KPV

Properties

Substance class	Synthetic tripeptide of lysine, proline and valine. FDA's evaluation states "KPV is reported to be a tripeptide composed of the amino acids lysine (K), proline (P), and valine (V)" and that "It is naturally produced in the body and is a fragment derived from the neuropeptide produced in the pituitary gland called alpha-melanocyte-stimulating hormone (alpha-MSH)". PROVENANCE: FDA's footnote for that second sentence points at a wellness-clinic blog post, not at a published characterisation. The relationship itself is independently documented in the peer-reviewed literature — see the parent_hormone_relationship entry, which carries a primary source.	source
Sequence	H-Lys-Pro-Val-OH	source
Parent hormone relationship	KPV is the C-terminal three residues, positions 11 to 13, of alpha-melanocyte-stimulating hormone. A peer-reviewed paper gives the parent sequence explicitly as "alpha-melanocyte-stimulating hormone [alpha-MSH (1-13), SYSMEHFRWGKPV]" and refers to "its carboxy-terminal tripeptide (11-13, KPV)", so the last three letters of the parent string are the whole of this compound. Note what this does NOT establish: the parent hormone has a much larger structure and its own receptor pharmacology, and findings reported for alpha-MSH are not findings for this tripeptide.	source
Other names	KPV is the common name; FDA's abbreviation list expands it as "lysine-proline-valine". FDA states that "KPV is a common name and not a United States Adopted Name (USAN)" and that it "has encountered multiple salts, and derivatives, including different active moieties, sold commercially under the same common name for similarly situated products". FDA also states that inconsistent naming conventions that do not follow INN, IUPAC or USAN standards "represent a safety risk for patients as they may be dosed with a different BDS than the physician ordered".	source
Substance registry names	FDA's Global Substance Registration System files this molecule under three names only — the common-chemistry name "ACTH-(11-13)" and the systematic names "L-lysyl-L-prolyl-L-valine" and "L-Valine, L-lysyl-L-prolyl-". It does not record "KPV", "alpha-MSH (11-13)" or any melanocortin-derived name at all. PubChem, by contrast, titles the same structure "Msh (11-13)" and lists "alpha-MSH(11-13)", "Lys-pro-val" and "ACTH-(11-13)" among its synonyms. The molecule therefore travels under at least three naming families depending on which registry is consulted.	source
Cas number	67727-97-3	source
Unii	READ THE DISCREPANCY BEFORE USING THIS. FDA's Global Substance Registration System holds an approved record for "L-lysyl-L-prolyl-L-valine" with the UNII 7V6LGD8S5R, CAS 67727-97-3, formula C16H30N4O4 and molecular weight 342.4344, cross-referenced to PubChem CID 125672. Two other FDA surfaces disagree with it. FDA's own 503A evaluation lists the UNII code for both KPV (free base) and KPV acetate as "Not available", and the withdrawn nomination answered "Does the substance have a UNII code? NO". FDA's public UNII lookup at precision.fda.gov returns "The UNII (7V6LGD8S5R) does not exist" for that code as of this entry. The registry record is recorded here with that conflict stated rather than resolved.	source
Molecular formula	C16H30N4O4	source
Molecular weight	342.43 g/mol	source
Molecular data independent cross check	PubChem's record for the tripeptide, CID 125672, is titled "Msh (11-13)" and carries the molecular formula C16H30N4O4, matching FDA's figure. The same record lists CAS 67727-97-3 and the systematic name (2S)-2-[[(2S)-1-[(2S)-2,6-diaminohexanoyl]pyrrolidine-2-carbonyl]amino]-3- methylbutanoic acid among its synonyms. Recorded as a cross-check on FDA's table, not as an independent measurement — both trace to the same structure.	source
Acetate salt identifiers	KPV acetate is a separate bulk drug substance from KPV (free base) in FDA's analysis, with molecular formula C16H30N4O4.CH3COOH and molecular weight 402.5 g/mol against the free base's C16H30N4O4 and 342.43 g/mol. Neither has a UNII code in FDA's evaluation, and FDA notes that "The CAS number for KPV acetate is the same as that for KPV (free base) in most public references" — so, unlike BPC-157, the CAS number does not separate the two forms here. FDA states the two are different active pharmaceutical ingredients sharing the same active moiety, and that the single nomination it received named one form in the title of its certificate of analysis and a different one by molecular formula.	source
Appearance	KPV (free base) is described by FDA as a white to off-white lyophilized powder. FDA describes KPV acetate separately as a white to off-white solid powder.	source
Solubility	Different for the two forms, and both figures are supplier-sourced. FDA states that KPV (free base) "is soluble in water up to 0.70 mg/mL" and that KPV acetate "is reported to dissolve in water at 5 mg/mL". PROVENANCE: FDA's footnotes attribute the free-base figure to a supplier certificate of analysis and the acetate figure to a supplier product page, not to a published measurement. FDA treats the free base's low solubility as a characterisation gap, writing that because the nominator gave no formulation detail it "cannot evaluate how the physical and chemical characteristics, especially limited water solubility (0.7 mg/mL) and particle size, impact the performance of final products".	source
Storage	READ THE PROVENANCE BEFORE USING THIS. FDA's evaluation reports that lyophilized KPV (free base) "is stable up to 3 years when stored at -20 degrees C in a tightly closed container, up to 2 years at 4 degrees C, and up to 3 months at 15 degrees C", and that on reconstitution "the aqueous solution is recommended to be stored at -80 degrees C for 6 months, at -2 degrees C for 1 month, and 10 degrees C for 1 week". FDA's footnote attributes every one of those figures to a supplier certificate of analysis, not to a published stability study, and FDA states the conclusion as what "is reported" rather than as an agency determination. For KPV acetate, FDA reports a different condition from the nominator's certificate of analysis: "in a sealed container at 2 degrees C to 8 degrees C". There is no United States, European, Japanese or International pharmacopoeial monograph for either form and no approved product label, so no body with standing to determine handling conditions has done so. FDA separately warns that peptides "can be extremely sensitive to product formulation, process, and environmental conditions (e.g., pH, heat (temperature), concentration, in-process related impurities, excipients etc.), which may lead to the aggregation and degradation of peptides", that this "could result in loss of their biological activity", and that significant amounts of aggregates can form during storage.	source
Forced degradation chemistry	This is the one piece of handling chemistry for this compound that rests on a peer-reviewed measurement rather than a supplier page. A validated stability-indicating HPLC method reports that under acid, alkali and hydrogen peroxide stress, KPV "yielded lys-pro-diketopiperazine as major degradation product", identified by mass spectrometry, and that the method separated the intact peptide from those degradation products. The same paper reports a limit of detection of 0.01 micrograms per mL and a limit of quantitation of 0.25 micrograms per mL. FDA's evaluation independently records, citing a doctoral dissertation, that KPV acetate forms Lys-Pro-DKP under acid and alkaline hydrolysis and oxidative degradation by hydrogen peroxide, that basic conditions produced three further nonpolar degradation products whose structures were not elucidated, and that treatment with 0.5% hydrogen peroxide was rapid, degrading the peptide to Lys-Pro-DKP, proline and valine.	source
Skin permeation in vitro	Measured once, in excised human skin, and the passive result was below the detection limit. In dermatomed human cadaver skin, "KPV permeation was less than detectable levels (limit of detection, 0.01 micrograms/mL) by simple passive diffusion". Microneedle treatment raised permeation to 4.4 micrograms per square cm per hour; iontophoresis and iontophoresis combined with microneedles increased the permeation rate by 8-fold and 35-fold respectively over microneedles alone. This is an ex vivo permeation experiment, not a measurement in a person, and the barrier-breaching methods it used are laboratory techniques.	source
Mechanism as described in cited work	Not established, and specifically not melanocortin-receptor-mediated. FDA's reviewers state that "several lines of evidence suggest that MC receptors are unlikely to be the molecular targets underlying the anti-inflammatory and wound-healing properties of KPV", citing in vitro work in which KPV could not displace radiolabelled alpha-MSH binding in rat brain tissue, murine melanoma cells or MC1R-expressing murine macrophages, and did not raise cyclic AMP in MC1-receptor-expressing murine macrophages as alpha-MSH did. FDA records two proposed alternatives — inhibition of nuclear factor-kappa B activation, and inhibition of the effects of proinflammatory cytokines such as interleukin 1 beta — and a proposed route of entry, the di/tripeptide transporter PepT1. FDA's conclusion is that "the molecular targets underlying the pharmacological effects of KPV- related BDSs remain unknown".	source
Human pharmacokinetics	None. FDA states it "did not identify clinical studies in humans assessing pharmacokinetics or pharmacodynamics of KPV (free base) or KPV acetate via any route of administration". FDA also states that neither the nominator submitted nor did the agency identify any nonclinical pharmacokinetic or toxicokinetic study of either substance, so there is no animal figure to quote either.	source
Nonclinical toxicology	None exists. FDA states that at the time of its evaluation the nominator did not submit, and FDA did not identify, acute toxicity studies, repeat-dose toxicity studies, genotoxicity studies, nonclinical developmental and reproductive studies, or nonclinical carcinogenicity studies of KPV (free base) or KPV acetate. That is the entire toxicology record: five categories, all empty.	source
Approval status	Not an approved drug anywhere. FDA states there is "no applicable United States Pharmacopeia (USP) or National Formulary (NF) drug substance monograph for KPV (free base) or its acetate form, and neither are a component of an FDA-approved drug". FDA adds that a search of the European Pharmacopoeia (11.8 edition, 2025) and the Japanese Pharmacopoeia (18th Edition) found no monograph for either form, and that the European Medicines Agency "did not list any products containing KPV (free base) or KPV acetate that are authorized for use".	source
Fda 503a bulks list status	Not on the 503A Bulks List. In an evaluation dated 5/12/2026, FDA concluded that a balancing of the statutory criteria weighs against adding KPV (free base) or KPV acetate to that list, and wrote "Accordingly, we propose not adding KPV (free base) or KPV acetate to the 503A Bulks List." FDA's stated grounds were that both substances are not well-characterised physically and chemically, that the extent of use in compounding is unknown, and that there is "non-existing information on the use of these substances administered in humans to make a conclusion on their clinical safety and effectiveness", alongside the existence of approved therapies for the conditions proposed.	source
Nomination history	One nomination, since withdrawn. FDA records that the nomination of "KPV (lysine-proline-valine)" came from Wells Pharmacy Network under Document ID FDA-2015-N-3534-0294 and was withdrawn under Document ID FDA-2015-N-3534-0484, and that FDA then chose to evaluate both forms "at its discretion" and "on its own initiative". The nominated dosage form was a cream or gel at 0.1% strength for topical administration, and the nominated use was, in FDA's words, "wound healing and inflammatory conditions". FDA notes the nomination was internally inconsistent: it is unclear whether the free base or the acetate was intended, and the certificate of analysis submitted "refers to one BDS by name in the title and a different BDS by the molecular formula".	source
Fda advisory committee review	FDA put KPV-related bulk drug substances to its Pharmacy Compounding Advisory Committee at a meeting held July 23-24, 2026, with the published voting questions "Should KPV (free base) be placed on the list?" and "Should KPV acetate be placed on the list?". The same meeting covered BPC-157, TB-500, MOTS-c, Emideltide, Epitalon and Semax. An advisory committee recommendation does not bind FDA, and as of the date of this entry FDA's meeting page carried briefing documents, the questions, the agenda, the roster and the presentation slides, but no minutes, transcript or vote record. This file therefore does not state how the committee voted.	source
Fda significant safety risks listing	KPV appears on FDA's page of bulk drug substances that may present significant safety risks, in the table headed "Bulk drug substances nominated but withdrawn". FDA's published entry reads in full "FDA has not identified any human exposure data on drug products containing KPV administered via any route of administration. FDA lacks important information regarding any safety issues raised by KPV, including whether it would cause harm if administered to humans." Page content current as of 04/22/2026.	source
Compounding volume reported to fda	Zero. FDA reports that according to outsourcing facility product reports submitted to the agency, outsourcing facilities "have not reported preparing single or multiple-API compounded drug products containing KPV (free base) or KPV acetate from January 2017 to June 2025". FDA notes separately that compounders operating under section 503A generally do not report to that database, so this figure covers registered outsourcing facilities rather than all compounding.	source
Adverse event reports	None retrieved, from either database FDA searched. FDA states that a search of the FDA Adverse Event Reporting System and the medical literature for adverse events associated with KPV through December 3, 2025 "did not retrieve any reports and the literature search did not identify any cases of adverse events", and that a search of the Human Foods Complaint System covering 1/1/2004 to 12/3/2025 "did not retrieve cases where KPV was administered". FDA's own footnote states that reporting is voluntary, that compounders under section 503A generally do not report adverse events to FDA, and that the agency "cannot make definitive conclusions regarding the safety of KPV based on FAERS data alone".	source
Clinical trial registrations	None. A query of the ClinicalTrials.gov API on 2026-09-17 for KPV as an intervention, and a separate free-text query of the whole registry for "KPV" and for "KPV peptide", each returned a total count of 0. FDA independently consulted ClinicalTrials.gov for both its effectiveness and its human safety sections and reports finding no clinical studies of either substance.	source
Anti doping status	Not established by any source this file could verify, and deliberately not inferred. No statement from a national or international anti-doping authority naming KPV was retrievable during data entry; the United States Anti-Doping Agency's published prohibited-list page does not name KPV, lysine-proline-valine or alpha-MSH. What was verified is narrower: a 2026 peer-reviewed critical review in a sports medicine journal names KPV among "synthetic fragments" that are "promoted for muscle growth, fat metabolism, recovery, and anti-inflammatory effects" in recreational and professional sport and bodybuilding, and states that clinical evidence supporting peptide use in sport is limited. That review records promotion, not prohibited status. Athletes should ask their own anti-doping authority rather than rely on this entry.	source
Fda characterisation verdict	Both forms judged poorly characterised. FDA concludes that KPV (free base) and KPV acetate are each "deemed to be not well-characterized from the physical and chemical characterization perspective", citing inconsistent naming conventions that do not follow INN, IUPAC or USAN standards, and missing quality-control attributes — impurities, aggregates and microbiological testing. For the free base FDA notes there was no certificate of analysis in the nomination at all, and that the certificates it found in the literature "only contain purity testing result", with no impurity limits or results. For the acetate FDA notes the nominator's certificate reported a total impurity limit of not more than 2.0% with a result of 0.9% and an individual impurity limit of not more than 1.0% with a result of 0.24%, but gave no information on the nature of any single impurity, no aggregate testing and no microbiological testing. FDA states that inconsistent naming is itself a safety risk because patients "may be dosed with a different BDS than the physician ordered".	source
Immunogenicity assessment	Not done. FDA states that "The nominators did not provide, and FDA did not identify clinical studies or human exposure data assessing immunogenicity or aggregation of KPV-related BDSs", and that "Based on available information there is insufficient data to conclude that KPV (free base) or KPV acetate do not present these risks". FDA notes that peptides with as few as two amino acids have been shown to aggregate, and that aggregation is a risk factor for immunogenicity.	source

What the research does not show

There is no human data of any kind. Not a weak trial, not an uncontrolled case series, not a pharmacokinetic sample — nothing. FDA searched the published medical literature, ClinicalTrials.gov, its own adverse event system and its foods complaint system, and states that it did not find information on products containing KPV administered to humans by any route. Everything else on this page is chemistry, regulatory record, or animal and cell-culture work.
No clinical trial of KPV has ever been registered. A query of the ClinicalTrials.gov registry on 2026-09-17 returned a total count of 0 for KPV as an intervention and 0 on a free-text search of the whole registry. There is not a completed trial whose results went unpublished, nor a trial under way; there is no trial. source
The evidence base is preclinical and narrow. FDA's reviewers identified pharmacological studies in in vitro and in vivo models and nothing beyond them, and the published work clusters in two areas: rodent gut inflammation (mouse DSS and TNBS colitis, mouse transfer colitis, mouse colitis-associated tumour models) and inflammation in cultured cells. Cell lines and mouse colitis models are not people with a condition, and a result in one is not a prediction about the other. source
A large share of the animal work does not test KPV on its own; it tests a delivery system carrying KPV, and the delivery system is doing much of the work. Laroui 2010 loaded KPV into 400 nm nanoparticles inside an alginate-chitosan hydrogel and reports that "KPV can be delivered at a concentration that is 12,000-fold lower than that of KPV in free solution, but with similar therapeutic efficacy". Xiao 2017 used hyaluronic-acid- functionalised nanoparticles inside a chitosan/alginate hydrogel and reports that the functionalised system performed better than the plain nanoparticle system. Later papers in this line use self-assembled carrier-free nanodrugs, mucoadhesive hydrogels and cross-linked hydrogels. None of that transfers to the raw peptide, and a result obtained with a nanoparticle is a result about the nanoparticle. source
Route of administration in the published work does not match how this compound is supplied or used. The mouse colitis studies delivered KPV in drinking water or by targeted colonic release. The single nomination FDA evaluated proposed a topical cream or gel. FDA's internet survey found the compound promoted instead as "single-API injectable, oral, topical, and nasal spray drug products". No study exists for any of those routes in a person, and the routes studied in rodents are not the routes being sold. source
The one human-tissue permeation experiment found that unaided permeation was undetectable. In dermatomed human cadaver skin, passive diffusion gave KPV permeation below the assay's detection limit; only microneedle abrasion, iontophoresis, or both together produced measurable transport. FDA reads this both ways, noting it "could limit the systemic bioavailability of KPV applied topically" and equally "could also limit the potential usefulness of KPV as a topical therapeutic agent". A topical product that does not cross the stratum corneum is not a mild version of one that does. source
Much of the literature people cite for KPV is not about KPV. FDA records that of the nine references submitted with the nomination, "eight references are studies on various alpha-MSH ... derivatives conducted in animals" and one concerned skin permeation — none was a study of KPV given to humans. FDA separately excluded from its own evaluation the submitted articles describing N-acetylated KPV and the KPV dimer, as "out of the scope of this evaluation". The parent hormone, the acetylated peptide, the dimer and the tripeptide are four different molecules. source
Where a study has compared the parent hormone with the tripeptide directly, they behaved differently. Getting 2003 reports that macrophage activation, measured as release of KC and interleukin-1 beta, "was inhibited by alpha-MSH and MTII but not by KPV", and that KPV "failed to increase cAMP" where the melanocortin agonist did. Anyone extending an alpha-MSH finding to KPV is extending it across a difference that this paper measured. source
Null results exist and are rarely cited. A 2018 study that modified the lysine residue of the tripeptide reports that antimicrobial assays "under a variety of conditions, showed no activity for Ac-KPV-NH2 or the alpha- or epsilon-glycoalkylated analogs". Separately, a published comment on the 2000 antimicrobial paper reports that its authors repeated the growth inhibition assays and could not observe the effect; as abstracted, the experiments they describe used alpha-MSH rather than the tripeptide, so the failed replication bears on the parent hormone directly and on the tripeptide only by association. source
The mechanism is unknown, which makes the animal findings hard to assess. FDA states that "the molecular targets underlying the pharmacological effects of KPV-related BDSs remain unknown", and that several lines of evidence indicate melanocortin receptors are unlikely to be those targets — KPV did not displace radiolabelled alpha-MSH binding in three preparations, and pharmacological and genetic approaches failed to implicate the MC2, MC3 or MC4 receptors. The proposed alternatives, NF-kappa B inhibition and PepT1-mediated uptake, are proposals in the literature, not established targets. source
There is no toxicology. FDA states that it identified no acute toxicity study, no repeat-dose toxicity study, no genotoxicity study, no developmental or reproductive toxicity study and no carcinogenicity study of either form, and no pharmacokinetic or toxicokinetic study in any species. Unlike BPC-157, where a published preclinical safety package at least exists to argue about, here there is nothing to read. source
The absence of adverse event reports is not a safety finding. FDA retrieved no reports from its adverse event system through December 3, 2025 and no cases from its foods complaint system since 2004 — and states in the same document that reporting is voluntary, that compounders operating under section 503A generally do not report adverse events to FDA, and that it "cannot make definitive conclusions regarding the safety of KPV based on FAERS data alone". An empty database for a substance nobody reports on says nothing. source
FDA considers the substance itself poorly characterised, and the certificates of analysis circulating for it report purity and little else. FDA found no certificate of analysis for the free base in the nomination at all, and states that the ones it found in the literature "only contain purity testing result", with no impurity limits, no aggregate data and no microbiological testing. For the acetate the nominator's certificate gave impurity totals but no identification of any individual impurity. A purity percentage without an impurity profile does not address what FDA names as the concern. source
The naming of this compound does not distinguish the substances being sold. FDA treats KPV (free base) and KPV acetate as different active pharmaceutical ingredients, records that "The CAS number for KPV acetate is the same as that for KPV (free base) in most public references", and lists no UNII code for either. Published work exists on the free acid (H-Lys-Pro-Val-OH), on the amide (H-KPV-NH2) and on the acetylated amide (Ac-KPV-NH2). A figure attached to the name "KPV" in a third-party source cannot be assigned to a specific substance without checking, and the usual identifiers do not settle it. source
The storage and solubility figures published on this site, and on every other site that carries them, trace through FDA's evaluation to supplier product pages and supplier certificates of analysis rather than to a published stability study. They are recorded here because FDA recorded them, with that provenance stated. The one exception is the forced-degradation chemistry, which comes from a peer-reviewed stability-indicating assay and is labelled as such.
Immunogenicity and aggregation have not been assessed for this compound at all. FDA states there is insufficient data to conclude that either form does not present those risks, and notes that peptides as short as two residues have been shown to aggregate. Short does not mean inert.
The anti-doping position is unresolved rather than permissive. No statement from an anti-doping authority naming this compound was retrievable during data entry, and this file does not infer one in either direction from statements about other substances.
The published research does not establish a dose, a route, a schedule, a duration, or a formulation for any use in a person, and it does not establish what happens with long-term use, because no human study of any length has been published.

Storage and handling

READ THE PROVENANCE BEFORE USING THIS. FDA's evaluation reports that lyophilized KPV (free base) "is stable up to 3 years when stored at -20 degrees C in a tightly closed container, up to 2 years at 4 degrees C, and up to 3 months at 15 degrees C", and that on reconstitution "the aqueous solution is recommended to be stored at -80 degrees C for 6 months, at -2 degrees C for 1 month, and 10 degrees C for 1 week". FDA's footnote attributes every one of those figures to a supplier certificate of analysis, not to a published stability study, and FDA states the conclusion as what "is reported" rather than as an agency determination. For KPV acetate, FDA reports a different condition from the nominator's certificate of analysis: "in a sealed container at 2 degrees C to 8 degrees C". There is no United States, European, Japanese or International pharmacopoeial monograph for either form and no approved product label, so no body with standing to determine handling conditions has done so. FDA separately warns that peptides "can be extremely sensitive to product formulation, process, and environmental conditions (e.g., pH, heat (temperature), concentration, in-process related impurities, excipients etc.), which may lead to the aggregation and degradation of peptides", that this "could result in loss of their biological activity", and that significant amounts of aggregates can form during storage. source

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