FDA's advisers backed KPV as a skin cream. FDA found no human data on it at all.

Why this note exists

KPV is one of the most widely stocked compounds in pepmg's index. In the index generated on September 8, 2026, 93 of 108 vendors carried it, across 127 listings; only eight compounds were carried by more vendors.[21] The most common size was 10 mg, on 70 of the 127 listings, and eight listings were capsules, a tablet or other non-injectable products.[21] KPV also appears in the names of 87 blend listings that pepmg files under other compounds, 58 of them under BPC-157 .[21][22] It was one of the six peptide families the July advisory committee backed, which pepmg covered in its note on the vote. That note gave KPV one line. This one reads FDA's full review of it.

A note on what kind of evidence this is: almost nothing below is human data, and each paragraph says what it is about. Mouse results are labeled as mouse results in the same sentence as the finding. Cell-culture and cadaver-skin experiments are labeled as laboratory work. The one human drug trial discussed is of a different tripeptide, KdPT, and is labeled as such every time.

The vote

What the committee was asked, and what FDA staff had proposed

KPV reached the committee by an unusual route. Wells Pharmacy Network nominated it for the 503A Bulks List and later withdrew the nomination; FDA then evaluated both KPV free base and KPV acetate "on its own initiative," partly because "[t]he nominator of KPV-related BDSs provided inconsistent information in the nomination package regarding the specific BDS proposed."[1] The nomination proposed "cream and gel, 0.1% for topical administration," for "wound healing, inflammatory conditions (psoriasis, eczema, etc.)."[1] The committee was asked two questions: whether KPV free base should be placed on the list, and whether KPV acetate should.[5]

FDA's review, dated May 12, 2026, concluded that "a balancing of the criteria weighs against KPV (free base) or KPV acetate being placed on that list," and ended: "Accordingly, we propose not adding KPV (free base) or KPV acetate to the 503A Bulks List."[1] The committee disagreed. STAT reported an 8 to 6 vote to add KPV "for wound healing and inflammatory conditions," and RAPS reported the tally as 8 to 6 with one abstention.[3][4] FDA had posted no minutes or vote record on the meeting page when this note was written, so the count comes from contemporaneous reporting, not from FDA.[2]

A recommendation is not a listing. FDA's briefing document says the agency "will not issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized."[1] FDA's 503A bulk substances page, content current as of May 14, 2026, did not list KPV when checked on September 14, 2026, and none of the 18 FDA documents on compounding published in the Federal Register since the meeting proposes adding it.[8][9] FDA's safety-risk page still carries KPV among withdrawn nominations, with the entry: "FDA has not identified any human exposure data on drug products containing KPV administered via any route of administration. FDA lacks important information regarding any safety issues raised by KPV, including whether it would cause harm if administered to humans."[7]

The review

What FDA looked for and did not find

Each figure is FDA's statement about what the nominator did not submit and FDA did not identify, from the May 12, 2026 evaluation.[1]

The nomination's own evidence is the clearest measure of the gap. It cited nine references. FDA records that eight were animal studies of various α-MSH derivatives and one was a study of KPV passing through human cadaver skin, and that "none were studies of KPV administered in humans."[1] FDA's own searches added nothing in people: "The nomination did not include, and FDA has not identified, any clinical studies or human exposure data for KPV via any route of administration. Therefore, potential safety risks associated with the use of KPV in humans are unknown."[1]

The adverse-event databases were empty too. FDA's search of its Adverse Event Reporting System through December 3, 2025 "did not retrieve any reports," the literature search found no adverse-event cases, and a search of the foods and supplements complaint system covering 2004 to 2025 found no cases where KPV was administered.[1] An empty database is not a clean safety record. FDA notes that compounders under section 503A "generally do not report adverse events to FDA," and its meeting slides add that the lack of reports "does not imply that the substance is safe or lacks toxicities."[1][6] Outsourcing facilities reported compounding no KPV products between January 2017 and June 2025.[1]

FDA also judged both forms "not well-characterized." KPV has no United States Adopted Name, and FDA wrote that it has "encountered multiple salts, and derivatives, including different active moieties, sold commercially under the same common name."[1] The certificate of analysis submitted with the nomination "refers to one BDS by name in the title and a different BDS by the molecular formula," and FDA found that most certificates it could locate for the free base reported purity alone, with no impurity limits and no microbiological testing, which it notes is required for topical products.[1] On immunogenicity it could not rule anything out: "Peptides with as few as two amino acids have been shown to aggregate," and "there is insufficient data to conclude that KPV (free base) or KPV acetate do not present these risks."[1]

The route

The nominated product is a cream. In the lab, KPV did not cross untreated skin.

The one piece of human-tissue evidence in the file cuts against the use that was voted on. This is laboratory work on donated skin, not a study in living people. Researchers at Auburn University applied KPV to dermatomed human skin and reported that "KPV permeation was less than detectable levels (limit of detection, 0.01 μg/mL) by simple passive diffusion."[10] Puncturing the skin with microneedles raised permeation to 4.4 μg/cm² per hour, and adding a small electric current, iontophoresis, raised it 35-fold over microneedles alone.[10]

FDA drew both conclusions that follow. Poor penetration "could limit the systemic bioavailability of KPV applied topically to the skin, and, thereby, preclude systemic toxicity. However, it could also limit the potential usefulness of KPV as a topical therapeutic agent."[1] And if a product did push it through, "[i]t remains to be determined whether such strategies may also increase the systemic absorption of topically administered KPV" in a living body.[1] FDA found no study of the 0.1% cream itself, and the nominator gave no information on how it would be compounded or in what vehicle.[1]

That matters beyond the cream. FDA evaluated KPV in the context of the nominated uses, but acknowledges that "inclusion of a substance on the 503A Bulks List may not be limited to a specific use."[1] And the market is not selling a cream. FDA's internet search found KPV promoted "as single-API injectable, oral, topical, and nasal spray drug products, as well as multi-API products containing substances such as BPC-157, TB-500, AOD-9604, and Follistatin-344."[1] In pepmg's index the most common KPV listing is 10 mg.[21] FDA found no human data for injection, for oral use, or for the cream.[1]

The animal record

Why anyone is interested: mice and cell cultures

Every result in this section is from mice or from cells in culture. KPV is the last three amino acids, positions 11 to 13, of α-melanocyte-stimulating hormone (α-MSH).[1] In 1989, researchers in Texas reported that in mice this fragment inhibited chemically induced ear swelling "in a dose-related fashion," compared with saline and a large dose of corticosteroid.[11] In 2003 a London group reported that KPV given systemically reduced the influx of white blood cells in a mouse model of crystal-induced peritonitis, including in mice with a nonfunctional MC1 receptor, and concluded that KPV "is unlikely to mediate its effects through melanocortin receptors but is more likely to act through inhibition of IL-1beta functions."[12]

The gut work is the most developed. In two mouse models of colitis, KPV-treated mice recovered faster and regained more weight, and in mice lacking a working MC1 receptor, "KPV treatment rescued all animals in the treatment group from death during DSS colitis."[13] A 2008 study found that nanomolar KPV blunted inflammatory signaling in human intestinal and T-cell lines in culture, that the transporter PepT1 carries it into cells, and that KPV in drinking water reduced chemically induced colitis in mice.[14] A 2010 follow-up packaged KPV in nanoparticles inside a gel and reported similar efficacy in mice at "a concentration that is 12,000-fold lower than that of KPV in free solution."[15]

FDA's reading of that literature: nonclinical studies suggest "anti-inflammatory and wound-healing properties in in-vivo and in-vitro models," but "the molecular targets underlying the pharmacological effects of KPV-related BDSs remain unknown."[1] FDA also cites KPV's effectiveness "in rodent models of wound healing" and notes that "researchers have suggested that investigational clinical studies are needed" to learn whether it could help heal skin wounds and ulcers.[1] That suggestion came from a 2019 review by two Münster dermatologists, who proposed that such peptides "are promising future candidates for the treatment of cutaneous wounds and skin ulcers."[16] Seven years later, the registry holds no such study.[18]

The analogue

KdPT: one human trial, of a different tripeptide

The closest human data belong to KdPT, also written K(D)PT: lysine, D-proline, threonine. It is a different molecule. The 2019 review describes it as a derivative that contains amino acids 193 to 195 of interleukin-1β, and says that both KPV and KdPT have anti-inflammatory effects in the laboratory but lack the pigment-inducing activity of α-MSH.[16]

KdPT was taken into a multicenter, randomized, double-blind phase IIa trial in mild-to-moderate ulcerative colitis, published in 2017, comparing oral KdPT at 20, 50 or 100 mg twice a day with placebo, added to patients' existing medication.[17] The primary objective was the time to a sustained improvement of at least 50% in a colitis activity index by week 8, pooled KdPT against placebo. The authors report higher remission rates at weeks 2 and 4 and a higher response rate at week 8, and say the pooled group "met the primary endpoint after additional analyses."[17] They also report "a very high placebo rate after week 4," call the study "preliminary," and describe all doses as well tolerated.[17] The published abstract does not say how many patients took part, and the paper lists Dr. August Wolff GmbH & Co. KG, a German drug company, among the authors' affiliations.[17]

A ClinicalTrials.gov search for KdPT returns no records.[19] KdPT is not KPV, and a colitis trial of an oral analogue says nothing directly about a KPV vial or a KPV cream.

What comes next

No trial is waiting to report

A ClinicalTrials.gov search for KPV on September 14, 2026 returned no studies, and a PubMed search for KPV or Lys-Pro-Val restricted to clinical-trial publication types returned no records.[18][20] There is no registered trial whose results could change this picture soon.

Three things this note is not saying

First, it is not saying KPV does not work. Its effect in people has not been measured, and the animal results are real results in animals; absence of human evidence runs in both directions.[1][13]

Second, it is not saying KPV is dangerous. FDA's position is that the risks "are unknown," which is not the same as known to be harmful; the review names product quality, immunogenicity and aggregation as concerns it could not rule out.[1]

Third, it is not saying the committee acted improperly. Advisory committees exist to give FDA an outside view, and FDA has not yet ruled.[2][8] What this note is saying is narrower: the peptide 93 of 108 tracked vendors list was recommended for compounding as a 0.1% skin cream at a point when FDA could find no study of KPV in a person by any route, no pharmacokinetic or toxicology study in any species, and one laboratory experiment showing that it does not pass through untreated human skin in detectable amounts.[1][10][21]

Questions people are asking