PCAC · Voted Thursday, July 23, 2026
KPV at the compounding committee: recommended
On July 23, 2026, the committee voted to recommend adding KPV — both the free base and the acetate — to the 503A Bulks List: 8–6, with one abstention. FDA staff had proposed adding neither form. As of September 25, 2026, FDA has not acted on the recommendation.
FDA staff's position, June 29: 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.
Published July 16, 2026 · Updated September 25, 2026 · By the Grey Peptides Editorial Board · ✓ Sourced from FDA's briefing document
FDA staff had proposed adding neither form of KPV; the committee disagreed. What that changes today: nothing yet. As of September 25, 2026, FDA has not added KPV to the 503A Bulks List or placed it in Category 1, so compounding it still falls outside the 503A exemption.
| Substances | KPV (free base) and KPV acetate |
| Also known as | Lys-Pro-Val, α-MSH(11-13) |
| Length | 3 amino acids (lysine–proline–valine) |
| Use FDA reviewed | Wound healing and inflammatory conditions |
| Forms proposed | Proposed in the nomination for topical and oral use in inflammatory and wound-healing indications |
| Nomination | Nomination withdrawn; FDA evaluated at its own discretion |
| FDA staff position | Proposed not adding either form to the 503A Bulks List |
| Committee vote | Recommended — 8–6, 1 abstention (July 23, 2026) |
What FDA reviewed it for
Nominated for wound healing and inflammatory conditions such as psoriasis and eczema.
This is not a detail to skip past. FDA evaluates a bulk drug substance in the context of the use proposed for it — so the question in front of the committee was not "is KPV useful?" but "does the evidence support compounding KPV for wound healing and inflammatory conditions?" A substance can have an interesting research literature in a completely different area and still fail this test, because that literature was never the thing under review.
FDA's specific objections
FDA weighs four criteria: whether the substance is well characterised physically and chemically, whether it has been used historically in compounding, what evidence exists on effectiveness, and what safety issues its use in compounding raises. Here is where KPV landed on each.
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.
What is specific to KPV
Six of the seven objections above could be written about almost any of the compounds on the July agenda. These next points could not — they are what makes this file different from the other six.
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.
The evidence picture
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. Our KPV article walks through the colitis studies.
Two readings of the same file are worth separating. FDA's conclusion is about a regulatory question — whether the record supports letting pharmacists compound this substance for this use. That is a higher bar than "there is some interesting science here," and a lower bar than "this substance is harmful." Almost everything FDA said about KPV is a statement about missing information, not a finding of harm. Reporting that as "FDA says KPV is dangerous" is wrong. So is reporting it as "FDA found no safety problems."
Where this sits in our encyclopedia
Our entry on this compound covers the underlying pharmacology, the published literature, and the status picture independent of this meeting. The two are separate reads: the encyclopedia entry is about the compound, and this page is about the regulatory file.
Mechanism, evidence grade, half-life, approval status, and sources. PCAC July 2026 — the full picture
All seven compounds, what the vote does and doesn't change, and what to watch. Peptide Regulatory Status Tracker
Category 1/2/3, 503A vs 503B, and where every peptide sits.
The other six compounds
BPC-157 · TB-500 · MOTS-c · Emideltide (DSIP) · Semax · Epitalon
FDA — July 23–24, 2026 Meeting of the Pharmacy Compounding Advisory Committee ↗
FDA briefing documents released June 29, 2026. Federal Register notice 91 FR 20465, published April 16, 2026 (FR Doc. 2026-07361), Docket No. FDA-2025-N-6895. FDA Briefing Document for KPV (free base) and KPV acetate, released June 29, 2026.
- FDA — July 23–24, 2026 PCAC meeting page: briefing documents, roster, presentations, video (last updated Aug 6, 2026)
- FDA — Questions put to the committee (separate free-base and acetate votes)
- FDA — Bulk drug substances nominated under 503A, by category (updated May 14, 2026; read Sept 25, 2026)
- FDA — Next PCAC meeting, before the end of February 2027 (no date set)
- Hyman, Phelps & McNamara, FDA Law Blog — July 24 votes
- McDermott — PCAC backs majority of peptides in two-day public meeting
- RAPS Regulatory Focus — committee backs two more peptides, rejects one (July 24, 2026)
- Fierce Pharma — first-day votes (July 23, 2026)
- Frier Levitt — what the recommendations mean (Sept 17, 2026)
FDA had not posted minutes as of September 25, 2026, so tallies are as reported by the sources above. Published reports agree on every tally except epitalon's. Hyman, Phelps & McNamara's FDA Law Blog and McDermott report 7–4; RAPS reports 7–5; all three give one abstention. FDA has not posted minutes, and we will record the official count when it does. The outcome is not in dispute.