If the FDA allows these seven peptides to be reclassified, that means compounding pharmacies can legally produce them
A group of independent advisers to the FDA is meeting Thursday and Friday to vote whether to reclassify seven peptides, which would broaden their availability in the U.S.
Hot-button peptides like BPC-157 and TB-500 that are used to speed up muscle recovery or improve sleep may soon become more broadly available to Americans.
The products are popular with a group of unlikely allies, including the "looksmaxxxing" and fitness communities, longevity experts, dermatologists and medical spas, and companies that operate compounding pharmacies like Noom and Hims & Hers Health $(HIMS)$, both of which made a name selling GLP-1 medications, which are also peptides.
They all stand to benefit from a peptide boom if the Food and Drug Administration decides to reclassify seven peptides, allowing these products to be legally compounded. The next step is a meeting Thursday and Friday of independent advisers to the FDA who will vote on reclassifying each peptide.
"Americans are already using peptide therapies to address poor sleep, slow recovery, and metabolic health, and many report meaningful benefits," Hims said in public comments. "What is missing is not demand or use; it is the structured medical framework needed to understand, document, and build on that real-world experience. Without it, we are left with a growing body of anecdotal use and no systematic way to learn from it, protect patients, or improve outcomes."
Right now, peptides like BPC-157, KPV, TB-500, MOTS-C, emideltide, epitalon and Semax operate in a legal gray area.
Three years ago, the FDA placed restrictions on 14 peptides over safety risks, meaning they now fall somewhere between the unregulated world of supplements and the highly structured process of testing new drugs. People have continued to seek them out, often buying "for research-use only" ingredients - sometimes from labs in China - mixing them, and then injecting them into their bodies. ("Everyone has a Chinese peptide dealer now" was a headline in the San Francisco Standard last year.)
Advocates of reclassification say putting regulatory guardrails in place will protect peptide users. A survey of 500 doctors who were familiar with peptides found that 48% have had patients disclose that they used a non-FDA-approved peptide over the last year.
Opponents, however, are worried about the lack of research to back up the health claims and the safety risks that untested injections pose to patients. There have been several highly publicized incidents of people being hospitalized after taking a peptide, including two women attending the Revolution Against Aging and Death Festival in Las Vegas last year.
Alec Ginsberg, a fourth-generation pharmacist who owns C.O. Bigelow Apothecaries in New York, doesn't sell peptides in his store, which is stocked with a mix of vitamins, high-end beauty supplies and medications - all products he believes to be safe.
"I feel differently about peptides," Ginsberg said. "I would never wade into that because I won't sell anything that I think could lead to harm, and we don't know enough about them."
The FDA's own scientists have already recommended against reclassifying these peptides. They cite a lack of research, that nearly no other countries have approved use of these products, and their concerns about how the peptides are made, including the degradation and concentration of active ingredients.
In their report, the staffers also noted that there have been few well-run studies assessing the safety and efficacy of peptides, which are essentially instructors, telling amino-acid chains how to fix or improve certain cells. Traditionally, before an FDA advisory committee meeting, the regulator's staff make their own recommendations. The individuals on the committee, which now includes several pro-peptide members, are then free to take different positions from that of the FDA scientists.
Here's what to know about the peptides under discussion this week:
Thursday's votes:
BPC-157: It is well-known to peptide enthusiasts - and one of the few to have at least one study conducted in humans that appears to back up some of the claims for its benefits. BPC-157 was discovered by researchers in Croatia in the 1990s and is primarily used as a treatment for interstitial cystitis, knee pain and ulcerative colitis. Some clinics call it the "wolverine compound" because of its healing properties, though New Zealand has recommended that BPC-157 is classified as a prescription drug.
Back in 2005, researchers conducted a randomized, double-blind, placebo-controlled study in 46 patients with ulcerative colitis. According to an abstract presented at a medical meeting, there were improvements based on the Disease Activity Index, a common score for assessing the severity of ulcerative colitis. However, the FDA said the study lacked the information needed to support the safety and efficacy of BPC-157.
KPV: This peptide is made up of three peptides: lysine (K), proline $(P)$ and valine. It's mostly used for wound healing and skin health and to address other inflammatory conditions.
TB-500: TB-500 is another peptide primarily used for wound healing, though the FDA noted that it's marketed for at least 14 other health concerns, like hair loss, blood clots and dry-eye disorder. It was first synthesized from thymosin <BETA>4 in 2003 and has since been used to help horses and greyhounds improve racing performance.
MOTS-C: People use this peptide, which is composed of 16 amino acids, to lose weight and better manage weight-related concerns like insulin resistance, osteoporosis and metabolism. It was discovered 11 years ago.
Friday's votes:
Emideltide: This peptide has been promoted as a tool to address insomnia, narcolepsy or opioid withdrawal. It's sometimes called the delta-sleep-inducing peptide. Unlike the other peptides, there are some studies assessing its clinical effectiveness; however, they were all conducted in the '80s and '90s, and the FDA described the results as "inconclusive and at best preliminary."
Epitalon: This is another peptide that's promoted as a solution for insomnia. It was first synthesized and tested in the late 1980s in Russia, where it can be used for research purposes. About 15 years ago, the FDA briefly granted the peptide an orphan-drug designation, which provides incentives to a developer to work on therapies for diseases that affect fewer than 200,000 people in the U.S. That designation was later withdrawn or revoked by BioDiem, an Australian biotech that had planned to test epitalon for retinitis pigmentosa, a condition that affects at least 80,000 people in the U.S. There are at least three studies testing epitalon in humans, including in retinitis pigmentosa.
Semax: Semax is the only peptide under discussion to be formally approved in other country. It's cleared for use in Russia to treat stroke or optic-nerve conditions, though it's marketed online for dozens of conditions, like ADHD and Alzheimer's disease.
It is dispensed in nasal drops. One of the FDA's concerns is that it doesn't have any information about the containers that would be used by compounding pharmacies to dispense the medication.
-Jaimy Lee
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(END) Dow Jones Newswires
July 23, 2026 09:18 ET (13:18 GMT)
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