An advisory committee to the Food and Drug Administration convened Thursday to evaluate whether compounding pharmacies should be allowed to produce seven peptides that were previously banned over safety concerns.
Despite being prohibited, some of these peptides have become increasingly popular among consumers who purchase them from longevity clinics, alternative health providers, biohacking influencers and even TikTok. The peptides may be produced in unregulated labs, often in China, and sold as “research grade” compounds.
The F.D.A. is evaluating the peptides for specific uses, like treating ulcerative colitis, insomnia and osteoporosis. But they are marketed and used for many other purposes, which could be permitted off-label if the drugs were cleared.
F.D.A. staff scientists reviewed the research on the peptides and have recommended against clearing the peptides, citing a lack of safety and efficacy data in humans. Here’s what they found.
BPC-157
BPC-157, sometimes referred to as Body Protection Compound or bepecin, is one of the most popular “gray market” peptides.
The F.D.A. is evaluating it to treat ulcerative colitis, and it is also marketed as helping to reduce gastrointestinal inflammation and prevent ulcers. Another common use is to support muscle and joint healing — it is sometimes referred to as the “Wolverine compound,” after the Marvel superhero, especially when taken in combination with another peptide, TB-500.
A few small studies in humans have suggested BPC-157 might have benefits for knee pain, bladder-related pain or ulcerative colitis symptoms. But these had notable limitations: Two lacked a placebo group, and another was not published in a peer-reviewed journal.
Research in animals suggests that BPC-157 could be helpful for healing stomach and small intestine lesions and for musculoskeletal damage, among other things.
No serious side effects were reported in the human studies, but a few adverse events, including one that led to an emergency room visit, have been reported to the F.D.A. Limited safety data from animal studies suggest the peptide could affect blood clotting and liver function.
The F.D.A. report also mentions a general concern that the peptides being evaluated could trigger a potentially dangerous immune reaction, particularly when injected or inhaled.
KPV
The F.D.A. is evaluating KPV, a peptide derived from a hormone made by the pituitary gland, for wound healing and inflammatory skin conditions. It is administered in a cream or gel.
Other promoted uses of KPV include strengthening the immune system, treating inflammatory bowel diseases, protecting against nerve damage and stroke and aiding recovery from Covid-19, Lyme disease and mold toxicity.
A few studies in mice and cells have suggested KPV has some anti-inflammatory properties.
F.D.A. scientists could not find any published data on KPV safety or efficacy in patients. However, one study tested the peptide on human cadaver skin and found that it wasn’t very good at permeating the skin, which the report noted could “limit the potential usefulness of KPV as a topical therapeutic.”
TB-500
TB-500 was initially developed as a veterinary drug “marketed to boost performance in equine and greyhound sports,” the F.D.A. report said.
The advisory committee is evaluating the injected peptide for wound healing. It is also marketed online for promoting tissue repair and regeneration, reducing inflammation and improving endurance, among other claims.
The report references one mouse study suggesting TB-500 improved wound healing and another in cells that showed no effect.
The experts could not find any articles about use of the peptide in humans, and they warned that there is a general lack of safety information.
MOTS-c
MOTS-c is a peptide created from mitochondria DNA that appears to play a role in cellular metabolism.
The F.D.A. committee is evaluating the peptide for obesity and osteoporosis; it is also promoted for metabolic, liver and muscle health, among other uses.
A handful of studies in animals and cells have suggested the peptide could help with weight loss, blood sugar control and bone growth.
But the F.D.A. advisers cautioned against making too much of those findings, since there is no published research available in humans. There is also virtually no data on either the short-term or the long-term safety of the peptide.
Emideltide
Emideltide, also known as the delta sleep-inducing peptide, is naturally produced in the brain. Levels fluctuate throughout the day, which suggests it is connected to circadian rhythms, and it has been shown to increase deep sleep in animals.
The F.D.A. is considering an emideltide injections for insomnia, narcolepsy and opioid withdrawal. (Scientists think it acts through the opioid system.) It’s also marketed for stress, pain, cancer and neurodegenerative diseases, including Alzheimer’s and Parkinson’s.
There are several human studies of emideltide, most from the 1980s involving intravenous infusions. The research has generally suggested that emideltide helps people with insomnia fall asleep faster and stay asleep longer compared with a placebo. But the studies were very small and had limitations and did not all show a clear benefit.
The human data was even more limited for narcolepsy — just a single case report in one patient.
Two small studies on opioid withdrawal found that emideltide at least temporarily improved symptoms in a majority of people, but neither included a placebo control.
There is little safety data on the compound. One rat study suggested it slightly lowered heart rate and increased body temperature. No significant adverse events were reported in the insomnia trials, according to the F.D.A. report, but some patients in the withdrawal studies reported low blood pressure, headaches, nausea and other side effects.
Semax
The F.D.A. is evaluating an injection and nasal spray of semax for three conditions: cerebral ischemia (impaired blood flow to the brain), migraine and trigeminal neuralgia (episodic facial pain).
Wellness clinics also market the peptide as a treatment for mental health disorders including anxiety, depression and A.D.H.D., as well as neurological diseases such as A.L.S. and Parkinson’s.
Semax is available as an intranasal drug in Russia, and much of the human research is published in Russian or in conference presentations that don’t offer complete data. One of the few studies available in English found that a nasal spray decreased pain scores in 12 people with migraine, but the peptide wasn’t compared with a placebo. The same study found no benefit for trigeminal neuralgia.
A few rodent studies reported that semax limited the damage from ischemia. Researchers think the peptide may have an anticoagulant effect. Another proposed benefit is that it increases levels of growth factors in the brain associated with neuroplasticity. Other studies in rats suggest semax has a pain-relieving effect, though scientists don’t know how it might be helping.
There is one report of an adverse event involving a semax nasal spray: A woman reported eye pain and burning that resulted in hospitalization. The anti-clotting effects of semax could increase the risk of bleeding, the F.D.A. report warned.
Epitalon
Epitalon is a derivative of a substance extracted from the pineal glands of cattle. The pineal gland controls the sleep-wake cycle, and the peptide is proposed to help with insomnia.
One human study suggested that epitalon may increase melatonin production, a finding backed up by research in monkeys, which showed that it could help regulate circadian rhythms.
Epitalon is also marketed as a longevity peptide, with claims that it slows aging, improves skin health, increases energy and prevents a number of age-related diseases.
The longevity claims stem from epitalon’s reported ability to lengthen telomeres, part of DNA chromosomes that are thought to be involved in longevity. A few mouse studies suggest that epitalon can extend life span, potentially by restricting tumor development.
However, scientists have flagged concerns generally (outside of the research on epitalon) that long telomeres may be linked to cancer. And the F.D.A. report cautioned that long-term, continuous exposure to epitalon could be carcinogenic.
On Thursday, a majority of members on the F.D.A. advisory committee voted in favor of wider access to BPC-157, KPV, TB-500 and MOTS-c. The committee will meet again on Friday to vote on the other peptides.
Christina Jewett contributed reporting.
