KPV Not available

Immunity

KPV

An unapproved three-amino-acid peptide

Not FDA-approved · not available for sale or prescription

FDA advisory vote, July 2026 · FDA staff opposed · no FDA action

Why it’s not available
Stylised model of the real sequence

Overview.

KPV has no published human clinical trials; all evidence comes from cell and animal studies. It is the C-terminal tripeptide of alpha-melanocyte-stimulating hormone (alpha-MSH) and, in those studies, retains anti-inflammatory activity without the parent hormone's pigmentation effects. Its preclinical literature is mainly in gut-inflammation and skin models.

Also known as Lysine-Proline-Valine

The molecule, decoded.

Sequence

KPV

Length
3 residues
Molecular weight
342.4 g/mol
Formula
C16H30N4O4
CAS number
67727-97-3
Half-life
Not established
Routes studied
in vitro (keratinocyte, epithelial cell culture), oral (as a delivery-conjugate prodrug, mouse model), intraperitoneal/rectal (mouse colitis models)
Modifications
none reported (free tripeptide with unmodified termini); acetylated and conjugated prodrug forms have been studied experimentally

How it works.

KPV downregulates NF-κB signaling and pro-inflammatory cytokine release (e.g., IL-1β, IL-6) in intestinal epithelial and immune cells, and reduces oxidative-stress-driven MAPK activation and pyroptosis/apoptosis pathways in keratinocytes. It is proposed to act independently of classical melanocortin-receptor-mediated pigmentation pathways.

Evidence · Lab and animal studies only

What the research shows

mouse study2026

An oral self-immolative prodrug conjugate of KPV ('proKPV') achieved 3.8-fold greater colonic drug accumulation than free KPV in a mouse colitis model and produced comparable anti-inflammatory efficacy at a 20-fold lower dose; the conjugate also reduced inflammation in a mouse model of acute lung injury.

mouse models of DSS colitis and acute lung injury

Source
cell study2025

KPV (50 µg/mL) restored viability and reduced IL-1β secretion in human HaCaT keratinocytes exposed to fine particulate matter (PM10), acting via suppression of ROS-driven ERK/p38 MAPK signaling and reduced pro-apoptotic protein expression; effects were also shown in a 3D human skin model.

human HaCaT keratinocyte line and 3D reconstructed human skin model

Source
narrative review2025

A 2025 short narrative review of host-defense peptides for inflammatory bowel disease listed KPV, an α-MSH-derived peptide, alongside cathelicidins and defensins as agents that downregulate NF-κB signaling and modulate cytokine release; its view of their potential for IBD rests on preclinical mechanistic data, not human trials.

narrative review, no direct human trial

Source

What to know first.

Based on: lab and animal studies only; human safety is not established.

Reported side effects

  • Unknown: no human studies have been published

Cautions

  • No human safety or efficacy trial has been published; all evidence is in vitro or animal
  • Not approved and cannot currently be compounded legally; FDA has not acted on the July 2026 advisory vote

Checked 2026-09

Where it stands.

Not FDA-approved · not available for sale or prescription. KPV is not FDA-approved and is not available for sale or prescription. In July 2026, FDA staff recommended against adding it to the list of substances pharmacies may compound; FDA’s advisory committee voted 8–6, with 1 abstention, to recommend it anyway. The vote is advisory, and FDA has not acted on it.
FDA
Not approved. Reviewed at the PCAC on 23 Jul 2026 for wound healing and inflammatory conditions: FDA proposed NOT adding KPV (free base) or KPV acetate to the 503A Bulks List; the committee voted 8 yes, 6 no, 1 abstain on each form to recommend inclusion (non-binding). No proposed or final FDA rule as of 26 Sep 2026.
Compounding
Nominated for the 503A Bulks List by Wells Pharmacy Network (received 25 Mar 2021, FDA-2015-N-3534-0294). KPV was held in 503A Category 2; Wells withdrew on 14 Apr 2026 (FDA-2015-N-3534-0484), and FDA's Category 2 page (updated 22 Apr 2026) lists KPV under 'nominated but withdrawn' ('FDA has not identified any human exposure data'). FDA presented KPV to the PCAC on 23 Jul 2026 and proposed NOT including it; the committee voted 8-6-1 on each form to recommend inclusion (non-binding). As of 26 Sep 2026 FDA has published no proposed or final rule: the substance is not on the 503A bulks list (21 CFR 216.23, unchanged since 2019) and is not in 503A Category 1.
Sport (WADA)
Not named in the WADA 2026 Prohibited List. However, S0 (Non-Approved Substances, prohibited at all times) covers any pharmacological substance not addressed elsewhere on the List that has no current governmental approval for human therapeutic use, including drugs in pre-clinical development, and KPV appears to fall within that definition.
References (6)
  1. PubMed · PMID 41533788
  2. PubMed · PMID 40073467
  3. PubMed · PMID 41241376
  4. U.S. FDA · download
  5. U.S. FDA · certain bulk drug substances use compounding may present signifi
  6. World Anti-Doping Agency

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