KPV
An alpha-MSH-derived tripeptide studied mainly in gut and skin inflammation models, KPV is unapproved, scheduled for FDA compounding review, and unnamed but not exempt under WADA rules.
What it is
KPV is a tripeptide made of the amino acids lysine, proline, and valine, corresponding to the C-terminal fragment of the hormone alpha-melanocyte-stimulating hormone, or alpha-MSH S1. In laboratory work it has been characterized as an anti-inflammatory molecule that can enter cells through the intestinal peptide transporter PepT1 and dampen NF-kB and MAP kinase signaling S1. It is not an approved drug and has been studied mainly in cell cultures and animal models rather than in people S1S2.
Marketed as
Sellers in the research-chemical and gray market promote KPV with marketing claims that it soothes gut inflammation, calms skin conditions, and speeds recovery S2. These are marketing claims, not established clinical effects: KPV is not approved for any use, and its promoted benefits have not been demonstrated in human trials S1S2. Suppliers frequently attach a research use only label, a framing that sidesteps the fact that the material is being sold for use in people without any regulatory review S2.
Regulatory status (US)
KPV is not an FDA-approved drug and holds no marketing authorization in the United States S2. It was previously nominated as a bulk drug substance for pharmacy compounding under section 503A, but that nomination was withdrawn, and FDA has stated it lacks important information about whether KPV would cause harm if administered to humans S2. As a result, KPV does not currently sit on the 503A bulks list, and it is not among the substances FDA placed in its Category 2 significant-safety-risk grouping S2. FDA has scheduled KPV for discussion at the Pharmacy Compounding Advisory Committee meeting on July 23, 2026, alongside other peptides being considered for the 503A list S3.
KPV's compounding status is pending; the July 2026 PCAC discussion could change whether it is eligible for 503A compounding S3.
Around the world
KPV has no approved therapeutic status in major regulatory jurisdictions and is not marketed as a licensed medicine internationally S1S2. Its scientific record consists of preclinical laboratory work published in peer-reviewed journals rather than approvals by any national health authority S1S5.
Evidence
The most-cited work on KPV is preclinical. A 2008 Gastroenterology study by Dalmasso and colleagues reported that KPV is taken up by intestinal cells via the PepT1 transporter and reduced inflammation in cultured human cells and in two mouse models of colitis S1. Separate melanocortin-focused research likewise described anti-inflammatory activity for the KPV tripeptide in murine models of inflammatory bowel disease S5. These findings come from cells and animals; there are no adequate and well-controlled human trials establishing that KPV is safe or effective for any condition S1S2.
Anti-doping
KPV is not named individually on the 2026 WADA Prohibited List S4. The List's S0 Non-Approved Substances category is an all-inclusive catch-all that prohibits any pharmacological substance without approval by a governmental health authority for human therapeutic use, and an unapproved peptide such as KPV can fall within it S4. Athletes subject to anti-doping rules therefore face doping risk from KPV regardless of its absence from the named list S4.
Safety
Because KPV has not been evaluated in controlled human studies, its safety profile in people is not established S1S2. FDA has specifically noted that it lacks important information about whether KPV would cause harm when administered to humans S2. Material sold on the gray market is not manufactured or tested under the quality standards that apply to approved drugs, which adds purity and contamination uncertainty on top of the unknown biological risks S2.
What's changing
The regulatory picture is active. FDA has placed KPV on the agenda of the July 23, 2026 Pharmacy Compounding Advisory Committee meeting, where the committee will discuss whether it belongs on the 503A bulk drug substances list for compounding S3. The committee makes non-binding recommendations, and FDA is not obligated to follow them S3. Any change in compounding status would not alter KPV's WADA position, which is governed separately S3S4.
Sources
Every reference below is a primary source cited in this entry, drawn from the approved corpus.
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01
PepT1-mediated tripeptide KPV uptake reduces intestinal inflammation (Dalmasso et al., Gastroenterology, 2008)pubmed.ncbi.nlm.nih.gov · primary-research
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03
July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committeefda.gov · regulatory
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04
The 2026 Prohibited List (International Standard), World Anti-Doping Agencywada-ama.org · regulatory-primary
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05
Melanocortin-derived tripeptide KPV has anti-inflammatory potential in murine models of inflammatory bowel disease (J Invest Dermatol, 2008)pubmed.ncbi.nlm.nih.gov · primary-research
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