FDA staff propose rejecting all seven peptides before next week's compounding committee

Seven documents, one conclusion

The committee will consider BPC-157, KPV, TB-500 and MOTS-c on July 23, and emideltide — better known as DSIP — semax and epitalon on July 24. Each compound is on the agenda twice, as a free base and as an acetate salt, because FDA treats those as different active ingredients. Fourteen substances in total.

FDA staff reached the same conclusion on all fourteen. The reasoning is consistent to the point of being formulaic: none of the substances is adequately characterised chemically, the information needed to assess immunogenicity risk is not available, the evidence of effectiveness for the reviewed use is insufficient or absent, and approved drugs already exist for the conditions each was nominated to treat.

The part that isn't uniform

The individual files diverge in ways the summary flattens. Emideltide is the only compound FDA credits with genuine historical use in compounding — and staff still propose against it, on the strength of the other criteria. Semax is the only one where FDA says parts of the available evidence demonstrated a lack of effectiveness rather than simply failing to establish it; staff also flag anticoagulant activity in animals and, separately, that semax potentiated amphetamine-induced dopamine release in mice. BPC-157 is the only one where FDA cites adverse-event reports involving compounded product. For KPV and MOTS-c, staff describe the human-use information as essentially non-existent.

One detail has gone largely unreported: all seven nominations were withdrawn. FDA is evaluating the substances at its own discretion, working from packages their sponsors abandoned.

What a vote would and wouldn't do

An advisory committee recommendation is advice. Adding a substance to the 503A Bulks List requires FDA rulemaking, and being on the list means a licensed pharmacist may use the substance in compounding for an individual patient — it is not drug approval, and it does not touch research-use-only material. Removal from Category 2 in April did not make these compounds eligible either. The three states get collapsed constantly, and they are not the same.

The public comment docket, FDA-2025-N-6895, closes July 22 and had drawn 1,876 comments as of July 16. A second meeting covering five more peptides is expected before the end of February 2027.

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