Key Takeaways
- The FDA is considering allowing compounding pharmacies to make six peptides.
- Research on wellness peptides like BPC-157 and TB-500 is largely limited to animal studies, with little evidence that they’re safe and effective in humans.
An advisory committee for the Food and Drug Administration (FDA) recently voted to add six popular peptides to an approved drug compounding list.
The FDA’s Pharmacy Compounding Advisory Committee has recommended loosening restrictions on BPC-157, KPV, TB-500, MOTS-c, epitalon, and semax, which would allow pharmacies to use these peptides to make custom medications. Emideltide, a peptide that has been evaluated for insomnia and opioid withdrawal, was rejected by the committee.
Although the FDA still has to review and approve the panel’s advice, physicians are concerned about the lack of human evidence on the effect of peptides.
“This vote may expand access through compounding pharmacies, but it does not make these peptides FDA-approved or clinically validated, and that distinction matters for patient safety,” Elan L Goldwaser, DO, a sports medicine specialist at ColumbiaDoctors and assistant professor at Columbia University Medical Center, told Verywell in an email. “It also risks normalizing products that have moved ahead of the evidence.”
Here’s a closer look at the six peptides, the conditions they’re being evaluated for, and why experts say the evidence still falls short.
1. BPC-157: Promoting Injury Recovery
The FDA has evaluated BPC-157 as a treatment for ulcerative colitis, a lifelong inflammatory bowel disease that begins in the rectum and can spread throughout the colon.
BPC-157, sometimes referred to as Body Protection Compound 157, is a synthetic peptide derived from a protein in human gastric juice. It has been especially popular among athletes because animal studies have shown that it could help heal injuries, such as fractures, tendon ruptures, and ligament tears, as well as reduce knee pain. However, these benefits have not been confirmed in human studies.
“I want to be very clear there’s really no controlled human clinical data showing that it improves ligament or tendon healing in people, and so when you hear about success, it’s almost entirely anecdotal athletes self-reporting faster recovery,” said Rachel Frank, MD, a sports medicine specialist at UCHealth CU Sports Medicine, a service of University of Colorado Hospital. “They’re often doing other things like physical therapy.”
“So when they talk about the success of BPC-157, is it because of that peptide or is it because of the other things and they just happen to be using the peptide at the same time?” she added.
The FDA noted that the peptide could trigger an unwanted immune response. In addition, the agency has not identified any safety information “for the proposed routes of administration,” which include a subcutaneous injection.
2. TB-500: Wound Healing
TB-500 is another trending peptide among athletes. The peptide was originally marketed for veterinary use in racehorses and greyhounds. Now the FDA is evaluating its use for wound healing.
The advisory committee noted that TB-500 has been marketed online for helping with tissue repair and regeneration, improving flexibility, and boosting the immune system. Similar to BPC-157, TB-500 has been promoted for healing muscle injuries and treating chronic diseases and inflammation.
“The problem is that those ideas are driven mainly by preclinical data, while human orthopedic evidence remains lacking,” Goldwaser said.
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3. KPV: Wound Healing and Inflammatory Conditions
The FDA has been evaluating KPV, a peptide made of three amino acids—lysine (K), proline (P), and valine (V)—for wound healing and treating inflammatory conditions such as colitis. A 2007 study found that it could be a therapeutic agent for inflammatory bowel disease.
However, most research has been conducted in labs and on mice. The FDA said that it has “not identified any human exposure data on drug products containing KPV administered via any route of administration.”
A 2017 study in the Journal of Pharmaceutical Sciences tested a topical KPV on human cadaver skin and found that it did not permeate well through skin. The committee said the result of that study “could limit the systemic toxicity of KPV applied topically to the skin.”
4. MOTS-c: Obesity and Metabolic Health
The FDA has been evaluating MOTS-c, created from mitochondrial DNA, for compounded uses in obesity and osteoporosis, a common bone disease that can lead to an increased risk of fractures.
Research has found that MOTS-c may improve glucose metabolism in skeletal muscle, suggesting that it could help treat diseases such as type 2 diabetes and obesity.
Similar to other peptide data, these findings have been limited to animal studies.
The FDA also acknowledged that it “lacks important information regarding any safety issues raised by MOTs-c, including whether it would cause harm if administered to humans.”
5. Semax: Migraine and Cognitive Disorders
Semax is a synthetic peptide developed in Russia that has been studied for its effects on the brain, including attention and memory formation. Researchers have also investigated its potential as a treatment for Alzheimer’s disease. However, the evidence in humans remains limited.
The FDA is evaluating how the peptide can treat a migraine and two neurological conditions, cerebral ischemia and trigeminal neuralgia. However, the agency noted that the peptide poses the risk of a potentially dangerous immune response.
6. Epitalon: Insomnia and Healthy Aging
Epitalon, a pineal polypeptide extract from cattle, has been studied for its potential anti-aging abilities. In a 2025 study published in the International Journal of Molecular Sciences, epitalon-treated cells demonstrated high telomere lengths, which are repetitive DNA caps that are associated with longevity. However, the peptide’s actual effectiveness remained unclear.
Researchers have also looked at how it could improve sleep by increasing melatonin production. In a 2001 animal study, monkeys treated with epitalon showed significantly stimulated melatonin synthesis, suggesting the peptide could normalize circadian rhythms.
The FDA is evaluating whether epitalon can be used as an insomnia treatment. However, similar to other peptides, the agency said there is not enough information on whether the drug could cause harm when administered to humans.
Experts Urge Caution as Interest in Peptides Grows
Frank said it will take a few months before the FDA decides whether to add the six peptides to an approved bulk drug compounding list.
Even so, she said that the once niche peptides are becoming more mainstream, making it important for people to access them through a legitimate, regulated source.
“The challenge is that now we’re going to legitimize these peptides that have potentially been indicated for very narrow indications—for example, ulcerative colitis,” Frank said. “It’s one step positive in that it’s going to provide a legitimate source for these peptides when they’re used for appropriate indications. The question is, will these indications be extrapolated to these peptides being a miracle treatment for everything in the body and mind?”
