For clinicians
KPV for prescribers: status, evidence and what FDA has said
A neutral reference. It reports KPV's regulatory status, the quality of its human evidence and what FDA has said about it. It does not suggest a dose, a protocol or a source.
Status reviewed 2026-10-01 · By the Grey Peptides Editorial Board · Regulatory fields generated from our tracker
| Also known as | Lys-Pro-Val, α-MSH(11-13) |
| Substances FDA reviewed | KPV (free base) and KPV acetate |
| FDA approval | Not FDA-approved |
| Compounding (503A) | Not compoundable; PCAC recommended it 8–6 (Jul 2026), FDA has not acted |
| Outsourcing (503B) | No 503B status recorded |
| FDA advisory committee | Reviewed July 23–24, 2026 (docket FDA-2025-N-6895): recommended, 8–6, 1 abstention |
| WADA 2026 List | Prohibited (S0 catch-all) |
| WADA 2027 List | Prohibited (S0 catch-all) |
| Evidence grade | Low |
| Status reviewed | 2026-10-01 |
What FDA has said
FDA staff's position, in its briefing for the July 23–24, 2026 committee meeting: FDA proposes not adding either KPV substance to the 503A Bulks List. The blunt finding: it could not locate information on the use of these substances in humans at all — so no conclusion on clinical safety or effectiveness was possible.
The use FDA evaluated. Nominated for wound healing and inflammatory conditions such as psoriasis and eczema.
FDA's objections
KPV is a common name, not a USAN. FDA says neither form is well characterised, citing nomenclature inconsistency and the absence of substance-specific quality control data — impurities, aggregates, microbiological testing — in the published literature, together with the absence of a Certificate of Analysis in the nomination package.
FDA says the extent of KPV's use in compounding is unknown.
There was a lack of evidence to evaluate effectiveness for either form.
FDA describes the information on human use as non-existent, and notes it could not assess immunogenicity or aggregation risk. Its conclusion is that potential safety risks in humans are unknown — not that they are absent.
Specific to KPV
At three amino acids, KPV is the shortest substance under review. Peptide length bears on immunogenicity risk, but FDA did not treat short length as resolving the question — it said the information needed to assess that risk was not available.
FDA notes approved therapies are already available both for wound management and for the various inflammatory diseases named in the nomination.
FDA lists KPV among substances it has identified as potentially presenting significant safety risks outside Category 2 (page current as of 2026-04-22). In FDA's words:
FDA has not identified any human exposure data on drug products containing KPV administered via any route of administration. FDA lacks important information regarding any safety issues raised by KPV, including whether it would cause harm if administered to humans.
Monitoring: what the literature does and does not say
- No label. KPV has no FDA-approved label, and therefore no labelled guidance on monitoring.
- What FDA has said about its risks is quoted above, from its list of bulk substances that may present significant safety risks.
- Immunogenicity. FDA's July 2026 review found no adequate information to assess the risk that KPV provokes an immune response.
- What is in the vial. FDA judged the substance not well characterised physically and chemically — the property FDA relies on to know what a compounded product actually contains.
- Findings specific to KPV. FDA's review also describes points particular to this compound, some of them safety signals; they are set out above in FDA's own terms.
These are gaps, not a monitoring schedule. This page does not supply one, and for a compound in this position the human evidence would not support one.
Compounding: where it stands
Today's position for KPV: Not compoundable; PCAC recommended it 8–6 (Jul 2026), FDA has not acted. An FDA advisory committee's vote is a non-binding recommendation; until FDA acts, a vote does not change what may be compounded. Our explainer on the 503A and 503B categories sets out what each status means, and the regulatory tracker is updated as FDA acts.
The evidence
Grey Peptides grades KPV's evidence base as low. It is a preclinical research peptide, studied mainly in colitis and skin-inflammation models. FDA's finding — that it could not locate human-use information — matches that grade rather than contradicting it.
The encyclopedia entry lists the human and animal studies we hold, each with its PMID and FDA's full briefing is summarised on our page for the July 2026 review.
What this page leaves out
Doses, regimens, cycle lengths and sources. That is deliberate. A reference that reports status and evidence is useful only if it is not also a protocol, and for a compound in this position there is no approved one to report.
Sources
- US Food and Drug Administration. Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026: briefing documents, docket FDA-2025-N-6895. FDA
- US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Content current as of 2026-04-22; read 2026-10-01. FDA
- Grey Peptides regulatory tracker, row for KPV, reviewed 2026-10-01. Tracker · dataset
- World Anti-Doping Agency. Prohibited List 2027, dated August 26, 2026, in force January 1, 2027. WADA
This page is a reference for qualified professionals. It is not medical advice, it does not recommend any treatment, and it is not a substitute for the prescriber's own judgement and their state and federal obligations.
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