FDA advisory panel to review safety of seven experimental peptide therapies
The FDA's advisory committee will evaluate seven peptide compounds, including TB-500 and BPC-157, amid debate over their safety and potential market access.
The Food and Drug Administration’s advisory committee began a two-day meeting to assess seven experimental peptide therapies, such as TB-500, BPC-157 and MOTs-C. None of the compounds has completed the large-scale clinical trials normally required for FDA approval, and most data come from preclinical animal studies.
Proponents argue that current restrictions on compounding these substances have driven a gray market of overseas suppliers, while FDA scientists have recommended against allowing compounding pharmacies to produce any of the seven peptides. The panel will consider evidence for uses ranging from migraine relief and ulcerative colitis to opioid withdrawal and wound healing.
"The data comes primarily from preclinical work involving animals and is quite limited for humans," FDA scientists said in their review.
If the committee votes to reclassify the peptides, clinicians could prescribe them beyond the narrow indications under review. The agenda includes votes on four compounds Thursday—BPC-157, KPV, TB-500 and MOTs-C—and three others Friday—Emideltide, Epitalon and Semax. Final decisions rest with FDA leadership.