What does the research show about kpv?

KPV

Grey marketNot approved for human use in the US, and sold anyway.

KPV is not FDA-approved. Its claimed benefits for gut and skin inflammation and wound healing rest on animal and lab studies, mainly mouse and rat colitis models. FDA's 2026 compounding review found no clinical studies or human exposure data for KPV by any route, stated its risks in humans are unknown, and found its identity and purity data lacking.

Add to Bio HackChecked 2026-11-13

Status: Not FDA-approved for any use in the US. FDA removed KPV from compounding category 2 on April 22, 2026, after its nomination was withdrawn, and did not place it in category 1. Under a draft, interim HHS policy announced October 30, 2026, HHS does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians compounding with KPV while the 503A bulks list is developed through rulemaking.
Also called: KPV peptide, KPV tripeptide, Lys-Pro-Val, lysine-proline-valine, KPV acetate, alpha-MSH 11-13
Taken for: gut inflammation, inflammatory bowel disease, colitis, skin inflammation, psoriasis, eczema, wound healing

Strong several reviews agree · Moderate one review or consistent trials · Limited one or a few small studies · Untested no study in people, listed with what it rests on

Shown to help0

No benefit shown in research yet.

Reported risks3

LimitedFDA states it has not identified any human exposure data on KPV and lacks important safety information. It removed KPV from category 2 in April 2026.How often is not known
LimitedFDA states potential safety risks of KPV in humans are unknown, with no clinical studies and insufficient data to rule out immune reactions.How often is not known
LimitedHHS states it does not intend to take enforcement action against licensed compounders using KPV during rulemaking, and that compounded drugs are not FDA-approved.How often is not known

What people take it for, and what was found

Claimed, not studied in people3

Untested

Gut inflammation and colitis

Not studied in people. In mice and rats with induced colitis, KPV reduced colon inflammation and weight loss.

No study in people. This rests on animal studies, lab studies.

The numbers and sources

Effect: In human intestinal and immune cell lines, KPV entered cells through the PepT1 transporter, inhibited NF-kappaB and MAP kinase inflammatory signaling, and reduced pro-inflammatory cytokine secretion. Given in drinking water, it reduced DSS- and TNBS-induced colitis in mice, with lower pro-inflammatory cytokine expression [8]. In two mouse colitis models, KPV-treated mice recovered earlier, regained more body weight and had fewer inflammatory cells in the colon. In mice with a nonfunctional melanocortin-1 receptor, KPV kept all treated animals alive through DSS colitis [9]. KPV delivered by mouth in nanoparticles reduced mucosal damage and TNF-alpha in a mouse model of ulcerative colitis [10]. KPV in a rectal hydrogel reduced weight loss, disease activity scores, colon shortening and inflammatory cytokines in rats with TNBS colitis [11].
Population: Mice and rats with chemically induced or transfer colitis, and human cell lines in the lab [8][9][10][11].
Sources: [8], [9], [10], [11]
Caveats: Colitis induced in rodents does not show what happens in people with inflammatory bowel disease. Two of the studies gave KPV inside a delivery system, nanoparticles or a hydrogel, rather than on its own [10][11]. FDA found no clinical studies or human exposure data for KPV by any route [3].

Untested

Skin inflammation, psoriasis and eczema

Not studied in people. KPV is the end piece of alpha-MSH, a hormone that reduced skin inflammation in animals. No KPV study of psoriasis or eczema was located.

No study in people. This rests on how it acts in the body, lab studies.

The numbers and sources

Effect: A 2008 review reports that the anti-inflammatory effects of alpha-MSH were confirmed in animal models including irritant and allergic contact dermatitis, and that KPV, its C-terminal tripeptide, keeps the anti-inflammatory effect without alpha-MSH's pigmenting action. The authors propose KPV for future treatment of inflammatory skin disease [12]. A 2007 review attributes most of alpha-MSH's anti-inflammatory activity to KPV [13]. In human skin cells (keratinocytes) in the lab, KPV did not raise cyclic AMP, and raised intracellular calcium only when the cyclic AMP pathway was blocked [14].
Population: Animal models of skin inflammation treated with alpha-MSH, reviewed in [12]. Human keratinocytes in the lab [14].
Sources: [12], [13], [14]
Caveats: The animal skin findings in these abstracts are for alpha-MSH, the parent hormone, not for KPV itself [12][13]. No study of KPV in a psoriasis or eczema model was located for this page.

Untested

Wound healing (eye and mouth)

Not studied in people. KPV eye drops sped healing of scraped corneas in rabbits, and a gel containing KPV aided healing of mouth ulcers in rats.

No study in people. This rests on animal studies, lab studies.

The numbers and sources

Effect: After the corneal surface was scraped off in both eyes, rabbits given KPV eye drops had smaller remaining defects than those given saline. At 60 hours, 8 of 8 corneas treated with KPV or with a nitric oxide donor had fully healed over, against none given placebo. Blocking nitric oxide production inhibited the effect of KPV, and in cultured rabbit corneal cells KPV raised cell viability [15]. In rats with chemotherapy-induced mouth ulcers, a hydrogel carrying KPV and EGCG, an antibacterial compound, improved food intake, body weight recovery and tissue repair, and lowered IL-1beta and TNF-alpha [16].
Population: Rabbits, and rabbit corneal cells in the lab [15]. Rats with chemotherapy-induced oral mucositis [16].
Sources: [15], [16]
Caveats: The gel also contained EGCG, which has its own antibacterial activity, so its effect cannot be assigned to KPV alone [16]. Scraped corneas and mouth ulcers in animals do not show what happens to wounds in people.

Risks

Reported risks3

LimitedHow often is not known

FDA compounding category 2 listing

FDA states it has not identified any human exposure data on KPV and lacks important safety information. It removed KPV from category 2 in April 2026.

The numbers and sources

How common: How often is not known: the sources give no rate.
Effect: FDA states that it has not identified any human exposure data on drug products containing KPV and that it lacks important information regarding any safety issues raised by KPV. KPV appears on FDA's list of substances previously in category 2 whose nominations were withdrawn by the nominators [1]. FDA removed KPV from category 2 on April 22, 2026, because the nomination was withdrawn, and KPV does not appear in category 1 of that update [2].
Population: Compounded drug products in the US [1][2].
Sources: [1], [2]
Caveats: A regulatory assessment of compounded products, not a study of harm.

LimitedHow often is not known

FDA's 2026 safety review

FDA states potential safety risks of KPV in humans are unknown, with no clinical studies and insufficient data to rule out immune reactions.

The numbers and sources

How common: How often is not known: the sources give no rate.
Effect: FDA's briefing document for its Pharmacy Compounding Advisory Committee found no clinical studies or human exposure data for KPV by any route, and no human pharmacokinetic studies, and concluded that potential safety risks in humans are unknown. FDA described KPV as not well characterized: tests for impurities, aggregates and microbial quality were not found in the published literature, and the nomination included no certificate of analysis. FDA found insufficient data to rule out immune reactions or aggregation. It concluded that the balance of criteria weighs against placing KPV on the list of substances allowed for pharmacy compounding [3].
Population: FDA review of published literature, adverse event databases and the nomination [3].
Sources: [3]
Caveats: The advisory committee met on July 23, 2026, and its votes are advice to FDA, which makes the final determination [3]. Trade press reported that the committee voted 8 to 6, with 1 abstention, to recommend adding KPV to the 503A bulks list [4][5]. No FDA-published tally was located for this page.

LimitedHow often is not known

HHS interim compounding policy

HHS states it does not intend to take enforcement action against licensed compounders using KPV during rulemaking, and that compounded drugs are not FDA-approved.

The numbers and sources

How common: How often is not known: the sources give no rate.
Effect: In a notice of a draft, interim policy, HHS states that it does not intend to take enforcement action against a State-licensed pharmacy, Federal facility or licensed physician compounding with a peptide listed in the policy's Appendix A while the 503A bulks list is developed through rulemaking [6]. KPV is on that list [7]. The notice states: "Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed." HHS may revisit the policy "if, among other things, a safety signal or product quality issue arises" with a compounded product it covers, and the policy is "not binding on HHS or the public" [6].
Population: Compounded drug products in the US [6][7].
Sources: [6], [7]
Caveats: A statement of enforcement intent, not an FDA approval and not a study of harm. FDA's future rulemaking may or may not add KPV to the 503A bulks list [6].

Checked, no increase found1

Limited

Reported adverse events

FDA's databases held no adverse event reports for KPV through December 2025. Reporting is voluntary, and compounding pharmacies generally do not report.

The numbers and sources

How common: How often is not known: the sources give no rate.
Effect: FDA's adverse event database held no reports for KPV through December 3, 2025, and FDA found no case reports in the published literature. FDA's food and supplement complaint system held no cases in which KPV was given, from January 2004 to December 3, 2025 [3].
Population: Voluntary reports to FDA [3].
Sources: [3]
Caveats: Reporting is voluntary and incomplete, and FDA notes that pharmacies compounding under section 503A generally do not report adverse events to it [3]. No reports does not mean no harm.

Sources

U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
U.S. Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act. Updated April 22, 2026. 2026. https://web.archive.org/web/20260422215502/https://www.fda.gov/media/94155/download
U.S. Food and Drug Administration. FDA Briefing Document: KPV-Related Bulk Drug Substances (KPV (free base) and KPV acetate). Pharmacy Compounding Advisory Committee, July 23-24, 2026. 2026. https://www.fda.gov/media/193346/download
Jacobus N. FDA Panel Votes to Loosen Restrictions for Four Peptides. Pharmaceutical Executive. 2026. https://www.pharmexec.com/view/fda-votes-loosen-restrictions-four-peptides
Steinzor P. FDA Panel Backs 6 Peptides for Compounding. AJMC. 2026. https://ajmc.com/view/fda-panel-backs-6-peptides-for-compounding
U.S. Department of Health and Human Services. Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances. Federal Register 91:68526. 2026. https://www.federalregister.gov/documents/2026/10/30/2026-22192/enforcement-discretion-policy-regarding-503a-compounding-using-certain-peptide-bulk-drug-substances
U.S. Department of Health and Human Services. HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, with Appendices A and B. 2026. https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf
Dalmasso G, Charrier-Hisamuddin L, Nguyen HT, Yan Y, Sitaraman S, Merlin D. PepT1-mediated tripeptide KPV uptake reduces intestinal inflammation. Gastroenterology. 2008. https://doi.org/10.1053/j.gastro.2007.10.026
Kannengiesser K, Maaser C, Heidemann J, et al. Melanocortin-derived tripeptide KPV has anti-inflammatory potential in murine models of inflammatory bowel disease. Inflammatory Bowel Diseases. 2008. https://doi.org/10.1002/ibd.20334
Xiao B, Xu Z, Viennois E, et al. Orally Targeted Delivery of Tripeptide KPV via Hyaluronic Acid-Functionalized Nanoparticles Efficiently Alleviates Ulcerative Colitis. Molecular Therapy. 2017. https://doi.org/10.1016/j.ymthe.2016.11.020
Sun J, Xue P, Liu J, et al. Self-Cross-Linked Hydrogel of Cysteamine-Grafted γ-Polyglutamic Acid Stabilized Tripeptide KPV for Alleviating TNBS-Induced Ulcerative Colitis in Rats. ACS Biomaterials Science & Engineering. 2021. https://doi.org/10.1021/acsbiomaterials.1c00792
Brzoska T, Luger TA, Maaser C, Abels C, Böhm M. Alpha-melanocyte-stimulating hormone and related tripeptides: biochemistry, antiinflammatory and protective effects in vitro and in vivo, and future perspectives for the treatment of immune-mediated inflammatory diseases. Endocrine Reviews. 2008. https://doi.org/10.1210/er.2007-0027
Luger TA, Brzoska T. alpha-MSH related peptides: a new class of anti-inflammatory and immunomodulating drugs. Annals of the Rheumatic Diseases. 2007. https://doi.org/10.1136/ard.2007.079780
Elliott RJ, Szabo M, Wagner MJ, Kemp EH, MacNeil S, Haycock JW. alpha-Melanocyte-stimulating hormone, MSH 11-13 KPV and adrenocorticotropic hormone signalling in human keratinocyte cells. Journal of Investigative Dermatology. 2004. https://doi.org/10.1111/j.0022-202x.2004.22404.x
Bonfiglio V, Camillieri G, Avitabile T, Leggio GM, Drago F. Effects of the COOH-terminal tripeptide alpha-MSH(11-13) on corneal epithelial wound healing: role of nitric oxide. Experimental Eye Research. 2006. https://doi.org/10.1016/j.exer.2006.07.014
Shao W, Chen R, Lin G, et al. In situ mucoadhesive hydrogel capturing tripeptide KPV: the anti-inflammatory, antibacterial and repairing effect on chemotherapy-induced oral mucositis. Biomaterials Science. 2022. https://doi.org/10.1039/d1bm01466h

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