KPV peptide regulatory status

United States: FDA

Category 2 listing

FDA’s list of “certain bulk drug substances for use in compounding that may present significant safety risks” includes KPV, with the note: “FDA has not identified any human exposure data on drug products containing KPV administered via any route of administration.” The page was current as of April 22, 2026 [FDA 2026].

July 23–24, 2026 Pharmacy Compounding Advisory Committee

The committee discussed KPV (free base) and KPV acetate for “wound healing and inflammatory conditions” [FDA PCAC 2026]. FDA’s briefing document concluded that the evaluation criteria “weigh against” adding either form to the 503A bulks list, because:

• neither form is well characterised (no standard nomenclature, and no public impurity, aggregate or microbial data);
• the extent of KPV use in compounding is unknown;
• there is no human effectiveness or safety information; and
• FDA-approved treatments exist for the conditions proposed [FDA briefing 2026].

Published reporting states the committee voted, by a close margin, to recommend that KPV be considered for the list [HealthEd]. FDA had not posted minutes when we checked. Committee votes are advisory: adding a substance requires rulemaking, and listing would permit compounding, not approve a drug.

Identifiers

FDA’s Global Substance Registration System lists UNII 7V6LGD8S5R for KPV acetate (1:1) [FDA GSRS]. The July 2026 briefing, prepared earlier, recorded no UNII for either form [FDA briefing 2026].

World Anti-Doping Agency

KPV is not named on the 2026 Prohibited List. Section S0 prohibits at all times “any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use” [WADA 2026]. A 2026 review of peptide use in sport names KPV among fragments promoted to athletes [Coutinho 2026]. Athletes should check with their anti-doping organisation.

Australia: TGA

United Kingdom: MHRA

We found no MHRA publication naming KPV. A search of MHRA material on GOV.UK for peptides returned items on unlicensed weight-loss medicines and GLP-1 products, none mentioning KPV [MHRA]. An absence of a named warning does not mean KPV is authorised; it is not a licensed medicine in the UK as far as we could find.

Europe and pharmacopoeias

FDA reported that the European Medicines Agency lists no authorised product containing KPV, and that the European and Japanese pharmacopoeias have no KPV monograph [FDA briefing 2026].