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Tissue peptides

KPV (Lys-Pro-Val)

Also known as Lys-Pro-Val, Lysine-proline-valine, alpha-MSH(11-13), MSH 11-13, KPV acetate, H-Lys-Pro-Val-OH

Preclinical only

Melanocortin-derived (alpha-MSH fragment) anti-inflammatory tripeptide. Investigational; not an approved drug.

Not FDA-approved. Not on FDA's 503A category lists (May 14, 2026). Source, May 14, 2026

Identity. KPV is the C-terminal tripeptide of alpha-MSH (residues 11-13). Free base CAS 67727-97-3, MW 342.43 g/mol (C16H30N4O4). FDA notes KPV is a common name, not a USAN. KPV free base and KPV acetate (MW 402.5) are distinct bulk drug substances that share one active moiety and one CAS number. KPV is not the dimer (CKPV)2 or the tripeptide K(D)PT. Ask the pharmacy whether the 10 mg vial is free base or acetate, and what the labeled concentration is after reconstitution. Whether the mcg dose is based on free base or salt is not established. A salt-form vial may deliver about 15% less peptide per mg than the label implies. Palmitoylated Pal-alpha-MSH(11-13) and nanoparticle KPV conjugates in the literature are different molecules and must not be used for dosing.

At a glance

These dosages are a helpful guide, not a prescription. Every clinician is expected to do their own due diligence before prescribing.

No established human dose

Evidence is limited to animal and in vitro work. Published studies cover mouse colitis (DSS, TNBS, transfer) and peritonitis models, human cell lines, and cadaver-skin permeation. FDA's May 2026 review found no human studies, pharmacokinetic data, case reports or FAERS reports, and no repeat-dose toxicity studies. No dosing guidance is given. The only dose figures located came from a compounding-vendor page and are not trial data. FDA's review team recommended against 503A listing. A secondary report says the July 2026 advisory committee voted 8-6-1 in favor (advisory only).

No allowed source establishes a dose, route or schedule for KPV; the dispensing pharmacy's labeled concentration governs.
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Dosing detail

Clinical practice

Clinical practice

No dose, titration, ceiling, frequency, route, timing or cycle is given. The only source of those figures was a compounding-vendor page, and no independent page stated the same figures. The one remaining source (Peptide Dossier, updated September 9, 2026) finds that the human evidence does not establish a standard dose, route or schedule. It says its earlier version gave 100-200 mcg as a starting range, which it now calls an unvalidated protocol claim. The dispensing pharmacy's labeled concentration governs any dose.

Safety

Serious warnings

  • No boxed warning exists because KPV has no approved labeling. FDA: 'The nomination did not include, and FDA has not identified, any clinical studies or human exposure data for KPV via any route of administration. Therefore, potential safety risks associated with the use of KPV in humans are unknown.'2
  • FDA is 'particularly concerned about the lack of any human data on drug products containing these substances administered via any route of administration, including lack of information to assess immunogenicity or aggregation of KPV-related substances.'2
  • FDA lists KPV among withdrawn nominations: 'FDA lacks important information regarding any safety issues raised by KPV, including whether it would cause harm if administered to humans.'3
  • FDA found no repeat-dose toxicity studies: 'the nominator did not submit, and FDA did not identify repeat-dose toxicity studies of KPV (free base) or KPV acetate', so there is no animal-derived safety margin to scale from.2

Contraindications

  • No contraindications are established because no human safety data exist. This is an absence of data, not evidence of safety. Pregnancy, lactation, pediatric use and active infection or immunosuppression are unstudied.2

Adverse effects

  • No human adverse-event data exist. FDA: 'The FAERS search did not retrieve any reports and the literature search did not identify any cases of adverse events' (FAERS searched through December 3, 2025). No case reports of KPV use in humans were found.2

Monitoring

  • No validated laboratory monitoring exists. FDA flags immunogenicity and aggregation as unassessed ('there is insufficient data to conclude that KPV (free base) or KPV acetate do not present these risks'). At each contact, document baseline status, injection-site reactions, hypersensitivity and new symptoms. Record dose, timing and concurrent medication changes. Treat new or worsening symptoms as a possible adverse effect.2

Handling

Reconstitution

Dilution conversions written for a 5 mg vial in 1 mL (5 mg/mL, so 500 mcg per 0.1 mL) do not transfer to the 10 mg formulary vial. Arithmetic for a 10 mg vial on a U-100 syringe (100 units = 1 mL), for illustration only and not a dose recommendation: with 2 mL = 5 mg/mL: 250 mcg = 0.05 mL = 5 units, 500 mcg = 0.1 mL = 10 units, 1 mg = 0.2 mL = 20 units. With 1 mL = 10 mg/mL: 250 mcg = 0.025 mL = 2.5 units, 500 mcg = 5 units, 1 mg = 10 units. Applying '10 units = 500 mcg' (correct at 5 mg/mL) to 10 mg/mL delivers 1 mg, a 2x overdose. Using 2 mL is easier to measure at the smallest dose. Always state the mcg dose, mL volume and syringe units together. The pharmacy label governs.

Storage before mixing

FDA's briefing cites a vendor report that lyophilized KPV (free base) is stable up to 3 years at -20°C, up to 2 years at 4°C and up to 3 months at 15°C, and a nominator CoA for KPV acetate stating 'in a sealed container at 2°C to 8°C.'

Storage after mixing

FDA's briefing, citing a vendor CoA, prints 'Upon reconstitution, reports indicate the aqueous solution is recommended to be stored at -80°C for 6 months, at -2°C for 1 month, and 10°C for 1 week' (-2°C is as printed, probably a typo for -20°C). The only measured figure near refrigeration is 1 week at 10°C. No 2-8°C reconstituted stability data were identified. The dispensing pharmacy's labeled beyond-use date overrides any figure here.2

Evidence

Evidence is limited to animal and in vitro work. Published studies cover mouse colitis (DSS, TNBS, transfer) and peritonitis models, human cell lines, and cadaver-skin permeation. FDA's May 2026 review found no human studies, pharmacokinetic data, case reports or FAERS reports, and no repeat-dose toxicity studies. No dosing guidance is given. The only dose figures located came from a compounding-vendor page and are not trial data. FDA's review team recommended against 503A listing. A secondary report says the July 2026 advisory committee voted 8-6-1 in favor (advisory only).

Mechanism

KPV is the C-terminal tripeptide of alpha-MSH. In cell and mouse models it inhibits NF-kappaB and MAP kinase signaling and cytokine secretion, and it enters cells through the PepT1 transporter. In a peritonitis model its effect did not appear to act through melanocortin receptors. Inhibition of IL-1beta functions was proposed instead.45

Availability

Amounts offered

  • 10 mg

Custom strengths on request.

References

According to PubMed

  1. 1KPV Peptide Dosage Guide: Complete Protocols & Administration (Peptide Dossier editorial, updated September 9, 2026)Peptide Dossier, 2026
  2. 2FDA Briefing Document, PCAC July 23-24, 2026: Evaluation of KPV-related bulk drug substances (KPV free base and KPV acetate) for inclusion on the 503A Bulk Drug Substances List, memo dated 5/12/2026U.S. FDA, 2026
  3. 3Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (table of withdrawn nominations, KPV entry); content current as of 04/22/2026U.S. FDA, 2026
  4. 4PepT1-mediated tripeptide KPV uptake reduces intestinal inflammationGastroenterology 2008;134(1):166-78 (PMC2431115), 2008
  5. 5Dissection of the anti-inflammatory effect of the core and C-terminal (KPV) alpha-melanocyte-stimulating hormone peptidesJ Pharmacol Exp Ther 2003;306(2):631-7, 2003
  6. 6Melanocortin-derived tripeptide KPV has anti-inflammatory potential in murine models of inflammatory bowel diseaseInflamm Bowel Dis 2008;14(3):324-31, 2008
  7. 7Drug-loaded nanoparticles targeted to the colon with polysaccharide hydrogel reduce colitis in a mouse modelGastroenterology 2010;138(3):843-53, 2010
  8. 8Orally targeted delivery of tripeptide KPV via hyaluronic acid-functionalized nanoparticles efficiently alleviates ulcerative colitisMol Ther 2017;25(7):1628-1640 (PMC5498804), 2017
  9. 9Inflammation-triggered self-immolative conjugates enable oral peptide delivery by overcoming gastrointestinal barriersSci Adv 2026;12(3):eaea2989 (PMC12802832), 2026
  10. 10Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act (Category 1, 2, 3 lists), updated May 14, 2026; KPV not listedU.S. FDA, 2026
  11. 11FDA PCAC Meeting July 23-24, 2026 Agenda (BPC-related and KPV-related bulk drug substances)U.S. FDA, 2026
  12. 12PEPTIDE-L WAVE! PCAC Approves Four Bulk Drug Substances for the 503A List (secondary report of advisory vote; not an FDA record)FDA Law Blog (Hyman, Phelps & McNamara), July 24, 2026, 2026
  13. 13Synthetic Peptides in Pharmacy Compounding: Analysis of PCAC Recommendations and Industry Safety Standards (abstract only; full text not retrieved)Int J Pharm Compd 2026;30(4):329-336, 2026

Last reviewed 2026-10-14. 20 figures checked against their sources. How this works