Metabolic & longevity

Epitalon: The Evidence Card. Every PubMed Record, Who Wrote It, and What Holds Up

Epitalon evidence census: 165 PubMed records read one by one, 73-93% from one lineage, 3 human studies, 0 trials located, open data and code. Version 1.0-rc.

In short

Epitalon evidence census: 165 PubMed records read one by one, 73-93% from one lineage, 3 human studies, 0 trials located, open data and code. Version 1.0-rc.

What is Epitalon? The microgram hypothesis and the dose the internet keeps getting wrong
Epitalon: The Evidence Card. Every PubMed Record, Who Wrote It, and What Holds Up

Epitalon is the synthetic tetrapeptide Ala-Glu-Asp-Gly (AEDG), built in St Petersburg from the amino-acid composition of Epithalamin, a crude extract of bovine pineal glands. We read all 256 PubMed records filed under either name, one by one. After removing nine false positives, 165 concern the synthetic peptide. Between 72.7% and 92.7% of them, depending on how a collaborator is defined, carry an author from the originating group or its co-author network; three describe studies in people; no registered trial was located; and one core finding, telomere elongation in cultured human cells, has been partially reproduced by a laboratory with no co-authorship link to the group. This page is the census, the method and the data.

Version 1.0-rc, 17 October 2026. Condor Research Editorial. Last reviewed: 17 October 2026. Counts, identifiers, registry results and regulatory entries were checked against the primary databases on that date; the literal queries are in the method note, and the classified census can be downloaded as dataset.json.

What does the evidence on Epitalon amount to?

Evidence level, in one line: preclinical and concentrated in one lineage. No registered trial was located; there are three small human reports on the synthetic peptide, all from the originating institute; and one partial replication in vitro by an unlinked laboratory, published in 2025, whose corrected figures and text disagree.

Measure (unit) Condor census, 17 Oct 2026
PubMed records, all literature names (record) 174 retrieved; 165 after reading each record (9 false positives)
Records tagged with the MeSH term “Humans” (record) 54 of 165
Studies that gave the peptide to people (publication) 3
Records with a clinical-trial publication type (record) 1
Registered trials (registry entry) 0 located in ClinicalTrials.gov, ISRCTN, EU CTIS and EU CTR, 11 search terms
Records with no authorship link to the origin group (record) 12 of 165 (7.3%) under the headline definition; 12 to 45 across five definitions
Core findings reproduced by an unlinked laboratory (finding) 1, partially, in vitro (telomere elongation, 2025); in the corrected figures the fibroblast panel shows no significant change
Classification agreement, blind second coder (40-record sample) Substance 87.5%, Cohen’s kappa 0.78; model 100%, kappa 1.00

The Condor Evidence Card for Epitalon, version 1.0-rc. The gap between “Humans” tags and human studies is the point: the tag also marks work on human cells and tissue. The comparison with the earlier automated Evidence Index row is in the method note.

72.7% to 92.7% of the 165 Epitalon records carry an author from the St Petersburg originating group (lower figure) or from the group or its co-author network (upper figure).

3 studies have given synthetic Epitalon to people. None was located in a trial registry, and none reports blinding.

2 of 5 mouse cohorts whose full survival tables we read show a significantly longer mean lifespan; in one of the other three, survival of the longest-lived tenth was significantly shorter than in controls. All come from one collaboration.

0 trials of Epitalon or Epithalamin located in ClinicalTrials.gov, ISRCTN, the EU Clinical Trials Information System or the EU Clinical Trials Register on 17 October 2026.

What exactly is Epitalon, and what is it not?

Epitalon is one defined molecule: L-alanyl-L-glutamyl-L-aspartyl-glycine, four residues long, formula C14H22N4O9, molecular weight 390.35 g/mol, PubChem CID 219042.3 MeSH files it as a Supplementary Concept, “alanyl-glutamyl-aspartyl-glycine”, with Epitalon, Epithalon, Epithalone, Ala-Glu-Asp-Gly and AE-0 peptide as entry terms.4 Epithalamin is something else: a polypeptide extract of bovine pineal glands, which MeSH records separately under CAS 64082-79-7.5 The FDA’s 2026 review states the same distinction in plain terms: it treats Epitalon and Epithalamin as different substances.6

Field Epitalon (synthetic AEDG) Epithalamin (pineal extract)
What it is One synthetic tetrapeptide A mixture of polypeptides extracted from bovine pineal tissue
Sequence / composition H-Ala-Glu-Asp-Gly-OH Not a single defined sequence
Formula, MW C14H22N4O9, 390.35 g/mol; acetate salt C16H26N4O11, 450.40 g/mol Not applicable
CAS 307297-39-8 (free base); 307297-40-1 (acetate, per FDA) 64082-79-7 (per MeSH)
Identifiers PubChem CID 219042; UNII O65P17785G; InChIKey HGHOBRRUMWJWCU-FXQIFTODSA-N MeSH Supplementary Concept “epithalamin”
First PubMed record 2000 1975
PubMed records, 17 Oct 2026 165 (25 shared with Epithalamin) 103 (25 shared with Epitalon)
Human studies in PubMed 3 22

Identity of the two substances. Sources: PubChem CID 219042 and its computed properties; MeSH records 67421253 and 67027437; FDA briefing document of May 2026 for the acetate salt. All accessed 17 October 2026.

Three naming problems run through the record, and each one changes what a search returns.

  • PubChem merges the two. The synonym list of CID 219042 includes “Epithalamin”, “Epithalamine” and CAS 64082-79-7, the number MeSH assigns to the extract.3 A pipeline that pulls synonyms from PubChem, as most automated evidence counters do, will fold 82 Epithalamin-only records into a count for the synthetic peptide.
  • The same sequence has three origin stories. Most papers describe it as designed from the amino-acid composition of the pineal extract. The 2002 retinitis pigmentosa paper says it was designed from a retinal extract, Retinalamin, and that the peptides derived from the pineal and retinal extracts are identical.7 Five papers from B. I. Kuznik’s group in Chita describe it as derived from posterior pituitary extracts.89 The molecule is the same; the narrative around it is not.
  • The sequence itself is misprinted. Two abstracts from the originating group give it as Ala-Glu-Asp-Glu.1011 A 2025 review also found one paper drawing Epitalon with non-standard γ-linked bonds.1

The confusion has practical consequences beyond bibliometrics. The FDA’s 2026 review lists inconsistent naming as a reason the substance is “not well-characterized”.6 And the human mortality data most often attached to “Epitalon” online come from Epithalamin, a different preparation, sometimes given together with a thymus extract. A 2026 paper outside PubMed frames part of this literature as a “translational dosing error” rooted in the same confusion; we do not reproduce quantities here.12 For the Pinealon comparison, see our page on Pinealon (Glu-Asp-Arg).

How large is the Epitalon literature once the names are untangled?

We ran two PubMed queries on 17 October 2026, one for each substance, using the MeSH Supplementary Concept plus every literature name in title and abstract. The Epitalon query returned 174 records; the Epithalamin query returned 107; together, 256 unique records. We then read every title and abstract and classified each record by substance, model, design, year, authorship group and country.

Stacked bar chart of PubMed records per year from 1975 to 2026. The upper panel, Epithalamin, has small dark bars from 1975 to 2013. The lower panel, Epitalon, starts in 2000, peaks at 20 records in 2002, and is almost entirely dark; rust-coloured records with no authorship link appear mainly in 2025 and 2026.
Figure 1. PubMed records per year for Epithalamin (top) and Epitalon (bottom), coloured by authorship group. The 25 records indexed under both names appear in both panels. Source: Condor Research census, cut-off 17 October 2026.
Model Epitalon records Of which with no authorship link Epithalamin records
Animal in vivo 80 1 50
In vitro / ex vivo 44 3 11
Review 24 5 19
Chemistry, biophysics, analytical 8 1 1
In silico 4 0 0
Human in vivo 3 0 22
Other (erratum, bibliography) 2 2 0
Total 165 12 103

Census of the two literatures by model. Excluded: 9 false positives (the string “AEDG” or the sub-sequence Ala-Glu-Asp-Gly used for something else, from underwater sensor routing to a plant extract) and 4 records on other pineal extracts (Crinofizin, an unnamed Romanian extract, Pineamin). Full list in dataset.json.

Four features of the Epitalon record stand out. It is old: 101 of 165 records date from 2000 to 2009, with a peak of 20 in 2002, and only 27 appeared from 2020 onwards. It is concentrated: 88 records, 53%, sit in two journals, Bulletin of Experimental Biology and Medicine (54) and Advances in Gerontology (34). It is partly invisible to English readers: 56 records are in Russian, with an English abstract at best. And it is animal-heavy: 80 animal studies against 3 in people, with Drosophila, chickens and rhesus monkeys alongside mice and rats.

How concentrated is the authorship?

This section measures who signed the papers, nothing more. Shared authorship does not show that a result is wrong, and the absence of shared authorship does not show that a study is an experimental replication; that question is handled finding by finding in the next section. The unit is the PubMed record.

Headline definition. The originating core is any record signed by V. Kh. Khavinson, V. N. Anisimov, V. G. Morozov or V. M. Dilman, or by anyone affiliated with the St Petersburg Institute of Bioregulation and Gerontology. Its network is every other author who co-signed at least one core record, in any year: 284 people. A record has “no authorship link” only if none of its authors belongs to either set.

Five horizontal 100 percent bars. Epitalon all records: 73 percent origin group, 20 percent network, 7 percent no link. Epitalon primary experimental: 75, 22 and 4 percent. Epitalon human studies: 100 percent origin group. Epithalamin all records and human studies: about 58 percent origin, 18 percent network, 23 percent no link.
Figure 2. Authorship concentration under the headline definition (unit: PubMed record). Source: Condor Research census, cut-off 17 October 2026.
Definition Core share, all 165 Core or network, all 165 Core or network, 139 primary experiments Records with no link (all / primary)
A. Headline: core by name or affiliation; network = any co-author, any year 72.7% 92.7% 96.4% 12 / 5
B. Core by the four names only, affiliation ignored 67.3% 92.7% 96.4% 12 / 5
C. Temporal network: co-authorship with the core in the same year or earlier 72.7% 90.3% 93.5% 16 / 9
D. Strict network: at least two co-signed core records 72.7% 92.7% 96.4% 12 / 5
E. Lower bound: core only, no network 72.7% 72.7% 74.8% 45 / 35

Sensitivity of the authorship-concentration figure to its definition. By affiliation alone: 129 of 165 Epitalon records carry an affiliation field, and 69 of those 129 (53.5%) name the Institute of Bioregulation and Gerontology. By funding: only 3 Epitalon records carry MEDLINE grant data and 30 a generic “research support” tag, too few to classify by funder. Script: 10_sensitivity.py.

Under the headline definition, 120 records (72.7%) come from the core group and 33 (20.0%) from its network without the core. Twelve (7.3%) have no link, and seven of those twelve are reviews, an erratum or a bibliography. The unlinked experimental literature on Epitalon is five records:

Year Group, country Model What was tested Record
2015 Belgian public-health laboratory, Brussels Analytical Identification of Epitalon in two illegal pharmaceutical preparations 13
2022 China, with US co-author Mouse oocytes in vitro Oocyte quality during post-ovulatory ageing: reactive oxygen species, spindle defects, mitochondria 14
2025 South Korea Bovine oocytes and embryos in vitro Telomerase activity, maturation rate, blastocyst hatching after thawing 15
2025 Brunel University London, UK Human cell lines Telomere length, hTERT mRNA, telomerase activity, ALT activity; correction published 16
2026 China Lymphoma models, in vitro and in vivo Epitalon used as a tool against therapy-induced senescent cells 17

Every experimental Epitalon record with no authorship link to the origin group located in PubMed, 17 October 2026. Under the temporal definition (C) four more records qualify; they are listed in dataset.json.

In 26 years, five experimental papers on Epitalon were signed by groups that had never published with its inventors.

Epithalamin looks less concentrated on paper: 24 of 103 records (23%) have no link to the group. That figure needs context. Epithalamin was manufactured in Russia, the 1998 diabetes study names the St Petersburg manufacturer Samson,18 and a 2005 primate paper calls it a pharmacopoeial drug.19 Unlinked Epithalamin papers are, almost without exception, Soviet and Russian clinicians and physiologists using an available domestic product. Only one unlinked experimental record comes from a Western laboratory, and it found no effect of the extract on rat pineal androgen receptors.20

We have a separate page on the 2025 Brunel study: Epitalon and telomerase: the replication record. Here we place it in the whole census.

Which findings have been replicated by unlinked laboratories?

Strategy. For each of the seven claims that recur in reviews and marketing, we ran the two census queries combined with the claim’s terms (for example telomer*, hTERT or “alternative lengthening” for telomeres), read every hit with no authorship link, and placed it in one of six categories: direct replication (same model and protocol), conceptual replication (same result in another model or protocol), partial replication (some outcomes reproduced, others not, or report internally inconsistent), conceptual support (a related result), null result, or no information (nothing located). Queries and hits are in dataset.json. The unit is the publication.

A ledger of seven findings with squares for each supporting record. Telomere elongation in human cells: three dark squares and one rust square labelled partial, inconsistent. Oocyte quality: two rust squares labelled conceptual support. Lifespan: six squares, four hollow. Tumours: eight squares, one hollow. Melatonin: seven squares, one hollow. Retina: six. DNA binding: seven. The last five rows read none located.
Figure 3. Replication ledger. Each square is one PubMed record; hollow squares are records whose abstract reports no effect. PMIDs for every square are in dataset.json. Source: Condor Research census, cut-off 17 October 2026.
Finding Origin group and network Unlinked laboratories Category
Telomerase induction and telomere elongation in cultured human cells 3 records, from 200321 to 201922 1 (2025)16 Partial replication in vitro; corrected figures and text disagree
Oocyte and embryo quality in vitro 0 21415 Conceptual support; no direct replication
Lifespan of mice and rats 5 mouse cohorts in full text: 2 significant gains in mean, 3 no significant change; 2 rat publications (abstracts) 0 No information
Spontaneous or induced tumours in rodents 8 records, 1 null23 0 No information
Melatonin secretion and pineal function 7 records, 1 null24 0 No information; the external-laboratory test with origin co-authors was null
Retina 6 records 0 No information
Binding to DNA, gene promoters or histones 7 records, in silico or cell-free 0 No information

Replication status of the recurring claims, PubMed, 17 October 2026. “Null” means the abstract reports no effect on the claim’s main outcome. “No information” means no unlinked study was located, not that none exists.

Telomeres. The founding claim is a 2003 report that Epitalon induced the catalytic subunit of telomerase, telomerase activity and telomere elongation in telomerase-negative human fetal fibroblasts,21 followed by a 2004 report that treated fibroblasts went past their division limit, 44 passages against 34.25 The group’s 2019 study in lymphocytes from 11 men is less tidy than its citations suggest: telomere length rose significantly in 5 donors and fell in 2.22 The 2025 Brunel study is the only test by an unlinked laboratory.16 We read it together with its correction,26 which replaced the images of the three data figures (the published versions lacked axes, scales and some bars); the legends were unchanged and the text was not corrected.

Read against the corrected figures, the result is narrower than the abstract. In the two breast-cancer lines, telomere length rose across a concentration series, with ALT activity rather than telomerase. In the normal fibroblast line, the type of cell used in 2003, the corrected panel marks the change in telomere length against untreated cells as not significant, although the text reports a significant increase. The significant increase appears in Figure 1D, which the legend assigns to the epithelial line but whose axis label names the fibroblast line. For telomerase activity, two different comparisons are mixed. Against the positive-control cancer line, activity in both normal lines is low; but the significance marks in those panels refer to that comparison, and the text reports a fourfold relative increase over untreated fibroblasts, a comparison the corrected panels neither confirm nor refute visually. The rise in hTERT mRNA is marked significant in the fibroblasts and not significant in the epithelial line. The peptide was a gift from a commercial research-peptide supplier, and the paper reports no analytical check of its identity. We classify the study as a partial, internally inconsistent replication in vitro, not as confirmation of the 2003 fibroblast result.

Lifespan. All rodent lifespan studies of Epitalon come from the Anisimov and Khavinson collaboration. We read the full survival tables of four publications covering five mouse cohorts; the two rat publications are available to us only as abstracts.

Cohort (publication) Animals per group, control / Epitalon Mean lifespan, days (control / Epitalon) Median Longest-lived 10% Maximum
Female CBA mice (2001)27 50 / 50 (60 randomised per group, 10 killed for tissue) 685 / 721, significant 705 / 732 738 / 842 in the table; 793 in the text 740 / 1053; one animal
Female HER-2/neu transgenic mice (2002)28 24 / 24 289 / 328, significant not reported not reported 360 / 410
Female SHR mice (2003)29 50 / 50 analysed (54 randomised) 456 / 455 512 / 487 709 / 803, significant 739 / 830
Female SAMP-1 mice (2005)30 33 / 30 (saline control) 537 / 582, not significant 582 / 569 693 / 741, significant 702 / 759
Female SAMR-1 mice (2005)30 33 / 29 (saline control) 521 / 546, not significant 508 / 556 738 / 671, significantly shorter 766 / 727
Female rats, three light regimens (2007)31 abstract only no change under standard light maximum lifespan longer under natural and constant light
Male rats, three light regimens (2008)32 abstract only “virtually did not change” slower population ageing rate under natural and constant light

Rodent lifespan data for Epitalon. Mouse rows from the full survival tables (the 2005 tables checked against the page images of the Russian original); rat rows from abstracts. “Significant” follows each paper’s own test. Maximum lifespan is the single longest-lived animal.

The full texts change the balance in one direction and the details in another. The 2005 paper, which we could not assess from its abstract, states that Epitalon had no statistically significant effect on mean lifespan in either substrain, and in SAMR-1 mice the longest-lived tenth died significantly earlier than saline controls. By cohort, the mean lifespan of the whole group rose significantly in 2 of 5 mouse cohorts (CBA and HER-2/neu) and did not change significantly in 3. Maximum lifespan was higher in 4 of 5, but it is one animal per group: in the CBA study, the 10-month gain rests on a single mouse that outlived every other. The CBA paper also gives two different values for its longest-lived tenth. No lifespan study by a group without a co-authorship link was located in PubMed as of 17 October 2026, in any species.

Melatonin. The pineal claim rests on rhesus monkey studies co-signed by Khavinson,33 a rat pinealocyte culture34 and two human reports. The one experiment run in a laboratory outside Russia, at a Paris chronobiology laboratory and co-signed by Khavinson and Anisimov, is null on every measure.24 Pineal glands from young (9-week) and old (27-month) male Wistar rats were perifused for nine and a half hours; the tetrapeptide was added to the perifusate at three concentrations, alone and together with the beta-adrenergic agonist isoproterenol. The system worked: old glands secreted less melatonin than young ones, and isoproterenol raised secretion. The tetrapeptide changed neither basal nor stimulated secretion at any concentration or age. Each condition used three chambers of one gland each, so small effects cannot be excluded, and the authors note that in vitro and in vivo conditions, or species, may differ. It is cited far less than the positive monkey work.

Tumours. Epitalon was reported to reduce mammary tumours in HER-2/neu mice35 and colon tumours after a chemical carcinogen,36 among others; it had no inhibitory effect on chemically induced bladder tumours.23 In the SHR mouse study, total spontaneous tumour incidence did not change.29 The FDA’s 2026 review read the same studies as too limited to inform carcinogenic risk, and flagged telomerase activation itself as a theoretical concern.6

What human evidence exists for Epitalon?

Three PubMed records describe synthetic Epitalon given to people, and one further report on the night-shift study sits outside PubMed. The FDA’s 2026 briefing lists three human studies: the 2002 retinitis pigmentosa paper, the English version of the Ivko night-shift paper and the World Heart Journal report, which it counts as two separate studies.6 It does not list the 2007 Korkushko paper, in which Epitalon and Epithalamin are reported together. We group the two night-shift reports as one study, because they describe the same numbers of women, groups and protocol; that correspondence is our inference, since the full text supplied to us for the Russian Ivko paper turned out to be a different paper by the same group. We read the other reports in full.

Study Design and control Participants per arm Allocation; blinding Duration; losses Declared primary endpoint Reported result Funding; interests
Khavinson et al. 20027 Two-arm clinical comparison; control = conventional therapy (vasodilators, angioprotectors); plus a 124-rat experiment 162 patients with retinitis pigmentosa examined; 46 controls; Epitalon arm not sized explicitly Randomisation not reported; no blinding reported 10 days of treatment; follow-up and losses not reported None declared; ERG amplitudes, visual acuity, visual fields ERG amplitudes rose; “positive clinical effect” in over 90% (authors’ wording); 31.5% of controls improved Not stated; references cite the first author’s patents on the tetrapeptide
Korkushko et al. 2007 (Russian)37 Three arms: Epithalamin, Epitalon, saline placebo; plus monkeys 40 healthy elderly (60 to 79): 15 / 15 / 10; analysed in the low-melatonin subgroup, 12 Epitalon vs 8 placebo “Randomised”, method not stated; blinding not stated 10 days of treatment; losses not reported None declared; plasma melatonin over 24 hours Night melatonin rose (03:00, 20 to 49 pg/ml) vs no change on placebo Not stated
Ivko et al. 2020 (Russian; English 2021)3839 and Khavinson, Linkova, Ivko 202140 Placebo-controlled; reference group of women with normal melatonin output 75 night-shift women (reported as 40 to 59 years in the World Heart Journal; 40 to 50 in the FDA’s reading); 35 reference; 40 with low output split between peptide and saline placebo (arm sizes not given) “Randomly divided”, method not stated; blinding not stated 20 days; losses not reported None declared; urinary 6-sulfatoxymelatonin; clock-gene expression in blood cells 6-sulfatoxymelatonin up 1.7-fold; Cry2 and Csnk1e expression shifted toward reference values No conflict declared; test product a commercial preparation from the manufacturer (formulation not described here)

Every human study of synthetic Epitalon located, read in full text where available (17 October 2026). No amounts or administration details are given here. The Ivko and World Heart Journal reports appear to describe the same 75 women, groups and 20-day protocol; we count them as one study, an inferred correspondence pending the Russian full text.

Translated into a level of evidence: two small comparisons described as randomised, with surrogate endpoints, no stated allocation method and no reported blinding, and one comparison against conventional therapy for which randomisation is not reported. None was registered or declared a primary endpoint, and none reports losses. That is hypothesis-generating material. The FDA reached the same conclusion from the other direction: it found no study of Epitalon in people with insomnia, the use it evaluated, and no clinical data on safety.6

Epithalamin, the extract, has a larger and older human record: 22 PubMed records from 1977 to 2011, six indexed as randomised controlled trials. These are the source of the mortality figures that circulate online. We read the four central reports in full.

Report Population and arms Allocation; blinding; control Treatment; follow-up Mortality reported Notes from the full text
Khavinson & Morozov 2003, St Petersburg arm41 94 women aged 66 to 94: placebo 22, thymus extract 24, Epithalamin 24, both 24; plus a separate group of 20 given both extracts “Stratification randomisation”; described as double blind; placebo Treatment period 2 years; follow-up 6 years 81.8% placebo vs 45.8% Epithalamin Epithalamin effect inseparable from co-arms in the headline “2.5-fold” and “4.1-fold” figures, which refer to combined treatment
Khavinson & Morozov 2003, Kiev arm41 152 people with accelerated ageing: placebo 48, thymus extract 58, Epithalamin 46 “Stratification randomisation”; blinding not stated; placebo Treatment period 1992 to 1994; follow-up 8 years 13.6% vs 8.5% The percentages do not correspond to whole numbers of deaths in groups of these sizes
Korkushko et al. 200642 70 coronary patients with accelerated ageing: Epithalamin 36, saline 34 Described as randomised; method and blinding not stated; saline Treatment period 1992 to 1995; follow-up 12 years Alive: 28/36 vs 19/34 (deaths 22% vs 44%); reported as “28% lower” Its melatonin table matches, to rounding, the Epithalamin table of the 2007 paper, which describes healthy elderly volunteers
Korkushko et al. 201143 79 coronary patients aged 60 to 69: Epithalamin 39, basic therapy alone 40 “Divided at random”, method not stated; blinding not stated; no placebo Treatment period 1992 to 1995; follow-up 15 years Alive: 26/39 vs 16/40; Kaplan-Meier, log-rank Same institute, treatment years and three-year results as 2006, with different group sizes and a different control

The central Epithalamin mortality reports, read in full text. None was registered, declared a primary endpoint or reported losses to follow-up. All four share the originating group.

The full texts raise a problem that the abstracts hide. The Kiev reports of 2003, 2006 and 2011 all describe Epithalamin given at the Institute of Gerontology in Kiev from 1992, through 1994 in the 2003 report and through 1995 in the later two, and the 2006 and 2011 papers report identical three-year changes in cardiovascular functional age and exercise tolerance. Yet the Epithalamin group is 46, 36 and 39 people, the control is 48, 34 and 40, and the control is placebo, saline and basic therapy alone in turn. Our reading that they overlap is an inference: whether they are one cohort, overlapping subsets or different groups cannot be settled from the papers; they cannot be counted as three independent trials. Across all 22 Epithalamin human records, at least 6 abstracts describe the extract given alongside other agents. None of this transfers to synthetic Epitalon, which has never been tested in a comparable cohort.

Has Epitalon been tested in a registered clinical trial?

No. We queried four registries on 17 October 2026 with 11 terms: Epitalon, Epithalon, Epithalone, Epitalone, AEDG, Ala-Glu-Asp-Gly, alanyl-glutamyl-aspartyl-glycine, Epithalamin, Epithalamine, Epitalamin and “pineal peptide”.

Registry How searched Studies found
ClinicalTrials.gov44 API v2, each term as condition/other term and as intervention 0
ISRCTN45 Public query API, each term 0
EU Clinical Trials Information System (CTIS)46 Public search API, each term 0
EU Clinical Trials Register (EudraCT)47 Web search: “epitalon”; and “epithalamin OR epithalon OR epithalone OR AEDG” 0

Trial registries, 17 October 2026. The literal queries and raw responses are in the dataset.

Epitalon did once enter a regulatory pathway that could have led to a trial. On 2 September 2010 the FDA granted an orphan designation for “treatment of retinitis pigmentosa” to an Australian sponsor, BioDiem Ltd; the designation is now listed as withdrawn or revoked, and no orphan approval followed.48 The FDA’s 2026 briefing dates the withdrawal to 6 January 2016.6 No registered study came out of it.

What does this literature allow us to say, and what not?

  1. “Epitalon” and “Epithalamin” are not interchangeable, and their evidence cannot be pooled. They have separable literatures (165 and 103 records, 25 shared), different identifiers in MeSH and at the FDA, and very different human records (3 against 22). PubChem’s synonym list merges them, so automated counts inherit the error. Every human mortality figure in this field belongs to the extract.
  2. Authorship is highly concentrated. Between 72.7% and 92.7% of Epitalon records, depending on the definition, carry an author from the originating group or its co-author network; the range for primary experiments is 74.8% to 96.4%. Under the headline definition, unlinked experimental work amounts to five records, four of them since 2022. This measures authorship, not the validity of any single result.
  3. The core telomere claim has no clean independent replication. The 2025 Brunel study is the only unlinked test. Its corrected figures show telomere elongation in two cancer lines and in a panel labelled inconsistently between the two normal lines, and no significant change in the fibroblast panel, the cell type of the 2003 claim; its uncorrected text reports increases in both normal lines. No unlinked study measuring telomeres in an animal or person given Epitalon was located.
  4. The lifespan claim is weaker than its reputation, even inside the group’s own data. In the five mouse cohorts whose survival tables we read, mean lifespan rose significantly in two and did not change significantly in three; in one, the longest-lived tenth died significantly earlier than controls. Gains in maximum lifespan rest on single animals. No unlinked lifespan study was located.
  5. The melatonin claim has a negative result that is rarely cited. The only test run in an external laboratory found no effect on basal or stimulated melatonin secretion by isolated rat pineal glands, young or old, although its small size cannot exclude small effects.
  6. Human evidence for the synthetic peptide is hypothesis-generating, not more. Two small comparisons described as randomised and one comparison for which randomisation is not reported, none registered, none with a declared primary endpoint, a stated allocation method or reported blinding, all with surrogate endpoints and no published safety data, which is also the FDA’s reading.
  7. The Epithalamin mortality data are weaker than their abstracts. Three Kiev reports of treatment started in 1992 give different group sizes and different controls, two report identical intermediate results, and one reproduces a melatonin table that another paper presents for a different population. They cannot be treated as independent trials.
  8. The MeSH “Humans” tag overstates human evidence about 18-fold here. 54 of 165 records carry it; 3 are studies in people. Any tool that counts the tag as human evidence is counting cell cultures.
  9. There is no toxicology package. The FDA found no pharmacokinetic, acute, repeat-dose, reproductive or two-year carcinogenicity studies, and no clinical study of immunogenicity.6

Legality attaches to what a substance is used for and where, not to the molecule. For Europe, the verified facts are these: no authorisation of Epitalon as a medicine was located in the Union Register or reported for the member states the FDA checked, no EU clinical trial was located, and no Novel Food entry or authorisation was located. Presenting or supplying it for human use brings it within the definition of a medicinal product, a regime it has never satisfied; how member states classify and enforce the supply of such substances differs.

Jurisdiction or body Status Primary source, date checked
European Union, centralised authorisation No current or past authorisation, refusal or current orphan designation for Epitalon in the Union Register Union Register of medicinal products49, 17 Oct 2026
EU member states and others No approved products in Belgium, France, Germany, Ireland, Italy, Norway, Spain, the United Kingdom, Canada or Australia; not in the European Pharmacopoeia FDA briefing document, May 20266
EU medicines law A product “presented as having properties for treating or preventing disease in human beings”, or used to modify physiological functions by a pharmacological, immunological or metabolic action, is a medicinal product Directive 2001/83/EC, Art. 1(2)50
EU clinical trials None registered CTIS and EU CTR4647, 17 Oct 2026
EU food law (Novel Food) No entry among the 966 entries of the Novel Food status Catalogue; no authorisation located. Placing a novel food on the market requires prior authorisation Novel Food Catalogue51, 17 Oct 2026; Regulation (EU) 2015/228352
World Anti-Doping Agency Not named in the 2026 Prohibited List. Section S0 prohibits at all times any pharmacological substance not covered elsewhere “with no current approval by any governmental regulatory health authority for human therapeutic use”; we found no such approval for Epitalon WADA Prohibited List 202653
United States, FDA approval Not approved; not a component of any approved drug; no USP monograph FDA briefing document6
United States, compounding (503A) Formerly in category 2 (“may present significant safety risks”); the nominations were withdrawn. FDA evaluated it on its own initiative for insomnia and recommended against listing. On 24 July 2026 the advisory committee recommended listing: 7 in favour and 1 abstention; published tallies differ on the votes against (4 or 5), and official minutes had not been posted by 17 October 2026. FDA’s category list, updated 14 May 2026, places it in no category; we found no Federal Register action after the vote FDA category 2 page (22 Apr 2026)54; FDA nominated-substances list55; meeting page56; vote as reported by RAPS57 and other trade press; Federal Register58
United States, orphan drug Designated 2 Sep 2010 for retinitis pigmentosa (BioDiem Ltd); withdrawn or revoked FDA OOPD database48
Russia Epithalamin is described in the literature as a Russian pharmacopoeial preparation made by Samson, St Petersburg.1819 We could not verify current registration of Epithalamin or Epitalon in the state register (GRLS), which sits behind a CAPTCHA Not verified with a primary source

Regulatory status of Epitalon by jurisdiction. “Not named” on the WADA list is not the same as permitted; the S0 reading is ours, from WADA’s wording, not a WADA statement about Epitalon.

Three points need care. First, the FDA advisory vote is a recommendation, not a decision, and its exact tally is not yet on the official record; the agency’s own reviewers had concluded that the evidence weighed against listing, citing poor characterisation, possible immunogenicity and the absence of efficacy and safety data.6 Second, national enforcement differs across EU member states even though the definition of a medicinal product is common; possession or import for human use can carry penalties in some countries and not in others. Third, products sold as Epitalon are not always what the label says: the 2015 Belgian analysis identified it in two illegal pharmaceutical preparations,13 and the FDA notes that different salts are sold under the same common name.6

What is still unknown about Epitalon?

  • Pharmacokinetics. No study in any species reports absorption, half-life, distribution or clearance; the FDA found none.6 For a four-residue peptide made of common amino acids, how much survives intact in blood is an open question, not a detail.
  • A lifespan test by an unlinked laboratory. None was located in PubMed as of 17 October 2026, in any organism.
  • A melatonin test by an unlinked laboratory. None was located; the only external-laboratory experiment, with origin co-authors, was null; the positive primate and human data come from the group.
  • Mechanism. DNA- and histone-binding models are computational or cell-free, from the originating group. No biochemical test by an unlinked laboratory was located.
  • Telomeres in vivo. No study measuring telomere length in animals or people given Epitalon by an unlinked laboratory was located.
  • Carcinogenic potential. Telomerase activation and ALT induction in cancer lines raise a question that existing rodent tumour studies, short and from one group, were not designed to answer.616
  • Whether AEDG occurs naturally. A 2017 mass-spectrometry paper from the group reports AEDG in the pineal polypeptide complex;59 no reproduction by another laboratory was located.
  • The human cohorts. Whether the 12- and 15-year Epithalamin cohorts are one population, and how allocation was done, cannot be settled from abstracts.

Method note

Synonyms first. We took synonyms from PubChem CID 219042 and from the MeSH Supplementary Concept records, and kept PubChem’s merged Epithalamin synonyms as a separate query rather than folding them in.345 Database codes and vendor catalogue numbers were not used as search terms.

PubMed queries, run 17 October 2026 through NCBI E-utilities.

  • Epitalon: ("alanyl-glutamyl-aspartyl-glycine"[nm] OR epitalon[tiab] OR epithalon[tiab] OR epithalone[tiab] OR epitalone[tiab] OR "Ala-Glu-Asp-Gly"[tiab] OR AEDG[tiab] OR "alanyl-glutamyl-aspartyl-glycine"[tiab]): 174 records.
  • Epithalamin: ("epithalamin"[nm] OR epithalamin*[tiab] OR epitalamin*[tiab] OR "pineal peptide preparation"[tiab] OR "pineal polypeptide extract"[tiab]): 107 records.
  • Union: 256 records. For comparability with the Evidence Index we also ran its own name query with the corrected publication-type filter: 174 records, 58 tagged “Humans”, 1 tagged as a clinical trial.

Classification. One reader classified every record from its title and abstract, and from MeSH and publication types when there was no abstract (23 records). Substance: Epitalon, Epithalamin, both, another pineal extract, or false positive. Model: in vitro or ex vivo (cells, tissues, isolated organs, enzymes, including human cells), animal in vivo, human in vivo (the substance given to, or tested in, people), review, chemistry or analytical, in silico, other. One record first read as in vitro was reclassified as a human study after the FDA’s description of its English version showed a placebo-controlled design.

Full texts. Fourteen full texts were read: the three human studies of Epitalon and the World Heart Journal report, four Epithalamin human reports, four mouse lifespan publications, the 2003 melatonin experiment, and the 2025 Brunel study with its correction. The 2002 retinitis pigmentosa paper and the 2005 Russian lifespan paper were read from OCR text, and every number used from them was checked against the page images of the original. The file supplied for the Russian night-shift study turned out to be a different paper by the same group (an in vitro study, PMID 33342107), so that study’s design comes from the World Heart Journal report and the FDA briefing. The two rat lifespan publications were not available in full. Full texts are cited, not redistributed; short quotations only.

Blind double coding. A random sample of 40 records (15% of 256, rounded up to the minimum of 40; seed 20261017) was classified a second time by an independent coder, a separate model instance given only titles, abstracts, publication types and MeSH headings, with no access to the first coder’s labels. Agreement on model was 100% (Cohen’s kappa 1.00); on substance, 87.5% (kappa 0.78). The five substance disagreements concern records where the abstract does not name the preparation (two older papers on unnamed “pineal peptides” that PubMed indexes under the Epithalamin concept), one record that discusses both substances, and one sequence-motif analysis. First-coder labels were kept, with reasons, in doublecode/agreement.json.

Replication search. For each recurring claim, the census queries were combined with the claim’s terms and every unlinked hit was read and assigned a category (direct replication, conceptual replication, partial replication, conceptual support, null result, no information). Script: 12_replication_search.py; terms and hits in dataset.json.

Authorship concentration. Headline definition: origin core = any author normalised to Khavinson V, Anisimov V, Morozov V or Dilman V, or any affiliation to the Institute of Bioregulation and Gerontology; network = all co-authors of core records (284 names after normalising transliterations). Four alternative definitions (names only; temporal network; strict network; core only), an affiliation-only reading and a funding check are reported in the sensitivity table. Country is taken from the affiliation field; for 83 older records without one, it is inferred from the language of the article and flagged as inferred.

Registries and regulators. ClinicalTrials.gov API v2, ISRCTN API and the CTIS public search API were queried by script; the EU Clinical Trials Register was searched through its web interface. Regulatory entries were read on the official pages listed in the table and the references.

Limitations. One coder classified all records and a second coder checked a 40-record sample; borderline cases are flagged in the note field. Abstracts, not full texts, were the basis, and 56 Epitalon records are in Russian. Authorship rules can over-count dependence when common surnames collide and under-count it when a collaborator never co-signed with the core; the sensitivity table brackets this. PubMed is not exhaustive: Russian-language journals outside MEDLINE, such as the World Heart Journal paper above, are missed. “Null” marks only what an abstract states. Every negative statement on this page means “not located in the sources named, on 17 October 2026”.

Comparison with the earlier automated count. Condor’s Research Compound Evidence Index (22 September 2026, unpublished) recorded for Epitalon: 173 records, 57 tagged “Humans”, 0 trials in PubMed, 0 on ClinicalTrials.gov, confidence medium. Its trial filter used a publication-type syntax that PubMed now returns as zero for every compound; with the corrected syntax the same name query returns 1. The census replaces that row.

Measure Evidence Index, 22 Sep 2026 Same query, corrected filter, 17 Oct 2026 Census, 17 Oct 2026
Records 173 174 165 (after reading)
“Humans” tag 57 58 54; 3 human studies
Clinical-trial publication type 0 1 1
Registered trials 0 (ClinicalTrials.gov) 0 0 in four registries

Evolution of the Epitalon row of the Evidence Index. Script: 05_index_row.py.

Data and code. dataset.json contains every record with its classification and full author list, a data dictionary, the queries, registry responses, the sensitivity analysis, the double-coding results, the replication ledger with search terms, the human-study tables and the regulatory table. The scripts that reproduce every number and figure (01_fetch_pubmed.py to 12_replication_search.py) are published with it. Licence: CC BY 4.0.

How to cite. Condor Research Editorial. Epitalon Evidence Card: a census of the Epitalon and Epithalamin literature. Version 1.0-rc, 17 October 2026. https://condorresearch.com/research/what-is-epitalon/. Dataset: dataset.json, CC BY 4.0.

Changelog. Version 1.0-rc2 (18 October 2026): RUO review wording changes. Version 1.0-rc (17 October 2026): Key findings box added; FDA listing of human studies described exactly; Brunel telomerase comparisons separated and Figure 1D labelling noted; Kiev and Ivko/World Heart Journal correspondences marked as inferred; Kiev treatment years corrected (1992 to 1994 in the 2003 report); residual treatment-frequency wording removed from the Epithalamin table; “not randomised” replaced by “randomisation not reported”. Version 0.95 (17 October 2026): 14 full texts read. Human-study tables rebuilt from full text (design, arms, allocation, blinding, duration, losses, endpoints, interests); Ivko 2020 and the World Heart Journal 2021 report merged as one cohort; third origin story for the sequence (retinal extract) added. Lifespan rebuilt by cohort with survival tables: the 2005 paper moves from “not assessable” to “no significant change in mean lifespan” in two cohorts, with shorter survival of the longest-lived tenth in SAMR-1; the CBA maximum rests on one animal. Melatonin null described in detail. Brunel 2025 reclassified from conceptual to partial, internally inconsistent replication after reading the corrected figures. New conclusion on the Kiev Epithalamin reports. Version 0.9 (17 October 2026): first public version of the census; authorship concentration with sensitivity analysis; replication categories; blind double coding of a 40-record sample; correction to the 2025 Brunel study read and described; FDA advisory tally stated as reported, pending minutes.

Laboratory supply of the reference material is described on the product pages for Epitalon (vial) and Epitalon capsules; related compounds from the same programme are mapped in the Khavinson bioregulators catalogue.

References

  1. Araj SK, Brzezik J, Mądra-Gackowska K, et al. Overview of Epitalon-Highly Bioactive Pineal Tetrapeptide with Promising Properties. Int J Mol Sci. 2025. PMID 40141333. DOI 10.3390/ijms26062691.
  2. Jain A, Gallacher DM, Issa MA, et al. Epitalon and Epithalamin: A Narrative Review of Mechanistic, Preclinical, and Clinical Evidence. Int J Mol Sci. 2026. PMID 42884164. DOI 10.3390/ijms27198922.
  3. National Center for Biotechnology Information. PubChem Compound Summary for CID 219042, Epitalon (synonyms and computed properties). Accessed 2026-10-17. Link.
  4. National Library of Medicine. MeSH Supplementary Concept: alanyl-glutamyl-aspartyl-glycine (UID 67421253). Accessed 2026-10-17. Link.
  5. National Library of Medicine. MeSH Supplementary Concept: epithalamin (UID 67027437), registry number 64082-79-7. Accessed 2026-10-17. Link.
  6. US Food and Drug Administration. FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: Epitalon-related bulk drug substances (epitalon free base and epitalon acetate). Dated 2026-05-12. Accessed 2026-10-17. Link.
  7. Khavinson V, Razumovsky M, Trofimova S, et al. Pineal-regulating tetrapeptide epitalon improves eye retina condition in retinitis pigmentosa. Neuro Endocrinol Lett. 2002. PMID 12195242.
  8. Kuznik BI, Pateyuk AV, Rusaeva NS, et al. Effects of peptides Lys-Glu-Asp-Gly and Ala-Glu-Asp-Gly on hormonal activity and structure of the thyroid gland in hypophysectomized young chickens and old hens. Bull Exp Biol Med. 2011. PMID 22268052. DOI 10.1007/s10517-011-1177-3.
  9. Kuznik BI, Pateiuk AV, Rusaeva NS, et al. [Effects of Lys-Glu-Asp-Gly and Ala-Glu-Asp-Gly peptides on hormonal activity and thyroid morphology in hypophysectomized mature and old birds]. Adv Gerontol. 2011. PMID 21809626.
  10. Khavinson VK, Myl’nikov SV. Effect of pineal tetrapeptide on antioxidant defense in Drosophila melanogaster. Bull Exp Biol Med. 2000. PMID 10977918. DOI 10.1007/BF02439268.
  11. Alimova IN, Bashurin DA, Popovich IG, et al. [Effect of Epitalon and Vilon treatment on mammary carcinogenesis in transgenic erbB-2/NEU mice]. Vopr Onkol. 2002. PMID 12101568.
  12. Jung C-H. The microgram hypothesis: a translational dosing error in Epitalon peptide research and its implications for human aging application. Aging Pathobiol Ther. 2026. Not indexed in PubMed. DOI 10.31491/APT.2026.06.227. Link.
  13. Vanhee C, Moens G, Van Hoeck E, et al. Identification of the small research tetra peptide Epitalon, assumed to be a potential treatment for cancer, old age and Retinitis Pigmentosa in two illegal pharmaceutical preparations. Drug Test Anal. 2015. PMID 25535022. DOI 10.1002/dta.1771.
  14. Yue X, Liu SL, Guo JN, et al. Epitalon protects against post-ovulatory aging-related damage of mouse oocytes in vitro. Aging (Albany NY). 2022. PMID 35413689. DOI 10.18632/aging.204007.
  15. Ullah S, Haider Z, Perera CD, et al. Epitalon-activated telomerase enhance bovine oocyte maturation rate and post-thawed embryo development. Life Sci. 2025. PMID 39788414. DOI 10.1016/j.lfs.2025.123381.
  16. Al-Dulaimi S, Thomas R, Matta S, et al. Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activity. Biogerontology. 2025. PMID 40908429. DOI 10.1007/s10522-025-10315-x.
  17. Zhang Y, Qian S, Yang Q, et al. LCP2 mediates SUV39H1-driven cellular senescence-related chemoresistance in natural killer/T-cell lymphoma. Cell Death Dis. 2026. PMID 42209466. DOI 10.1038/s41419-026-08897-6.
  18. Shustov SB, Khavinson VKh, Shutak TS, et al. [Epithalamin effects on carbohydrate metabolism and cardiovascular system in patients with non-insulin dependent diabetes mellitus]. Klin Med (Mosk). 1998. PMID 9821374.
  19. Goncharova ND, Vengerin AA, Khavinson VKh, et al. Pineal peptides restore the age-related disturbances in hormonal functions of the pineal gland and the pancreas. Exp Gerontol. 2005. PMID 15664732. DOI 10.1016/j.exger.2004.10.004.
  20. Gupta D, Haldar C, Coeleveld M, et al. Ontogeny, circadian rhythm pattern, and hormonal modulation of 5 alpha-dihydrotestosterone receptors in the rat pineal. Neuroendocrinology. 1993. PMID 8097577. DOI 10.1159/000126341.
  21. Khavinson VKh, Bondarev IE, Butyugov AA. Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells. Bull Exp Biol Med. 2003. PMID 12937682. DOI 10.1023/a:1025493705728.
  22. Khavinson VK, Pendina AA, Efimova OA, et al. Effect of Peptide AEDG on Telomere Length and Mitotic Index of PHA-Stimulated Human Blood Lymphocytes. Bull Exp Biol Med. 2019. PMID 31761987. DOI 10.1007/s10517-019-04664-0.
  23. Pliss GB, Mel’nikov AS, Malinin VV, et al. [Effect of vilon and epithalone on induction and growth of induced bladder neoplasms in rats]. Vopr Onkol. 2001. PMID 11785104.
  24. Djeridane Y, Khavinson VKh, Anisimov VN, et al. Effect of a synthetic pineal tetrapeptide (Ala-Glu-Asp-GLy) on melatonin secretion by the pineal gland of young and old rats. J Endocrinol Invest. 2003. PMID 12809170. DOI 10.1007/BF03345159.
  25. Khavinson VKh, Bondarev IE, Butyugov AA, et al. Peptide promotes overcoming of the division limit in human somatic cell. Bull Exp Biol Med. 2004. PMID 15455129. DOI 10.1023/b:bebm.0000038164.49947.8c.
  26. Al-Dulaimi S, Thomas R, Matta S, et al. Correction: Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activity. Biogerontology. 2025. PMID 41240216. DOI 10.1007/s10522-025-10326-8.
  27. Anisimov VN, Khavinson VK, Mikhalski AI, et al. Effect of synthetic thymic and pineal peptides on biomarkers of ageing, survival and spontaneous tumour incidence in female CBA mice. Mech Ageing Dev. 2001. PMID 11163623. DOI 10.1016/s0047-6374(00)00184-6.
  28. Anisimov VN, Khavinson VKh, Alimova IN, et al. Epithalon decelerates aging and suppresses development of breast adenocarcinomas in transgenic her-2/neu mice. Bull Exp Biol Med. 2002. PMID 12459848. DOI 10.1023/a:1021104819170.
  29. Anisimov VN, Khavinson VKh, Popovich IG, et al. Effect of Epitalon on biomarkers of aging, life span and spontaneous tumor incidence in female Swiss-derived SHR mice. Biogerontology. 2003. PMID 14501183. DOI 10.1023/a:1025114230714.
  30. Anisimov VN, Popovich IG, Zabezhinskiĭ MA, et al. [Effect of epitalon and melatonin on life span and spontaneous carcinogenesis in senescence accelerated mice (SAM)]. Vopr Onkol. 2005. PMID 15909815.
  31. Vinogradova IA, Bukalev AV, Zabezhinski MA, et al. Effect of Ala-Glu-Asp-Gly peptide on life span and development of spontaneous tumors in female rats exposed to different illumination regimes. Bull Exp Biol Med. 2007. PMID 18856211. DOI 10.1007/s10517-007-0441-z.
  32. Vinogradova IA, Bukalev AV, Zabezhinski MA, et al. Geroprotective effect of ala-glu-asp-gly peptide in male rats exposed to different illumination regimens. Bull Exp Biol Med. 2008. PMID 19110597. DOI 10.1007/s10517-008-0121-7.
  33. Khavinson V, Goncharova N, Lapin B. Synthetic tetrapeptide epitalon restores disturbed neuroendocrine regulation in senescent monkeys. Neuro Endocrinol Lett. 2001. PMID 11524632.
  34. Khavinson VKh, Linkova NS, Kvetnoy IM, et al. Molecular cellular mechanisms of peptide regulation of melatonin synthesis in pinealocyte culture. Bull Exp Biol Med. 2012. PMID 22816096. DOI 10.1007/s10517-012-1689-5.
  35. Anisimov VN, Khavinson VK, Provinciali M, et al. Inhibitory effect of the peptide epitalon on the development of spontaneous mammary tumors in HER-2/neu transgenic mice. Int J Cancer. 2002. PMID 12209581. DOI 10.1002/ijc.10570.
  36. Anisimov VN, Khavinson VKh, Popovich IG, et al. Inhibitory effect of peptide Epitalon on colon carcinogenesis induced by 1,2-dimethylhydrazine in rats. Cancer Lett. 2002. PMID 12049808. DOI 10.1016/s0304-3835(02)00090-3.
  37. Korkushko OV, Lapin BA, Goncharova ND, et al. [Normalizing effect of the pineal gland peptides on the daily melatonin rhythm in old monkeys and elderly people]. Adv Gerontol. 2007. PMID 17969590.
  38. Ivko OM, Linkova NS, Ilina AR, et al. [AEDG peptide regulates human circadian rhythms genes expression during pineal gland accelerated aging.]. Adv Gerontol. 2020. PMID 33280326.
  39. Ivko OM, Linkova NS, Ilina AR, Sharova AA, Ryzhak GA. AEDG peptide regulation of the expression of human circadian rhythm genes upon accelerated aging of the pineal gland. Adv Gerontol. 2021;11(1):53-58. DOI 10.1134/S2079057021010380. Link.
  40. Khavinson V, Linkova N, Ivko O. AEDG peptide regulates the expression of circadian genes Clock, Cry2, Csnk1e in human immune cells. World Heart Journal. 2021;13(1):189-191. Not indexed in PubMed; no DOI. Listed as Article 47 in the issue’s table of contents: issue page; ProQuest record.
  41. Khavinson VKh, Morozov VG. Peptides of pineal gland and thymus prolong human life. Neuro Endocrinol Lett. 2003. PMID 14523363.
  42. Korkushko OV, Khavinson VKh, Shatilo VB, et al. Geroprotective effect of epithalamine (pineal gland peptide preparation) in elderly subjects with accelerated aging. Bull Exp Biol Med. 2006. PMID 17426848. DOI 10.1007/s10517-006-0365-z.
  43. Korkushko OV, Khavinson VKh, Shatilo VB, et al. Peptide geroprotector from the pituitary gland inhibits rapid aging of elderly people: results of 15-year follow-up. Bull Exp Biol Med. 2011. PMID 22451889. DOI 10.1007/s10517-011-1332-x.
  44. ClinicalTrials.gov API v2, 11 search terms, query.term and query.intr. Searched 2026-10-17. Link.
  45. ISRCTN registry, public query API, 11 search terms. Searched 2026-10-17. Link.
  46. EU Clinical Trials Information System (CTIS), public search API, 11 search terms. Searched 2026-10-17. Link.
  47. EU Clinical Trials Register (EudraCT). Searched 2026-10-17. Link.
  48. US Food and Drug Administration. Orphan Drug Designations and Approvals database: Epitalon, treatment of retinitis pigmentosa, designated 2010-09-02. Accessed 2026-10-17. Link.
  49. European Commission. Union Register of medicinal products for human use: active, non-active and refused products; orphan designations. Searched 2026-10-17. Link.
  50. Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use, Article 1(2), consolidated text. EUR-Lex. Link.
  51. European Commission. EU Novel Food status Catalogue (966 entries read 2026-10-17). Link.
  52. Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods. EUR-Lex. Link.
  53. World Anti-Doping Agency. International Standard Prohibited List 2026, in effect from 2026-01-01 (section S0 and index). Accessed 2026-10-17. Link.
  54. US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (page modified 2026-04-22). Accessed 2026-10-17. Link.
  55. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A (updated 2026-05-14). Accessed 2026-10-17. Link.
  56. US Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee (agenda and materials). Accessed 2026-10-17. Link.
  57. Regulatory Affairs Professionals Society (RAPS). FDA advisory committee backs two more peptides, rejects one for compounding list. 2026. Secondary source for the vote count. Accessed 2026-10-17. Link.
  58. Federal Register. Pharmacy Compounding Advisory Committee; Notice of Meeting (2026-04-16, document 2026-07361). Search of the Federal Register API for ‘epitalon’, 2026-10-17: 1 document. Link.
  59. Khavinson VK, Kopylov AT, Vaskovsky BV, et al. Identification of Peptide AEDG in the Polypeptide Complex of the Pineal Gland. Bull Exp Biol Med. 2017. PMID 29124531. DOI 10.1007/s10517-017-3922-8.

Epitalon is discussed on this page as a laboratory reference compound for research use only (RUO): not for human or veterinary use, not for diagnostic or therapeutic application, and not for any food or cosmetic purpose. The human studies described here are summarised as published literature. Nothing on this page describes, recommends or implies human use, and no part of it should be read as a claim that Epitalon improves lifespan, sleep, vision or any other function in people.

Reference data
CAS number
307297-39-8
Molecular formula
C14H22N4O9
Molecular weight
390.34
Purity
≥99% (HPLC)
Presentation
10mg/vial
Storage
Store at -20°C, protect from light
Amino-acid sequence
Ala-Glu-Asp-Gly
Frequently asked
Is Epitalon the same as Epithalamin?

No. Epitalon is the synthetic tetrapeptide Ala-Glu-Asp-Gly (PubChem CID 219042, CAS 307297-39-8). Epithalamin is a polypeptide extract of bovine pineal glands (MeSH registry number 64082-79-7). MeSH and the FDA treat them as different substances; PubChem lists Epithalamin among Epitalon's synonyms, which merges the two literatures in automated searches. On 17 October 2026 PubMed held 165 Epitalon records and 103 Epithalamin records, 25 of them shared.

How many human studies of Epitalon have been published?

Three: a 2002 comparison against conventional therapy in retinitis pigmentosa (162 patients examined, 46 controls, randomisation not reported), a 2007 comparison, described as randomised, of melatonin in 40 healthy elderly people (15 given Epitalon) and a 2020-2021 placebo-controlled study of a urinary melatonin metabolite in 40 women working night shifts, apparently reported twice (inferred correspondence). All come from the St Petersburg originating group; none was registered, declared a primary endpoint, stated its allocation method or reported blinding. The mortality studies concern Epithalamin, the extract.

Has the Epitalon telomerase finding been replicated?

Only partially. The one test by an unlinked laboratory, a 2025 Brunel University London study (PMID 40908429), reports telomere extension in two breast cancer lines and normal cells. Its correction (PMID 41240216) replaced all three data figures: in the corrected figures the normal fibroblast line, the cell type of the 2003 claim, shows no significant change in telomere length, and telomerase activity in both normal lines is near background, while the uncorrected text reports increases. No unlinked study measuring telomeres in animals or people given Epitalon was located in PubMed as of 17 October 2026.

Are there clinical trials of Epitalon?

No registered trial of Epitalon or Epithalamin was located on 17 October 2026 in ClinicalTrials.gov, ISRCTN, the EU Clinical Trials Information System or the EU Clinical Trials Register, using 11 search terms. An FDA orphan designation for retinitis pigmentosa granted in 2010 was later withdrawn without a registered study.

Is Epitalon legal in the EU?

No EU marketing authorisation, Novel Food Catalogue entry or EU clinical trial for Epitalon was located on 17 October 2026. Under Directive 2001/83/EC a product presented for treating or preventing disease in people, or used to modify physiological functions, is a medicinal product, so supplying Epitalon for human use falls under medicines law. Enforcement differs between member states.

Is Epitalon banned by WADA, and what did the FDA decide in 2026?

Epitalon is not named on the WADA 2026 Prohibited List; section S0 covers pharmacological substances without approval by any government health authority for human therapeutic use, and no such approval for Epitalon was found. In the US it is not approved. FDA staff recommended against adding it to the 503A compounding list; on 24 July 2026 the advisory committee recommended listing, with 7 in favour and 1 abstention; published tallies differ on the votes against (4 or 5) and official minutes had not been posted by 17 October 2026. No subsequent FDA action was located in the Federal Register.

References
1Araj SK, Brzezik J, Mądra-Gackowska K, et al. Overview of Epitalon-Highly Bioactive Pineal Tetrapeptide with Promising Properties. Int J Mol Sci. 2025. PMID 40141333. DOI 10.3390/ijms26062691. link
2Jain A, Gallacher DM, Issa MA, et al. Epitalon and Epithalamin: A Narrative Review of Mechanistic, Preclinical, and Clinical Evidence. Int J Mol Sci. 2026. PMID 42884164. DOI 10.3390/ijms27198922. link
3National Center for Biotechnology Information. PubChem Compound Summary for CID 219042, Epitalon (synonyms and computed properties). Accessed 2026-10-17. link
4National Library of Medicine. MeSH Supplementary Concept: alanyl-glutamyl-aspartyl-glycine (UID 67421253). Accessed 2026-10-17. link
5National Library of Medicine. MeSH Supplementary Concept: epithalamin (UID 67027437), registry number 64082-79-7. Accessed 2026-10-17. link
6US Food and Drug Administration. FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: Epitalon-related bulk drug substances (epitalon free base and epitalon acetate). Dated 2026-05-12. Accessed 2026-10-17. link
7Khavinson V, Razumovsky M, Trofimova S, et al. Pineal-regulating tetrapeptide epitalon improves eye retina condition in retinitis pigmentosa. Neuro Endocrinol Lett. 2002. PMID 12195242. link
8Kuznik BI, Pateyuk AV, Rusaeva NS, et al. Effects of peptides Lys-Glu-Asp-Gly and Ala-Glu-Asp-Gly on hormonal activity and structure of the thyroid gland in hypophysectomized young chickens and old hens. Bull Exp Biol Med. 2011. PMID 22268052. DOI 10.1007/s10517-011-1177-3. link
9Kuznik BI, Pateiuk AV, Rusaeva NS, et al. [Effects of Lys-Glu-Asp-Gly and Ala-Glu-Asp-Gly peptides on hormonal activity and thyroid morphology in hypophysectomized mature and old birds]. Adv Gerontol. 2011. PMID 21809626. link
10Khavinson VK, Myl'nikov SV. Effect of pineal tetrapeptide on antioxidant defense in Drosophila melanogaster. Bull Exp Biol Med. 2000. PMID 10977918. DOI 10.1007/BF02439268. link
11Alimova IN, Bashurin DA, Popovich IG, et al. [Effect of Epitalon and Vilon treatment on mammary carcinogenesis in transgenic erbB-2/NEU mice]. Vopr Onkol. 2002. PMID 12101568. link
12Jung C-H. The microgram hypothesis: a translational dosing error in Epitalon peptide research and its implications for human aging application. Aging Pathobiol Ther. 2026. Not indexed in PubMed. DOI 10.31491/APT.2026.06.227. link
13Vanhee C, Moens G, Van Hoeck E, et al. Identification of the small research tetra peptide Epitalon, assumed to be a potential treatment for cancer, old age and Retinitis Pigmentosa in two illegal pharmaceutical preparations. Drug Test Anal. 2015. PMID 25535022. DOI 10.1002/dta.1771. link
14Yue X, Liu SL, Guo JN, et al. Epitalon protects against post-ovulatory aging-related damage of mouse oocytes in vitro. Aging (Albany NY). 2022. PMID 35413689. DOI 10.18632/aging.204007. link
15Ullah S, Haider Z, Perera CD, et al. Epitalon-activated telomerase enhance bovine oocyte maturation rate and post-thawed embryo development. Life Sci. 2025. PMID 39788414. DOI 10.1016/j.lfs.2025.123381. link
16Al-Dulaimi S, Thomas R, Matta S, et al. Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activity. Biogerontology. 2025. PMID 40908429. DOI 10.1007/s10522-025-10315-x. link
17Zhang Y, Qian S, Yang Q, et al. LCP2 mediates SUV39H1-driven cellular senescence-related chemoresistance in natural killer/T-cell lymphoma. Cell Death Dis. 2026. PMID 42209466. DOI 10.1038/s41419-026-08897-6. link
18Shustov SB, Khavinson VKh, Shutak TS, et al. [Epithalamin effects on carbohydrate metabolism and cardiovascular system in patients with non-insulin dependent diabetes mellitus]. Klin Med (Mosk). 1998. PMID 9821374. link
19Goncharova ND, Vengerin AA, Khavinson VKh, et al. Pineal peptides restore the age-related disturbances in hormonal functions of the pineal gland and the pancreas. Exp Gerontol. 2005. PMID 15664732. DOI 10.1016/j.exger.2004.10.004. link
20Gupta D, Haldar C, Coeleveld M, et al. Ontogeny, circadian rhythm pattern, and hormonal modulation of 5 alpha-dihydrotestosterone receptors in the rat pineal. Neuroendocrinology. 1993. PMID 8097577. DOI 10.1159/000126341. link
21Khavinson VKh, Bondarev IE, Butyugov AA. Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells. Bull Exp Biol Med. 2003. PMID 12937682. DOI 10.1023/a:1025493705728. link
22Khavinson VK, Pendina AA, Efimova OA, et al. Effect of Peptide AEDG on Telomere Length and Mitotic Index of PHA-Stimulated Human Blood Lymphocytes. Bull Exp Biol Med. 2019. PMID 31761987. DOI 10.1007/s10517-019-04664-0. link
23Pliss GB, Mel'nikov AS, Malinin VV, et al. [Effect of vilon and epithalone on induction and growth of induced bladder neoplasms in rats]. Vopr Onkol. 2001. PMID 11785104. link
24Djeridane Y, Khavinson VKh, Anisimov VN, et al. Effect of a synthetic pineal tetrapeptide (Ala-Glu-Asp-GLy) on melatonin secretion by the pineal gland of young and old rats. J Endocrinol Invest. 2003. PMID 12809170. DOI 10.1007/BF03345159. link
25Khavinson VKh, Bondarev IE, Butyugov AA, et al. Peptide promotes overcoming of the division limit in human somatic cell. Bull Exp Biol Med. 2004. PMID 15455129. DOI 10.1023/b:bebm.0000038164.49947.8c. link
26Al-Dulaimi S, Thomas R, Matta S, et al. Correction: Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activity. Biogerontology. 2025. PMID 41240216. DOI 10.1007/s10522-025-10326-8. link
27Anisimov VN, Khavinson VK, Mikhalski AI, et al. Effect of synthetic thymic and pineal peptides on biomarkers of ageing, survival and spontaneous tumour incidence in female CBA mice. Mech Ageing Dev. 2001. PMID 11163623. DOI 10.1016/s0047-6374(00)00184-6. link
28Anisimov VN, Khavinson VKh, Alimova IN, et al. Epithalon decelerates aging and suppresses development of breast adenocarcinomas in transgenic her-2/neu mice. Bull Exp Biol Med. 2002. PMID 12459848. DOI 10.1023/a:1021104819170. link
29Anisimov VN, Khavinson VKh, Popovich IG, et al. Effect of Epitalon on biomarkers of aging, life span and spontaneous tumor incidence in female Swiss-derived SHR mice. Biogerontology. 2003. PMID 14501183. DOI 10.1023/a:1025114230714. link
30Anisimov VN, Popovich IG, Zabezhinskiĭ MA, et al. [Effect of epitalon and melatonin on life span and spontaneous carcinogenesis in senescence accelerated mice (SAM)]. Vopr Onkol. 2005. PMID 15909815. link
31Vinogradova IA, Bukalev AV, Zabezhinski MA, et al. Effect of Ala-Glu-Asp-Gly peptide on life span and development of spontaneous tumors in female rats exposed to different illumination regimes. Bull Exp Biol Med. 2007. PMID 18856211. DOI 10.1007/s10517-007-0441-z. link
32Vinogradova IA, Bukalev AV, Zabezhinski MA, et al. Geroprotective effect of ala-glu-asp-gly peptide in male rats exposed to different illumination regimens. Bull Exp Biol Med. 2008. PMID 19110597. DOI 10.1007/s10517-008-0121-7. link
33Khavinson V, Goncharova N, Lapin B. Synthetic tetrapeptide epitalon restores disturbed neuroendocrine regulation in senescent monkeys. Neuro Endocrinol Lett. 2001. PMID 11524632. link
34Khavinson VKh, Linkova NS, Kvetnoy IM, et al. Molecular cellular mechanisms of peptide regulation of melatonin synthesis in pinealocyte culture. Bull Exp Biol Med. 2012. PMID 22816096. DOI 10.1007/s10517-012-1689-5. link
35Anisimov VN, Khavinson VK, Provinciali M, et al. Inhibitory effect of the peptide epitalon on the development of spontaneous mammary tumors in HER-2/neu transgenic mice. Int J Cancer. 2002. PMID 12209581. DOI 10.1002/ijc.10570. link
36Anisimov VN, Khavinson VKh, Popovich IG, et al. Inhibitory effect of peptide Epitalon on colon carcinogenesis induced by 1,2-dimethylhydrazine in rats. Cancer Lett. 2002. PMID 12049808. DOI 10.1016/s0304-3835(02)00090-3. link
37Korkushko OV, Lapin BA, Goncharova ND, et al. [Normalizing effect of the pineal gland peptides on the daily melatonin rhythm in old monkeys and elderly people]. Adv Gerontol. 2007. PMID 17969590. link
38Ivko OM, Linkova NS, Ilina AR, et al. [AEDG peptide regulates human circadian rhythms genes expression during pineal gland accelerated aging.]. Adv Gerontol. 2020. PMID 33280326. link
39Ivko OM, Linkova NS, Ilina AR, Sharova AA, Ryzhak GA. AEDG peptide regulation of the expression of human circadian rhythm genes upon accelerated aging of the pineal gland. Adv Gerontol. 2021;11(1):53-58. DOI 10.1134/S2079057021010380. link
40Khavinson V, Linkova N, Ivko O. AEDG peptide regulates the expression of circadian genes Clock, Cry2, Csnk1e in human immune cells. World Heart Journal. 2021;13(1):189-191. Not indexed in PubMed; no DOI. Listed as Article 47 in the issue's table of contents: issue page; ProQuest record. link
41Khavinson VKh, Morozov VG. Peptides of pineal gland and thymus prolong human life. Neuro Endocrinol Lett. 2003. PMID 14523363. link
42Korkushko OV, Khavinson VKh, Shatilo VB, et al. Geroprotective effect of epithalamine (pineal gland peptide preparation) in elderly subjects with accelerated aging. Bull Exp Biol Med. 2006. PMID 17426848. DOI 10.1007/s10517-006-0365-z. link
43Korkushko OV, Khavinson VKh, Shatilo VB, et al. Peptide geroprotector from the pituitary gland inhibits rapid aging of elderly people: results of 15-year follow-up. Bull Exp Biol Med. 2011. PMID 22451889. DOI 10.1007/s10517-011-1332-x. link
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Condor Research Editorial
Written by Condor Research Editorial. References link to the primary literature; preprints and regulatory documents are labelled as such. Research use only — no therapeutic claims. RUO disclaimer → · Editorial policy →
What is Epitalon? The microgram hypothesis and the dose the internet keeps getting wrong
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Epitalon
≥99% HPLC · Certificate of analysis per batch · Dispatched across Europe
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