FDA Advisory Panel Recommends Six of Seven Peptides for Compounding, Rejects Emideltide

The U.S. Food and Drug Administration's Pharmacy Compounding Advisory Committee voted over two days, July 23-24, 2026, to recommend adding six of seven nominated peptides to the Section 503A bulk drug substances list, the list of ingredients that traditional compounding pharmacies may use. The panel voted against the seventh, emideltide, also described as delta sleep-inducing peptide or DSIP. The votes are advisory and non-binding, and the FDA had not announced a final decision as of publication.

On the meeting's first day, the panel voted 8-6, with one abstention, to recommend BPC-157 for compounding to address ulcerative colitis, according to PharmExec and the FDA Law Blog. The panel reached the same 8-6-1 split recommending KPV, discussed for wound treatment and inflammatory conditions, and TB-500, discussed for wound healing. MOTS-c, discussed for potential use in obesity and osteoporosis, was recommended by a narrower 7-5 vote with two abstentions.

All four July 23 votes ran counter to the position FDA's own scientific review staff had taken ahead of the meeting; reviewers had told the committee they had not found sufficient human safety and effectiveness data to support any of the seven peptides, as Peptide Science Daily has reported. One dissenting panel member said, according to the FDA Law Blog, that she was "concerned that we are responding to market induced demand rather than a decision based in solid science."

The committee reconvened July 24 to consider the remaining three substances. It voted 8-5 to recommend semax for cerebral ischemia, migraine and trigeminal neuralgia, and 7-4, with one abstention, to recommend epitalon for insomnia, according to STAT News. Pharmacist David Pope, who backed epitalon, said a physician and pharmacist are "key to judging the risk to determine if the peptide is right" for a given patient, according to STAT and RAPS.

Emideltide fared differently. The panel voted 6-7, with one abstention, against recommending it for the 503A list, the only rejection among the seven substances discussed at the meeting, according to STAT News and RAPS. FDA reviewer Katie Park told the committee there was "a lack of safety and efficacy data to support using emideltide for treating insomnia, narcolepsy and opioid use disorder," RAPS reported. Pope, who had supported epitalon a day earlier, voted against emideltide, citing concerns about the downstream effects of a favorable recommendation, according to RAPS.

A favorable committee vote does not by itself add a substance to the 503A list. The FDA must still conduct notice-and-comment rulemaking, a process attorney Dustin Robinson told PharmExec could realistically take eight to twelve months before compounding pharmacies would have unambiguous legal authority to use the six recommended peptides. The agency is not obligated to follow the committee's recommendations, and it had not said when it would act as of publication.

None of the seven peptides is an FDA-approved drug, and a favorable PCAC recommendation would not change that. Compounded preparations are not reviewed by the FDA for safety, effectiveness or manufacturing quality before reaching patients. The review followed a 2023 FDA decision that had placed the peptides in a restrictive compounding category over concerns including impurities, immunogenicity risk and limited human safety data, and it came amid public support for wider peptide access from Health Secretary Robert F. Kennedy Jr., as Peptide Science Daily has reported. Readers should treat the committee's votes as a recommendation within an unresolved regulatory process, not a change in the approval status of any peptide.