#22Healing, Repair & Immune
KPV
alpha-MSH-derived tripeptide
Evidence: laboratory-onlyReviewed 2026-08-09
July 2026 PCAC recommendation
Recommended for possible 503A list inclusion
KPV-related bulk drug substances for wound healing and inflammatory conditions
Nonbinding advisory recommendation; not FDA drug approval and not a final addition to the 503A Bulks List as of 2026-08-09.Investigated uses
- Wound healing and inflammatory conditions in preclinical/FDA review contexts.
Mechanism and hypotheses
- KPV is an alpha-MSH-derived tripeptide; no human clinical administration evidence was identified in the FDA review.
- Hypothesized: Anti-inflammatory and wound-healing effects are laboratory/preclinical hypotheses.
Human evidence
- FDA found no human clinical studies supporting the reviewed KPV uses. Limitations: Absence of human administration data prevents estimating efficacy, incidence of adverse events or a safe dose.
Safety highlights
- No controlled human adverse-event incidence exists.
- Immunogenicity, impurities and route-specific risks remain unresolved.
Regulatory context
No FDA-approved KPV drug was identified. In July 2026, PCAC recommended KPV-related bulk drug substances for possible inclusion on the 503A Bulks List for wound healing and inflammatory conditions. The recommendation is nonbinding and was not a final FDA listing as of August 9, 2026.
Sources used for this entry
- KPV human evidence search — PubMed
- PubMed search: KPV — PubMed
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks — U.S. Food and Drug Administration
- July 23–24, 2026 Pharmacy Compounding Advisory Committee meeting — U.S. Food and Drug Administration
- Drugs@FDA database — U.S. Food and Drug Administration
- EMA medicines search — European Medicines Agency
- FDA advisory committee backs two more peptides, rejects one for compounding list — Regulatory Affairs Professionals Society
- 21 CFR 216.23 — Bulk drug substances that can be used to compound drug products in accordance with section 503A — Electronic Code of Federal Regulations