FDA Advisory Panel Day 2 Results: Semax and Epitalon Recommended, Emideltide Rejected — Full Two-Day Scorecard
By RUOcodes.com Research Team
Published: · Updated: Sep 6, 2026
FDA PCAC Day 2 results: Semax, Epitalon, and Emideltide vote outcomes explained — what passed, what didn't, and what happens next.
Now that the votes are in, the next question is what actually happens next and when. For the complete five-step road map from advisory recommendation to legal compounding access — including the realistic 2027–2028 timeline and the Category 1 wildcard — read The FDA Voted. Now What? The Complete Regulatory Road Map After the PCAC Peptide Decision . For research and educational purposes only. Not medical advice. This post is a follow-up to our July 23 coverage of the FDA Pharmacy Compounding Advisory Committee hearings . If you missed Day 1, the short version is that the committee voted to recommend BPC-157 , KPV , TB-500 , and MOTS-c for inclusion on the 503A Bulk Drug Substances List by margins of 8–6 across three of the four compounds. Day 2 wrapped on Friday, July 24, 2026, and delivered one surprise in a largely consistent pattern. TL;DR: Day 2 Final Results — Semax and Epitalon Approved, Emideltide Rejected The FDA advisory committee voted to recommend Semax and Epitalon for compounding pharmacy access and voted against Emideltide. That brings the final two-day score to 6 out of 7 peptides recommended for inclusion on the 503A list, with Emideltide being the only compound that did not make it through. As with Day 1, these recommendations are non-binding. The FDA makes the final call. A rulemaking process must follow before anything changes at a pharmacy. The realistic timeline for access remains 2027 for most of these compounds. The Day 2 PCAC Votes: Semax, Epitalon, and Emideltide Semax PCAC Vote: 8–5 In Favor — Recommended for Compounding Semax received the strongest majority of Day 2 and one of the strongest of the entire two-day meeting. The committee voted 8–5 to recommend Semax for inclusion on the 503A Bulk Drug Substances List for the treatment of cerebral ischemia, migraine, and trigeminal neuralgia. This result carries particular weight because Semax has the most developed evidence base of the three Day 2…
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