Peptide dossier, updated Oct 31, 2026
KPV
A three-amino-acid peptide (lysine-proline-valine). It matches the last three amino acids of alpha-MSH, a natural hormone, which is why PubMed also files it as alpha-MSH(11-13). FDA found no human data on it by any route. Since Oct 30, HHS has said it will pause enforcement against some pharmacies that compound it. This page lays out what each source actually says.
See all 7 verified records for KPV on the Records page
Human studies
ClinicalTrials.gov returns no study for “KPV” or “Lys-Pro-Val” as of Oct 31, 2026. In PubMed, “KPV” limited to the clinical-trial publication type returns 0 results, and we found no human clinical study among the papers we screened.
Registry entries are written by the sponsors and are not reviewed for scientific merit. The absence of a registered study is not evidence about safety or effect.
FDA review
Two FDA documents address KPV: the safety-risk page (content current Apr 22, 2026) and a briefing document for the July advisory committee, in a memo dated May 12, 2026.
What the briefing document found
- FDA evaluated KPV (free base) and KPV acetate for the 503A bulks list. The nomination was withdrawn, so FDA reviewed both on its own initiative.
- The uses evaluated were wound healing and inflammatory conditions. The proposed products were a 0.1% cream and gel for topical use.
- FDA lists the sequence as H-Lys-Pro-Val-OH. It notes that “KPV” is a common name, not a United States Adopted Name, and that no USP or National Formulary monograph exists and neither form is part of an FDA-approved drug.
- No human data: the nomination included none and FDA found none. The nominator submitted 8 articles, all describing nonclinical studies.
- Published literature showed no studies of compounded KPV products used in humans. Outsourcing facilities reported preparing no KPV products from January 2017 to June 2025.
- A search of FDA’s adverse event database (FAERS) retrieved no reports.
What FDA concluded
- It proposed not adding either form to the list.
- FDA called both forms not well characterized: names that do not follow standard nomenclature, and no impurity, aggregate or microbiological test results in the literature or in the nomination package.
- It could not assess how the cream and gel would perform, because the nomination did not describe the formulation. It gave KPV’s water solubility as up to 0.70 mg/mL.
- It said there is no information on use in humans from which to judge safety or effectiveness, and that approved therapies exist for wounds and for inflammatory diseases such as psoriasis and eczema.
- It noted that websites promote KPV in oral, injectable, topical and nasal-spray forms. Its safety-risk page says it has not identified human exposure data for any route.
Published research
PubMed returns 68 results for “KPV” in the title or abstract and 73 for “Lys-Pro-Val,” with some unrelated acronym hits. The papers we screened are cell studies, animal studies, drug-delivery work and reviews.
Animal, lab and formulation studies
- Mouse colitis, 2008. In two mouse models of inflammatory bowel disease, KPV treatment led to earlier weight recovery and fewer inflammatory changes. The authors call KPV an interesting option for IBD. Inflamm Bowel Dis PubMed
- Intestinal uptake, 2008. A lab and cell study of how the PepT1 transporter takes KPV into intestinal cells. Gastroenterology PubMed
- Delivery systems, 2017–2026. Many recent papers load KPV into hydrogels or nanoparticles and test them in mouse colitis or mucosal-injury models. These test the carrier as much as the peptide. Acta Biomater, 2022 PubMed
- Cell study, 2026. In mouse 3T3-L1 fat-cell precursors, KPV reduced fat-cell differentiation and triglyceride content in a dose-dependent way. Tissue Cell PubMed
Read with care
- Mouse and cell results are not evidence of an effect in people. FDA found no human data.
- We read abstracts only, not full text, funding or author disclosures.
- Recent reviews that cover KPV alongside other peptides, in wound healing and in inflammatory bowel disease. Int J Med Sci, 2025 PubMed Drug Discov Today, 2025 PubMed
- A 2026 sports-medicine review lists KPV among peptides promoted for muscle growth and recovery, and says the clinical evidence for peptide use in sport is limited. J Sports Med Phys Fitness PubMed
FDA warning letters
We did not find an FDA warning letter that names KPV.
This rests on web searches, not a full pull of FDA’s database. FDA’s list of letters cannot be searched by peptide, so a letter could exist that we did not find.
SEC filings
We did not find an SEC filing that names KPV. EDGAR’s full-text search was not available to us, so this rests on web searches of sec.gov.
What a company says in a filing is its own claim about its business. It is not a finding about KPV.
Timeline
Newest first. Every entry links to the document it comes from.
- Government or registry record
- Journal
- Oct 30, 2026RegulatoryHHS publishes draft policy pausing enforcement on six compounded peptides, KPV among them
State-licensed pharmacies, federal facilities and licensed physicians would not face enforcement for compounding it, under conditions including a patient-specific prescription and quality testing. Not FDA approval. HHS says it may revisit the policy if a safety or quality problem arises.
- July 23–24, 2026RegulatoryFDA advisory committee recommends KPV for the compounding list
The committee recommended six of the seven peptides it reviewed; emideltide was the exception. The vote is nonbinding: compounding stays unlawful until FDA finishes rulemaking or Congress changes the law. Vote counts differ between trade-press reports, and no official tally was in the FDA documents we could read.
- Jul 2026LiteratureSports-medicine review lists KPV among promoted peptides
A critical review in J Sports Med Phys Fitness says the clinical evidence for peptide use in sport is limited and the long-term risks are poorly defined.
- May 12, 2026RegulatoryFDA staff brief the committee: it proposes not adding KPV
The briefing memo concludes that the balance of criteria weighs against listing. Details above.
- Apr 22, 2026RegulatoryFDA’s safety-risk page lists KPV
The page showed content current as of Apr 22, 2026. Its wording on this peptide is quoted above.
- Jan 1, 2022Anti-dopingWADA’s 2022 Prohibited List does not name KPV
We checked the 2022 and 2026 lists. Neither names KPV. Section S0 covers any substance with no current approval from a government health authority for human therapeutic use; we found no WADA statement on KPV.
- Mar 2008LiteratureMouse colitis study of the KPV tripeptide
One of the early reports of anti-inflammatory effects in animal models of inflammatory bowel disease.
Still not covered
Left off rather than guessed:
- Policy coverage: HHS’s list of covered peptides sits in a policy attachment we could not open. KPV acetate for topical and oral dosage forms comes from a law-firm summary of that list, not from the document itself.
- Panel vote counts: not in the FDA documents we could read, and trade-press tallies differ.
- Free base versus acetate: FDA evaluated both, and the committee voted on separate items. We do not know whether the free base was covered by the vote.
- Patents: not researched for this dossier.
- Seller claims and independent lab reports: how it is marketed versus what testing finds. FDA notes it is promoted for several uses, but we have not collected testing data.
- Unread items: full text of every paper; WADA lists for years other than 2022 and 2026.
- Warning letter and SEC completeness: web searches only.