FDA panel backs unapproved peptides despite safety concerns Written byDDN editorial team

FDA panel backs unapproved peptides despite safety concerns Positive results for GLP-1 drugs in alcohol use disorder, a new collaboration to advance in vivo CAR T therapies, Phase 3 readouts in oncology, rare disease, and vitiligo, and more led the news this week. Written byDDN editorial team https://www.drugdiscoverynews.com/fda-panel-backs-unapproved-peptides-despite-safety-concerns-17408 An FDA advisory committee has voted to recommend adding six unapproved peptides to the agency's 503A bulk compounding list, a move that could eventually allow compounding pharmacies to produce the substances for patient-specific prescriptions despite ongoing concerns over their safety and efficacy. In closely split votes, the panel backed BPC-157, KPV, TB-500, MOTS-c, epitalon, and semax for a range of proposed uses including wound healing, ulcerative colitis, weight loss, migraines, pain, and insomnia, while rejecting emideltide for opioid withdrawal and sleep disorders. FDA scientific reviewers had advised against adding any of the peptides, citing a lack of robust clinical evidence and unanswered safety questions, but supporters argued that regulated compounding would provide a safer alternative to the growing grey market, where the substances are widely sold as research-grade products despite not being approved for human use. The recommendation does not immediately legalize compounded versions of the peptides, with the FDA now needing to decide whether to initiate the rulemaking process to add them to the 503A bulk compounding list, a step that could take a year or more. – Bree Foster