid": null,
   "doi": null,
   "title": "Substituted tryptophan-containing dipeptides with cholecystokinin-negative or -positive activity",
   "year": 2004,
   "journal": "Rospatent / Espacenet",
   "lang": "en",
   "first_author": "Seredenin S.B.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "patent",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute (inventors Seredenin, Gudasheva, Kolik...)",
   "affiliation_source": "Europe PMC listing",
   "duplicate_of": null,
   "note": "Listed by Europe PMC (source PAT).",
   "evidence_type": "P",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PATENT:RU2429874",
   "pmid": null,
   "doi": null,
   "title": "Analgesic agent for visceral pain management",
   "year": 2011,
   "journal": "Rospatent / Espacenet",
   "lang": "en",
   "first_author": "Seredenin S.B.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "patent",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute (inventors Seredenin, Gudasheva, Kolik...)",
   "affiliation_source": "Europe PMC listing",
   "duplicate_of": null,
   "note": "Listed by Europe PMC (source PAT).",
   "evidence_type": "P",
   "origin": "Z",
   "compound": "L"
  },
  {
   "id": "PATENT:Neznamov2019",
   "pmid": null,
   "doi": null,
   "title": "Применение амида N-(6-фенилгексаноил)глицил-L-триптофана (ГБ-115) в качестве средства, обладающего анксиолитическим ... действием",
   "year": 2019,
   "journal": "Patent (Rospatent) per Google Scholar",
   "lang": "ru",
   "first_author": "Neznamov G.G.",
   "n_authors": null,
   "in_pubmed": false,
   "study_type": "use patent (anxiolytic indication)",
   "species": null,
   "n_participants": null,
   "affiliation": "Zakusov Institute (Neznamov, Seredenin, Dorofeeva)",
   "affiliation_source": "Scholar listing; number not captured",
   "duplicate_of": null,
   "note": "",
   "evidence_type": "P",
   "origin": "Z",
   "compound": "L"
  }
 ],
 "human_studies": [
  {
   "key": "pilot",
   "label": "Open pilot in GAD",
   "year_run": "after permit No. 616 of 2016-08-31",
   "phase": "IIa pilot (per the article)",
   "population": "Adults with generalised anxiety disorder (ICD-10 F41.1), aged 22-53, one Moscow psychiatric hospital",
   "design": "open-label, single arm, no control group; protocol-defined dose-finding stage (successive cohorts of 5) before the remaining patients continued at the level selected",
   "n": 31,
   "n_note": "31 enrolled; 1 withdrew on day 5 (starting cohort); 5 analysed at the starting level; 25 analysed at the selected level (the 2022 abstracts use these 25)",
   "duration": "21 days",
   "blinding": "none",
   "control": "none",
   "registry": "Ministry of Health permit No. 616 of 2016-08-31; not on ClinicalTrials.gov",
   "endpoints": "HARS, symptom severity scale, Spielberger-Khanin, MFI-20, CGI, computerised cognitive battery",
   "result": "Full text reports mean HAM-A 22.2 to 6.3 and MFI-20 64.3 to 36.0 over 21 days (n=25, within-patient Wilcoxon tests, no control); CGI much or very much improved in 92% at day 21; authors list pilot nature, open design and small sample as limitations",
   "safety": "5 adverse events in 4 of 31 patients (12.9%), all mild except one blood-pressure rise; 3 judged possibly related",
   "sponsor": "Zakusov Institute (developers)",
   "origin": "Z",
   "publications": [
    "31626171",
    "PMC9564032",
    "PMC9563656"
   ],
   "access": "full text (publisher web version, OCR checked against page images); two CC BY congress abstracts"
  },
  {
   "key": "sad",
   "label": "Phase I, single ascending dose",
   "year_run": "2015-2016 (permit 21 Oct 2015)",
   "phase": "I",
   "population": "Healthy volunteers",
   "design": "open-label, five ascending single-dose cohorts of three",
   "n": 15,
   "n_note": "15 (five groups of 3); Raskin 2017 reanalyses 3 of the 15",
   "duration": "single administration",
   "blinding": "none",
   "control": "none",
   "registry": "Russian Ministry of Health permit No. 600 of 2015-10-21; not on ClinicalTrials.gov",
   "endpoints": "plasma pharmacokinetics (HPLC-MS)",
   "result": "Parent compound detected in all volunteers; exposure rose in proportion across the dose range studied (linear pharmacokinetics); short elimination half-life reported",
   "safety": "not the focus of the published articles",
   "sponsor": "Zakusov Institute with Maluna-Pharm JSC",
   "origin": "Z",
   "publications": [
    "DOI:Zherdev2017",
    "DOI:Raskin2017"
   ],
   "access": "full text (open access)"
  },
  {
   "key": "food",
   "label": "Phase I, food interaction",
   "year_run": "2021 (permit 11 Oct 2021)",
   "phase": "I",
   "population": "Healthy volunteers (36 screened)",
   "design": "open-label, randomised, three-period crossover",
   "n": 26,
   "n_note": "26 randomised, all completed",
   "duration": "single administration per period",
   "blinding": "none",
   "control": "within-subject crossover",
   "registry": "Ministry of Health permit No. 623 of 2021-10-11; not on ClinicalTrials.gov",
   "endpoints": "Cmax, AUC, Tmax under two prandial conditions",
   "result": "A food effect on systemic exposure of roughly a quarter (AUC); authors judge it minor",
   "safety": "one adverse event in one volunteer",
   "sponsor": "Valenta Pharm (authors employees), with a Zakusov co-author",
   "origin": "ZV",
   "publications": [
    "DOI:ClinPharmTher2023-1"
   ],
   "access": "full text (open access)"
  },
  {
   "key": "ph2",
   "label": "Phase II, dose-finding",
   "year_run": "2021-06-06 to 2022-01-03",
   "phase": "II",
   "population": "Adults with anxiety in neurasthenia (F48.0) or adjustment disorder (F43.2); GAD excluded",
   "design": "double-blind, randomised, placebo-controlled, four parallel arms (three dose levels and placebo), 8 centres",
   "n": 168,
   "n_note": "174 screened, 168 randomised (43/42/41/42), 3 withdrew",
   "duration": "28 days + 7-day follow-up",
   "blinding": "double",
   "control": "placebo",
   "registry": "Ministry of Health permit No. 208 of 2021-04-15; not on ClinicalTrials.gov",
   "endpoints": "Primary: share of patients much or very much improved on CGI-I at day 29",
   "result": "Authors report the primary endpoint met in the middle of the three active arms only: 57.1% vs 28.6% on placebo (p=0.0148); the other two arms reached 39.5% and 43.9% (not significant). No adjustment for three comparisons is described",
   "safety": "155 adverse events in 50 patients; patients with events 26-30% in active arms vs 35.7% on placebo; no serious events; one proteinuria case with unknown outcome",
   "sponsor": "Valenta Pharm",
   "origin": "V",
   "publications": [
    "DOI:ClinPharmTher2023-4"
   ],
   "access": "full text (open access)"
  },
  {
   "key": "ph3",
   "label": "Phase III, placebo-controlled",
   "year_run": "2022-10-12 to 2023-01-03 (registry)",
   "phase": "III",
   "population": "Adults 18-70 with anxiety in neurasthenia (F48.0) or adjustment disorder (F43.2), HARS 18-24, MFI-20 >50",
   "design": "double-blind, randomised, placebo-controlled, parallel, 10 centres in Russia",
   "n": 220,
   "n_note": "221 screened, 220 randomised (110/110), 219 completed",
   "duration": "28 days + follow-up to day 43",
   "blinding": "quadruple (registry)",
   "control": "placebo",
   "registry": "NCT05586789 (registered 2022-10-14, two days after the registered start); no results posted",
   "endpoints": "Primary: share with >=50% HARS reduction at day 29 (matches the registered primary outcome)",
   "result": "Authors report 70.0% (77/110) vs 24.5% (27/110), p<0.0001, and all secondary endpoints significant (p<0.05). ITT with LOCF",
   "safety": "patients with adverse events 25.5% vs 14.6% (p=0.063); all mild; no serious events or discontinuations for adverse events",
   "sponsor": "Valenta Pharm; co-author from the originating centre",
   "origin": "ZV",
   "publications": [
    "DOI:10.31363/2313-7053-2024-1047"
   ],
   "access": "full text (open access)"
  },
  {
   "key": "be",
   "label": "Bioequivalence of two product strengths",
   "year_run": "not stated in the abstract",
   "phase": "I (bioequivalence)",
   "population": "Healthy volunteers",
   "design": "open-label, randomised, two-period crossover",
   "n": 36,
   "n_note": "36 (two sequence groups of 18)",
   "duration": "single administration per period",
   "blinding": "none",
   "control": "reference tablet",
   "registry": "not on ClinicalTrials.gov",
   "endpoints": "Cmax, AUC; 90% CI within 80.00-125.00%",
   "result": "Two product strengths bioequivalent",
   "safety": "22 mild adverse events in 13 of 36 volunteers",
   "sponsor": "Valenta Pharm",
   "origin": "V",
   "publications": [
    "DOI:10.37489/2587-7836-2025-4-96-104"
   ],
   "access": "full text (open access)"
  },
  {
   "key": "ph4",
   "label": "Phase IV vs fabomotizole",
   "year_run": "registry start 2025-01-13",
   "phase": "IV",
   "population": "Adults with anxiety in neurasthenia or adjustment disorder (same entry criteria as phase III)",
   "design": "open-label, randomised, active comparator (fabomotizole, Afobazol), multicentre",
   "n": 200,
   "n_note": "200 randomised (100/100) per the abstract; registry: 250 estimated, still 'recruiting'; the article cites NCT06843044 and a clinical study report dated 2025-09-30 (protocol RAN-04-05-2024)",
   "duration": "28 days",
   "blinding": "none (open-label)",
   "control": "active (fabomotizole)",
   "registry": "NCT06843044 (registered 2025-02-17; status RECRUITING, last update 2025-07-02; no results posted)",
   "endpoints": "Primary: share with >=50% HARS reduction at day 29",
   "result": "Abstract reports 63.3% (n=62) vs 49.0% (n=49), p<0.043; response denominator 62/98 on Ranquilon and 49/100 on fabomotizole; adverse-event \"n=44\" fits no other figure (see text)",
   "safety": "patients with adverse events 16.0% vs 12.0% (p=0.415); all mild",
   "sponsor": "Valenta Pharm (employee among authors)",
   "origin": "V",
   "publications": [
    "42565399"
   ],
   "access": "abstract and reference list only (publisher web page; full text not obtained)"
  }
 ],
 "claims": [
  {
   "claim": "It was approved in Russia in 2022.",
   "verdict": "Contradicted",
   "evidence": "The Russian marketing authorisation LP-No(004206)-(RG-RU) is dated 29 December 2023; 2022 is the year the phase III trial ran.",
   "sources": [
    "vidal",
    "DOI:10.31363/2313-7053-2024-1047",
    "NCT05586789"
   ]
  },
  {
   "claim": "It is approved for generalised anxiety disorder.",
   "verdict": "Contradicted",
   "evidence": "The registered indication is anxiety states in neurasthenia and adjustment disorder. The only GAD data are an open, uncontrolled pilot of 31 patients (25 analysed at the selected level); the phase II and III trials excluded GAD.",
   "sources": [
    "vidal",
    "31626171",
    "DOI:ClinPharmTher2023-4"
   ]
  },
  {
   "claim": "It is a CCK-B (CCK2) antagonist.",
   "verdict": "Not supported by the binding data located",
   "evidence": "Early papers by the developers labelled it a CCK2 antagonist on the basis of design and behavioural pharmacology. Their 2011 binding screen of 45 receptors, published only as a congress abstract, reports weak micromolar affinity for CCK1, kappa-opioid and bombesin BB3 receptors and no affinity for CCK2; the Russian label says CCK1.",
   "sources": [
    "17886432",
    "23113301",
    "ecnp2011",
    "vidal"
   ]
  },
  {
   "claim": "It has a molecular weight of about 410 Da and crosses the blood-brain barrier easily.",
   "verdict": "Partly contradicted",
   "evidence": "Molecular weight is 434.5 g/mol (PubChem). Brain penetration has been reported in rats by the originating group; no human brain-exposure data exist.",
   "sources": [
    "pubchem",
    "DOI:10.24411/2587-7836-2019-10037"
   ]
  },
  {
   "claim": "It causes no tolerance and no withdrawal.",
   "verdict": "Animal data only",
   "evidence": "Shown in rats after 30 days of administration, compared with diazepam, by the originating group. Human trials lasted 28 days at most; no dependence, abuse-liability or discontinuation study in people was located.",
   "sources": [
    "21899090",
    "22238979"
   ]
  },
  {
   "claim": "It has no side effects and replaces benzodiazepines.",
   "verdict": "Contradicted",
   "evidence": "The phase III report gives adverse events in 25.5% of patients on the drug and 14.6% on placebo (p=0.063); the Russian label lists adverse reactions including proteinuria and reversible loss of visual acuity. No human comparison with a benzodiazepine was located; the only one is in four rhesus monkeys.",
   "sources": [
    "DOI:10.31363/2313-7053-2024-1047",
    "vidal",
    "39847298"
   ]
  },
  {
   "claim": "It is a nootropic that improves cognition and fatigue.",
   "verdict": "Not shown",
   "evidence": "Attention and reaction time improved from baseline in the uncontrolled pilot (n=25) and fatigue scores fell in controlled trials, where fatigue was an entry criterion; no trial had a cognitive primary endpoint.",
   "sources": [
    "PMC9563656",
    "DOI:10.31363/2313-7053-2024-1047"
   ]
  },
  {
   "claim": "It helps depression, panic, social anxiety, ADHD or insomnia.",
   "verdict": "No human data",
   "evidence": "Antidepressant-like effects were reported in mice by the originating group; panic disorder and depression were exclusion criteria in the controlled trials. No study in ADHD, social anxiety or insomnia was located.",
   "sources": [
    "21476266",
    "DOI:ClinPharmTher2023-4"
   ]
  },
  {
   "claim": "It helps with opioid dependence.",
   "verdict": "No human data",
   "evidence": "Rat studies by the originating group report that it altered morphine analgesia and tolerance; no human study of opioid use or withdrawal was located.",
   "sources": [
    "18239806",
    "DOI:Konstantinopolsky2016"
   ]
  },
  {
   "claim": "Russian trials show it is effective and well tolerated.",
   "verdict": "Reported by the sponsor; not replicated",
   "evidence": "The sponsor-run phase II (n=168) and phase III (n=220) report meeting their primary endpoints and mild adverse events over 28 days; no trial by an unaffiliated group was located. This table records what the reports say; it is not an assessment of efficacy.",
   "sources": [
    "DOI:ClinPharmTher2023-4",
    "DOI:10.31363/2313-7053-2024-1047"
   ]
  },
  {
   "claim": "It works better than standard anxiolytics and antidepressants.",
   "verdict": "Not shown",
   "evidence": "The only active-comparator trial is open-label against fabomotizole (Afobazol), a drug used mainly in Russia; its abstract reports 63.3% vs 49.0% responders (p<0.043) and contains unresolved internal discrepancies. No comparison with an SSRI, SNRI, buspirone or benzodiazepine was located.",
   "sources": [
    "42565399"
   ]
  },
  {
   "claim": "Peptide-like molecules are always degraded before reaching plasma.",
   "verdict": "Contradicted",
   "evidence": "Pharmacokinetic studies report the parent compound in plasma in humans.",
   "sources": [
    "DOI:Zherdev2017",
    "DOI:ClinPharmTher2023-1"
   ]
  }
 ],
 "mechanism_labels": [
  {
   "year": 2003,
   "source": "12910281",
   "wording": "\"peptide antagonist of central cholecystokinin receptors\"",
   "target": "central (unspecified)"
  },
  {
   "year": 2007,
   "source": "17886432",
   "wording": "premise: CCK-4 binds \"CCK2-type receptors\"; receptor interaction \"presumed\"; rat behaviour only",
   "target": "CCK2 (design premise)"
  },
  {
   "year": 2007,
   "source": "17523442",
   "wording": "\"short peptide antagonist of CCK2-receptors\"",
   "target": "CCK2"
  },
  {
   "year": 2011,
   "source": "ecnp2011",
   "wording": "45-receptor screen: CCK1 Ki 61 µM, KOP Ki 10 µM, BB3 Ki 9.7 µM; \"no affinity to CCK2 receptors\" (congress abstract)",
   "target": "CCK1, KOP, BB3 (binding, micromolar)"
  },
  {
   "year": 2012,
   "source": "23113301",
   "wording": "CCK-4 type 2 receptor activation \"abolished the antianxiety effect\"; \"common pharmacological target\" with CCK-4",
   "target": "CCK2 (pharmacological inference)"
  },
  {
   "year": 2016,
   "source": "27590755",
   "wording": "\"cholecystokinin-4 analogue with antagonistic activity\"",
   "target": "unspecified"
  },
  {
   "year": 2019,
   "source": "31626171",
   "wording": "\"low-affinity blocker of central cholecystokinin receptors\"",
   "target": "central, low affinity"
  },
  {
   "year": 2022,
   "source": "PMC9564032",
   "wording": "\"central antagonist of cholecystokinin-1 receptors\"",
   "target": "CCK1"
  },
  {
   "year": 2023,
   "source": "vidal",
   "wording": "\"low-affinity blocker of type 1 cholecystokinin receptors (CCK1)\" (Russian label via Vidal; our translation)",
   "target": "CCK1, low affinity"
  },
  {
   "year": 2024,
   "source": "DOI:10.31363/2313-7053-2024-1047",
   "wording": "\"blocker of cholecystokinin receptors\"",
   "target": "unspecified"
  },
  {
   "year": 2025,
   "source": "39847298",
   "wording": "\"antagonistic properties in relation to CCK1 receptors\"",
   "target": "CCK1"
  }
 ],
 "timeline": [
  {
   "date": "2003",
   "event": "First PubMed record: anxioselective effects in inbred mice and rats",
   "source": "12910281"
  },
  {
   "date": "2004",
   "event": "Russian patent RU2227144 on tryptophan-containing dipeptides with CCK activity",
   "source": "PATENT:RU2227144"
  },
  {
   "date": "2007",
   "event": "Design and synthesis paper: L-Trp analogues anxiolytic, D-Trp analogues anxiogenic",
   "source": "17886432"
  },
  {
   "date": "2007",
   "event": "Rat pharmacokinetics: resistant to peptidases; absolute bioavailability 4.65% in rats",
   "source": "18457023"
  },
  {
   "date": "2010",
   "event": "Preclinical safety package (acute, 6-month, genotoxicity, reproduction)",
   "source": "20726348"
  },
  {
   "date": "2011",
   "event": "Rat study: no tolerance or withdrawal after 30 days, unlike diazepam",
   "source": "21899090"
  },
  {
   "date": "2013",
   "event": "NMR: biologically active conformation is a beta-II turn",
   "source": "24397028"
  },
  {
   "date": "2015",
   "event": "Phase I permit (No. 600, 21 Oct 2015); single ascending dose in 15 volunteers",
   "source": "DOI:Zherdev2017"
  },
  {
   "date": "2019",
   "event": "First clinical article: open pilot in 31 patients with GAD",
   "source": "31626171"
  },
  {
   "date": "2021",
   "event": "Phase II (Apr permit, Jun start) and phase I food-interaction study (Oct permit)",
   "source": "DOI:ClinPharmTher2023-4"
  },
  {
   "date": "2022",
   "event": "Phase III runs (registry: 12 Oct 2022 to 3 Jan 2023); NCT05586789 registered 14 Oct",
   "source": "NCT05586789"
  },
  {
   "date": "2023-12-29",
   "event": "Russian marketing authorisation LP-No(004206)-(RG-RU), holder Valenta Pharm",
   "source": "vidal"
  },
  {
   "date": "2024-08-23",
   "event": "Authorisation re-issued (pereoformlenie)",
   "source": "vidal"
  },
  {
   "date": "2024-12",
   "event": "Phase III published (Bekhterev Review)",
   "source": "DOI:10.31363/2313-7053-2024-1047"
  },
  {
   "date": "2025-01-13",
   "event": "Phase IV vs fabomotizole starts (NCT06843044)",
   "source": "NCT06843044"
  },
  {
   "date": "2025",
   "event": "Bioequivalence of two product strengths published (issue 4/2025)",
   "source": "DOI:10.37489/2587-7836-2025-4-96-104"
  },
  {
   "date": "2026-08",
   "event": "Phase IV results published; registry still shows 'recruiting'",
   "source": "42565399"
  },
  {
   "date": "2026-10-25",
   "event": "Cut-off of this dossier",
   "source": null
  }
 ],
 "regulatory": [
  {
   "jurisdiction": "Russia",
   "status": "Prescription-only medicine since 2023-12-29 (LP-No(004206)-(RG-RU)), re-issued 2024-08-23; holder Valenta Pharm JSC, manufacturer Dalkhimfarm JSC (Khabarovsk); ATC N05BX; indication: anxiety states in neurasthenia and adjustment disorder",
   "source": "Vidal.ru entry (updated 2024-09-09), cross-checked against footnote 1 of the phase III article; the state register GRLS was not queried (CAPTCHA)",
   "checked": "2026-10-25"
  },
  {
   "jurisdiction": "European Union (centralised)",
   "status": "No match for GB-115, Ranquilon, phenylhexanoyl or cholecystokinin among 2,754 records of the EMA medicines dataset (timestamp 2026-10-24)",
   "source": "EMA medicines JSON report",
   "checked": "2026-10-25"
  },
  {
   "jurisdiction": "EU member states",
   "status": "No national authorisation was located; national registers were not searched one by one",
   "source": "not searched",
   "checked": "2026-10-25"
  },
  {
   "jurisdiction": "United States",
   "status": "No match in Drugs@FDA (openFDA, brand and ingredient queries). The substance has an FDA UNII (G5YT2F7SG8), which identifies a substance and is not an approval. ClinicalTrials.gov marks both registered trials as not FDA-regulated",
   "source": "openFDA drugsfda API; PubChem synonyms; ClinicalTrials.gov oversight module",
   "checked": "2026-10-25"
  },
  {
   "jurisdiction": "WADA",
   "status": "Not named on the 2026 Prohibited List. Section S0 covers substances with no current approval by any governmental health authority for human therapeutic use; Ranquilon holds a Russian approval. No WADA or RUSADA statement on the compound was located, so its S0 status is a reading of the text, not a confirmed classification",
   "source": "WADA Prohibited List 2026 (valid 1 January 2026), full text searched",
   "checked": "2026-10-25"
  },
  {
   "jurisdiction": "Trial registries",
   "status": "ClinicalTrials.gov: 2 studies (NCT05586789, NCT06843044), both sponsored by Valenta Pharm, neither with posted results. ISRCTN: 0 for 'ranquilon' and 'GB-115'. EU CTIS and the clinical-trial section of the Russian GRLS were not queried (the GRLS medicines register was searched manually; see Russia)",
   "source": "ClinicalTrials.gov API v2; ISRCTN query API",
   "checked": "2026-10-25"
  }
 ],
 "metrics": {
  "unit": "publication record (unique; one duplicate publication removed)",
  "n_unique": 52,
  "by_type": {
   "A": 23,
   "C": 6,
   "R": 7,
   "H": 10,
   "O": 1,
   "K": 2,
   "P": 3
  },
  "by_year_type": {
   "0": {
    "C": 1
   },
   "2003": {
    "A": 1
   },
   "2004": {
    "P": 1
   },
   "2007": {
    "C": 1,
    "A": 3
   },
   "2008": {
    "A": 1
   },
   "2010": {
    "A": 1
   },
   "2011": {
    "A": 4,
    "R": 1,
    "C": 1,
    "K": 1,
    "P": 1
   },
   "2012": {
    "A": 2,
    "C": 1
   },
   "2013": {
    "A": 1,
    "C": 1,
    "R": 1
   },
   "2014": {
    "A": 2,
    "C": 1
   },
   "2015": {
    "A": 2,
    "R": 1
   },
   "2016": {
    "A": 3
   },
   "2017": {
    "H": 2,
    "A": 1
   },
   "2018": {
    "R": 2
   },
   "2019": {
    "H": 1,
    "A": 1,
    "R": 1,
    "P": 1
   },
   "2022": {
    "H": 2
   },
   "2023": {
    "O": 1,
    "H": 2,
    "R": 1,
    "K": 1
   },
   "2024": {
    "H": 1
   },
   "2025": {
    "A": 1,
    "H": 1
   },
   "2026": {
    "H": 1
   }
  },
  "in_pubmed": 24,
  "concentration": {
   "S1_headline_any_zakusov_author_empirical": {
    "k": 36,
    "n": 40,
    "pct": 90.0
   },
   "S2_zakusov_without_company_empirical": {
    "k": 34,
    "n": 40,
    "pct": 85.0
   },
   "S3_originator_or_authorisation_holder_empirical": {
    "k": 39,
    "n": 40,
    "pct": 97.5
   },
   "S4a_any_zakusov_excluding_D_enantiomer": {
    "k": 36,
    "n": 39,
    "pct": 92.3
   },
   "S4b_originator_or_holder_excluding_D_enantiomer": {
    "k": 39,
    "n": 39,
    "pct": 100.0
   },
   "S5_any_zakusov_pubmed_indexed_empirical": {
    "k": 20,
    "n": 22,
    "pct": 90.9
   },
   "S6_any_zakusov_all_records_incl_reviews_patents_congress": {
    "k": 47,
    "n": 52,
    "pct": 90.4
   },
   "S7_any_zakusov_human_publications": {
    "k": 7,
    "n": 10,
    "pct": 70.0
   },
   "S7b_originator_or_holder_human_publications": {
    "k": 10,
    "n": 10,
    "pct": 100.0
   },
   "S8_any_zakusov_human_studies(cohort)": {
    "k": 4,
    "n": 7,
    "pct": 57.1
   },
   "S8b_originator_or_holder_human_studies(cohort)": {
    "k": 7,
    "n": 7,
    "pct": 100.0
   },
   "S9_independent_records_on_L_compound_any_type": {
    "k": 0,
    "n": 52
   }
  },
  "empirical_definition": "evidence_type in H, A, C, O and compound not 'mention only'; excludes reviews, patents and congress abstracts without human data",
  "independent_records": [
   "PMID:37582869",
   "DOI:10.37489/2587-7836-2023-3-19-27"
  ],
  "recalculations": {
   "phase3_responders": {
    "active": "77/110",
    "placebo": "27/110",
    "risk_difference_pp_newcombe95": [
     45.5,
     32.8,
     56.0
    ],
    "odds_ratio_woolf95": [
     7.17,
     3.95,
     13.01
    ],
    "nnt": 2.2,
    "formulas": "RD = 77/110 - 27/110 = 0.455; OR = (77*83)/(33*27) = 7.17",
    "note": "The article reports an 'odds ratio with 95% CI 0.452 (0.3197-0.5843)' and calls 0.3197 the lower CI bound of the between-group difference; the values correspond to the risk difference as a proportion. The article does not define its odds ratio: described as a mislabelled statistic, not a calculation error."
   },
   "phase3_adverse_event_patients": {
    "active": "28/110",
    "placebo": "16/110",
    "z_test": [
     2.02,
     0.0431
    ],
    "fisher_exact_p": 0.0629,
    "note": "Reported p=0.063 is reproduced by Fisher's exact test."
   },
   "phase3_attrition": {
    "planned": "about 15% after randomisation, 12% at screening (sample-size section)",
    "observed": "1/220 after randomisation (0.5%); 1/221 at screening (0.5%)"
   },
   "phase3_enrolment_window_from_registry": {
    "start": "2022-10-12",
    "primary_completion": "2022-11-22",
    "days": 41,
    "inference": "Compatible with randomisation within about two weeks; registry dates are not recruitment dates and the article gives none, so the recruitment period is not established."
   },
   "phase2_cgi_responders_ITT": {
    "arms": {
     "low": "39.5% of 43",
     "middle": "57.1% of 42",
     "high": "43.9% of 41",
     "placebo": "28.6% of 42"
    },
    "middle_vs_placebo_pp_newcombe95": [
     28.6,
     7.4,
     46.4
    ],
    "reported_p": 0.0148,
    "fisher_exact_p_reconstructed": 0.0148,
    "bonferroni_threshold_3_comparisons": 0.0167,
    "note": "Counts reconstructed from percentages and arm sizes (24/42 and 12/42 reproduce 57.1% and 28.6%). Non-monotonic dose-response; no multiplicity adjustment described."
   },
   "phase4_responders": {
    "reported": "63.3% (n=62) vs 49.0% (n=49), p<0.043; 100 per arm randomised",
    "status": "internal discrepancy pending full text; denominators not reconstructed",
    "adverse_events_inconsistency": "abstract: '29 AEs were reported in 14.0% (n=44) of patients'; 16+12=28 patients, i.e. 14.0% of 200; 44 does not match"
   },
   "placebo_or_comparator_response": {
    "phase2_CGI_I_placebo": 28.6,
    "phase3_HARS_placebo": 24.5,
    "phase4_HARS_fabomotizole": 49.0
   }
  }
 },
 "double_coding": {
  "n": 40,
  "share_of_census_pct": 76.9,
  "rule": "max(15% of 52, 40) = 40 records, random sample, seed 20261025",
  "variables": {
   "evidence_type": {
    "percent_agreement": 95.0,
    "cohen_kappa": 0.93,
    "n_coder2_U": 0,
    "excluding_U": {
     "n": 40,
     "percent_agreement": 95.0,
     "cohen_kappa": 0.93
    }
   },
   "origin": {
    "percent_agreement": 67.5,
    "cohen_kappa": 0.36,
    "n_coder2_U": 13,
    "excluding_U": {
     "n": 27,
     "percent_agreement": 100.0,
     "cohen_kappa": 1.0
    }
   },
   "compound": {
    "percent_agreement": 87.5,
    "cohen_kappa": 0.5,
    "n_coder2_U": 0,
    "excluding_U": {
     "n": 40,
     "percent_agreement": 87.5,
     "cohen_kappa": 0.5
    }
   }
  },
  "disagreements": [
   {
    "id": "DOI:10.24411/2587-7836-2018-10001",
    "variable": "evidence_type",
    "coder1": "R",
    "coder2": "H",
    "coder2_note": "own PK data in rats, rabbits and volunteers (GB-115 1-15 mg); Zakusov authors"
   },
   {
    "id": "DOI:10.24411/2587-7836-2019-10037",
    "variable": "evidence_type",
    "coder1": "R",
    "coder2": "A",
    "coder2_note": "rat BBB penetration of three peptides incl. GB-115"
   },
   {
    "id": "ELIB:23152784",
    "variable": "origin",
    "coder1": "Z",
    "coder2": "U",
    "coder2_note": "title: synthesis of GB-115; no affiliations"
   },
   {
    "id": "PATENT:RU2227144",
    "variable": "origin",
    "coder1": "Z",
    "coder2": "U",
    "coder2_note": "patent on a class of tryptophan dipeptides; no affiliation, GB-115 not named"
   },
   {
    "id": "PATENT:RU2429874",
    "variable": "origin",
    "coder1": "Z",
    "coder2": "U",
    "coder2_note": "analgesic agent patent; GB-115 not named; no affiliation"
   },
   {
    "id": "PMID:17523442",
    "variable": "origin",
    "coder1": "Z",
    "coder2": "U",
    "coder2_note": "rats and mice; no affiliations"
   },
   {
    "id": "PMID:17886432",
    "variable": "origin",
    "coder1": "Z",
    "coder2": "U",
    "coder2_note": "design and synthesis in title; no affiliations"
   },
   {
    "id": "PMID:20726348",
    "variable": "origin",
    "coder1": "Z",
    "coder2": "U",
    "coder2_note": "preclinical safety in mice, rats, rabbits; no affiliations"
   },
   {
    "id": "PMID:21476266",
    "variable": "origin",
    "coder1": "Z",
    "coder2": "U",
    "coder2_note": "mouse Porsolt test; abstract formula says D-Trp but the compound is named GB-115 throughout, so L; no affiliations"
   },
   {
    "id": "PMID:22238979",
    "variable": "origin",
    "coder1": "Z",
    "coder2": "U",
    "coder2_note": "rat benzodiazepine withdrawal; no affiliations"
   },
   {
    "id": "PMID:27017703",
    "variable": "origin",
    "coder1": "Z",
    "coder2": "U",
    "coder2_note": "rat PK/PD; no affiliations"
   },
   {
    "id": "SCHOLAR:Gudasheva2015",
    "variable": "origin",
    "coder1": "Z",
    "coder2": "U",
    "coder2_note": "theory/technology overview; listing only"
   },
   {
    "id": "SCHOLAR:Klumova2012",
    "variable": "origin",
    "coder1": "Z",
    "coder2": "U",
    "coder2_note": "analytical method for GB-115 tablets"
   },
   {
    "id": "SCHOLAR:Kolik2011ECNP",
    "variable": "origin",
    "coder1": "Z",
    "coder2": "U",
    "coder2_note": "ECNP abstract, no data visible"
   },
   {
    "id": "SCHOLAR:Zherdev2016",
    "variable": "origin",
    "coder1": "Z",
    "coder2": "U",
    "coder2_note": "PK/PD of compositions, presumed animal from title; listing only"
   },
   {
    "id": "PATENT:RU2227144",
    "variable": "compound",
    "coder1": "L",
    "coder2": "M",
    "coder2_note": "patent on a class of tryptophan dipeptides; no affiliation, GB-115 not named"
   },
   {
    "id": "PATENT:RU2429874",
    "variable": "compound",
    "coder1": "L",
    "coder2": "M",
    "coder2_note": "analgesic agent patent; GB-115 not named; no affiliation"
   },
   {
    "id": "PMID:21899085",
    "variable": "compound",
    "coder1": "L",
    "coder2": "M",
    "coder2_note": "strategy review, GB-115 one of three examples; abstract places work at Zakusov, author affiliations empty"
   },
   {
    "id": "PMID:30295186",
    "variable": "compound",
    "coder1": "L",
    "coder2": "M",
    "coder2_note": "overview of dipeptide drug design; GB-115 one of four examples"
   },
   {
    "id": "SCHOLAR:Gudasheva2015",
    "variable": "compound",
    "coder1": "L",
    "coder2": "M",
    "coder2_note": "theory/technology overview; listing only"
   }
  ],
  "coders": "Coder 1 = dossier author; codes frozen in coder1.json before coder 2 started. Coder 2 = separate language-model instance (Claude Sonnet) that saw only CODEBOOK.md and sample-blind.json (title, journal, year, authors, affiliations, abstract or first-page text; 7 records had a bibliographic listing only)."
 },
 "evidence_index_row": {
  "total_pubmed": 24,
  "humanos_pubmed": 2,
  "ensayos_pm": "not checked (publication-type filter unreliable)",
  "ct_total": 2,
  "ct_intervencion": 2,
  "human_publications_all_sources": 10,
  "human_studies": 7,
  "confianza": "baja-media",
  "fecha": "2026-10-25"
 },
 "originator_share_benchmark": {
  "date": "2026-10-25",
  "method": "Share of PubMed records (title/abstract query) with at least one author whose PubMed-printed affiliation matches the originating institution. Records without any affiliation are excluded from the denominator. PubMed lists affiliations for all authors only from about 2014; earlier records often carry the first author's only.",
  "compounds": [
   {
    "key": "gb115",
    "compound": "GB-115 (Ranquilon)",
    "query": "\"GB-115\"[tiab] OR GB115[tiab] OR ranquilon[tiab]",
    "originator": "Zakusov Institute / Valenta Pharm",
    "originator_regex": "zakusov|valenta|institute of pharmacology[^;]{0,80}(moscow|russia)",
    "records": 24,
    "with_affiliation": 14,
    "origin_with_affiliation": 12,
    "pct_origin_of_records_with_affiliation": 85.7,
    "pct_origin_nonreview": 84.6,
    "n_nonreview": 13,
    "pct_origin_since_2014": 66.7,
    "n_since_2014": 6,
    "sensitivity_pct_origin_or_moscow_state_university": 92.9,
    "pmids": [
     {
      "pmid": "42565399",
      "year": "2026",
      "review": false,
      "n_aff": 8,
      "origin": true,
      "origin_or_msu": true
     },
     {
      "pmid": "39847298",
      "year": "2025",
      "review": false,
      "n_aff": 7,
      "origin": false,
      "origin_or_msu": false
     },
     {
      "pmid": "37582869",
      "year": "2023",
      "review": false,
      "n_aff": 3,
      "origin": false,
      "origin_or_msu": true
     },
     {
      "pmid": "31626171",
      "year": "2019",
      "review": false,
      "n_aff": 8,
      "origin": true,
      "origin_or_msu": true
     },
     {
      "pmid": "30295186",
      "year": "2018",
      "review": true,
      "n_aff": 3,
      "origin": true,
      "origin_or_msu": true
     },
     {
      "pmid": "27590755",
      "year": "2016",
      "review": false,
      "n_aff": 4,
      "origin": true,
      "origin_or_msu": true
     },
     {
      "pmid": "27017703",
      "year": "2015",
      "review": false,
      "n_aff": 0,
      "origin": false,
      "origin_or_msu": false
     },
     {
      "pmid": "25322652",
      "year": "2014",
      "review": false,
      "n_aff": 0,
      "origin": false,
      "origin_or_msu": false
     },
     {
      "pmid": "24397028",
      "year": "2013",
      "review": false,
      "n_aff": 0,
      "origin": false,
      "origin_or_msu": false
     },
     {
      "pmid": "24130989",
      "year": "2013",
      "review": false,
      "n_aff": 1,
      "origin": true,
      "origin_or_msu": true
     },
     {
      "pmid": "23113301",
      "year": "2012",
      "review": false,
      "n_aff": 1,
      "origin": true,
      "origin_or_msu": true
     },
     {
      "pmid": "22977846",
      "year": "2012",
      "review": false,
      "n_aff": 1,
      "origin": true,
      "origin_or_msu": true
     },
     {
      "pmid": "22238979",
      "year": "2011",
      "review": false,
      "n_aff": 0,
      "origin": false,
      "origin_or_msu": false
     },
     {
      "pmid": "22235394",
      "year": "2011",
      "review": false,
      "n_aff": 1,
      "origin": true,
      "origin_or_msu": true
     },
     {
      "pmid": "21899090",
      "year": "2011",
      "review": false,
      "n_aff": 0,
      "origin": false,
      "origin_or_msu": false
     },
     {
      "pmid": "21899085",
      "year": "2011",
      "review": false,
      "n_aff": 0,
      "origin": false,
      "origin_or_msu": false
     },
     {
      "pmid": "21476266",
      "year": "2011",
      "review": false,
      "n_aff": 0,
      "origin": false,
      "origin_or_msu": false
     },
     {
      "pmid": "20726348",
      "year": "2010",
      "review": false,
      "n_aff": 0,
      "origin": false,
      "origin_or_msu": false
     },
     {
      "pmid": "19145294",
      "year": "2008",
      "review": false,
      "n_aff": 1,
      "origin": true,
      "origin_or_msu": true
     },
     {
      "pmid": "18457023",
      "year": "2007",
      "review": false,
      "n_aff": 1,
      "origin": true,
      "origin_or_msu": true
     },
     {
      "pmid": "18239806",
      "year": "2007",
      "review": false,
      "n_aff": 1,
      "origin": true,
      "origin_or_msu": true
     },
     {
      "pmid": "17886432",
      "year": "2007",
      "review": false,
      "n_aff": 0,
      "origin": false,
      "origin_or_msu": false
     },
     {
      "pmid": "17523442",
      "year": "2007",
      "review": false,
      "n_aff": 0,
      "origin": false,
      "origin_or_msu": false
     },
     {
      "pmid": "12910281",
      "year": "2003",
      "review": false,
      "n_aff": 1,
      "origin": true,
      "origin_or_msu": true
     }
    ]
   },
   {
    "key": "fabomotizole",
    "compound": "Fabomotizole (Afobazole)",
    "query": "afobazole[tiab] OR fabomotizole[tiab] OR afobazol[tiab]",
    "originator": "Zakusov Institute",
    "originator_regex": "zakusov|valenta|institute of pharmacology[^;]{0,80}(moscow|russia)",
    "records": 142,
    "with_affiliation": 90,
    "origin_with_affiliation": 59,
    "pct_origin_of_records_with_affiliation": 65.6,
    "pct_origin_nonreview": 68.2,
    "n_nonreview": 85,
    "pct_origin_since_2014": 63.6,
    "n_since_2014": 55,
    "sensitivity_pct_origin_or_moscow_state_university": 68.9,
    "pmids": [
     {
      "pmid": "42565399",
      "year": "2026",
      "review": false,
      "n_aff": 8,
      "origin": true,
      "origin_or_msu": true
     },
     {
      "pmid": "42360212",
      "year": "2026",
      "review": true,
      "n_aff": 1,
      "origin": false,
      "origin_or_msu": false
     },
     {
      "pmid": "42154013",
      "year": "2026",
      "review": false,
      "n_aff": 7,
      "origin": false,
      "origin_or_msu": false
     },
     {
      "pmid": "41745462",
      "year": "2026",
      "review": false,
      "n_aff": 13,
      "origin": false,
      "origin_or_msu": false
     },
     {
      "pmid": "41489256",
      "year": "2026",
      "review": false,
      "n_aff": 8,
      "origin": false,
      "origin_or_msu": false
     },
     {
      "pmid": "41162433",
      "year": "2025",
      "review": false,
      "n_aff": 8,
      "origin": false,
      "origin_or_msu": false
     },
     {
      "pmid": "40570073",
      "year": "2025",
      "review": false,
      "n_aff": 6,
      "origin": false,
      "origin_or_msu": false
     },
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  "date": "2026-10-25",
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