Peptides Go Mainstream: What Hims & Hers’ 2026 Move Tells Us About the Category

Condor Research supplies characterised reference materials for laboratory research use only. This article is commentary on an industry development. Nothing here is a recommendation to use any compound in humans.

What Hims actually said

Two things, and they are different in kind.

The first is a near-term commercial plan. CEO Andrew Dudum told investors the company will, before the end of 2026, offer substances that compounding pharmacies are already permitted to make — Reuters and Endpoints both list NAD+, sermorelin and glutathione. Nothing about that requires a regulatory change. It is a product launch inside existing rules.

The second is a bet. The company has begun testing active pharmaceutical ingredients, BPC-157 among them, at its Menlo Park manufacturing site. Dudum’s phrasing to investors was conditional and precise: “if and when the FDA does decide to move these peptides to the Category 1 list, we’ll be able to move extremely quickly.” He has separately said the company is waiting for “full and final rulemaking” before selling the peptides under review.

That distinction is the whole story. Hims is not launching BPC-157. It is building the supply chain, the analytical work and the clinical guidelines now so that it can launch on day one if the rules change, while selling the already-permitted substances in the meantime. The company’s new chief medical officer, Anant Vinjamoori, testified at the July advisory committee meeting in favour of lifting the restrictions.

Wall Street was unimpressed in the short term, and for a specific reason. The substances Hims can sell today are already widely available, so the near-term revenue impact is limited. “There’s no ‘release the floodgates’ demand like there is for other peptides that are in process of being rescheduled,” Paul Cerro of Cedar Grove Capital Management told Reuters. Morningstar’s Keonhee Kim made the sharper observation: because so much of this category moves through grey or unauthorised channels, it is genuinely hard to size what a legitimate offering is worth.

For context on scale: Hims reported second-quarter revenue of $753 million, up roughly 38% year on year, with subscribers approaching 2.9 million, alongside a net loss of $86.3 million driven by one-off costs including its Eucalyptus acquisition, restructuring after pivoting away from compounded weight-loss products, and legal provisions related to an FTC suit filed earlier in August.

The correction the coverage needs: NAD+ is not a peptide

Reuters, Endpoints and most of the trade press describe the first tranche — NAD+, sermorelin, glutathione — as peptides. One of those three is not, and the distinction is not pedantry. It goes to what this category actually is.

Sermorelin is a peptide. It is the first 29 amino acids of growth hormone-releasing hormone, the fragment that retains receptor activity. A chain of amino acids joined by peptide bonds, made by solid-phase synthesis. Unambiguous.

Glutathione is a peptide, but an unusual one, and the way it is unusual is genuinely interesting. It is a tripeptide — glutamate, cysteine, glycine — but the first bond is not a standard peptide bond. It connects the side-chain carboxyl of glutamate to cysteine, a γ-linkage rather than the usual α-linkage. That single structural quirk is why glutathione is not made on a ribosome like ordinary peptides, and why most peptidases cannot cut it. The cell builds it with two dedicated enzymes instead. A molecule that resists the normal degradation machinery because of one non-standard bond is a useful thing to keep in mind when thinking about peptide stability in general.

NAD+ is not a peptide at all. Nicotinamide adenine dinucleotide contains no amino acids and no peptide bonds. It is a dinucleotide coenzyme — two nucleotides joined through their phosphate groups — that shuttles electrons in redox reactions. Calling it a peptide is roughly like calling glucose a protein.

Why does it matter that a wire service got this wrong? Because “peptide” has stopped being a chemical description and started being a marketing category. Once the word means “wellness compound sold by injection or nasal spray”, it stops carrying information, and the actual scientific distinctions — which of these molecules are ribosomally derived, which survive gastric proteases, which are large enough to raise immunogenicity questions, which have a receptor anyone has identified — get flattened into a single shelf label. That flattening is precisely what makes the field hard to reason about.

What the move actually signals

Three things, none of which is “peptides have been validated”.

Distribution is being built ahead of permission. The reason Hims can talk about moving “extremely quickly” is that it already owns one of the most popular compounding pharmacies in the US. The bottleneck in this category has never been demand; it has been a lawful route from a manufacturer to a person with a prescription. A company that owns pharmacy, telehealth and manufacturing can assemble that route in weeks once the rule exists. That is a structural change in who is positioned to serve this market, and it happened before any regulatory decision.

Analytical rigour is arriving for commercial reasons. “Stability and validation testing” is an unglamorous phrase that carries the most weight in the story. Stability testing establishes how a substance degrades under defined conditions over time; validation establishes that the analytical methods used to measure it actually measure what they claim. FDA’s own reviewers identified exactly this gap in July, noting that certificates of analysis available for BPC-157 typically report purity and nothing else. A company that intends to sell at scale under a pharmacy licence cannot operate on a purity number alone, because it inherits liability for what it dispenses. The standard is being raised by exposure to consequences, not by conviction.

The grey market is now a competitive argument, not just a compliance problem. Part of the case made at the advisory committee was harm reduction: that refusing a regulated route pushes people toward an unregulated one. Whatever one thinks of that argument as regulatory logic, it doubles as a commercial thesis. The pitch is not that these compounds are proven. It is that if people are going to obtain them anyway, they should obtain characterised material through a channel with a licence attached. That is an honest description of the situation and a weak description of the evidence, simultaneously.

What has not changed

The peptides Hims is preparing for are still not approved medicines. The July advisory vote was a non-binding recommendation, made against the unanimous position of FDA’s own scientific reviewers, and adding a substance to the 503A Bulks List requires rulemaking and sign-off from the Secretary of Health and Human Services. Industry observers quoted by Reuters expect roughly a year. Until that completes, compounding these substances is not lawful, whatever preparation any company has done.

One shortcut exists. Mark Mikhael, CEO of compounder Olympia Pharmaceuticals, told Reuters that regulators could permit certain peptides in the interim through enforcement discretion — the mechanism by which FDA declines to act against a practice it has not formally authorised. That would move considerably faster than a final rule, and it is the single development most likely to change the picture before 2027.

There is also a vocabulary problem in Dudum’s own framing worth flagging. The “Category 1 list” is not the 503A Bulks List. Category 1 belongs to FDA’s interim policy for nominated substances, the bucket the agency has said it will not act against while evaluation continues. The advisory committee voted on the Bulks List, which is created by rulemaking. In April 2026 FDA removed twelve peptides from Category 2, the “significant safety risks” bucket — and that removal placed them in neither Category 1 nor on the Bulks List. It simply took away a warning. Three different objects, routinely reported as one.

The honest read

A listed company with a pharmacy, a manufacturing site and 2.9 million subscribers is preparing to enter a category that regulators have not yet opened, on the strength of an advisory vote that its own chief medical officer testified in favour of. That is not validation of the science. It is a well-capitalised bet on a rule change, made by an organisation that will do the stability work regardless because its licence depends on it.

The most useful thing to take from it is that second part. The compounds did not change in July 2026. What changed is who is now obliged to characterise them properly, and that obligation is going to produce data — on degradation, on impurity profiles, on batch consistency — that a decade of grey-market supply never generated. If anything genuinely good comes out of this cycle, it is likelier to come from the analytical requirements than from the vote.

Related reading

• What the July 2026 FDA compounding vote actually was
• The peptide grey market, explained
• Why Silicon Valley loves peptides
• NAD+, NMN and NR: what the human evidence shows
• Sermorelin: a GHRH fragment, explained