Skip to content

Reference information only. Therapept does not sell peptides and does not provide medical advice.Research-use notice

Therapept

Tripeptide corresponding to the C-terminal sequence of α-melanocyte-stimulating hormone

KPV — evidence

What has been published, classified by the kind of document it is. This is not a protocol, not a score, and not a recommendation for use.

Evidence overview

4 records in this file

  • ANIMAL2
  • REGULATORY2

Research areas. Intestinal inflammation models; United States compounding.

Publication span. 2008–2026.

What we know

  • Two 2008 murine colitis papers (Dalmasso; Kannengiesser) are primary sources for the preclinical gut-inflammation literature.
  • No FDA-approved product exists. FDA's withdrawn-nominations table states that human exposure data have not been identified.
  • PCAC discussed KPV-related bulk substances on 23 July 2026. FDA briefing materials proposed against 503A Bulks List inclusion. That is not a listing decision.

Editorial reading of the records below, labelled as Therapept analysis. How records are built

What remains uncertain

  • Controlled human interventional data.
  • Whether commercial certificates labelled KPV describe Lys-Pro-Val rather than a related melanocortin fragment.

Regulatory notes

No FDA-approved product

  • No approved drug product exists in Drugs@FDA.
  • Listed on FDA's table of bulk substances nominated for compounding and subsequently withdrawn. FDA states it has not identified human exposure data.
  • On 23 July 2026 PCAC discussed KPV (free base) and KPV acetate (uses evaluated: wound healing and inflammatory conditions). FDA briefing materials proposed that they NOT be included on the 503A Bulks List. Nominations had been withdrawn; FDA elected to proceed. Committee recommendations are non-binding; FDA has not published a listing decision as of this review.

Regulatory status describes how a substance is classified. It is not a safety assessment of any particular material.

Studies and documents

  1. REGULATORY2026FDA compounding classification

    FDA — bulk substances nominated for compounding and withdrawn: KPV

    U.S. Food and Drug AdministrationFDA compounding communications

    Objective
    To record FDA's published compounding position on KPV.
    Endpoint investigated
    Compounding classification

    KPV appears on FDA's withdrawn-nominations table. FDA states it has not identified any human exposure data on drug products containing KPV via any route, and that it lacks information on whether the drug would cause harm if administered to humans.

    Limitations. Withdrawn nomination; not a clinical trial review. Human exposure data are stated as not identified.

    FDA — Certain bulk drug substances for use in compounding may present significant safety risksReviewed 12 September 2026

  2. REGULATORY2026FDA advisory-committee briefing

    FDA PCAC briefing — KPV-related bulk drug substances (23 July 2026)

    U.S. Food and Drug AdministrationFDA PCAC briefing

    Objective
    To record FDA staff's published proposal on 503A Bulks List inclusion for KPV.
    Endpoint investigated
    Proposed compounding-list classification

    PCAC discussed KPV (free base) and KPV acetate on 23 July 2026 (uses evaluated: wound healing and inflammatory conditions). The briefing-document introduction states that FDA is proposing that both NOT be included on the 503A Bulks List. Nominations had been withdrawn; FDA elected to proceed. A committee recommendation is not a listing decision.

    Limitations. Staff proposal and committee advice are non-binding. FDA has not published a listing decision as of this review.

    FDA — PCAC briefing for KPV-related bulk drug substancesReviewed 12 September 2026

  3. ANIMAL2008In vivo (murine colitis)

    Melanocortin-derived tripeptide KPV has anti-inflammatory potential in murine models of inflammatory bowel disease

    Kannengiesser K, et al.Inflammatory Bowel Diseases

    Population
    Two murine colitis models, including MC1R-mutant mice
    Objective
    To test KPV in two murine colitis models and whether effects required MC1R signalling.
    Endpoint investigated
    Colitis severity and survival in mice

    Reports anti-inflammatory effects of KPV in two murine colitis models, described as at least partly independent of MC1R signalling. In MC1R-mutant mice, the authors report that KPV treatment rescued animals in the treatment group from death during DSS colitis.

    Limitations. Rodent IBD models. Rescue of survival in a mutant-mouse DSS model is not a human clinical endpoint.

    DOI 10.1002/ibd.20334Kannengiesser et al., Inflamm Bowel Dis (2008)Reviewed 12 September 2026

  4. ANIMAL2008In vitro with in-vivo murine colitis models

    PepT1-mediated tripeptide KPV uptake reduces intestinal inflammation

    Dalmasso G, Charrier-Hisamuddin L, Nguyen HT, Yan Y, Sitaraman S, Merlin DGastroenterology

    Population
    Cultured intestinal epithelial and immune cells; DSS- and TNBS-induced colitis in mice
    Objective
    To test whether PepT1 transports KPV and whether oral KPV altered chemically induced colitis in mice.
    Endpoint investigated
    NF-κB and MAP-kinase signalling in culture; histological and cytokine measures in murine colitis

    Reports that nanomolar KPV inhibited NF-κB and MAP-kinase inflammatory signalling in cultured cells via hPepT1, and that oral KPV in drinking water reduced measures of DSS- and TNBS-induced colitis in mice. The work is a primary source for the preclinical gut-inflammation literature on this tripeptide.

    Limitations. Murine chemical-colitis models and cell culture. Findings do not establish human inflammatory-bowel outcomes.

    DOI 10.1053/j.gastro.2007.10.026Dalmasso et al., Gastroenterology (2008)Reviewed 12 September 2026

Last reviewed 12 September 2026 · Compiled by Therapept Editorial · How these records are built