# Melanotan II Melanotan II is in limbo: it is not approved, and it is on neither FDA list for compounding. No pharmacy may lawfully make it. The evidence grade is limited-human: three small studies in men from 1996 to 2000. Case reports describe serious harms after its use, including melanoma. 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 | MT-II, Melanotan-II | peer-reviewed | 2026-10-25 | [source](https://pubmed.ncbi.nlm.nih.gov/8637402/) | | Class | melanocortin | peer-reviewed | 2026-10-25 | [source](https://pubmed.ncbi.nlm.nih.gov/31953620/) | | 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 | 2026-10-25 | primary | 2026-10-25 | [source](https://www.fda.gov/media/94155/download) | | Evidence grade | limited-human | our assessment | 2026-10-25 | [source](https://peptideindex.ai/methodology#evidence-grade) | ## Name Melanotan II Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks ## Summary A lab-made peptide that copies part of a natural hormone that darkens the skin. People use it outside medical care to tan and as a sexual stimulant. Source: https://pubmed.ncbi.nlm.nih.gov/8637402/ ## Short answer Melanotan II is in limbo: it is not approved, and it is on neither FDA list for compounding. No pharmacy may lawfully make it. The evidence grade is limited-human: three small studies in men from 1996 to 2000. Case reports describe serious harms after its use, including melanoma. Source: https://peptideindex.ai/methodology#short-answer ## Known risks - FDA warns that Melanotan II made by a pharmacy may set off the immune system. It may also carry impurities [^1]. - FDA cites published case reports of serious harm after its use [^1]. They include melanoma, priapism, a racing-heart reaction and a brain swelling disorder [^1] [^16]. - Case reports describe new moles that came up fast after melanotan use [^15]. Others describe melanoma [^14]. A 2017 review counts four melanomas that grew from old moles [^20]. - A man who used Melanotan II bought online had a racing heart, muscle breakdown and kidney injury [^17]. He needed intensive care [^17]. - Melanotan II has caused priapism, a painful erection that will not go away [^18]. In one case it needed surgery [^18]. - A 2020 report links a loss of blood flow to part of a kidney to Melanotan II [^19]. - In the small trials, nausea, yawning and stretching, and less appetite were common [^12] [^13]. Severe nausea followed some shots [^13]. Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks ## What nobody knows yet - Whether Melanotan II causes melanoma is not settled. A 2017 review says conclusive evidence of a link is lacking [^20]. - No large trial has been published. The three studies had 3 to 10 men each and are more than 25 years old [^11] [^12] [^13]. - No study cited here tested Melanotan II in women, or tested long-term use [^11] [^12] [^13]. - A 2017 review calls the melanotan sold outside the law untested [^20]. - Whether it helps vitiligo, a loss of skin color, is being tested in one trial in China [^21]. The trial has posted no results [^21]. - FDA has not set a date for its committee to meet on Melanotan II [^4]. Its notice does not say which use the committee will review [^4]. Source: https://pubmed.ncbi.nlm.nih.gov/28266027/ ## What it is Melanotan II is a lab-made peptide, a short chain of the building blocks of protein [^11]. It copies part of alpha-MSH, a natural hormone that darkens the skin [^11]. It switches on melanocortin receptors, signal points that affect skin color and sexual response [^19]. Researchers at the University of Arizona first tested it in people in the 1990s [^11] [^12]. Today people use it outside medical care to tan without sun and as a sexual stimulant [^17] [^18]. Its other short name is MT-II [^11]. Bremelanotide is a variation of Melanotan II, made for sexual stimulation [^17]. It is a different molecule with its own record on this site. Its studies say nothing about Melanotan II. Afamelanotide, another related peptide, is also a different molecule [^20]. Source: https://pubmed.ncbi.nlm.nih.gov/8637402/ ## Where it stands legally Melanotan II is in limbo: FDA lists it as withdrawn from Category 2, and it has not added it to Category 1 [^1] [^2]. That is not approval, and it does not make compounding lawful. Checked 25 October 2026. Category 2 is FDA's list of substances that may raise significant safety risks [^1]. Category 1 is the list of substances under review that pharmacies may use while FDA decides [^3]. In April 2026, the groups that nominated Melanotan II withdrew, so it came off Category 2 [^1] [^8]. Taking a substance off Category 2 does not by itself let pharmacies use it [^8] [^9]. FDA's 503A list of 14 May 2026 does not name Melanotan II in any category [^2]. FDA says its Pharmacy Compounding Advisory Committee will discuss Melanotan II at a meeting before the end of February 2027 [^4] [^22]. The notice gives no exact date and no meeting materials [^4]. It does not say which use the committee will review [^4]. People use Melanotan II to tan and as a sexual stimulant [^17] [^18]. The committee gives advice only. FDA decides by writing a rule [^8]. A June 2026 pharmacy column expected Melanotan II to stay restricted [^23]. FDA's own page lists it as withdrawn from Category 2 [^1]. The FDA page is what this page follows. Until FDA acts, a pharmacy may not use Melanotan II under the federal compounding law [^3] [^5]. 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 limited-human: three small studies in men, all from one university group, point the same way [^11] [^12] [^13]. No large trial has been published. Each study lasted hours or weeks, so none shows what long-term use does. Tanning: in a 1996 pilot study of 3 healthy men, two tanned on the face and upper body [^11]. Mild nausea was common, and erections came on without sexual stimulation [^11]. Erection problems: in a 1998 study, 10 men whose erection problems had no physical cause got Melanotan II and a dummy shot [^12]. Neither the men nor the staff knew which was which [^12]. Eight of the 10 had erections with Melanotan II [^12]. In a 2000 study, 10 men with physical risk factors were tested the same way [^13]. Erections followed 12 of 19 shots of Melanotan II and 1 of 21 dummy shots [^13]. Sexual desire was also higher after Melanotan II [^13]. Borrowed evidence: bremelanotide is a variation of Melanotan II, not the same molecule [^17]. A study of bremelanotide does not show what Melanotan II does. The same holds for afamelanotide, a related peptide [^20]. Harms are known mostly from case reports, not trials [^1] [^20]. A case report shows that a harm can happen. It does not show how often it happens. Source: https://pubmed.ncbi.nlm.nih.gov/11018622/ ## Legitimate ways to get it There is no legal way to get Melanotan II in the US today [^1] [^2]. In 2020, FDA said no approved drug contains it [^5]. A pharmacy may use a substance with no official quality standard only if it is in an approved drug or on the federal list [^3] [^5]. Melanotan II is neither, and FDA is still deciding whether to add it [^2] [^4]. One trial in the registry is testing Melanotan II for vitiligo [^21]. Its only site is in China, so it is not a US route [^21]. The trials block below lists open trials, with the date the registry was last checked. Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks ## How people are getting it anyway This section describes what happens and is not a recommendation. Case reports describe people who bought Melanotan II online to tan [^17] [^18]. A 2021 report says unlicensed clinics also use it as a sexual stimulant [^18]. A 2017 review calls these products untested and likely risky [^20]. It adds that several national health groups have warned against them [^20]. FDA has warned a seller of research-use peptides that a "research use only" label does not stop a product from being a drug [^7]. That letter did not name Melanotan II [^7]. Pharmacies are the other channel a federal record names [^5]. In 2020, FDA warned a compounding pharmacy that its Melanotan II products did not meet the rules for compounding [^5]. Later that year, the pharmacy pleaded guilty to a federal charge of selling unapproved new drugs, Melanotan II among them [^6]. FDA warns that Melanotan II made by a pharmacy may set off the immune system [^1]. Source: https://pubmed.ncbi.nlm.nih.gov/28266027/ ## Access routes Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks ### None Detail: There is no legal route to Melanotan II in the US today. FDA lists it as withdrawn from Category 2, and it is not on the list of substances pharmacies may use. Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks ## Unofficial channels Source: https://pubmed.ncbi.nlm.nih.gov/28266027/ ### Research use seller What it is: Websites that sell Melanotan II straight to the public, often for tanning, for people to use on their own. Legal position: FDA says a research-use label does not stop a product meant for people from being a drug. An unapproved new drug may not be sold across state lines. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026) Documented risks: - A man who used Melanotan II bought online had a racing heart, muscle breakdown and kidney injury. (source: https://pubmed.ncbi.nlm.nih.gov/23121206/) - A 2017 review calls unregulated melanotan products untested and likely risky. (source: https://pubmed.ncbi.nlm.nih.gov/28266027/) Enforcement: - 2026-08-24: FDA warning letter to a seller of research-use peptides: a research-use label did not stop its products from being unapproved drugs. The letter does not name Melanotan II. (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: Melanotan II made by a pharmacy from a bulk substance that is not on FDA's list. Legal position: A pharmacy may compound with a substance that has no official standard and is in no approved drug only if it is on FDA's list. FDA said in 2020 that Melanotan II is not on that list. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020) Documented risks: - FDA warns that Melanotan II made by a pharmacy may set off the immune system and may carry impurities. (source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) Enforcement: - 2020-04-01: FDA warning letter to a compounding pharmacy: Melanotan II was among bulk substances that made its products ineligible under section 503A. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020) - 2020-10-29: Department of Justice: the same pharmacy pleaded guilty to distributing unapproved new drugs, Melanotan II among them. (source: https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution) Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020 ## 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. - nct NCT07437560, url https://clinicaltrials.gov/study/NCT07437560, phase Phase 2, title Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo, status recruiting, sponsor Hudson Biotech, countries China, us states none listed Source: https://clinicaltrials.gov/api/v2/studies?query.intr=Melanotan+II+OR+melanotan&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/94155/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: categories of 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. FDA: notice of the next Pharmacy Compounding Advisory Committee meeting, before the end of February 2027 Type: regulatory Tier: primary Source: https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee ### 5. FDA warning letter to a compounding pharmacy, 1 April 2020 Type: regulatory Tier: primary Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020 ### 6. US Department of Justice: a compounding pharmacy pleads guilty to distributing unapproved drugs, 29 October 2020 Type: regulatory Tier: primary Source: https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution ### 7. FDA warning letter to a 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 ### 8. 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/ ### 9. Goodwin: FDA signals a possible change in its stance on compounding some peptides Type: legal-analysis Tier: legal-analysis Source: https://www.goodwinlaw.com/en/insights/blogs/2026/05/fda-signals-potentially-evolving-stance-toward-compounding-of-certain-peptides ### 10. ArentFox Schiff: warning letters to five peptide sellers, and why research use only is no legal strategy Type: legal-analysis Tier: legal-analysis Source: https://www.afslaw.com/perspectives/alerts/ruo-ined-five-peptide-vendors-learn-research-use-only-not-legal-strategy ### 11. Melanotan II in 3 healthy men, a pilot phase 1 study, 1996 Type: human-trial Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/8637402/ ### 12. Melanotan II in 10 men with erection problems of no physical cause, a blinded crossover trial, 1998 Type: rct Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/9679884/ ### 13. Melanotan II in 10 men with erection problems and physical risk factors, a blinded crossover trial, 2000 Type: rct Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/11018622/ ### 14. Case letter: melanoma after melanotan use, 2011 Type: reference Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/21564053/ ### 15. Case letter: new moles appearing quickly after melanotan, 2009 Type: reference Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/19575725/ ### 16. Case letter: melanotan and the brain swelling disorder PRES, 2013 Type: reference Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/23648958/ ### 17. Case report: whole-body toxicity and muscle breakdown after Melanotan II bought online, 2012 Type: reference Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/23121206/ ### 18. Case report: priapism after Melanotan II, 2021 Type: reference Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/33460908/ ### 19. Case report and review: loss of blood flow to a kidney after Melanotan II, 2020 Type: reference Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/31953620/ ### 20. Review: the risks of unregulated melanotan I and II use, 2017 Type: reference Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/28266027/ ### 21. ClinicalTrials.gov NCT07437560: Melanotan II with light therapy for vitiligo, recruiting in China Type: reference Tier: primary Source: https://clinicaltrials.gov/study/NCT07437560 ### 22. RAPS: FDA considers adding a dozen peptides to its compounding list Type: reference Tier: established-news Source: https://www.raps.org/resource/fda-considers-adding-a-dozen-peptides-to-its-bulk-drug-compounding-list.html ### 23. Pharmacy Times: a pharmacist on what the peptide category change means, 4 June 2026 Type: reference Tier: established-news Source: https://www.pharmacytimes.com/view/the-peptide-reclassification-everyone-s-talking-about-a-pharmacist-s-take-on-what-rfk-jr-s-announcement-actually-means Last verified: 2026-10-26. Sources: - https://clinicaltrials.gov/api/v2/studies?query.intr=Melanotan+II+OR+melanotan&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://pubmed.ncbi.nlm.nih.gov/11018622/ - https://pubmed.ncbi.nlm.nih.gov/28266027/ - https://pubmed.ncbi.nlm.nih.gov/31953620/ - https://pubmed.ncbi.nlm.nih.gov/8637402/ - https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks - 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: categories of 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]: FDA: notice of the next Pharmacy Compounding Advisory Committee meeting, before the end of February 2027 https://www.fda.gov/advisory-committees/pharmacy-compounding-advisory-committee/meeting-pharmacy-compounding-advisory-committee [^5]: FDA warning letter to a compounding pharmacy, 1 April 2020 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020 [^6]: US Department of Justice: a compounding pharmacy pleads guilty to distributing unapproved drugs, 29 October 2020 https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution [^7]: FDA warning letter to a 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 [^8]: 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/ [^9]: Goodwin: FDA signals a possible change in its stance on compounding some peptides https://www.goodwinlaw.com/en/insights/blogs/2026/05/fda-signals-potentially-evolving-stance-toward-compounding-of-certain-peptides [^11]: Melanotan II in 3 healthy men, a pilot phase 1 study, 1996 https://pubmed.ncbi.nlm.nih.gov/8637402/ [^12]: Melanotan II in 10 men with erection problems of no physical cause, a blinded crossover trial, 1998 https://pubmed.ncbi.nlm.nih.gov/9679884/ [^13]: Melanotan II in 10 men with erection problems and physical risk factors, a blinded crossover trial, 2000 https://pubmed.ncbi.nlm.nih.gov/11018622/ [^14]: Case letter: melanoma after melanotan use, 2011 https://pubmed.ncbi.nlm.nih.gov/21564053/ [^15]: Case letter: new moles appearing quickly after melanotan, 2009 https://pubmed.ncbi.nlm.nih.gov/19575725/ [^16]: Case letter: melanotan and the brain swelling disorder PRES, 2013 https://pubmed.ncbi.nlm.nih.gov/23648958/ [^17]: Case report: whole-body toxicity and muscle breakdown after Melanotan II bought online, 2012 https://pubmed.ncbi.nlm.nih.gov/23121206/ [^18]: Case report: priapism after Melanotan II, 2021 https://pubmed.ncbi.nlm.nih.gov/33460908/ [^19]: Case report and review: loss of blood flow to a kidney after Melanotan II, 2020 https://pubmed.ncbi.nlm.nih.gov/31953620/ [^20]: Review: the risks of unregulated melanotan I and II use, 2017 https://pubmed.ncbi.nlm.nih.gov/28266027/ [^21]: ClinicalTrials.gov NCT07437560: Melanotan II with light therapy for vitiligo, recruiting in China https://clinicaltrials.gov/study/NCT07437560 [^22]: RAPS: FDA considers adding a dozen peptides to its compounding list https://www.raps.org/resource/fda-considers-adding-a-dozen-peptides-to-its-bulk-drug-compounding-list.html [^23]: Pharmacy Times: a pharmacist on what the peptide category change means, 4 June 2026 https://www.pharmacytimes.com/view/the-peptide-reclassification-everyone-s-talking-about-a-pharmacist-s-take-on-what-rfk-jr-s-announcement-actually-means