#Ulcerative-Colitis

2 stories

Regulatory July 23, 2026 · View digest

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).

Research July 3, 2026 · View digest

BPC-157 Pipeline Retrospective Ahead of July 23 PCAC Vote: Three Decades of Preclinical Research from the Sikiric Laboratory but No Approved Formulation, No Validated Dosing Regimen, No Completed Phase 2 Clinical Trial; Small Ulcerative Colitis Pilot Data Suggested Mucosal Healing but Full Results Never Published in Peer-Reviewed Form

Twenty days before the July 23 PCAC vote on 503A bulks list eligibility for BPC-157, the FDA staff briefing documents and independent analyst reviews converge on a consistent picture of the substance's pharmaceutical-development state. Three decades of preclinical research led primarily by Predrag Sikiric's laboratory at the University of Zagreb (200+ published rodent studies covering tendon-to-bone healing, gastric mucosal protection, and vascular regeneration) have not yielded an approved formulation, a validated human dosing regimen, or a completed Phase 2 clinical trial in any indication. Pharmacokinetic data from rat and dog studies show plasma half-life under 30 minutes after IM or IV dosing, though the biological effects (angiogenesis, anti-inflammation, tissue regeneration initiation) persist for weeks to months in animal models. A limited Phase 2 pilot evaluated oral BPC-157 in ulcerative colitis patients with preliminary data suggesting mucosal-healing improvement and clinical-symptom-score benefit, but full results have not been published in peer-reviewed form. The historical evidence base is what PCAC weighs against the July staff briefing conclusion of insufficient evidence for 503A bulks list eligibility. Several biotech companies have publicly signaled 2026 plans to develop BPC-157 analogs with improved pharmacokinetic properties for tendon repair and IBD, but no company has yet advanced an analog into IND-stage development.