Undercutting HHS Secretary Robert F. Kennedy Jr.'s recent push to expand access to peptides, FDA career scientists determined there isn't adequate evidence to support any of the ones under consideration for production by compounding pharmacies.
At an upcoming meeting of FDA's Pharmacy Compounding Advisory Committee (PCAC) on July 23 and 24, the free base and acetate peptides that will be discussed are:BPC-157 (15 amino acids) for ulcerative colitisKPV (3 amino acids) for wound healing and inflammatory conditionsTB-500 (7 amino acids) for wound healingMOTS-c (16 amino acids) for obesity and osteoporosisEmideltide (9 amino acids) for opioid withdrawal, chronic insomnia, and narcolepsySemax (7 amino acids) for cerebral ischemia, migraine, and trigeminal neuralgiaEpitalon (4 amino acids) for insomnia
In the briefing documents, FDA scientists weighed against all of them, noting that all had lacking, flawed, or completely absent information on safety and efficacy in humans. All peptides except TB-500 were described as "not well-characterized from the physical and chemical characterization perspective." Reviewers noted particular immunogenicity risk for injectable formulations.
Of these peptides, emideltide had the most research. It's been studied for use in humans since at least 1981, according to the documents, and compounded since 2018. Because of its limited water solubility, it's unclear how emideltide could be formulated in the proposed injectable dosage. Injection and intranasal products are available in integrative neurology clinics, medical concierge services, medical spas, wellness clinics, and online, though it's not known if these products are compounded. In studies of intravenous emideltide, subjects with withdrawal symptoms reported side effects like transient headache, nausea, and vertigo, as well as cases of hypotension that were "progressive" following the second injection.
