Last updated October 21, 2026. Approval line checked October 21, 2026. Compounding sources checked October 29, 2026.
FDA status
Not approved
Not approved. This record is not an FDA-approved drug product. Approval, where it exists, is specific to a drug product, indication, and route.
FDA primary source on fileBy signing up you agree to get PeptideX update emails. Unsubscribe anytime. Educational only, not medical advice.
Evidence tier
Animal Only. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 2/5. 180 PubMed citations indexed.
C-terminal tripeptide of alpha-MSH with potent anti-inflammatory activity mediated through NF-κB inhibition and melanocortin receptor (MC1R) activation in gut epithelial cells.
What the literature studies
Gut Inflammation & Immune Modulation
Evidence tier
Animal Only
Compounding record
HHS proposed 503A enforcement discretion (not final)
HHS proposed 503A enforcement discretion (not final). FDA substance context: KPV. Named in the proposed HHS 503A enforcement-discretion notice (Federal Register 2026-22192, October 2026). The policy is proposed, not final, and is not FDA approval. FDA's earlier record lists the nomination as withdrawn from Category 2 with potential significant safety risks. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.
Regulatory source checked October 29, 2026. This compounding label is separate from the approval line above.
Regulatory context and verification limits are documented below.
By signing up you agree to get PeptideX update emails. Unsubscribe anytime. Educational only, not medical advice.
Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.
KPV (Lys-Pro-Val) is the C-terminal tripeptide of alpha-MSH with anti-inflammatory activity in mouse colitis models; FDA states it has identified no human exposure data by any route, so human efficacy and safety are unknown, and it is not FDA-approved.
Tripeptide fragment of alpha-melanocyte-stimulating hormone (alpha-MSH) studied as an anti-inflammatory melanocortin-derived peptide [R1].
Not FDA-approved. FDA lists KPV under nominated-but-withdrawn bulk substances and states: "FDA has not identified any human exposure data on drug products containing KPV administered via any route of administration" and therefore lacks important information on whether it would cause harm in humans [FDA-RISK]. Secondary reports say PCAC recommended KPV among peptides in July 2026 (advisory only) [AJMC].
No published randomized controlled trials of KPV as a human therapeutic were identified. FDA's own review found no human exposure data [FDA-RISK]. Claims about gut, skin, or "systemic inflammation" benefits in people are not supported by clinical trial evidence as of this check.
Murine IBD models (DSS colitis and T-cell transfer colitis) showed anti-inflammatory potential for KPV [R1]. Animal results are not evidence of effect or safety in people.
Unknown human pharmacokinetics, immunogenicity, and long-term safety [FDA-RISK]. Gray-market capsules/injectables unverified. Melanocortin pathway peptides can have off-target pigment or autonomic effects in related compounds; KPV-specific human risk is uncharacterized.
Possible inclusion discussions under interim peptide compounding policy - text and covered list not public [OIRA]. Any 503A listing still needs rulemaking after advisory input [AJMC].
Last checked 2026-10-27
Education only. Not medical advice. No dosing guidance. peptidex.ai does not sell peptides or link to sellers.