FDA staff reviewers have told agency officials that the current evidence is insufficient to justify allowing compounding pharmacies to produce seven popular peptides, according to documents made public Monday. Their written comments come in advance of a July 23-24 meeting of the FDA's Pharmacy Compounding Advisory Committee, which has been tasked with deciding whether these peptides should be added to the list of bulk drug substances permitted for use in compounded medicines.
Peptides are short chains of amino acids that serve as protein building blocks and carry out a range of biological functions in the body. Over the past year they have seen a surge in public attention, often promoted by wellness influencers for an array of uses even though robust evidence of safety and effectiveness is limited and adequate human studies are lacking.
The advisory panel will consider whether compounding pharmacies should be allowed to manufacture seven specific peptides. The list provided for review includes:
- BPC-157 - proposed for ulcerative colitis;
- KPV - proposed for wound healing and inflammatory conditions;
- TB-500 - proposed for wound healing;
- MOTS-c - proposed for obesity and osteoporosis treatment;
- Emideltide - proposed for opioid withdrawal and chronic insomnia;
- Semax - proposed for cerebral ischemia, migraines, and chronic pain;
- Epitalon - proposed for insomnia.
FDA reviewers emphasized that evidence supporting the peptides' effectiveness for these proposed uses is limited. The staff specifically flagged the absence of human clinical trials adequate to support routine compounded use, calling attention to the gaps in the available data.
The question of compounding peptides is not new. In 2023 the Biden Administration issued a prohibition on compounding pharmacies manufacturing peptides, pointing to potential risks associated with immunogenicity, toxicity and impurity. The advisory committee's recommendations are advisory and non-binding, but they are expected to shape the FDA's subsequent policy decision.
Alongside the staff review, the FDA announced new members of the panel that will consider these petitions. New appointees include Melissa Loseke, who operates a wellness clinic in Omaha, Nebraska, and Gabriel Alizaidy, scientific director at Maximus Health, a provider that offers GLP-1 microdosing protocols and other peptide therapies.
The committee's deliberations on July 23-24 will weigh the limited clinical evidence presented to date against questions of safety and quality in compounding practice. The staff reviewers' conclusion that evidence is lacking provides context for those forthcoming discussions and the eventual regulatory outcome.