FDA Advisers Review Experimental Peptide Therapies for Compounding Approval

A slate of experimental peptide therapies are under scrutiny today in what marks the beginning of a two-day meeting to help determine whether the compounds will become available from specialized pharmacies.

The panel of advisers to the Food and Drug Administration is considering the evidence for seven compounds including some of the most sought-after: TB-500, BPC-157 and MOTs-C.

None of them has undergone the kind of large-scale trials to establish safety and effectiveness that are required for FDA drug approvals.

And yet the therapies have attracted enormous attention in the wellness space. They're promoted for injury recovery, muscle growth and fat loss, skin health, enhancing metabolism and more.

Proponents argue that the current Biden-era restrictions on compounding of the substances — due to safety concerns and a lack of data — have fueled a risky gray market of overseas suppliers.

The meeting represents yet another tension point between Health Secretary Robert F. Kennedy Jr.'s Make America Healthy Again agenda and the traditional medical and scientific establishment.

Kennedy has publicly advocated for lifting restrictions on peptides and talked up their benefits.

Meanwhile, FDA scientists are recommending against giving compounding pharmacies the go-ahead to produce any of the seven peptides under consideration. In a review of the evidence, they repeatedly note the data comes primarily from preclinical work involving animals — and is quite limited for humans.

Peptides are strings of amino acids — smaller than a protein — that often act as signaling molecules in our bodies and carry out many critical functions.

They can be synthesized and delivered as drugs, often by injection. Some of those, like insulin, are naturally occurring in the body. Others are modified versions, as with the blockbuster GLP-1 obesity drugs.

For example, BPC-157 is based on a peptide found in human stomach juices, while TB-500 is related to a molecule found in many types of cells, called thymosin beta-4.

In June, the FDA overhauled the roster for the advisory committee. Many of the new members have ties to the peptide industry. Earlier this week, the agency made further changes, adding a handful of temporary voting members, largely from academic institutions.

The FDA committee is tasked with reviewing data that supports using these peptides for specific conditions, including migraines, ulcerative colitis, opioid withdrawal and wound healing. However, if the FDA ultimately reclassifies them, clinicians would have discretion to write prescriptions outside of those narrow indications.

The agenda for Thursday includes votes on four compounds: BPC-157, KPV, TB-500 and MOTs-C. On Friday, the panel will review three other peptides: Emideltide, Epitalon and Semax.

The committee will discuss each peptide one by one and vote on recommendations throughout the day, though FDA leadership makes the final call on whether to green-light the products.