# KPV KPV is in limbo: it is not approved, and it is on neither FDA list for compounding, so no pharmacy may lawfully make it. The evidence grade is animal-only. No study has tested it in people, so nobody knows if it helps or how safe it is. Status checked: 2026-10-25. Last verified: 2026-10-26. Primary source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks This page has not been individually reviewed by a clinician. Information, not medical advice. | Fact | Value | Tier | Checked | Source | |---|---|---|---|---| | Also called | lysine-proline-valine, KPV free base, KPV acetate | primary | 2026-10-25 | [source](https://www.fda.gov/media/193346/download) | | Class | healing-and-repair | primary | 2026-10-25 | [source](https://www.fda.gov/media/193346/download) | | Regulatory status | limbo | primary | 2026-10-25 | [source](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) | | Status source read | 2026-10-23 | primary | 2026-10-25 | [source](https://www.fda.gov/media/94155/download) | | Evidence grade | animal-only | our assessment | 2026-10-25 | [source](https://peptideindex.ai/methodology#evidence-grade) | ## Name KPV Source: https://www.fda.gov/media/193346/download ## Summary A lab-made chain of three amino acids taken from the end of a natural hormone. It is in no FDA-approved drug. It is sold for gut health and swelling. Source: https://www.fda.gov/media/193346/download ## Short answer KPV is in limbo: it is not approved, and it is on neither FDA list for compounding, so no pharmacy may lawfully make it. The evidence grade is animal-only. No study has tested it in people, so nobody knows if it helps or how safe it is. Source: https://peptideindex.ai/methodology#short-answer ## Known risks - FDA warns that a peptide like KPV may set off the immune system. Peptides can also clump together, which can make this worse [^6]. - FDA says the name KPV is used for more than one substance. A product sold as KPV may not hold the form a doctor ordered [^6]. - FDA found no test results for impurities, clumps or germs in KPV powder, so nobody knows how pure a product is [^6]. - FDA warns that shots made outside drug rules can carry germs or toxins straight into the body. That can put a life at risk [^9]. Source: https://www.fda.gov/media/193346/download ## What nobody knows yet - No study has tested KPV in people, so nobody knows if it helps any human illness [^6]. - Nobody knows what KPV does over time. No study has checked it for harm to organs, genes, unborn babies or for cancer [^6]. - Scientists do not know what KPV attaches to in the body. Studies suggest it does not use the same targets as the hormone it comes from [^6] [^14]. - KPV barely gets through skin on its own, so nobody knows if a cream would reach a wound [^19]. Source: https://www.fda.gov/media/193346/download ## What it is KPV is a lab-made chain of three amino acids: lysine, proline and valine [^6]. Amino acids are the building blocks of proteins. The same three sit at the end of alpha-MSH, a hormone the body makes [^21]. Alpha-MSH calms swelling but also darkens the skin. Researchers point to KPV because it seems to calm swelling without that effect [^21]. KPV is not part of any FDA-approved drug, and it has no official quality standard [^6]. FDA says the name is used loosely. Sellers use it for more than one form, such as the plain peptide and its acetate salt [^6]. Websites promote it for gut health, skin, wounds, the immune system and many other uses [^6]. It is promoted as shots, pills, creams and nasal sprays, alone or mixed with other peptides [^6]. Source: https://www.fda.gov/media/193346/download ## Where it stands legally KPV is in limbo: FDA lists it among the Category 2 substances whose nominations were withdrawn, and it has not added it to Category 1 [^1] [^2]. That is not approval, and it does not make compounding lawful. FDA reviewed it as a skin cream or gel for wounds and swelling, but websites promote it as shots, pills and nasal sprays for gut and immune health [^4] [^6]. Checked 23 October 2026. Category 2 is FDA's list of substances that may present significant safety risks. Category 1 is the list of substances pharmacies may use while FDA reviews them [^3]. The group that nominated KPV pulled its nomination, so FDA took it off Category 2 [^1] [^6]. FDA then reviewed it on its own. FDA's scientists found no study of KPV in people and advised against adding it to the list [^6] [^8]. On 23 July 2026, FDA's Pharmacy Compounding Advisory Committee met on KPV [^5] [^7]. News and legal reports say it voted 8 to 6, with 1 member abstaining, to recommend adding KPV to the list [^11] [^12] [^23]. FDA's meeting page does not show the vote [^5]. A committee vote is only advice [^22]. FDA decides by writing a rule [^11] [^12]. Until then, a pharmacy that makes KPV is outside federal law [^3] [^10]. Selling it for people to use is also illegal, even when the label says it is for research only [^9]. Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks ## What the evidence shows The evidence grade is animal-only: the studies that show an effect used mice, rabbits or cells, and FDA found no study of KPV in people [^6]. The evidence for each way of taking it is different, so each is kept apart below. In mice with a swollen belly lining, KPV given to the whole body cut the number of white blood cells that gathered there [^14]. Another team found that KPV eased swelling in two mouse models of bowel disease [^16]. By mouth: in mice with bowel swelling, KPV in drinking water eased the swelling [^15]. A later team packed KPV into tiny coated particles. Fed to mice with colitis, the coated particles protected the gut lining better than uncoated ones [^17]. On the eye: in rabbits whose eye surface was scraped, KPV drops helped it heal faster [^18]. On the skin: in a lab test on donated human skin, KPV did not pass through the skin on its own [^19]. FDA notes this could stop a cream from reaching the deeper skin [^6]. Many papers cited for KPV studied alpha-MSH, the larger hormone, or changed forms of KPV [^6] [^21]. Those are different molecules. Their results are not evidence for KPV [^6]. Two reviews call KPV a hopeful candidate for future skin and bowel treatments [^20] [^21]. One says studies in people are needed first [^6] [^20]. Source: https://www.fda.gov/media/193346/download ## Legitimate ways to get it There is no legal way to get KPV in the US today [^6]. No approved drug contains it, here or in Europe [^6]. A pharmacy may use a substance with no official quality standard only if it is in an approved drug or on the federal list. KPV is neither [^3] [^6]. That could change if FDA adds it by writing a rule after the committee vote [^11]. FDA found no clinical study of KPV in people [^6]. Any open trial would appear in the trials block below, with the date the official registry was last checked. Source: https://www.fda.gov/media/193346/download ## How people are getting it anyway This section describes what happens and is not a recommendation. People who use KPV get it in three main ways [^6] [^23]. The first is online sellers that label peptides for research use only. FDA says that label does not make it legal to sell a drug meant for people [^9] [^13]. The second is pharmacies that make it even though it is not on the federal list [^6]. FDA has warned a pharmacy for making drugs from substances that are not on the list [^10]. The third is websites that link people to a prescriber and a pharmacy through an online visit [^6]. In all three, nobody checks what is in the product the way FDA checks an approved drug. FDA found no test results for impurities or germs in KPV powder [^6]. FDA found no reports of harm from KPV in its files. FDA says that does not show KPV is free of harm, because pharmacies seldom report problems [^6]. So nobody knows how often harm happens. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026 ## Access routes Source: https://www.fda.gov/media/193346/download ### None Detail: There is no legal route to KPV in the US today. It is in no approved drug, has no official quality standard, and is not on the list pharmacies may use. Source: https://www.fda.gov/media/193346/download ## Unofficial channels Source: https://www.fda.gov/media/193346/download ### Research use seller What it is: Sold online with a label saying it is for research use only and not for people. Legal position: FDA treats these products as unapproved new drugs when the seller's claims show they are meant for people, whatever the label says. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026) Documented risks: - FDA warns that unapproved shots can carry toxins or germs straight into the body and cause a life-threatening illness. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026) - FDA found no test results for impurities, clumps or germs in KPV powder. (source: https://www.fda.gov/media/193346/download) Enforcement: - 2026-08-24: FDA warning letter to an online seller of research-use peptide shots. The letter did not name KPV. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026) Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026 ### Compounding outside the rules What it is: Made by a pharmacy from bulk KPV powder, as shots, pills, creams or nasal sprays. Legal position: KPV has no official quality standard, is in no approved drug and is not on the federal list. A pharmacy that compounds it loses the legal exemptions for compounded drugs. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prescription-dispensing-laboratories-inc-dba-pd-labs-579286-07302019) Documented risks: - FDA found no study of KPV in people by any route, so the safety of a compounded product is unknown. (source: https://www.fda.gov/media/193346/download) - FDA says products sold under the name KPV can hold different forms, so a patient may get a different substance than the one prescribed. (source: https://www.fda.gov/media/193346/download) Enforcement: - 2019-07-30: FDA warning letter to a Texas compounding pharmacy that made drugs from bulk substances not on the federal list. The letter did not name KPV. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prescription-dispensing-laboratories-inc-dba-pd-labs-579286-07302019) Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prescription-dispensing-laboratories-inc-dba-pd-labs-579286-07302019 ### Telehealth What it is: Websites that offer KPV made by a compounding pharmacy after an online visit with a prescriber. Legal position: A prescription does not make compounded KPV lawful. It is still made from a substance that is not on the federal list. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prescription-dispensing-laboratories-inc-dba-pd-labs-579286-07302019) Documented risks: - FDA found no human data on any product with KPV, including whether it sets off the immune system. (source: https://www.fda.gov/media/193346/download) Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prescription-dispensing-laboratories-inc-dba-pd-labs-579286-07302019 ## Recruiting trials Snapshot date: 2026-10-25. A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record. None in this snapshot. Source: https://clinicaltrials.gov/api/v2/studies?query.intr=KPV+OR+KPV+acetate&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState ## Sources Source: https://www.fda.gov/media/193346/download ### 1. FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2 Type: regulatory Tier: primary Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks ### 2. FDA: bulk drug substances nominated under section 503A, list updated 14 May 2026 Type: regulatory Tier: primary Source: https://www.fda.gov/media/94155/download ### 3. FDA: bulk drug substances used in compounding under section 503A Type: regulatory Tier: primary Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act ### 4. Federal Register: notice of the July 2026 Pharmacy Compounding Advisory Committee meeting Type: regulatory Tier: primary Source: https://www.federalregister.gov/documents/full_text/html/2026/04/16/2026-07361.html ### 5. FDA: Pharmacy Compounding Advisory Committee meeting, 23 and 24 July 2026 Type: regulatory Tier: primary Source: https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026 ### 6. FDA briefing document on KPV for the July 2026 committee meeting, 12 May 2026 Type: regulatory Tier: primary Source: https://www.fda.gov/media/193346/download ### 7. FDA: questions put to the committee at the July 2026 meeting Type: regulatory Tier: primary Source: https://www.fda.gov/media/193711/download ### 8. FDA: presentations to the committee on 23 July 2026, including KPV Type: regulatory Tier: primary Source: https://www.fda.gov/media/193773/download ### 9. FDA warning letter to an online seller of research-use peptides, 24 August 2026 Type: regulatory Tier: primary Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026 ### 10. FDA warning letter to a compounding pharmacy that used bulk substances not on the list, 30 July 2019 Type: regulatory Tier: primary Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prescription-dispensing-laboratories-inc-dba-pd-labs-579286-07302019 ### 11. McDermott Will & Schulte: what the July 2026 committee votes on peptides mean Type: legal-analysis Tier: legal-analysis Source: https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/ ### 12. FDA Law Blog: the committee recommends four peptides for the 503A list Type: legal-analysis Tier: legal-analysis Source: https://www.thefdalawblog.com/2026/07/peptide-l-wave-pcac-approves-four-bulk-drug-substances-for-the-503a-list/ ### 13. Sheppard Mullin: FDA's peptide policy and its warning letters to peptide sellers Type: legal-analysis Tier: legal-analysis Source: https://www.sheppard.com/insights/blogs/fda-balances-peptide-policy-with-enforcement-against-unlawful-peptide-sellers ### 14. KPV and alpha-MSH peptides in mice with inflammation of the belly lining, 2003 Type: animal Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/12750433/ ### 15. KPV taken up by gut cells, and KPV by mouth in two mouse colitis models, 2008 Type: animal Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/18061177/ ### 16. KPV in two mouse models of inflammatory bowel disease, 2008 Type: animal Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/18092346/ ### 17. KPV in tiny particles given by mouth to mice with ulcerative colitis, 2017 Type: animal Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/28143741/ ### 18. KPV eye drops and healing of the eye surface in rabbits, 2006 Type: animal Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/16965771/ ### 19. Getting KPV through donated human skin in the lab, 2017 Type: in-vitro Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/28343991/ ### 20. Review: melanocortin peptides, including KPV, as future wound treatments, 2019 Type: reference Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/30661264/ ### 21. Review: alpha-MSH and related three-amino-acid peptides, including KPV, 2008 Type: reference Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/18612139/ ### 22. STAT: FDA panel backs compounded BPC-157 and KPV peptides Type: reference Tier: established-news Source: https://www.statnews.com/2026/07/23/fda-panel-okays-peptides-compound-pharmacies-bpc-157-kpv/ ### 23. NBC News: FDA panel recommends easing peptide limits despite agency scientists Type: reference Tier: established-news Source: https://www.nbcnews.com/health/health-news/peptides-restrictions-ease-fda-panel-recommend-bpc-157-scientists-rcna588879 Last verified: 2026-10-26. Sources: - https://clinicaltrials.gov/api/v2/studies?query.intr=KPV+OR+KPV+acetate&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState - https://peptideindex.ai/methodology#evidence-grade - https://peptideindex.ai/methodology#short-answer - https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks - https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026 - https://www.fda.gov/media/193346/download - https://www.fda.gov/media/94155/download [^1]: FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2 https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks [^2]: FDA: bulk drug substances nominated under section 503A, list updated 14 May 2026 https://www.fda.gov/media/94155/download [^3]: FDA: bulk drug substances used in compounding under section 503A https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act [^4]: Federal Register: notice of the July 2026 Pharmacy Compounding Advisory Committee meeting https://www.federalregister.gov/documents/full_text/html/2026/04/16/2026-07361.html [^5]: FDA: Pharmacy Compounding Advisory Committee meeting, 23 and 24 July 2026 https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026 [^6]: FDA briefing document on KPV for the July 2026 committee meeting, 12 May 2026 https://www.fda.gov/media/193346/download [^7]: FDA: questions put to the committee at the July 2026 meeting https://www.fda.gov/media/193711/download [^8]: FDA: presentations to the committee on 23 July 2026, including KPV https://www.fda.gov/media/193773/download [^9]: FDA warning letter to an online seller of research-use peptides, 24 August 2026 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026 [^10]: FDA warning letter to a compounding pharmacy that used bulk substances not on the list, 30 July 2019 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prescription-dispensing-laboratories-inc-dba-pd-labs-579286-07302019 [^11]: McDermott Will & Schulte: what the July 2026 committee votes on peptides mean https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/ [^12]: FDA Law Blog: the committee recommends four peptides for the 503A list https://www.thefdalawblog.com/2026/07/peptide-l-wave-pcac-approves-four-bulk-drug-substances-for-the-503a-list/ [^13]: Sheppard Mullin: FDA's peptide policy and its warning letters to peptide sellers https://www.sheppard.com/insights/blogs/fda-balances-peptide-policy-with-enforcement-against-unlawful-peptide-sellers [^14]: KPV and alpha-MSH peptides in mice with inflammation of the belly lining, 2003 https://pubmed.ncbi.nlm.nih.gov/12750433/ [^15]: KPV taken up by gut cells, and KPV by mouth in two mouse colitis models, 2008 https://pubmed.ncbi.nlm.nih.gov/18061177/ [^16]: KPV in two mouse models of inflammatory bowel disease, 2008 https://pubmed.ncbi.nlm.nih.gov/18092346/ [^17]: KPV in tiny particles given by mouth to mice with ulcerative colitis, 2017 https://pubmed.ncbi.nlm.nih.gov/28143741/ [^18]: KPV eye drops and healing of the eye surface in rabbits, 2006 https://pubmed.ncbi.nlm.nih.gov/16965771/ [^19]: Getting KPV through donated human skin in the lab, 2017 https://pubmed.ncbi.nlm.nih.gov/28343991/ [^20]: Review: melanocortin peptides, including KPV, as future wound treatments, 2019 https://pubmed.ncbi.nlm.nih.gov/30661264/ [^21]: Review: alpha-MSH and related three-amino-acid peptides, including KPV, 2008 https://pubmed.ncbi.nlm.nih.gov/18612139/ [^22]: STAT: FDA panel backs compounded BPC-157 and KPV peptides https://www.statnews.com/2026/07/23/fda-panel-okays-peptides-compound-pharmacies-bpc-157-kpv/ [^23]: NBC News: FDA panel recommends easing peptide limits despite agency scientists https://www.nbcnews.com/health/health-news/peptides-restrictions-ease-fda-panel-recommend-bpc-157-scientists-rcna588879