San Francisco-based Hims & Hers plans to start selling compounded peptides by the end of 2026, with six more to follow pending final FDA rulemaking, executives said Aug. 10.
The direct-to-consumer telehealth company laid out a phased rollout on its second-quarter earnings call. Executives said they expect to offer a first group of already-permitted peptides — including sermorelin, glutathione and a product it markets as MEDplus — by year’s end, then expand to six wellness peptides an FDA advisory committee recommended in July.
“We are currently developing a best-in-class peptide experience including U.S.-manufactured products, clinical-led guidance and ongoing blood testing,” co-founder and CEO Andrew Dudum said. He said the company is “waiting on full and final rulemaking from the FDA” before launching the recommended peptides.
The FDA’s Pharmacy Compounding Advisory Committee voted July 24 to recommend six of seven peptides — including BPC-157, KPV, TB-500, MOTS-c, epitalon and semax — for the agency’s Section 503A bulk drug substances list, which governs what compounding pharmacies can prepare. The panel rejected the seventh, emideltide, citing insufficient evidence.
The recommendations are not binding, and the FDA has not issued a final rule. Hims & Hers is building manufacturing capacity ahead of that decision.
Mr. Dudum said the company is putting BPC-157 through stability and validation testing at its Menlo Park, Calif., facility so it can move quickly once rules are finalized. To develop dosing regimens, clinical protocols and clinician training for peptides and hormonal therapies, the company hired Anant Vinjamoori, MD, as chief medical officer of its Hims brand.
The peptide push comes as the telehealth company reworks its weight loss business, its largest growth engine. Hims has pulled back from compounded GLP-1 medications and steered patients toward branded drugs, including Novo Nordisk’s Wegovy pill. Peptides give the platform a new compounded category to sell as that access narrows.
For now, the timing of the peptide launch rests with the FDA, which has not said when — or whether — it will finalize the compounding rules the committee recommended.
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