KPV
Also sold as: lysine-proline-valine, Lys-Pro-Val, α-MSH(11-13), alpha-MSH (11-13), KPV acetate
KPV is not on the FDA 503A Bulks List and cannot lawfully be used as a bulk drug substance in compounded drug products; the only nomination for it was withdrawn, which moved it no closer to the list, and FDA staff proposed not adding KPV (free base) or KPV acetate ahead of the Pharmacy Compounding Advisory Committee meeting on 23-24 July 2026. FDA states that the nomination did not include, and that FDA has not identified, any clinical studies or human exposure data for KPV via any route of administration.
Which molecule this is. A tripeptide of lysine (K), proline (P) and valine (V), corresponding to the C-terminal tripeptide of α-melanocyte-stimulating hormone. FDA evaluates two distinct substances: KPV (free base) and KPV acetate — different active pharmaceutical ingredients, and hence different bulk drug substances. The distinction is not academic: the sole nomination was internally inconsistent about which one it meant (the certificate of analysis named one substance in its title and a different one by molecular formula), and FDA could not tell which was intended. The 'α-MSH fragment' framing carries an implication FDA's own review rejects — see the mechanism finding below.
The FDA advisory committee vote, 23 July 2026
The Pharmacy Compounding Advisory Committee voted to recommend adding this substance to the 503A bulks list (8-6, one abstention), against FDA’s own staff, who had recommended not adding it.
It is still not on the list. An advisory committee makes recommendations; it does not change what is permitted. We checked the 503A bulks list on 29 July 2026 and it is still dated 14 May 2026, with this substance absent from it. Adding a substance requires separate FDA action, which has not happened.
Vote tally reported by ABC News and other outlets; FDA had not published minutes or a transcript as of 29 July 2026, so there is no primary document for the tally yet. We will replace it with FDA’s own record when it publishes. The bulks-list status is from the primary document.
FDA status
FDA has not approved this and it is not in active development toward approval. That says nothing about whether it is being sold — most substances in this category are.
Not an FDA-approved drug for any indication, and not in active development toward approval. That says nothing about whether it is sold — it is.
503A compounding
The nominator withdrew the nomination. This is not a legalisation event — the substance is not on the 503A bulks list and remains non-compoundable.
Absent from Categories 1, 2 and 3 in the list updated 2026-05-14 — verified by fetching and text-extracting the document directly. Category 2 contains exactly six substances (Cesium Chloride, Domperidone, Germanium Sesquioxide, Ibutamoren Mesylate, Kisspeptin-10, Quinacrine HCl for intrauterine administration); KPV is not among them and appears nowhere in the document. The single nomination — from Wells Pharmacy Network, Document ID FDA-2015-N-3534-0294 — was withdrawn (withdrawal at FDA-2015-N-3534-0484). Withdrawal is not a legalisation event: KPV is not on the 503A bulks list and remains non-compoundable. One detail distinguishes KPV from most of this cohort and cuts AGAINST the 'FDA dropped it, access is coming' reading — FDA did not drop it. The briefing document states the nomination was withdrawn 'and FDA is evaluating the substances at its discretion', on its own initiative, expressly because of its safety concerns. FDA carried the evaluation forward after the nominator walked away.
Evidence
No randomised controlled trials in humans. Read the notes — the details matter more than the label.
Zero human administration, and unusually well-evidenced as zero. The administration check did not rest on trial counts. FDA ran the check itself across PubMed, Embase, ClinicalTrials.gov, DailyMed and Drugs@FDA and reported that its search 'did not identify data, such as clinical studies, on these substances administered in humans'. The nominator cited nine references; FDA characterised them as eight studies of α-MSH derivatives conducted IN ANIMALS, plus one study of skin permeation using HUMAN CADAVER SKIN. Cadaver skin in vitro is not administration to a living human, and it is the only 'human' reference in the nomination — the likeliest source of a false 'human data exists' claim. Independently re-checked against the ClinicalTrials.gov API on 2026-07-16: no registration of any kind administers KPV. Keyword queries return only diet and amino-acid studies matching lysine, proline and valine as separate free amino acids — noise, not trials. The affirmative evidence is nonclinical only: anti-inflammatory and wound-healing activity in rodent models and in vitro. Reviewers Böhm and Luger (2019), cited by FDA, drew the conclusion the market skips — that investigational clinical studies ARE NEEDED to determine whether KPV could be used to promote healing of skin wounds and ulcers. That is a statement of an open question, not of a demonstrated effect.
“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.”Checked against the source on .
What FDA found
FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.
FDA staff propose not adding KPV (free base) or KPV acetate to the 503A Bulks List, ahead of the Pharmacy Compounding Advisory Committee meeting on 23-24 July 2026.
A staff proposal is not a final determination. The briefing document states: 'The FDA will not issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized.'
KPV-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“Accordingly, we propose not adding KPV (free base) or KPV acetate to the 503A Bulks List.”
Checked against the source on .FDA evaluated KPV only for the nominated uses — wound healing and inflammatory conditions (psoriasis, eczema) — in topical cream and gel form, and found a lack of evidence to evaluate effectiveness for either, noting that FDA-approved therapies with established efficacy already exist for both.
The gap between what was nominated and what is sold is the story here. FDA's own internet search recorded that 'websites promote KPV as single-API or multiple-API compounded drug products in oral, injectable, topical, and nasal spray formulations' and that 'KPV is promoted to treat inflammatory conditions, improve wound healing and skin health, and protect against nerve damage and stroke.' None of the oral, injectable or nasal routes was nominated, and neither nerve damage nor stroke was evaluated — no evidence was submitted for them and FDA identified none. This is an evidentiary vacuum, not a regulatory loophole. Inclusion on the 503A Bulks List is not necessarily limited to a specific use, so a 'do not add' outcome bars KPV for all of them regardless.
KPV-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026Checked against the source on .FDA found that melanocortin receptors are unlikely to be the molecular targets underlying KPV's anti-inflammatory and wound-healing properties, and concluded that the molecular targets remain unknown.
This is the finding most directly at odds with how KPV is marketed. The standard vendor framing — KPV is an α-MSH fragment, therefore it acts through the melanocortin receptors that give α-MSH its anti-inflammatory effects — is contradicted by the studies FDA cites. In vitro, KPV failed to displace radiolabeled α-MSH binding at rat brain tissue, murine melanoma cells and MC1R-expressing murine macrophages (Lyson et al. 1994; Mandrika et al. 2001; Tatro and Entwistle 1994); unlike α-MSH, it did not raise cyclic AMP in MC1 receptor-expressing murine macrophages (Mandrika et al. 2001); and pharmacological and genetic approaches failed to implicate MC2, MC3 or MC4 receptors in KPV's effects (Getting et al. 2003). Researchers have PROPOSED other mechanisms — inhibition of NF-κB activation, inhibition of proinflammatory cytokines such as interleukin 1β, and PepT1-mediated uptake — but FDA records these as proposals, not established findings. Sharing a sequence with a molecule is not sharing its mechanism.
KPV-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“However, the molecular targets underlying the pharmacological effects of KPV-related BDSs remain unknown.”
Checked against the source on .FDA deemed both KPV (free base) and KPV acetate not well-characterized from a physical and chemical characterization perspective, citing naming conventions that do not follow established chemical nomenclature standards and an absence of quality-control attributes — impurities, aggregates and microbiological tests — in the published literature.
There is no USP or NF monograph for either substance, and neither is a component of any FDA-approved drug. FDA had to characterise the free base partly from chemical-supplier listings because the nomination contained no certificate of analysis for it. This finding is about identity and purity, not efficacy — it means that what is in a vial sold as 'KPV' is not established by any public standard.
KPV-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026Checked against the source on .No registered outsourcing facility reported compounding any drug product containing KPV (free base) or KPV acetate to FDA between January 2017 and June 2025 — despite FDA's own internet search finding websites offering KPV from compounding pharmacies via telemedicine and online consultations.
Eight and a half years of mandatory reporting, zero reports. Outsourcing facilities register under section 503B and must list what they compounded every six months; the supply the market actually sees is therefore coming from somewhere other than the reporting channel. FDA notes the reports are retrospective and do not identify what a facility intends to produce in future — so this is a record of what was reported, not proof of what was made. Read alongside the second half of the same conclusion: 'the extent of KPV (free base) or KPV acetate use in compounding is unknown.'
KPV-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“According to OF reports submitted to the FDA, OFs have not reported preparing single or multiple-API compounded drug products containing KPV (free base) or KPV acetate from January 2017 to June 2025.”
Checked against the source on .The withdrawn nomination cited nine literature references in support of KPV; FDA characterised none of them as a study of KPV administered in humans.
The sentence to reach for when a vendor page cites 'the research'. FDA counted the citations and reported the count. Eight of the nine were studies of α-MSH derivatives conducted in animals; the ninth (Pawar et al. 2017) measured skin permeation across human cadaver skin in vitro. FDA also recorded that the references 'do not clearly identify whether the KPV form was a salt formulation or the free base' — so the nomination's own evidence base cannot be attributed to a specific substance.
KPV-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“The nomination cited nine literature references in support of the nomination; none were studies of KPV administered in humans.”
Checked against the source on .FDA identified no human pharmacokinetic or pharmacodynamic study of KPV (free base) or KPV acetate by any route, and no nonclinical pharmacokinetic or toxicokinetic study either.
Nothing is known about what happens to KPV in a human body: not absorption, not distribution, not metabolism, not elimination. This is the finding that makes route-switching indefensible. FDA evaluated a topical cream/gel at 0.1%, the only form nominated, and its single relevant permeation datum comes from cadaver skin in vitro. KPV is nonetheless promoted in oral, injectable and nasal spray forms, for which not even that datum exists.
KPV-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“FDA did not identify clinical studies in humans assessing pharmacokinetics or pharmacodynamics of KPV (free base) or KPV acetate via any route of administration.”
Checked against the source on .No pharmacopeia or foreign regulator recognises KPV. FDA searched the United States Pharmacopeia-National Formulary, the European Pharmacopoeia (11.8 edition, 2025) and the Japanese Pharmacopoeia (18th edition) and found no monograph for KPV (free base) or KPV acetate, and the European Medicines Agency lists no authorised product containing either.
Worth stating because 'available in other countries' is a standard move in this market. On the record FDA compiled, it is not — no monograph anywhere FDA looked, no EMA authorisation, and the nominator's own submission answered 'No' to whether the substance is recognised in foreign pharmacopeias or registered in other countries, and 'No' to whether information had been submitted to USP for monograph development.
KPV-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026Checked against the source on .FDA recorded that KPV acetate forms Lys-Pro-diketopiperazine as a major degradation product under acid hydrolysis, alkaline hydrolysis and oxidative degradation, producing several additional nonpolar degradation products under basic conditions whose structures have not been elucidated.
A three-amino-acid peptide is not therefore a simple one. Under forced degradation reported in Pawar's Auburn University dissertation, oxidative treatment broke KPV acetate down rapidly into the diketopiperazine plus free proline and valine, and base produced three further products — DP1, DP2, DP3 — that the source does not structurally identify. Relevant because the certificate of analysis in the nomination reported a total impurity result against a limit but, in FDA's words, carried 'no information on the nature of single impurity'. Unknown degradants in a substance with no toxicity data are two absences that compound each other.
KPV-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026Checked against the source on .
Documented safety signals
No safety signals were found — because no human exposure data exists to generate any. The FAERS search through 2025-12-03 retrieved no reports, the medical-literature search identified no adverse-event cases, and the Human Foods Complaint System search covering 2004-01-01 to 2025-12-03 retrieved no cases where KPV was administered.
An empty FAERS result is the single most misreadable line in this document, and the inverse of a clean safety record. FDA's own conclusion from the same evidence base is that 'potential safety risks associated with the use in humans are unknown' — and FDA states it is 'particularly concerned about the lack of any human data'. Absence of reports here reflects absence of studied exposure, not absence of harm. FAERS also has structural limits FDA notes in the same document: reporting is voluntary, and the Agency does not receive all adverse event reports.
KPV-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“The FAERS search did not retrieve any reports and the literature search did not identify any cases of adverse events.”
Checked against the source on .FDA identified no nonclinical toxicity studies of KPV of any kind — no acute toxicity, no repeat-dose toxicity, no genotoxicity, no reproductive toxicity, no carcinogenicity, and no pharmacokinetic or toxicokinetic studies.
The absence is total: the safety base is empty in animals as well as in humans. FDA's conclusion is that it 'did not identify nonclinical toxicity studies to inform safety considerations for potential clinical uses'.
KPV-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026Checked against the source on .FDA found insufficient data to conclude that KPV (free base) or KPV acetate do not present immunogenicity or aggregation risks.
Note the direction of the sentence — FDA is not asserting a risk, it is recording that the data needed to rule one out does not exist. Peptides may aggregate, and aggregation is a risk factor for immunogenicity; FDA cites work showing peptides as short as two amino acids can aggregate, so KPV's three-residue length does not exempt it. One consequence of an immune response FDA flags for peptide products generally is neutralising antibody activity, which could in principle neutralise the endogenous peptide counterpart.
KPV-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026Checked against the source on .An in-vitro study in human cadaver skin reported that KPV does not permeate well through skin — which FDA notes could limit systemic toxicity from topical use, but equally could limit its usefulness as a topical agent by preventing distribution below the stratum corneum.
The double-edge is the point, and both edges are speculative. Pawar et al. (2017) reported that strategies breaching the skin's structural tightness — iontophoresis, microneedle abrasion — increased KPV penetration into inner epidermal layers of cadaver skin in vitro. FDA's caution is that it remains to be determined whether such strategies would also increase systemic absorption in vivo 'and, thereby, facilitate the development of untoward systemic effects'. The barrier that might make topical KPV safe is the same barrier that might make it inert, and defeating it may trade one for the other. Relevant because FDA found KPV promoted in oral, injectable and nasal spray forms, for which this topical reasoning offers no reassurance at all.
KPV-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026Checked against the source on .
Questions people actually ask
Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.
- Is KPV legal in 2026?
KPV is not on the FDA 503A Bulks List, which means it cannot lawfully be used as a bulk drug substance to compound drug products under section 503A. Verified against the list as updated 2026-05-14: KPV appears in none of the three categories and is absent from the document entirely. There is also no USP or National Formulary monograph for KPV (free base) or KPV acetate, and neither substance is a component of any FDA-approved drug.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .- Did KPV become legal again when the nomination for it was withdrawn?
No. The withdrawal of the KPV nomination moved the substance sideways, not toward legality: a nomination is a request to be ADDED to the FDA 503A Bulks List, so withdrawing it leaves KPV off that list exactly as before, and off the list means not usable in 503A compounding. In KPV's case the withdrawal cut the other way entirely — FDA states that after the sole nomination was withdrawn it continued evaluating KPV (free base) and KPV acetate on its own initiative, and that it chose to do so because of its significant safety concerns.
KPV-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“The nomination was withdrawn, and FDA is evaluating the substances at its discretion. … Due to FDA's significant safety concerns related to this nomination/BDS, FDA is choosing to concurrently evaluate both BDSs (KPV (free base) and KPV acetate) …”
Checked against the source on .- Is there any human evidence that KPV works?
No. FDA states that the KPV nomination did not include, and that FDA has not identified, any clinical studies or human exposure data for KPV via any route of administration — a search that covered PubMed, Embase, ClinicalTrials.gov, DailyMed and Drugs@FDA. The evidence for KPV is nonclinical: rodent and in-vitro models of inflammation and wound healing. Reviewers Böhm and Luger (2019), cited by FDA, concluded that investigational clinical studies are needed to determine whether KPV could promote healing of skin wounds and ulcers.
KPV-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“The nomination did not include, and FDA has not identified, any clinical studies or human exposure data for KPV via any route of administration.”
Checked against the source on .- Is KPV safe?
Unknown — and FDA says so in those terms. FDA's conclusion on KPV is that potential safety risks associated with its use in humans are unknown, because no human data exists to characterise them: no clinical studies, no case reports, no adverse event reports in FAERS through 2025-12-03, and no acute, repeat-dose, genotoxicity, reproductive or carcinogenicity studies in animals either. The empty adverse-event record reflects an absence of studied exposure, not a clean safety record; FDA states it is particularly concerned about the lack of any human data on drug products containing these substances administered via any route.
KPV-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“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 bulk drug substances. Therefore, potential safety risks associated with the use in humans are unknown.”
Checked against the source on .- Can I get KPV from a compounding pharmacy?
KPV cannot lawfully be compounded, because it is not on the FDA 503A Bulks List. FDA's own internet search nonetheless found websites offering KPV from compounding pharmacies through telemedicine and online consultations, promoting it as an injectable, oral, topical and nasal spray product, and in combination with BPC-157, TB-500, AOD-9604 and Follistatin-344. Against that, no registered outsourcing facility reported compounding any KPV-containing product to FDA between January 2017 and June 2025.
KPV-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“Results from an internet search for compounded drug products containing KPV (free base) or KPV acetate revealed that online websites offer options for obtaining KPV from compounding pharmacies through use of telemedicine and online consultations.”
Checked against the source on .- What did FDA propose at the July 2026 PCAC meeting about KPV?
FDA staff proposed not adding KPV (free base) or KPV acetate to the 503A Bulks List, in a briefing document dated 2026-05-12 for the Pharmacy Compounding Advisory Committee meeting of 23-24 July 2026. The stated basis: the substances are not well-characterized from a physical and chemical characterization perspective, the extent of their use in compounding is unknown, there is no information on their administration in humans from which to draw conclusions about clinical safety or effectiveness, and FDA-approved therapies already exist for wounds and for inflammatory diseases. A staff proposal is not a final determination — FDA states it will not issue one until the advisory committee process has been considered and all reviews finalized.
KPV-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“Accordingly, we propose not adding KPV (free base) or KPV acetate to the 503A Bulks List.”
Checked against the source on .