FDA reports no identified human drug-product exposure to KPV by any route. Human-derived keratinocyte studies are in vitro and do not constitute clinical exposure.
Regulatory status
Not FDA-approved; FDA highlights lack of human exposure and safety data.
Main limitations
Clinical efficacy, human dose, pharmacokinetics, route-specific benefit or long-term safety.
Safety
Human safety, immunogenicity and product-quality risks are not adequately characterised.
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FDA reports no identified human drug-product exposure to KPV by any route. Human-derived keratinocyte studies are in vitro and do not constitute clinical exposure.
What the evidence actually supports
✓Use the human-cell mechanistic evidence as context, not as proof of clinical benefit.
What is not established / key limitations
×No controlled human administration trial identified.
Selected study & evidence records
FDA evidence audit: KPV human exposure
2026 · Regulatory evidence review / no human exposure identified
FDA states it has not identified human exposure data on drug products containing KPV by any route.
Human safety, immunogenicity and product-quality risks are not adequately characterised.
Human therapeutic safety, immunogenicity and product-quality risks are not adequately characterised.
Technical details
Mechanism / biologyC-terminal tripeptide of alpha-MSH studied for melanocortin-independent anti-inflammatory activity.
Route / formulation boundaryTopical, oral and injectable claims should be separated because route changes exposure and risk.
Identity / data-quality noteUse the canonical compound identity and studied formulation when interpreting evidence.
Dosing evidence statusDosing research conclusion recorded. No verified human drug-exposure regimen identified; human-cell and preclinical concentrations are not human dosing evidence.
Identifiers & alternate namesKpv · Lys-Pro-Val
Evidence rule: WhichPeps keeps human, animal, laboratory, regulatory and product/formulation evidence distinct. Common names help people find the page; they do not change the underlying scientific identity.
