Regulatory status

Status at a glance

503A compounding status

Advisory committee voted to include

FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted in favor of adding this substance to the 503A bulks list. PCAC votes are non-binding recommendations; FDA and HHS make the final decision, and the substance is not on the bulks list unless FDA adds it.

Vote held · FDA source document

FDA approval
Not FDA-approved for any use
503B outsourcing
Not determined
Anti-doping (WADA)
Not on the WADA Prohibited List
DEA schedule
Not a controlled substance

About peptide status

Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.

This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.

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Status as of

Key takeaway

KPV is a small anti-inflammatory peptide derived from the tail of the hormone alpha-MSH, sold on the "research peptide" market for gut and skin inflammation. Its evidence is preclinical, with no human efficacy trials, though a 2026 FDA advisory committee gave a non-binding favorable vote toward allowing it to be compounded. As of 2026 it is not FDA-approved.

At a glance

FDA status
Non-FDA-approved peptide sold in the wellness/gray market
What it is
Three-amino acid fragment of alpha-MSH with anti-inflammatory activity in lab models
Research
Evidence is animal and cell-based only; there are no human efficacy trials
Compounding status
A 2026 FDA advisory vote was favorable but non-binding; not yet compoundable on that basis
Evidence strength
Low research

Summary

KPV is a three-amino-acid alpha-MSH fragment studied for inflammation. Evidence is animal and cell-based, with no human efficacy trials. It is not FDA-approved.

What is KPV?

KPV is a tripeptide (lysine-proline-valine) corresponding to the tail end of alpha-MSH, a hormone with anti-inflammatory properties. It is sold through wellness and "research peptide" channels for gut inflammation, inflammatory bowel conditions, and skin, and it is not an approved medicine.

How does it work?

KPV retains much of alpha-MSH's anti-inflammatory activity. In laboratory models it is taken up into gut and immune cells, where it is proposed to reduce pro-inflammatory signaling, including the NF-kB pathway and downstream inflammatory messengers such as TNF-alpha. Notably, some of its anti-inflammatory activity appears independent of the MC1R receptor. These are cell and animal findings. This describes the proposed mechanism, separate from demonstrated benefit in people.

Is it FDA-approved?

Safety note

Status: Non-FDA-approved peptide sold in the wellness/gray market

Category: Wellness and performance · Primary body area: Digestive & weight

No. KPV is not approved by the FDA. In July 2026 the FDA's Pharmacy Compounding Advisory Committee gave KPV a non-binding favorable vote toward the 503A compounding list. Because that vote is only a recommendation and the FDA has not completed rulemaking, KPV is not currently on the list and cannot be legally compounded on that basis.

What does the research show?

Editor’s note

Evidence strength: Low research (0 human · 2 animal/cell studies)

The anti-inflammatory rationale is supported by consistent animal and cell data, but there are no human efficacy trials, and the regulatory status is a non-binding advisory recommendation rather than approval.

The evidence is preclinical. According to PubMed, two mouse studies of colitis reported these results:

Study findings for KPV
Form tested Model Finding
KPVMouse models of colitisReduced inflammation, partly independent of MC1R (here)
Nanoparticle-delivered KPVMice with colitisEased colitis, with mucosal healing and reduced TNF-alpha (here)

Its anti-inflammatory basis is reviewed here. There are no controlled human trials establishing KPV for gut or skin use, so its marketed benefit is unproven in people.

Sources: mouse colitis studies of KPV (Kannengiesser et al., Inflammatory Bowel Diseases, 2008, DOI: 10.1002/ibd.20334; Xiao et al., Molecular Therapy, 2017, DOI: 10.1016/j.ymthe.2016.11.020) and a review of alpha-MSH peptides (Luger and Brzoska, Annals of the Rheumatic Diseases, 2007, DOI: 10.1136/ard.2007.079780), all indexed on PubMed; and reporting on the July 2026 FDA advisory committee vote. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.

Registered human trials

0 registered human trials on ClinicalTrials.gov that we reviewed

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