Repair & immune · Research tripeptide
Also known as alpha-MSH(11-13), KPV tripeptide, Lys-Pro-Val
The three-amino-acid peptide lysine-proline-valine, studied in cell and animal inflammation models. It is not an FDA-approved drug.[1]
The evidence is mainly from cells, tissues, or animals. Any human information is limited or indirect and does not establish a clinical outcome.
Reviewed Jul 22, 2026 · U.S.-focused reference profile
Read the context, not only the compound name. Evidence and status can change with the form, route, population, and use. This profile does not assess individual suitability.
Orientation
Start with identity and research context. Similar names do not establish equivalent products or evidence.
Published research or product contexts. These are not personal indications.
Evidence can change with chemical form, formulation, route, ingredients, and manufacturing. A brand, salt, fragment, or cosmetic ingredient may not represent the same evidence.
What is known
The evidence is mainly from cells, tissues, or animals. Any human information is limited or indirect and does not establish a clinical outcome. This is a description, not a rating or recommendation.
Recovery and inflammatory research
FDA found no human exposure data for KPV by any route. Consequently, effectiveness and clinical safety have not been established.
Translation from cell and mouse models, human pharmacology, exposure, long-term effects, formulation identity, and safety are unresolved. The free base and acetate salt should not be treated as interchangeable.
Source [1]Published work includes human cell-line experiments and mouse colitis models reporting anti-inflammatory and antimicrobial signals. These findings do not demonstrate a benefit or safety profile in people.[2]
More human evidence does not automatically transfer to a different product, route, population, or purpose. Limited evidence does not prove no biological activity; it means the relevant clinical question is not established by the reviewed material.
What needs caution
Known published concerns and unanswered questions are kept separate so absence of evidence is never presented as reassurance.
FDA identified absent clinical and adequate nonclinical safety data, along with possible immunogenicity, aggregation, impurity, and product-characterization concerns. Unapproved products add quality and sterility risks.
Research or cosmetic products may add identity, strength, purity, sterility, contamination, or formulation concerns. This is separate from the evidence about the compound itself.Source [1]Translation from cell and mouse models, human pharmacology, exposure, long-term effects, formulation identity, and safety are unresolved. The free base and acetate salt should not be treated as interchangeable.
Human outcomes, long-term safety, formulation identity, and product consistency remain limited or unresolved in the cited material.Source [1]Common effects, important warnings, product-quality concerns, and evidence gaps are different kinds of information. A risk in one product label may not apply to every formulation; an uncertainty proves neither safety nor harm.
Match the product
Form describes the specific product; route describes how it reaches the body. These are sourced descriptions, not instructions.
The FDA nomination materials described inconsistent forms and proposed formulations. No FDA-approved KPV formulation exists.
No FDA-approved route or human exposure route was identified. Proposed compounded routes are not instructions or evidence of safety.
U.S. product context
No FDA-approved medicine was identified for this defined material. Research findings and products sold outside reviewed trials should not be treated as approval.
Status applies to a product, formulation, route, population, and use. It does not apply to a name in the abstract.
KPV is not an FDA-approved drug. In a May 2026 staff briefing prepared for the July 23-24 advisory-committee meeting, FDA said the evaluation criteria weighed against 503A Bulks List inclusion; FDA stated that no final determination would be issued until the advisory process and reviews were complete.
Specific form or route not separately published in this record.View sourceTake it forward
Organize a conversation with a qualified professional without creating a treatment recommendation, dose, or protocol.
Trace the record
Each source supports the section that cites it; publication does not imply endorsement or suitability.
FDA staff briefing for KPV-related substances
U.S. Food and Drug Administration. FDA Evaluation of KPV-Related Bulk Drug Substances (KPV (Free Base) and KPV Acetate). Pharmacy Compounding Advisory Committee briefing document. 2026.
U.S. Food and Drug Administration · Published May 12, 2026 · Accessed Jul 22, 2026 · Regulatory source
Open sourceKPV in cell and mouse colitis models
Dalmasso G, et al. The anti-inflammatory peptide KPV has anti-inflammatory and antimicrobial properties. Gastroenterology. 2008;134(1):166-178.
PubMed-indexed primary study · Published Jan 1, 2008 · Accessed Jul 22, 2026 · Preclinical study
Open sourceIdentity, human evidence, laboratory and animal findings, risks, uncertainty, and U.S. product status are shown separately. Missing information stays marked as unpublished instead of being inferred.
