PCAC Also Votes 8-6 With 1 Abstention on Thursday July 23 to Recommend Adding KPV (Lys-Pro-Val Tripeptide) to the 503A Bulks List, the Second Day-One Win for Broader Peptide Access; KPV Is an α-MSH-Derived Tripeptide Studied for Anti-Inflammatory Effects in the Gut and Nominated for Ulcerative Colitis and Inflammatory Conditions; PCAC Will Vote Later Thursday on TB-500 and MOTS-c to Complete Day 1 Before Reconvening Friday July 24 for the DSIP/Emideltide, Semax, and Epitalon Session
The FDA Pharmacy Compounding Advisory Committee (PCAC) voted identically 8-6 with 1 abstention on Thursday July 23, 2026 to recommend adding KPV to the Section 503A Bulk Drug Substances List. KPV is a tripeptide (lysine-proline-valine) derived from alpha-melanocyte-stimulating hormone (α-MSH) with anti-inflammatory activity documented primarily in preclinical inflammatory bowel disease and colitis models. It was nominated for ulcerative colitis and inflammatory conditions. FDA career staff recommended against adding KPV, noting thin human clinical trial evidence and 503A historical use questions. The 8-6 KPV vote matches the identical BPC-157 vote earlier in the session and reflects a coordinated panel disposition to override the FDA staff position on the two Day-1 morning peptides. The PCAC session continues Thursday afternoon with votes on TB-500 (thymosin beta-4 fragment for wound healing and tissue repair) and MOTS-c (mitochondrial-derived peptide for obesity and metabolic disease). The Friday July 24 session covers DSIP/Emideltide (delta sleep-inducing peptide), Semax (heptapeptide ACTH analog for cerebral ischemia and cognition), and Epitalon (tetrapeptide for anti-aging and insomnia).