U.S. regulatory status

KPV

Also known as Lysine-proline-valine · Lys-Pro-Val · KPV acetate

Under reviewRemoved from Category 2 (Apr 2026); not on the 503A list; before the FDA committee Jul 23, 2026

Is KPV legal right now?

KPV is a tripeptide (lysine-proline-valine) derived from the C-terminal end of the hormone alpha-MSH, studied mainly in laboratory and animal models for wound healing and inflammatory conditions such as inflammatory bowel disease. In the United States it is not an FDA-approved drug, there is no approved KPV product, and it is not on the FDA's Section 503A list of bulk drug substances eligible for pharmacy compounding. In April 2026 KPV was removed from the interim Category 2 list, but that removal reflects a withdrawn nomination and does not by itself make compounding lawful, and KPV was never on the Category 1 permitted list. It is scheduled for FDA advisory committee (PCAC) evaluation on July 23, 2026 (Docket FDA-2025-N-6895); the committee's role is advisory only, and any addition to the 503A list would still require formal FDA rulemaking.

Under review: Actively before the FDA advisory committee; a decision is pending and the status can move.

Verified Jul 16, 2026 (ET) · status held since Apr 16, 2026

Primary source: Federal Register All 4 sources

Where it sits in the process

Nominated(completed)
Under review(current stage)
Rulemaking(upcoming)
Compounding-legal(upcoming)

Next milestoneFDA advisory committee (PCAC) evaluates KPV for the 503A list - Jul 23, 2026 (in 7 days)

What changed last

No recorded changes yet - this entry has held one status since it was added.

Status elsewhere

KPV: regulatory status by jurisdiction
Jurisdiction	Status	Note
United States (FDA)	Under review	Not on the 503A list; removed from Category 2 in April 2026 (never in Category 1); under active PCAC review, meeting July 23-24, 2026 (Docket FDA-2025-N-6895).
Australia (TGA)	Unscheduled	Not individually named in the Poisons Standard; supply for human use is unlawful without ARTG registration, and the TGA is enforcing against unapproved peptides.
Sport / anti-doping (WADA)	Restricted	Not individually named, but prohibited at all times under the S0 catch-all for non-approved substances.

Sources & transparency

Sources for this entry

Federal Register - PCAC notice of meeting (Docket FDA-2025-N-6895) Federal Register · primaryKPV (free base and acetate) on the July 23, 2026 agenda.
FDA - 503A bulk drug substances: Category 1 & Category 2 lists FDA · primaryKPV is not on the 503A (Category 1) list; the FDA 503A categories govern compounding eligibility.
Frier Levitt - FDA to remove peptides from the Category 2 list (2026) analysisKPV among the peptides removed from Category 2 in April 2026; removal does not authorize compounding.
FDA Law Blog - FDA's Pep(tide) Rally (Hyman, Phelps & McNamara) analysisConfirms KPV on the July 2026 PCAC agenda; the vote is advisory and any listing requires rulemaking.

Last verified by a human: Jul 16, 2026 (ET) · how we verify
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