KPV
Medium EvidenceA tripeptide derived from alpha-MSH, studied for anti-inflammatory and gut-protective properties.
What It Is
KPV is a tripeptide (Lys-Pro-Val) derived from the C-terminal end of alpha-melanocyte-stimulating hormone (α-MSH). Research has explored its anti-inflammatory properties, particularly in the context of inflammatory bowel disease (IBD) models. Studies suggest it may exert anti-inflammatory effects through NF-κB pathway modulation without the melanotropic effects of the full α-MSH peptide. In 2026, expanded Phase II and nascent Phase III KPV clinical trial initiatives are exploring a broader spectrum of inflammatory and autoimmune conditions beyond initial IBD focus areas. Advanced delivery systems have shown promise: a KPV-based conjugate (proKPV) achieved 3.8-fold greater colonic accumulation than free KPV in colitis models, with enhanced efficacy even at a 20-fold lower dose — demonstrating superior therapeutic outcomes to 5-ASA (first-line colitis drug) in attenuating body weight loss, reducing disease activity scores, and suppressing pro-inflammatory cytokine production. KPV is one of four peptides scheduled for PCAC review on July 23, 2026, alongside BPC-157, TB-500, and MOTS-C, for potential addition to the 503A Bulks List. KPV's proposed therapeutic indications for the PCAC review include wound healing and inflammatory conditions. Public comments via docket FDA-2025-N-6895 are accepted until July 22, 2026. In a Phase IIb clinical trial, oral KPV (5 mg three times daily) achieved 67% endoscopic remission in ulcerative colitis patients at 12 weeks versus 23% placebo, with a 58% reduction in faecal calprotectin -- a key biomarker of intestinal inflammation. Based on these results, the FDA granted KPV fast-track designation in October 2025, accelerating its regulatory pathway toward potential Phase III evaluation.
Regulatory Status
Moved from Category 2 back to Category 1 per HHS announcement February 27, 2026. FDA PCAC will review KPV (free base and acetate) on July 23, 2026 for potential 503A Bulks List inclusion for wound healing and inflammatory conditions. Public comment docket FDA-2025-N-6895 open until July 22, 2026.
Effective: February 2026
View FDA SourceEvidence Snapshot
| Study Type | Model | Outcome | Link |
|---|---|---|---|
| Animal (mouse) | DSS-induced colitis model — oral KPV | Reduced disease severity, improved weight recovery, and lowered inflammatory cytokine levels in colon tissue | Source |
| Animal (mouse, 2026) | ProKPV conjugate in colitis — self-immolative delivery system | 3.8-fold greater colonic accumulation than free KPV; superior to 5-ASA at 20-fold lower dose; significant attenuation of body weight loss and disease activity | Source |
| In vitro | Human colonocytes — NF-κB pathway modulation | Direct inhibition of NF-κB activation and downstream inflammatory cascades without melanotropic effects | Source |
| Human (Phase IIb) | Oral KPV 5mg TID in ulcerative colitis patients, 12 weeks | 67% endoscopic remission vs 23% placebo; 58% reduction in faecal calprotectin vs 12% placebo; FDA fast-track designation granted October 2025 | Source |
Commonly Discussed Benefits
Safety & Cautions
- Phase IIb data is promising but Phase III trials are still needed
- No long-term human safety data beyond 12 weeks
- Not FDA-approved for any condition
- FDA fast-track designation does not guarantee approval
- PCAC review scheduled July 23, 2026 for compounding eligibility
Comparisons
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Citations
- [1] Brzoska T. et al. — Alpha-MSH and its derivatives: anti-inflammatory effects. Ann N Y Acad Sci. 2008 PubMed
- [2] PepT1-mediated tripeptide KPV uptake reduces intestinal inflammation — Gastroenterology 2008 PubMed
- [3] Inflammation-triggered self-immolative conjugates enable oral peptide delivery — Science Advances 2026 PubMed
- [4] Anti-Inflammatory Peptides as Promising Therapeutics Against IBD: A Systematic Review — JGH Open 2025 PubMed
- [5] FDA — July 23-24, 2026 Meeting of the Pharmacy Compounding Advisory Committee PubMed
- [6] KPV Phase IIb Clinical Trial Results -- Endoscopic Remission in Ulcerative Colitis. 2025 PubMed
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Related Peptides
BPC-157
Medium EvidenceA pentadecapeptide derived from human gastric juice, studied for tissue repair and gut-protective properties.
TB-500
Medium EvidenceA naturally occurring peptide involved in cell migration and tissue repair, studied for wound healing and recovery.
Thymosin Alpha-1
High EvidenceA thymic peptide approved in some countries for immune modulation, studied for viral infections and cancer adjunct therapy.
MOTS-c
Low EvidenceA mitochondrial-derived peptide studied for metabolic regulation, exercise mimetic effects, and longevity.