group
Sexual health and pigmentation compounds
Four compounds sold for desire and for tanning, covered one at a time: what each molecule is, what the trials measured, and how far each approval actually reaches.
Three of the four compounds here are melanocortin peptides: chemical relatives of alpha-melanocyte-stimulating hormone, the hormone that drives pigmentation. PT-141 is an approved drug for a sexual desire disorder. Melanotan I is an approved drug for a rare light-sensitivity disease. Melanotan II is neither, and it is the compound the other two are most often confused with. The fourth, kisspeptin-10, comes from a different system entirely: the hormone cascade that runs reproduction.
What people research them for is desire, erectile function and a tan, in various combinations. What the published work actually tested is narrower than that in every case, and the gap between the two is the whole of this page. Two of the four hold FDA approvals, and neither approval covers the use the compound is sold for on this market.
Every entry states what was measured, in whom, and what the registry returned when it was searched for this page on 2 August 2026. Twenty numbered sources sit at the foot of the page: eighteen primary papers, including the phase 3 trials behind one approval and the critical re-analyses that followed them, plus two entries from the FDA labelling database. Melanotan II gets the longest harm section on this site, because eight published case reports is what its record consists of.
Not medical advice
This page reports what has been documented about a compound. It is not medical advice, not a diagnosis, not a dosing protocol, and not a recommendation to obtain or use anything described here. Talk to a licensed clinician about anything concerning your health. Read the full disclaimer.
Reviewed against editorial standards Updated
The compounds in this group
Each row names what the compound is and what its published work covers. The evidence level is the strongest tier of evidence about that compound for the use it is sold for. It is a single figure for a whole entry rather than a claim by claim grading, so an entry may also describe work that is weaker, or that tested a different route or a different molecule, and each of those carries its own citation in the text. Where a compound's own review has been run, its page grades every claim area separately.
| Compound | Also known as | What the published work covers | Where it stands | Evidence level |
|---|---|---|---|---|
| PT-141 | Bremelanotide, Vyleesi | Two completed randomised phase 3 trials in premenopausal women, with a published open-label extension and a published critical re-analysis | FDA approved as Vyleesi in June 2019 for one indication. Ten registrations under bremelanotide, four under PT-141, one molecule | [Human RCT] |
| Kisspeptin-10 | Metastin, KP-10 | Human studies of reproductive hormone release. The desire trials most often cited for it used kisspeptin-54, a longer molecule | Unapproved. No product appears in the FDA labelling database. Anti-doping position unsettled | [Human open-label] |
| Melanotan I | Afamelanotide, Scenesse | A randomised trial and a long-term observational study of an implant in erythropoietic protoporphyria, a rare light-sensitivity disease | FDA approved as Scenesse in October 2019 as an implant for that disease. Afamelanotide is also sold separately for cosmetic tanning, a use no trial has tested | [Human RCT] |
| Melanotan II | MT-2, MT-II | A controlled human study of erectile response and sexual motivation in men, one registered trial recruiting in vitiligo, and a published case-report literature covering pigmented lesions and events outside the skin | Unapproved. No product appears in the FDA labelling database | [Human open-label] |
One chemical family, four separate records
Alpha-melanocyte-stimulating hormone is a thirteen amino acid hormone that acts on a set of five melanocortin receptors. Melanotan I is a close analog of it. Melanotan II is a smaller ring-shaped analog that is less selective across those receptors. PT-141 is a breakdown product of melanotan II. KPV, covered elsewhere on this site, is the last three amino acids of the same hormone.
Shared ancestry is a fact about chemistry. It is not a shared mechanism, and it is not shared evidence. The published receptor work differs from member to member, and for KPV in particular it runs against what the family relationship suggests: the citations for that are on the KPV page, where they belong. Nothing on this page should be read as transferring a result from one member to another.
The practical version of that rule: an approval held by melanotan I says nothing about melanotan II, a phase 3 result for PT-141 says nothing about the parent molecule it comes from, and a case report about melanotan II is not evidence about PT-141.
How the registration counts on this page were run
Every count came from the ClinicalTrials.gov v2 API on 2 August 2026, as a free-text search on the name and on each alias, and every record behind a count was opened and read. Where the same molecule carries two names it carries two counts, and they are not additive: bremelanotide returned 10 registrations and PT-141 returned 4, describing one drug indexed twice.
Kisspeptin is the other place a count misleads, for a different reason. A search on kisspeptin returns 45 registrations, but kisspeptin is a molecule the body already makes, so a large share of that number is research measuring a person's own kisspeptin rather than giving any. The five registrations that name kisspeptin-10 specifically are interventional and mechanistic, and they are described in the entry below.
The approval facts were read off DailyMed, the FDA labelling database. Searching it on 2 August 2026 returns labels for VYLEESI and for SCENESSE, and zero labels for melanotan and zero for kisspeptin.
The four compounds, one at a time
PT-141
Also known as Bremelanotide, Vyleesi
Plain-English version: A seven amino acid ring-shaped melanocortin agonist, and a breakdown product of melanotan II, approved in 2019 for one indication.
Strongest evidence, and what it covers [Human RCT] Sexual desire in premenopausal women [1] [2] [3] [4]
PT-141 is bremelanotide, a seven amino acid cyclic peptide that acts on melanocortin receptors, and it is also one of the breakdown products of melanotan II. It is the only compound in this group approved for a sexual indication: FDA approved it as Vyleesi in June 2019, for acquired, generalised hypoactive sexual desire disorder in premenopausal women [19]. It acts through receptors in the brain rather than on blood flow, which is what separates it from the PDE5 drugs it gets compared with.
The approval rests on the RECONNECT programme: two randomised phase 3 trials, NCT02333071 with 723 participants and NCT02338960 with 714, both completed and published together in Obstetrics and Gynecology in 2019 [1], with a long-term open-label extension published alongside them [2]. A critical literature grew up around how large the measured effect was: a 2021 re-analysis of the phase 3 data [3] and a 2024 paper examining the outcome measures those trials used [4], both in the Journal of Sex Research. On 2 August 2026 ClinicalTrials.gov returned 10 registrations under bremelanotide and 4 under PT-141, which are the same molecule counted twice.
Where it stands Bremelanotide holds an FDA approval as Vyleesi, and its labelling is published in the FDA labelling database DailyMed, checked 2 August 2026 [19]. The approval covers one population and one condition. A product sold as PT-141 is not the approved product, and the approval carries no statement about anyone outside that population.
Our takeThe strongest evidence base in this group by a distance, and the published criticism of the effect size is part of that evidence rather than an attack on it. Read the phase 3 papers and the re-analyses together, because the trials and their critics disagree about the size of the same result rather than about whether it happened.
Kisspeptin-10
Also known as Metastin, KP-10
Plain-English version: A ten amino acid fragment of the product of the KISS1 gene, which sits at the top of the reproductive hormone cascade.
Strongest evidence, and what it covers [Human open-label] Reproductive hormone release [5] [6]
Kisspeptin-10 is a ten amino acid fragment of the protein made by the KISS1 gene, which sits at the top of the chain running reproduction: it signals to the neurons releasing GnRH, which drive LH and FSH from the pituitary. It is sold for libido, and developed academically as a fertility and diagnostic tool.
Its own human record is mechanistic rather than clinical. A 2011 study reported that kisspeptin-10 raised LH and increased pulse frequency in men [5], and a 2015 study compared intravenous kisspeptin-10, kisspeptin-54 and GnRH head to head for gonadotrophin release in healthy men [6]. On 2 August 2026 a search on kisspeptin returned 45 registrations, and the five naming kisspeptin-10 are phase 1 to phase 3 mechanistic studies of insulin secretion, pubertal onset and the reproductive axis.
The near-name is the point to carry away. The two trials most often cited for kisspeptin and sexual desire, a randomised trial in women in JAMA Network Open in 2022 [7] and a randomised trial in men there in 2023 [8], both used kisspeptin-54, a longer molecule than the kisspeptin-10 sold on this market. Those trials set a tier for kisspeptin-54 and none for kisspeptin-10.
Where it stands Kisspeptin-10 holds no approval in the United States and no product carrying the name appears in the FDA labelling database DailyMed, which returned zero labels for kisspeptin when it was searched on 2 August 2026. On anti-doping, the 2026 WADA Prohibited List names kisspeptin and its agonist analogues at S2.2.1, the class covering testosterone-stimulating peptides in males, prohibited at all times; kisspeptin-10 is one of the endogenous kisspeptin forms that entry describes [22].
Our takeA substantial academic programme sits behind kisspeptin, and almost none of it is behind the ten amino acid version that gets sold. Anyone citing the JAMA Network Open desire trials for kisspeptin-10 is citing a trial of a different molecule.
Melanotan I
Also known as Afamelanotide, Scenesse
Plain-English version: A thirteen amino acid analog of the hormone that drives pigmentation, approved as an implant for a rare light-sensitivity disorder.
Strongest evidence, and what it covers [Human RCT] Photoprotection in erythropoietic protoporphyria, from an implanted pellet [9] [10]
Melanotan I is afamelanotide, a thirteen amino acid analog of alpha-melanocyte-stimulating hormone. Structurally it is the closest of these compounds to the natural hormone, and it is more selective across the melanocortin receptors than melanotan II. It has a brand name, Scenesse, and a real approval behind it.
That approval is narrow and specific. FDA approved Scenesse in October 2019 to reduce phototoxicity in adults with erythropoietic protoporphyria, a rare inherited disease in which sunlight causes severe pain, and the approved product is an implant placed under the skin by a trained specialist rather than anything a person handles themselves [20]. On 2 August 2026 ClinicalTrials.gov returned 23 registrations under afamelanotide, spread across phase 2 and phase 3.
The evidence behind it is what an approval of that kind looks like. A randomised multicentre trial published in the New England Journal of Medicine in 2015 tested the implant in erythropoietic protoporphyria patients and measured pain-free time in sunlight [9]. A long-term observational study followed 115 patients with the same disease and reported what happened over repeated treatment [10]. Both are human studies, both are about the same disease, and both are about the implant.
None of that reaches the use melanotan I is actually sold for. Cosmetic tanning is a different question, in a different population, by a different route, with a different endpoint, and no trial has tested it. Under this site's rules the trials above keep their tier for the question they answered, in the disease they were run in, and they set no tier at all for a cosmetic tan. A reader who sees an approval quoted on a tanning product page is looking at a real approval being used to answer a question it never addressed.
Where it stands Afamelanotide holds an FDA approval as Scenesse, granted October 2019, and its labelling is published in the FDA labelling database DailyMed, checked 2 August 2026 [20]. The approval covers reduction of phototoxicity in adults with erythropoietic protoporphyria, delivered as an implant under specialist supervision. It covers nothing else, and a product sold as melanotan I is not the approved product.
Our takeA genuine randomised trial, a genuine approval, and a genuine rare disease, all of it borrowed to sell something the trial never studied. The trial record here is strong evidence about the wrong question.
Melanotan II
Also known as MT-2, MT-II
Plain-English version: A ring-shaped seven amino acid analog of the pigmentation hormone, less selective than melanotan I, sold for tanning.
Strongest evidence, and what it covers [Human open-label] Erectile response and sexual motivation in men. The tanning use it is mostly sold for has no controlled record [11] [12] [13] [14] [15] [16] [17] [18] [21]
Melanotan II is a cyclic seven amino acid analog of alpha-melanocyte-stimulating hormone, less selective across the melanocortin receptors than melanotan I. PT-141 is one of its breakdown products, which is why accounts of it describe tanning and sexual effects.
Its clinical record has two halves that are usually described as one. A controlled human study exists: Wessells and colleagues gave melanotan II to men and measured erectile response and sexual motivation, and PubMed indexes it as a controlled clinical trial rather than a case series [21]. Separately there is one registration, NCT07437560, a phase 2 trial of melanotan II alongside narrowband UVB phototherapy for repigmentation in stable non-segmental vitiligo, recruiting with no results posted on 2 August 2026. Everything else on the record is case reports, and they are what the rest of this entry covers.
Three describe pigmented lesions in people who had injected it for a tan: a melanoma [11], one associated with melanotan-II [12], and a melanoma in situ [13]. A fourth reports eruptive naevi and darkening of existing naevi 24 hours after a single injection [14]. Darkening of an existing mole is among the earliest visual changes dermatologists look for.
Four describe events outside the skin: rhabdomyolysis, meaning muscle tissue breaking down [15]; posterior reversible encephalopathy syndrome, a brain condition visible on a scan [16]; renal infarction, a blocked blood supply to a kidney [17]; and priapism, a prolonged painful erection [18]. Each is a single case, the weakest tier this site assigns, in a named journal rather than a forum.
Where it stands Melanotan II holds no approval in the United States and no product carrying the name appears in the FDA labelling database DailyMed, which returned zero labels for melanotan when it was searched on 2 August 2026. Its one registered study, NCT07437560, was recruiting rather than reporting on that date.
Our takeThis is the one compound in the catalog where the documented harm literature is larger than the documented efficacy literature, by a wide margin. One controlled human study of erectile response, one recruiting trial, and eight published case reports is the whole record, and it is worth reading the reports rather than a summary of them.
What we do not know about this group
No trial has tested melanotan I or melanotan II for a cosmetic tan. The melanotan I record is about an implant in a rare inherited light-sensitivity disease [9] [10], and the melanotan II record is one recruiting vitiligo trial plus eight case reports [11] to [18]. The use these compounds are actually sold for has never been the subject of a published study of any design.
How often the events in the melanotan II case reports occur is unknown and cannot be established from the reports themselves. A case report describes what happened to one person. It carries no denominator, so it cannot support a rate in either direction, and nothing published supplies one.
For kisspeptin-10 the open question is whether anything measured with kisspeptin-54 carries across. The two molecules were compared head to head for gonadotrophin release in healthy men [6], which is one endpoint in one population. Whether the desire findings from the kisspeptin-54 trials [7] [8] would reproduce with the shorter fragment has not been tested.
The size of the PT-141 effect remains contested in the published literature rather than settled by it. The phase 3 trials reported a difference against placebo [1], and two later papers argued the difference was small and questioned the outcome measures used to detect it [3] [4]. Those papers disagree about the magnitude of the same result, and that disagreement is part of the record.
And nothing published measures what any of these four does over years. The longest human follow-up on the page is the melanotan I observational study in 115 patients with a rare disease [10], which is about a different molecule, a different formulation and a different population from anything sold on this market.
What this evidence can and cannot show
These results come from mice and rats in melanocortin receptor pharmacology in cultured cells and pigmentation studies in rodents, not from people. An animal model is a deliberate simplification: the injury is created on purpose, the animal is young and healthy, the dose is scaled to body weight in a way that does not translate directly, and the outcome is measured at a fixed point rather than lived with. Cell and tissue work is a further step removed, because the concentrations that produce an effect in a dish are often far above anything a body reaches. Mechanism is a reason to run a trial. It is not a substitute for one, and compounds that looked mechanistically convincing have failed in people many times.
Frequently asked questions
Is PT-141 the same as bremelanotide?
Yes, and it is the same as Vyleesi. One molecule, three names, and two registry counts that are not additive: on 2 August 2026 ClinicalTrials.gov returned 10 registrations under bremelanotide and 4 under PT-141. A product sold as PT-141 is not the FDA-approved product, whatever the shared molecule.
What was PT-141 approved for?
FDA approved it as Vyleesi in June 2019 for acquired, generalised hypoactive sexual desire disorder in premenopausal women, and the labelling is published in the FDA labelling database DailyMed [19]. The approval covers that population and that condition. It carries no statement about men, about postmenopausal women, or about anyone with a different diagnosis.
Did the kisspeptin trials use kisspeptin-10?
The two trials people cite for sexual desire did not. The 2022 trial in women and the 2023 trial in men, both in JAMA Network Open, used kisspeptin-54, a longer molecule than the kisspeptin-10 that is sold [7] [8]. Kisspeptin-10 has its own human record, and it is about reproductive hormone release rather than desire [5] [6].
Is melanotan I approved?
Afamelanotide is, as Scenesse, granted in October 2019 to reduce phototoxicity in adults with erythropoietic protoporphyria [20]. The approved product is an implant placed under the skin by a trained specialist, for a rare inherited disease. No trial has tested the compound for cosmetic tanning, and the approval says nothing about it.
How many trials of melanotan II are there?
One, and it has not reported. NCT07437560 is a phase 2 study of melanotan II alongside narrowband UVB phototherapy for repigmentation in stable non-segmental vitiligo, recruiting as of 2 August 2026. The rest of the published medical record on melanotan II is eight case reports [11] to [18].
What do the melanotan II case reports describe?
Three describe pigmented lesions in people who had injected it for a tan: a melanoma [11], a melanoma associated with melanotan-II [12] and a melanoma in situ [13]. A fourth describes eruptive naevi and darkening of existing naevi 24 hours after a single injection [14]. Four more describe systemic toxicity with rhabdomyolysis [15], posterior reversible encephalopathy syndrome [16], renal infarction [17] and priapism [18]. Each is a single case or a small series, and none of them supplies a rate.
Are PT-141 and melanotan II related?
Chemically, yes: PT-141 is one of the breakdown products of melanotan II, which is why accounts of melanotan II describe sexual effects as well as tanning. Their evidence bases are not related at all. PT-141 has two completed randomised phase 3 trials and an approval [1] [2]. Melanotan II has one recruiting trial and a case-report literature.
Does KPV work the same way as these, since it comes from the same hormone?
Family membership is a fact about chemistry rather than a shared mechanism, and KPV is the clearest illustration on this site of why the two are different. What the published receptor work on KPV reports, with its citations, is set out on the KPV page.
Will any of these show up on a drug test?
Melanotan II is reached by the 2026 WADA Prohibited List's S0 category, which catches any pharmacological substance not addressed by another section of the list and with no current approval by any governmental regulatory health authority, and S0 is prohibited at all times [22]. PT-141 and melanotan I stand differently: both hold current FDA approvals, as Vyleesi and Scenesse, which places them outside S0's own definition, and neither is named anywhere on the 2026 list [22]. Kisspeptin is named at S2.2.1, testosterone-stimulating peptides in males, in the entry reading kisspeptin and its agonist analogues, prohibited at all times [22]. Anti-doping status is decided by an athlete's own anti-doping organization against the current list, and that is the only body whose answer counts.
References
- Kingsberg SA, Clayton AH, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Simon JA. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol. 2019. PMID 31599840 DOI 10.1097/AOG.0000000000003500
- Simon JA, Kingsberg SA, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Clayton AH. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstet Gynecol. 2019. PMID 31599847 DOI 10.1097/AOG.0000000000003514
- Spielmans GI. Re-Analyzing Phase III Bremelanotide Trials for "Hypoactive Sexual Desire Disorder" in Women. J Sex Res. 2021. PMID 33678061 DOI 10.1080/00224499.2021.1885601
- Spielmans GI, Ellefson EM. Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder. J Sex Res. 2024. PMID 36809187 DOI 10.1080/00224499.2023.2175192
- George JT, Veldhuis JD, Roseweir AK, Newton CL, Faccenda E, Millar RP, Anderson RA. Kisspeptin-10 is a potent stimulator of LH and increases pulse frequency in men. J Clin Endocrinol Metab. 2011. PMID 21632807 DOI 10.1210/jc.2011-0089
- Jayasena CN, Abbara A, Narayanaswamy S, Comninos AN, Ratnasabapathy R, Bassett P, Mogford JT, Malik Z, Calley J, Ghatei MA, Bloom SR, Dhillo WS. Direct comparison of the effects of intravenous kisspeptin-10, kisspeptin-54 and GnRH on gonadotrophin secretion in healthy men. Hum Reprod. 2015. PMID 26089302 DOI 10.1093/humrep/dev143
- Thurston L, Hunjan T, Ertl N, Wall MB, Mills EG, Suladze S, Patel B, Alexander EC, Muzi B, Bassett PA, Rabiner EA, Bech P, Goldmeier D, Abbara A, Comninos AN, Dhillo WS. Effects of Kisspeptin Administration in Women With Hypoactive Sexual Desire Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2022. PMID 36287566 DOI 10.1001/jamanetworkopen.2022.36131
- Mills EG, Ertl N, Wall MB, Thurston L, Yang L, Suladze S, Hunjan T, Phylactou M, Patel B, Muzi B, Ettehad D, Bassett PA, Howard J, Rabiner EA, Bech P, Abbara A, Goldmeier D, Comninos AN, Dhillo WS. Effects of Kisspeptin on Sexual Brain Processing and Penile Tumescence in Men With Hypoactive Sexual Desire Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2023. PMID 36735255 DOI 10.1001/jamanetworkopen.2022.54313
- Langendonk JG, Balwani M, Anderson KE, Bonkovsky HL, Anstey AV, Bissell DM, Bloomer J, Edwards C, Neumann NJ, Parker C, Phillips JD, Lim HW, Hamzavi I, Deybach JC, Kauppinen R, Rhodes LE, Frank J, Murphy GM, Karstens FPJ, Sijbrands EJG, de Rooij FWM, Lebwohl M, Naik H, Goding CR, Wilson JHP, Desnick RJ. Afamelanotide for Erythropoietic Protoporphyria. N Engl J Med. 2015. PMID 26132941 DOI 10.1056/NEJMoa1411481
- Biolcati G, Marchesini E, Sorge F, Barbieri L, Schneider-Yin X, Minder EI. Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria. Br J Dermatol. 2015. PMID 25494545 DOI 10.1111/bjd.13598
- Paurobally D, Jason F, Dezfoulian B, Nikkels AF. Melanotan-associated melanoma. Br J Dermatol. 2011. PMID 21564053 DOI 10.1111/j.1365-2133.2011.10273.x
- Hjuler KF, Lorentzen HF. Melanoma associated with the use of melanotan-II. Dermatology. 2014. PMID 24355990 DOI 10.1159/000356389
- Ong S, Bowling J. Melanotan-associated melanoma in situ. Australas J Dermatol. 2012. PMID 22724573 DOI 10.1111/j.1440-0960.2012.00915.x
- Schulze F, Erdmann H, Hardkop LH, Anemüller W, Rose C, Zillikens D, Fischer TW. Eruptive naevi and darkening of pre-existing naevi 24 h after a single mono-dose injection of melanotan II. Eur J Dermatol. 2014. PMID 24334249 DOI 10.1684/ejd.2013.2227
- Nelson ME, Bryant SM, Aks SE. Melanotan II injection resulting in systemic toxicity and rhabdomyolysis. Clin Toxicol (Phila). 2012. PMID 23121206 DOI 10.3109/15563650.2012.740637
- Kaski D, Stafford N, Mehta A, Jenkins IH, Malhotra P. Melanotan and the posterior reversible encephalopathy syndrome. Ann Intern Med. 2013. PMID 23648958 DOI 10.7326/0003-4819-158-9-201305070-00020
- Peters B, Hadimeri H, Wahlberg R, Afghahi H. Melanotan II: a possible cause of renal infarction: review of the literature and case report. CEN Case Rep. 2020. PMID 31953620 DOI 10.1007/s13730-020-00447-z
- Dreyer BA, Amer T, Fraser M. Melanotan-induced priapism: a hard-earned tan. BMJ Case Rep. 2019. PMID 30796078 DOI 10.1136/bcr-2018-227644
- US National Library of Medicine, DailyMed. VYLEESI (bremelanotide injection) prescribing information, as published in the FDA labelling database. Searched 2 August 2026. DailyMed, National Library of Medicine. 2026. DailyMed label
- US National Library of Medicine, DailyMed. SCENESSE (afamelanotide) implant prescribing information, as published in the FDA labelling database. Searched 2 August 2026. DailyMed, National Library of Medicine. 2026. DailyMed label
- Wessells H, Levine N, Hadley ME, Dorr R, Hruby V. Melanocortin receptor agonists, penile erection, and sexual motivation: human studies with Melanotan II. Int J Impot Res. 2000. PMID 11035391 DOI 10.1038/sj.ijir.3900582
- World Anti-Doping Agency. The 2026 Prohibited List, international standard, effective 1 January 2026. Verified against the retrieved document on 9 August 2026: kisspeptin is named at S2.2.1; melanotan II is reached by the S0 definition; PT-141 and melanotan I hold current approvals that place them outside it. WADA. 2026. Prohibited List