Peptide profile

KPV: FDA Status, Research and Uses

By Living+. Updated October 28, 2026.

Key takeaway

KPV is a 3 amino acid peptide (lysine, proline, valine) that matches the tail end of the hormone alpha-MSH. It is not FDA approved, and FDA found no human studies of it by any route. It has been studied only in animals and lab tests, mainly for inflammation, gut colitis and eye surface repair ^{[1, 7, 8]}.

At a glance

Where it stands

Checked October 28, 2026

FDA approvedNoNo approved product
Pharmacy compounding (503A)HHS interim policyOn HHS's interim enforcement policy (Appendix A), released Oct 28, 2026. HHS does not intend to take action against a state-licensed pharmacy, federal facility or licensed physician compounding KPV acetate for topical and oral forms, with a patient-specific prescription and the policy's other conditions (FDA-registered source with a certificate of analysis, single ingredient, adverse event reporting). It is not FDA approval and not a place on the 503A bulks list; HHS may revisit it if a safety or quality problem arises. The July 2026 advisory committee voted in favor of listing it, and FDA's final rule is still pending.
Outsourcing facilities (503B)Not nominatedNot listed in any 503B category on FDA's 503B list updated March 21, 2025.
WADA (sport)UnclearNot named on the 2026 or 2027 List. S0 (non-approved substances) may apply, since it covers substances no government has approved for human use. The 2027 List, in force January 1, 2027, adds peptides as an S0 example.

Same data as the Status Tracker. Checked against 11 sources

Key facts

Class: Tripeptide fragment of alpha-melanocyte stimulating hormone (alpha-MSH 11-13) ^{[1, 7]}
Length: 3 amino acids (lysine, proline, valine) ^[1]
Half-life: Not established. FDA found no pharmacokinetic studies in animals or humans ^[1]
Route in studies: Drinking water and systemic dosing in mice, eye drops in rabbits, and lab tests on human cadaver skin ^{[8, 10, 11, 12]}
First studied: 1989 or earlier (anti-inflammatory tests in mice) ^[7]

How it works

KPV is made of three amino acids: lysine (K), proline (P) and valine (V) ^[1]. These are the last three building blocks, numbers 11 to 13, of alpha-MSH, a natural hormone made in the pituitary gland. A 1989 mouse study reported that this short piece reduced skin swelling in a dose-related way ^{[7, 1]}.

Full alpha-MSH acts mainly by binding melanocortin receptors. Several lines of evidence suggest KPV does not. In lab tests KPV did not displace alpha-MSH from these receptors, and in mice its effects did not depend on them ^{[1, 10]}. Researchers have proposed instead that KPV blocks NF-kappaB, a switch that turns on inflammatory genes, and that it limits the effects of the signal interleukin 1 ^{[1, 10]}.

In human gut and immune cell lines, KPV entered cells through a transporter called PepT1. At nanomolar levels it lowered inflammatory signals ^[8]. In a lab test on human cadaver skin, KPV did not pass through intact skin at detectable levels. Microneedles and a mild electric current raised delivery ^[12]. FDA notes that poor skin uptake could limit both side effects and usefulness of a skin cream ^[1]. None of these findings have been tested in people ^[1].

What the research shows

4 animal studies1 lab study

2008Animal study
Colitis in mice and human cell lines (Dalmasso et al.)
Studied for gut inflammation
Mice and human cell lines Cell studies plus two chemical colitis models in mice, KPV given in drinking water
KPV lowered inflammatory signaling in cells and reduced colitis markers in mice ^[8].
Read the study
2006Animal study
Corneal scrape model (Bonfiglio et al.)
Studied for eye surface repair
Rabbits Corneal surface removed, eye drops four times a day for 4 days vs saline
At 60 hours, 8 of 8 corneas given KPV or a nitric oxide donor were fully covered vs none on placebo ^[11].
Read the study
2003Animal study
Peritonitis models in mice (Getting et al.)
Mice Crystal-induced and interleukin 1 induced inflammation of the abdominal lining
KPV reduced white blood cell buildup. The effect did not appear to use melanocortin receptors ^[10].
Read the study
1989Animal study
Ear swelling in mice (Hiltz and Lipton)
Mice Chemical ear swelling model, graded doses vs saline and a corticosteroid
The alpha-MSH 11-13 fragment reduced ear swelling in a dose-related way ^[7].
Read the study
2017Lab study
Skin permeation test (Pawar et al.)
Human cadaver skin (lab) Lab permeation study with iontophoresis and microneedles
No detectable KPV crossed intact skin. Microneedles raised it to 4.4 micrograms per square cm per hour ^[12].
Read the study

Doses used in studies

No human dose of KPV has been established. FDA found no clinical studies or human exposure data for KPV by any route ^[1]. The doses below come from animal and lab studies only.

In mouse colitis studies, KPV was given at 100 micromolar in drinking water ^[9]. In rabbits, eye drops of 1, 5 or 10 mg per mL (30 microliters) were given four times a day for 4 days ^[11]. The product proposed for compounding was a 0.1% cream or gel, and FDA found no human data for it ^[1].

Dosing is set by a licensed provider.

Side effects and safety

The safety of KPV in humans is unknown. FDA says it found no human exposure data on KPV by any route and lacks important information on whether it would cause harm ^[2]. FDA's adverse event database and the medical literature had no reports of side effects, because no human use has been documented ^[1].

FDA also found no animal toxicity studies of KPV, including acute, repeat-dose and gene damage studies ^[1]. FDA notes that even very short peptides can clump, and that there is no data on immune reactions to KPV ^[1]. There is no FDA label or boxed warning because no KPV product is approved ^[1].

Legal and regulatory history

October 28, 2026
HHS issued an interim enforcement policy for certain peptides used in 503A compounding. Until a final rule decides whether KPV goes on the 503A bulks list, HHS does not intend to take action against state-licensed pharmacies, federal facilities or licensed physicians who compound it under the policy's conditions ^[15]. For KPV acetate, the policy covers topical and oral dosage forms ^[15]. For oral forms, the compounder must document adequate oral bioavailability in humans ^[15]. Conditions include a single active ingredient, bulk substance from an FDA-registered facility with a certificate of analysis, reporting of serious adverse events to FDA and a patient-specific prescription ^[15]. The policy is not FDA approval and does not place KPV on the 503A bulks list ^[15]. HHS may revisit it if a safety signal or product quality issue arises ^[15]. A Federal Register notice of availability, which calls the policy a draft, publishes October 30, 2026 ^[16]. Source
July 23, 2026
FDA's Pharmacy Compounding Advisory Committee discussed KPV for the 503A bulks list, for wound repair and inflammatory conditions. FDA staff proposed that KPV and KPV acetate NOT be added. FDA's final decision comes after the committee process ^{[4, 5]}. HHS's October 28, 2026 policy states the committee voted in favor of inclusion ^[15]. Source
May 14, 2026
FDA's 503A categories list, updated May 14, 2026, does not place KPV in category 1, 2 or 3. FDA lists it with substances previously in category 2 whose nominations were withdrawn ^{[3, 2]}. Source
April 16, 2026
A Federal Register notice (91 FR 20465) announced the July 2026 advisory committee meeting covering KPV ^[13]. Source
January 1, 2026
The WADA 2026 Prohibited List took effect. It does not name KPV, but its S0 class bans any drug substance with no government approval for human use. WADA has not said whether that covers KPV ^[6]. Source

Common questions

What is KPV peptide?

KPV is a 3 amino acid peptide (lysine, proline, valine) that matches amino acids 11 to 13 of the hormone alpha-MSH ^{[1, 7]}.

Is KPV FDA approved?

No. FDA says KPV has no USP monograph and is not part of any FDA-approved drug ^[1].

Has KPV been tested in humans?

No. FDA found no clinical studies or human exposure data for KPV by any route ^[1].

Can a US pharmacy compound KPV?

KPV is still not on the 503A bulks list and is not FDA approved, and FDA's final rule is pending ^{[1, 3, 15]}. FDA staff proposed against adding it in July 2026 ^[5]. Since October 28, 2026, an HHS interim policy says HHS does not intend to take action against state-licensed pharmacies, federal facilities or licensed physicians who compound KPV acetate under set conditions ^[15]. It covers topical and oral forms ^[15]. The policy is not FDA approval, and HHS may revisit it ^[15].

Is KPV the same as alpha-MSH?

No. It is only the last 3 amino acids. Unlike alpha-MSH, it does not appear to act through melanocortin receptors ^{[1, 10]}.

Does KPV absorb through the skin?

In a lab test on human cadaver skin, no KPV crossed intact skin at detectable levels ^[12].

Is KPV banned by WADA?

Unclear. KPV is not named. WADA's S0 class bans any drug substance with no current government approval for human use, but WADA has not said whether that covers KPV ^[6].

What are the side effects of KPV?

They are unknown. FDA found no human data and no animal toxicity studies ^[1].

Key takeaway

At a glance

Key facts

How it works

What the research shows

Colitis in mice and human cell lines (Dalmasso et al.)

Corneal scrape model (Bonfiglio et al.)

Peritonitis models in mice (Getting et al.)

Ear swelling in mice (Hiltz and Lipton)

Skin permeation test (Pawar et al.)

Doses used in studies

Side effects and safety

Legal and regulatory history

Common questions

Sources