PCAC Day 2 on Friday July 24, 2026 Votes to Recommend Semax 8-5 for Adult Cerebral Ischemia, Migraine, and Trigeminal Neuralgia and to Recommend Epitalon 7-4 for Adult Insomnia While Narrowly Voting to Recommend Against Adding Emideltide (Delta Sleep-Inducing Peptide, DSIP) to the Section 503A Bulks List; Two of Three Day-2 Peptides Clear the Panel Against FDA Career-Staff Recommendation While Emideltide Becomes the Only Peptide of the Seven Under Two-Day Review That Failed to Secure a Majority
The FDA Pharmacy Compounding Advisory Committee (PCAC) closed the two-day peptide session Friday July 24, 2026 with two more advisory wins and one narrow rejection. Semax, a synthetic heptapeptide derived from the ACTH(4-10) sequence developed in Russia as a nootropic, was recommended 8-5 for the Section 503A Bulks List for adult cerebral ischemia, migraine, and trigeminal neuralgia. Epitalon, a synthetic tetrapeptide nominated for insomnia and anti-aging, was recommended 7-4 for adult insomnia. Emideltide (delta sleep-inducing peptide, DSIP), a nonapeptide first isolated from rabbit brain in 1974 and nominated for insomnia and opioid withdrawal, was narrowly voted against, the sole rejection of the two-day session. STAT News framed the Day 2 outcome as 'FDA advisory panel narrowly rejects compounding of one peptide, backs two others.' FDA career-staff briefing documents released June 29-30 recommended against all three Day-2 peptides, citing insufficient evidence of effectiveness for Epitalon in insomnia and 'balancing of the criteria weighs against' Semax. The recommendations are advisory only.