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Hims & Hers Compounded Peptides: Year-End Launch Plans

Hims & Hers plans compounded peptides NAD+, sermorelin, and glutathione by year-end, with six more awaiting FDA rulemaking. Analysts see a $2.2-3.3B market.

By PeptidesBeat Staff

Last reviewed

Hims & Hers Health (NYSE: HIMS) told investors on its Aug. 10 second-quarter earnings call that it plans to sell already-permitted peptides before the end of 2026, starting with NAD+, sermorelin, and glutathione, while six additional compounds wait on final FDA rulemaking. Reuters

Legal update: Aug 27, 2026 — Fifth Circuit upholds FDA GLP-1 delisting

The Fifth Circuit upheld the FDA's removal of semaglutide and tirzepatide from the drug shortage list. Bulk compounding of these GLP-1s for general use is no longer allowed; patient-specific compounding for an individual with a documented medical need remains legal. Read the full ruling analysis →

What Hims & Hers Announced

CEO Andrew Dudum said the company is “currently developing a best-in-class peptide experience including U.S. manufactured products, clinical led guidance, and ongoing blood testing,” and expects to “offer access to already allowed peptides with safe and well-established supply chains before the end of the year.” Hims is building clinical protocols, supply-chain capabilities, and provider training for the category, per MarketBeat’s earnings call highlights.

The year-end group is separate from the six peptides the FDA’s Pharmacy Compounding Advisory Committee (PCAC) recommended in July for the 503A Bulks List — BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax. Hims will offer those only after the FDA completes final rulemaking, and has already begun validation and stability testing on their APIs at its Menlo Park facility, starting with BPC-157.

The announcement landed alongside strong Q2 results: revenue above $753 million, up about 40% year over year, roughly three million subscribers with 300,000 net new additions, and a raised FY2026 revenue outlook of $3.1 billion to $3.3 billion.

NAD+, Sermorelin, Glutathione: The Year-End Three

The three compounds are already widely available as wellness products, which is why Hims can move quickly. According to Reuters, they are used to support metabolic function (NAD+), weight loss (sermorelin), and immune function (glutathione), respectively.

The regulatory distinction matters: “already allowed” does not mean FDA-approved. Medical Daily noted the move pushes a company with nearly three million subscribers “into a wellness category built largely on claims that clinical trials have not tested.” NAD+ in particular is already sold across the gray market, which analysts say limits the revenue impact of an authorized offering.

The Market Opportunity Analysts See

Analysts estimate the broader peptide market at $2.2 billion (Leerink’s Michael Cherny) to $3.3 billion (Needham & Co), and demand has increased since the FDA began its peptide review in April, Reuters reported. Leerink separately estimated the peptides under review could create a $2.2 billion annual telehealth market, with Hims potentially capturing about 20% of that opportunity, per Benzinga. These are analyst estimates, not company guidance.

Wall Street’s Caution on Near-Term Revenue

Despite the size of the prize, investors and analysts told Reuters the year-end offering is “unlikely to drive revenue growth this year.” Because NAD+ is already broadly available, the launch carries less revenue impact than peptides awaiting FDA action. “There’s no ‘release the floodgates’ demand like there is for other peptides that are in process of being rescheduled,” said Paul Cerro, CIO of Cedar Grove Capital Management. Morningstar’s Keonhee Kim added that gray-market sales make the NAD+ opportunity hard to value, though Hims has “a large number of subscribers, customer loyalty and the brand feels fairly strong.”

Telehealth Platforms and the Compounding Pipeline

Hims & Hers is the highest-profile telehealth platform to move into compounded peptides, but the category’s regulatory path has been years in the making. The company sold compounded GLP-1s beginning in 2023, acquired a California peptide manufacturing facility in early 2025, and pivoted toward FDA-approved medications and limited-scale compounded semaglutide under its March 2026 partnership with Novo Nordisk. The Aug 27, 2026 Fifth Circuit ruling does not change that Novo partnership — limited-scale, patient-specific 503A compounding for documented medical needs remains legal — but it does end the separate shortage-based bulk channel: compounded GLP-1s for general use are no longer lawful, which is exactly why the year-end launches focus on already-permitted peptides rather than GLP-1 copies. Hims now operates against both an FTC suit filed July 29 and the FDA’s rulemaking clock, with the July PCAC vote — six of seven peptides recommended over FDA staff objections — the key catalyst.

We covered the run-up to that vote in our July PCAC preview and the FDA enforcement wave that preceded it. State regulators are also filling gaps while the FDA deliberates, as we detailed in State Peptide Regulation Fills the Federal Oversight Gap.

What to Watch

Two timelines now run in parallel: the year-end launch of NAD+, sermorelin, and glutathione — already-legal products that analysts say will do little for 2026 revenue — and the final FDA rulemaking that will decide the far larger market for the six PCAC peptides. For a company with three million subscribers and a history of scaling telehealth categories quickly, the second is the one that matters. Track the rulemaking calendar on our PCAC tracker.

Nothing in this article is medical advice. NAD+, sermorelin, and glutathione described here are permitted compounding ingredients, not FDA-approved treatments for any condition.

Novo’s DDC request, the pending 503B exclusion, and the Fifth Circuit’s Aug 27 ruling — which ended bulk GLP-1 compounding for general use — all bear on Hims’ compounded-peptide plans: full analysis: Compounded GLP-1 Ban: Novo and Lilly’s FDA Push Explained.

Update — September 19, 2026: telehealth privacy

The Associated Press reported on Saturday, September 19, 2026 that an analysis of nearly 50 telehealth companies selling GLP-1 drugs found fewer than a third required any real-time video or audio consultation with a physician, and that some prescriptions were approved within minutes. The study behind that count is a JAMA research letter from Yale, published online July 6, 2026.

That reporting returns to the FTC’s case against Hims & Hers, filed July 29, 2026: the agency alleges the company shared consumers’ sensitive health information with third-party advertising platforms and deceived users about billing and cancellation. Hims disputes the claims, calling the action “an effort to generate headlines at our expense.” Our new report sets out the consultation gap, the study’s findings, and why federal health-privacy law generally does not reach these sellers — the FTC rescinded its 2021 health-apps policy statement on September 9, 2026, while the Health Breach Notification Rule still applies to most health apps: GLP-1 Telehealth: Fewer Than a Third Consult a Doctor.

PeptidesBeat is an independent editorial publication covering peptide policy, research, and industry developments. We do not sell peptides, recommend dosing, or provide medical advice. All content is informational. Peptides referenced may be subject to FDA restrictions; consult a licensed healthcare provider for any therapeutic question.


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