FDA Advisory Panel Weighs Approval of Seven Controversial Peptides for Compounding Pharmacies

An advisory committee to the Food and Drug Administration convened Thursday to evaluate whether compounding pharmacies should be permitted to produce seven peptides previously banned over safety concerns.

Despite their prohibition, several of these peptides have gained popularity among consumers who obtain them from longevity clinics, alternative health providers, biohacking influencers, and social media platforms. The substances are often manufactured in unregulated laboratories, frequently in China, and sold as “research grade” compounds.

The FDA is evaluating the peptides for specific indications, such as treating ulcerative colitis, insomnia, and osteoporosis. However, they are marketed and used for a much broader range of purposes, which could be permitted off-label if the drugs were cleared for compounding.

FDA staff scientists reviewed the available research and recommended against clearing the peptides, citing insufficient safety and efficacy data in humans. Here is a summary of their findings for each substance.

BPC-157

BPC-157, also known as Body Protection Compound or bepecin, is among the most widely used “gray market” peptides. The FDA is evaluating it for the treatment of ulcerative colitis; it is also marketed to reduce gastrointestinal inflammation, prevent ulcers, and support muscle and joint healing. It is sometimes called the “Wolverine compound,” particularly when combined with TB-500.

A few small human studies have suggested potential benefits for knee pain, bladder-related pain, and ulcerative colitis symptoms. However, these studies had significant limitations: two lacked a placebo control, and another was not published in a peer-reviewed journal. Animal research indicates BPC-157 may aid in healing stomach and small intestine lesions and musculoskeletal damage.

No serious side effects were reported in the human trials, though a few adverse events, including one requiring an emergency room visit, have been reported to the FDA. Limited animal safety data suggest the peptide could affect blood clotting and liver function. The FDA report also raises a general concern that the peptides under review could trigger dangerous immune reactions, particularly when injected or inhaled.

KPV

The FDA is evaluating KPV, a peptide derived from a pituitary hormone, for wound healing and inflammatory skin conditions via topical cream or gel. It is also promoted for immune system support, inflammatory bowel disease, nerve damage and stroke protection, and recovery from COVID-19, Lyme disease, and mold toxicity.

A handful of mouse and cell studies suggest KPV possesses anti-inflammatory properties. However, FDA scientists found no published data on safety or efficacy in patients. One study testing the peptide on human cadaver skin found it permeated poorly, 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,” according to the FDA report. The committee is evaluating the injected peptide for wound healing. It is also marketed online for tissue repair, inflammation reduction, and endurance improvement.

The report references one mouse study showing improved wound healing and a cell study showing no effect. The experts found no published articles on human use and warned of a general lack of safety information.

MOTS-c

MOTS-c is a mitochondrial-derived peptide that appears to play a role in cellular metabolism. The FDA committee is evaluating it for obesity and osteoporosis; it is also promoted for metabolic, liver, and muscle health.

A few animal and cell studies suggest the peptide could assist with weight loss, blood sugar control, and bone growth. However, the FDA advisers cautioned against overinterpreting these findings, as there is no published human research. There is also virtually no data on short-term or long-term safety.

Emideltide

Emideltide, also known as delta sleep-inducing peptide, is naturally produced in the brain. Its levels fluctuate daily, suggesting a link to circadian rhythms, and it has been shown to increase deep sleep in animals.

The FDA is considering emideltide injections for insomnia, narcolepsy, and opioid withdrawal (it is thought to act via the opioid system). It is also marketed for stress, pain, cancer, and neurodegenerative diseases such as Alzheimer’s and Parkinson’s.

Several human studies exist, mostly from the 1980s using intravenous infusions. The research generally suggests emideltide helps people with insomnia fall asleep faster and stay asleep longer compared to placebo, though the studies were small, had limitations, and did not all show clear benefit. Human data for narcolepsy is limited to a single case report. Two small studies on opioid withdrawal found temporary symptom improvement in a majority of patients, but neither included a placebo control.

Safety data is sparse. One rat study indicated a slight decrease in heart rate and increased body temperature. No significant adverse events were reported in the insomnia trials, but patients in the withdrawal studies reported low blood pressure, headaches, and nausea.

Semax

The FDA is evaluating semax injections and nasal spray for cerebral ischemia (impaired brain blood flow), migraine, and trigeminal neuralgia (episodic facial pain). Wellness clinics also market it for anxiety, depression, ADHD, and neurological diseases such as ALS 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 lacking complete data. One English-language study found a nasal spray decreased pain scores in 12 migraine patients but lacked a placebo comparison and found no benefit for trigeminal neuralgia.

Rodent studies suggest semax may limit ischemic damage, potentially via an anticoagulant effect, and increase brain growth factors associated with neuroplasticity. Rat studies also indicate a pain-relieving effect, though the mechanism is unknown. One adverse event report involved a woman who experienced eye pain and burning requiring hospitalization after using a semax nasal spray. The FDA report warns that potential anti-clotting effects could increase bleeding risk.

Epitalon

Epitalon is a derivative of a substance extracted from cattle pineal glands. The pineal gland regulates the sleep-wake cycle, and the peptide is proposed to help with insomnia. One human study suggested epitalon may increase melatonin production, a finding supported by monkey research showing it helps regulate circadian rhythms.

Epitalon is also marketed as a longevity peptide, with claims it slows aging, improves skin health, increases energy, and prevents age-related diseases. These claims stem from its reported ability to lengthen telomeres, DNA structures linked to longevity. A few mouse studies suggest epitalon can extend lifespan, potentially by restricting tumor development.

However, scientists have flagged general concerns that long telomeres may be linked to cancer, and the FDA report cautioned that long-term, continuous exposure to epitalon could be carcinogenic.

On Thursday, a majority of the FDA advisory committee members voted in favor of wider access to BPC-157, KPV, TB-500, and MOTS-c. The committee is scheduled to meet again Friday to vote on the remaining peptides.

Source link