myPeptides
English

All content is for general information only — not medical advice, not a dosing or usage recommendation, and not a claim of efficacy. Many substances are not approved as medicines or are prescription-only; whether possession and use are legal depends on the law of your country of residence and is your own responsibility. myPeptides does not sell or supply any substances — it is an information and organization tool. For health questions, consult a licensed physician or pharmacist.

Melanotan 1 vs Melanotan 2: differences, evidence and safety

Updated September 25, 202611 min

Melanotan 1 vs Melanotan 2: differences, evidence and safety

Answer first

Melanotan 1 (Melanotan I, afamelanotide) is a straight chain of 13 building blocks that prefers the pigment-cell receptor MC1R, and as an implant it is approved for one rare light disease. Melanotan 2 (Melanotan II) is a ring of seven that acts on several melanocortin receptors and is approved nowhere. No study comparing them directly was found for this page.

At a glance

AttributeMelanotan IMelanotan II
Substance classMelanocortinsMelanocortins
Legal categoryPrescription medicineResearch chemical
Approval status by market
United StatesApproved, prescription only (2019-10-08)Not approved
European UnionApproved, prescription only (2014-12-22)Not approved
GermanyApproved, prescription only (2014-12-22)Not approved
United KingdomApproved, prescription onlyNot approved
AustraliaScheduled substanceScheduled substance
CanadaApproved, prescription only (2026-07-09)Not approved
SwitzerlandNot approvedNot approved
WADA statusNot listed (2026)Prohibited (S0, 2026)
Development stageApprovedDiscontinued
Strongest evidencePhase 3 randomised trialPhase 1 randomised trial
Registered trials (ClinicalTrials.gov)15+0
Sequence length13 amino acids7 amino acids
Molecular weight1646.85 g/mol1024.2 g/mol
Last verified2026-09-062026-09-06

How they work

"Melanotan 1" and "Melanotan 2" are the search forms of two register entries, Melanotan I and Melanotan II. Melanotan I (MT-1) is known officially as afamelanotide. For Melanotan II (MT-II), no official name and no application for approval could be found in the records checked [1], [2]. Both copy the body's own alpha-melanocyte-stimulating hormone (α-MSH), the signal that tells pigment cells to make more pigment.

Melanotan I (afamelanotide)

  • A straight chain of 13 building blocks. Two of them were swapped so that enzymes break the molecule down more slowly than the natural hormone [3].
  • One preferred docking point. It latches onto the melanocortin-1 receptor (MC1R) on pigment cells. That switches on the dark form of pigment, eumelanin, with or without sunlight [3], [4]. No formal measurement of how strongly it prefers MC1R over the MC3, MC4 and MC5 receptors appears in the approval documents [3].
  • How long it stays. The substance itself lasts about 30 minutes in the blood. Released from the approved implant, the apparent half-life is about 15 hours, and the implant dissolves over 50 to 60 days [3], [4].

Melanotan II

  • A ring of seven building blocks. It copies positions 4 to 10 of α-MSH, with four deliberate chemical changes. Closing it into a 23-membered ring raised its potency about a hundredfold in a lizard skin test [5], [6].
  • Several receptors at once. The body has five melanocortin receptors, and Melanotan II is thought to act on more than one. The best laboratory study tested three of them, but not the one on pigment cells [7], [8].
  • Effects beyond the skin. Reduced appetite, erection and nausea are attributed to receptors in the brain, mostly on the basis of rodent work [9], [8]. In mice, a sharp drop in body temperature ran through histamine released by mast cells, a different system altogether [10].
  • How long it stays. No half-life in people could be found in the published literature reviewed for this page [11].

The core difference is selectivity. Melanotan I prefers the pigment-cell receptor, while Melanotan II acts on melanocortin receptors without preference. That lack of selectivity explains the erections and nausea seen in its human studies [2], [12].

What the studies show

No study that compares Melanotan I and Melanotan II directly could be found in the published record reviewed for this page. Both came out of the same Arizona research programme, but each was tested on its own, in different people and for different questions [8].

Melanotan I: pain-free time in the sun

Phase 3 RCT The American licensing trial enrolled 93 adults with erythropoietic protoporphyria, an inherited disorder in which sunlight causes burning pain within minutes. Of these, 48 received the implant and 45 a dummy implant, for 180 days [4].

This was trial CUV039 (NCT01605136). Over that period, the middle value (median) of pain-free hours in direct sunlight was 69.4 against 40.8 on the dummy implant (p = 0.04) [13].

Regulators summarise the same trial with other figures, because they count differently. The American label gives 64.1 against 40.5 hours. The European public summary gives an average of 116 against 61 hours [4], [14]. These are not further studies.

Phase 3 RCT The European trial CUV029 (NCT00979745) followed 74 adults for 270 days and counted a narrower window under stricter conditions. The medians were 6.0 hours against 0.8 (p = 0.005). Painful light reactions numbered 77 against 146 (p = 0.04) [13]. The two sets of hours were counted differently and cannot be compared with each other.

Melanotan I: the early skin-colour studies

Phase 1 RCT, 1991 Twenty-eight healthy men received a course of injections over twelve days under medical supervision, with strong sunscreen throughout. Skin darkened measurably in both skin-type groups (p < 0.001) and not at all on placebo [15].

Small open-label study, 2000 Seven volunteers were studied. A week after the last dose, the marker for eumelanin had risen by 49 ± 17.6 per cent in forehead skin (p = 0.019, three participants). In forearm skin it had risen by 98 ± 25.4 per cent (p = 0.003) [16].

These studies are often quoted as evidence for "melanotan" in general. They tested Melanotan I, not Melanotan II [16], [17]. Neither says anything about long-term safety [18].

Melanotan II: skin colour in three men

Human pilot study Three healthy men received the peptide under the skin over two weeks. Two of the three showed more pigment in the face, upper body and buttocks one week after the last dose. No other published measurement of the pigment effect of Melanotan II in people could be found [19].

Melanotan II: erection and nausea

Human phase 1 Two double-blind crossover studies enrolled ten men each, all with erectile problems. Pooled across the 20 men, 17 developed an erection without any sexual stimulation [12].

In the first group, firmness above 80 per cent lasted 38.0 minutes on the peptide against 3.0 minutes on placebo (p = 0.0045) [20]. In the second group the same measure gave 45.3 minutes against 1.9 minutes (p = 0.047) [21].

Increased sexual desire followed 13 of 19 doses of the peptide (68 per cent). After placebo it followed 4 of 21 doses (19 per cent), a difference beyond chance (p < 0.01). Severe nausea occurred in 12.9 per cent of participants [12].

What the two records have in common, and what they do not

The human record for Melanotan II found for this page is four papers and fewer than 25 men, all from one group, published between 1996 and 2000 [12]. The only registry entry found that names it describes itself as an example record, not a real trial [22].

Melanotan I has two published phase 3 licensing trials and an observational record of up to eight years from two specialist centres [13], [23]. The populations, forms, measured outcomes and durations differ completely, so the figures above cannot be set against each other.

Safety

The safety evidence differs in kind. For Melanotan I there is an approved label built on controlled trials. For Melanotan II there are a few study participants and a growing number of case reports.

Melanotan I in the approved trials. The American safety database covers 244 adults, 125 on the drug and 119 on a dummy implant [4].

  • Common effects. Reactions where the implant sits affected 21 per cent against 10 per cent, and nausea 19 per cent against 14 per cent. Headache is listed in Europe as very common, at about 20 per cent [4], [3].
  • Moles and skin checks. Skin darkening occurred in 4 per cent against none, and a new or changed mole in 4 per cent against 2. A full-body skin examination is required every six months [4], [3].
  • Melanoma history as a warning. The European information asks for extra caution in people with melanoma in themselves or their family, or with a known inherited risk [3].
  • Allergic reactions. Severe reactions, including anaphylaxis, have been reported since launch [4], [3].
  • Gaps. According to the product information, safety has not been studied beyond two years, and no cancer studies in animals were done. There is no boxed warning on the American label [3], [4].

Melanotan II. The FDA names four serious events from published case reports: melanoma, brain swelling known as PRES, a stimulant-like poisoning and a painful prolonged erection [24].

  • A stimulant-like poisoning. A 39-year-old man injected material bought online. His heart ran at 130 to 146 beats a minute, and his muscle enzyme rose from 1,760 to 17,773 units within 12 hours. He spent three days in intensive care [25].
  • Painful prolonged erection. Three cases are published, and two needed invasive treatment, one of them surgery [26], [27], [28].
  • Brain and kidney. Brain swelling was reported in a letter to a medical journal, and a Swedish team described a kidney infarct [29], [30].
  • New and darkening moles. In one German case they appeared within 24 hours of a single dose. A German dermoscopy study found that the changes made it harder to tell a mole from a melanoma [31], [32].
  • Official reports. The British regulator counted 18 reports covering 74 suspected effects. Suspected reports are not proof of cause [33].

Single case reports. Melanoma has been reported in single users [34], [35], [36], [37]. Some reports name Melanotan II, others only "melanotan". One case concerned the lining of the mouth after nasal spray use [35]. Another report describes new atypical moles within a week of two injections [38]. Where only "melanotan" is named, the peptide involved is not clear. Dermatologists have asked in print what exactly that word means [39].

Almost every reported case also involved heavy ultraviolet exposure, usually from sunbeds. A 2017 review states that conclusive evidence of a causal link is lacking [18].

Contents and needles. A Danish laboratory found less peptide than declared in every vial tested. Vials from two of three shops also held unknown impurities of 4.1 to 5.9 per cent [40]. The Australian regulator found a spread of more than double between identically labelled nasal sprays [41].

Self-injection carries a risk of serious infection, and shared needles can pass on blood-borne viruses [42], [43].

Why this page lists no doses. Melanotan I is a prescription medicine, placed as an implant only by staff accredited by the licence holder. Products sold as Melanotan II have no verified content, so any amount attached to them would describe nothing [3], [40].

As afamelanotide, Melanotan I is approved on prescription in the European Union since 22 December 2014, in the United States since 8 October 2019 and in Canada since 9 July 2026, for one rare light disease only [14], [44], [45]. England's cost-effectiveness body turned it down in 2023 [46]. Melanotan II is approved nowhere, and several regulators have warned the public about it [47], [33], [48], [49]. Australia lists both substances separately in Schedule 4, prescription-only [50]. Afamelanotide is not on the 2026 anti-doping list, while Melanotan II is banned at all times under section S0 [51]. More on this is under peptides banned in sport. Both monographs reflect the position on 6 September 2026.

Melanotan I

Status at a glance

MarketStatusDate
United StatesApproved, prescription only2019-10-08
European UnionApproved, prescription only2014-12-22
GermanyApproved, prescription only2014-12-22
United KingdomApproved, prescription only—
AustraliaScheduled substance—
CanadaApproved, prescription only2026-07-09
SwitzerlandNot approved—
Development stage
Approved
Strongest evidence
Phase 3 randomised trial
WADA status
Not listed
Last verified
2026-09-06
Version
1.0

This page lists no doses.

Melanotan II

Status at a glance

MarketStatusDate
United StatesNot approved—
European UnionNot approved—
GermanyNot approved—
United KingdomNot approved—
AustraliaScheduled substance—
CanadaNot approved—
SwitzerlandNot approved—
Development stage
Discontinued
Strongest evidence
Phase 1 randomised trial
WADA status
Prohibited (S0, 2026)
Last verified
2026-09-06
Version
1.0

Used together?

The blend directory holds no combination of Melanotan I and Melanotan II. Its only melanotan entry pairs Melanotan II with PT-141 (bremelanotide), a different molecule.

No study of the two peptides together could be found in either monograph. The approved form of Melanotan I is an implant placed by accredited staff, and nothing sold as a mixture falls under its licence [3].

What does exist is confusion between the two. Australia lists them as separate substances, yet a vial labelled "Melanotan I" could hold either one, or neither [50], [51]. The press label "Barbie peptide" is applied to both without distinction [39].

Frequently asked questions

Which is better, Melanotan 1 or Melanotan 2?

Neither can be ranked, because no study comparing them could be found in the sources reviewed for this page. In two phase 3 trials, Melanotan I as an implant increased pain-free time in the sun for people with a rare light disease. Melanotan II was tested in fewer than 25 men in the 1990s, for skin colour and erection. No study of it in that disease could be found.

Is Melanotan 1 or Melanotan 2 safer?

No study comparing their safety could be found in the sources reviewed for this page. Melanotan I has an approved label based on 244 trial participants, with required skin checks every six months. For Melanotan II, the evidence is a few study participants and published case reports, from which the FDA names four serious events. Laboratories also found product contents at odds with the label.

What is the difference between Melanotan 1 and Melanotan 2?

They are two different molecules. Melanotan I is a straight chain of 13 building blocks that prefers the MC1R receptor on pigment cells. Melanotan II is a ring of seven that acts on several melanocortin receptors, which is why erection and nausea appeared in its studies. Of the two, only Melanotan I holds an approval, and only as an implant.

Can Melanotan 1 and Melanotan 2 be taken together?

No study of the two together could be found, and the blend directory lists no such combination. The approved form of Melanotan I is an implant placed by accredited staff, so no mixture falls under its licence. The directory's only melanotan entry pairs Melanotan II with PT-141 (bremelanotide), a different molecule.

Is Melanotan 1 the same as afamelanotide?

Chemically, yes: both names describe the same peptide of 13 building blocks. As products they differ completely. Afamelanotide is an approved implant with checked content, while "Melanotan I" is the name used for unapproved tanning preparations of unknown origin.

Is Melanotan 2 approved in any country?

No. No approval and no assessment report from any medicines agency could be found in the registers checked. Australia lists it as prescription-only while no approved product is on its register, which makes any supply to consumers unlawful. The United States, the United Kingdom, Germany, Denmark and Norway have issued public warnings.

Do Melanotan 1 or Melanotan 2 cause melanoma?

The evidence cannot answer that. Melanoma has been reported in single users of products sold under both names, but almost all of them also used sunbeds heavily, and causation is not proven. Both peptides darken existing moles, which is why the Melanotan I label requires skin checks every six months.

Are Melanotan 1 and Melanotan 2 banned in sport?

Afamelanotide is not on the 2026 Prohibited List, because it is an approved medicine. Melanotan II is banned at all times under section S0, which covers substances approved by no health authority. A vial of unknown origin labelled "Melanotan I" could contain either, so the label settles nothing.

Can a vial sold as Melanotan 1 contain Melanotan 2?

It can. Products sold under either name are unapproved, so their contents are not checked before sale. Laboratory tests of Melanotan II products found contents that did not match the label. The Australian regulator treats both names as illegal therapeutic goods.

Sources

  1. PubChem, compound CID 16197727 (afamelanotide). National Library of Medicine. Formula C78H111N21O19, molecular weight 1,646.8, CAS 75921-69-6, UNII QW68W3J66U, DrugBank DB04931, KEGG D10511; the synonym list includes Melanotan I, Melanotan-1, MT-1 and NDP-alpha-MSH. Retrieved 6 September 2026. https://pubchem.ncbi.nlm.nih.gov/compound/16197727
  2. PubChem. Compound CID 92432, Melanotan II; CAS 121062-08-6, UNII UPF5CJ93X7, C50H69N15O9, 1024.2 g/mol, InChIKey JDKLPDJLXHXHNV-MFVUMRCOSA-N. Retrieved via PUG-REST on 6 September 2026. https://pubchem.ncbi.nlm.nih.gov/compound/92432
  3. European Medicines Agency. Afamelanotide implant — product information (Annex I summary of product characteristics, Annex II, Annex III), revision 13, updated 21 October 2025. Sections 4.1, 4.3 to 4.8, 5.1, 5.2, 6.1 to 6.5 and Annex II section B and E. https://www.ema.europa.eu/en/documents/product-information/scenesse-epar-product-information_en.pdf
  4. Afamelanotide implant, for subcutaneous use — US Prescribing Information. Clinuvel Inc., revision 08/2024. NDA 210797. DailyMed setid 94f53286-11dd-7fbb-e053-2a95a90a7c48. Full label check confirmed the absence of a boxed warning. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=94f53286-11dd-7fbb-e053-2a95a90a7c48
  5. Al-Obeidi F, Castrucci AM, Hadley ME, Hruby VJ (1989). Potent and prolonged acting cyclic lactam analogues of alpha-melanotropin: design based on molecular dynamics. Journal of Medicinal Chemistry 32(12):2555-61. PMID 2555512 · DOI 10.1021/jm00132a010
  6. Hadley ME, Marwan MM, al-Obeidi F, Hruby VJ, Castrucci AM (1989). Linear and cyclic alpha-melanotropin [4-10]-fragment analogues that exhibit superpotency and residual activity. Pigment Cell Research 2(6):478-84. PMID 2557603
  7. Bednarek MA, Silva MV, Arison B, MacNeil T, Kalyani RN, Huang RR, Weinberg DH (1999). Structure-function studies on the cyclic peptide MT-II, lactam derivative of alpha-melanotropin. Peptides 20(3):401-9. PMID 10447101 · DOI 10.1016/s0196-9781(99)00048-0. Binding and activation were tested at human MC3, MC4 and MC5 receptors, not at MC1R; no complete affinity table across all five receptors is available from a primary source.
  8. Hadley ME, Dorr RT (2006). Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization. Peptides 27(4):921-30. PMID 16412534 · DOI 10.1016/j.peptides.2005.01.029
  9. Zhang Y, Collazo R, Gao Y, Li G, Scarpace PJ (2010). Intermittent MTII application evokes repeated anorexia and robust fat and weight loss. Peptides 31(4):639-43. PMID 20034526
  10. Jain S, Panyutin A, Liu N, et al. (2018). Melanotan II causes hypothermia in mice by activation of mast cells and stimulation of histamine 1 receptors. American Journal of Physiology: Endocrinology and Metabolism 315(3):E357-E366. PMID 29812984
  11. Ugwu SO, Blanchard J, Nguyen LD, Hadley ME, Dorr RT (1994). A comparison of HPLC and bioassay methods for plasma melanotan-II (MT-II) determination: application to a pharmacokinetic study in rats. Biopharmaceutics and Drug Disposition 15(5):383-90. PMID 7981427
  12. Wessells H, Levine N, Hadley ME, Dorr R, Hruby V (2000). Melanocortin receptor agonists, penile erection, and sexual motivation: human studies with Melanotan II. International Journal of Impotence Research 12 Suppl 4:S74-9. PMID 11035391 · DOI 10.1038/sj.ijir.3900582
  13. Langendonk JG, Balwani M, Anderson KE et al. (2015). Afamelanotide for erythropoietic protoporphyria. New England Journal of Medicine 373(1):48-59. PMID 26132941. DOI 10.1056/NEJMoa1411481. Reports both licensing trials, CUV039 (NCT01605136, 180 days) and CUV029 (NCT00979745, 270 days).
  14. European Medicines Agency. European public assessment report for the afamelanotide implant. Marketing authorisation EU/1/14/969/001, authorised 22 December 2014 under exceptional circumstances; holder Clinuvel Europe Limited, Dublin; orphan designation of 8 May 2008. The public summary reports, for the registration trial in 93 patients over six months, an average of 116 hours of pain-free direct sun exposure against 61 hours on placebo. Retrieved 6 September 2026. https://www.ema.europa.eu/en/medicines/human/EPAR/scenesse
  15. Levine N, Sheftel SN, Eytan T et al. (1991). Induction of skin tanning by subcutaneous administration of a potent synthetic melanotropin. JAMA 266(19):2730-2736. PMID 1658407. Randomised, placebo-controlled, double-blind study in 28 healthy men.
  16. Dorr RT, Dvorakova K, Brooks C et al. (2000). Increased eumelanin expression and tanning is induced by a superpotent melanotropin Nle4-D-Phe7-alpha-MSH in humans. Photochemistry and Photobiology 72(4):526-532. PMID 11045725.
  17. Further studies frequently cited as melanotan evidence that in fact tested Melanotan I: Dorr RT et al. (2004), Archives of Dermatology 140(7):827-35, PMID 15262693; Fitzgerald LM et al. (2006), Peptides 27(2):388-94, PMID 16293341.
  18. Habbema L, Halk AB, Neumann M, Bergman W (2017). Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review. International Journal of Dermatology 56(10):975-980. PMID 28266027. DOI 10.1111/ijd.13585. Causation not proven.
  19. Dorr RT, Lines R, Levine N, Brooks C, Xiang L, Hruby VJ, Hadley ME (1996). Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study. Life Sciences 58(20):1777-84. PMID 8637402 · DOI 10.1016/0024-3205(96)00160-9
  20. Wessells H, Fuciarelli K, Hansen J, Hadley ME, Hruby VJ, Dorr R, Levine N (1998). Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study. Journal of Urology 160(2):389-93. PMID 9679884
  21. Wessells H, Gralnek D, Dorr R, Hruby VJ, Hadley ME, Levine N (2000). Effect of an alpha-melanocyte stimulating hormone analog on penile erection and sexual desire in men with organic erectile dysfunction. Urology 56(4):641-6. PMID 11018622 · DOI 10.1016/s0090-4295(00)00680-4
  22. ClinicalTrials.gov. NCT07437560, "Melanotan II (MT-II) as an adjunct to NB-UVB phototherapy for repigmentation in stable nonsegmental vitiligo", sponsor Hudson Biotech. The brief summary states: "This example interventional study record describes a randomized Phase 2 clinical trial evaluating investigational Melanotan II (MT-II) …"; the field isFdaRegulatedDrug is set to false. The same sponsor name appears on NCT07487363, whose brief summary begins "This fictional study is an example of a ClinicalTrials.gov-style record". Both records retrieved via API v2 on 6 September 2026. https://clinicaltrials.gov/study/NCT07437560
  23. Biolcati G, Marchesini E, Sorge F, Barbieri L et al. (2015). Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria. British Journal of Dermatology 172(6):1601-1612. PMID 25494545. DOI 10.1111/bjd.13598. 1,023 implants over up to eight years at the porphyria centres in Rome and Zurich.
  24. US Food and Drug Administration. Certain bulk drug substances for use in compounding that may present significant safety risks; entry "Melanotan II" under bulk drug substances nominated but withdrawn, naming four serious adverse events from published case reports. Content current as of 22 April 2026, retrieved 6 September 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
  25. Nelson ME, Bryant SM, Aks SE (2012). Melanotan II injection resulting in systemic toxicity and rhabdomyolysis. Clinical Toxicology 50(10):1169-73. PMID 23121206 · DOI 10.3109/15563650.2012.740637. The injected material was confirmed as Melanotan II by mass spectrometry against a purchased standard.
  26. Devlin J, Pomerleau A, Foote J (2013). Melanotan II overdose associated with priapism. Clinical Toxicology 51(4):383. PMID 23537392 · DOI 10.3109/15563650.2013.784775. No abstract is held at PubMed; title and attribution verified only.
  27. Dreyer BA, Amer T, Fraser M (2019). Melanotan-induced priapism: a hard-earned tan. BMJ Case Reports 12(2):e227644. PMID 30796078
  28. Mallory CW, Lopategui DM, Cordon BH (2021). Melanotan tanning injection: a rare cause of priapism. Sexual Medicine 9(1):100298. PMID 33460908
  29. Kaski D, Stafford N, Mehta A, Jenkins IH, Malhotra P (2013). Melanotan and the posterior reversible encephalopathy syndrome. Annals of Internal Medicine 158(9):707-8. PMID 23648958. No abstract is held at PubMed; title and attribution verified only.
  30. Peters B, Hadimeri H, Wahlberg R, Afghahi H (2020). Melanotan II: a possible cause of renal infarction: review of the literature and case report. CEN Case Reports 9(2):159-61. PMID 31953620
  31. Schulze F, Erdmann H, Hardkop LH, Anemuller W, Rose C, Zillikens D, Fischer TW (2014). Eruptive naevi and darkening of pre-existing naevi 24 h after a single mono-dose injection of melanotan II. European Journal of Dermatology 24(1):107-9. PMID 24334249 · DOI 10.1684/ejd.2013.2227
  32. Mang R, Krahl D, Assmann T (2012). Dermoskopische Veranderungen melanozytarer Navi unter Anwendung von Melanotan II. Der Hautarzt 63(11):880-4. PMID 23052015 · DOI 10.1007/s00105-012-2420-1. Sequential video dermoscopy before and during use.
  33. Medicines and Healthcare products Regulatory Agency. Press release of 17 November 2008 and news release of 29 August 2013 warning against melanotan sold as an unlicensed medicine; the 2013 release reports 18 reports covering 74 separate suspected adverse reactions and 72 websites closed within three months. MHRA primary documents were not retrievable on 6 September 2026; the wording is documented by five independent secondary reports (BBC News, The Guardian, Nursing Times, Herald Scotland, Lexology).
  34. Hjuler KF, Lorentzen HF (2014). Case report of melanoma after Melanotan II use (title paraphrased). Dermatology 228(1):34-6. PMID 24355990 · DOI 10.1159/000356389.
  35. Yassin Alsabbagh A, Bhujel N, Singh RP (2025). Case report discussing Melanotan II nasal spray as a possible risk factor for melanoma of the mouth lining (title paraphrased). International Journal of Oral and Maxillofacial Surgery 54(9):806-8. PMID 40210573 · DOI 10.1016/j.ijom.2025.03.014
  36. Paurobally D, Jason F, Dezfoulian B, Nikkels AF (2011). Case report of melanoma in a melanotan user (title paraphrased). British Journal of Dermatology 164(6):1403-1405. PMID 21564053. DOI 10.1111/j.1365-2133.2011.10273.x.
  37. Ong S, Bowling J (2012). Case report of an early, skin-confined melanoma in a melanotan user (title paraphrased). Australasian Journal of Dermatology 53(4):301-302. PMID 22724573. DOI 10.1111/j.1440-0960.2012.00915.x.
  38. Reid C, Fitzgerald T, Fabre A, Kirby B (2013). Atypical melanocytic naevi following melanotan injection. Irish Medical Journal 106(5):148-149. PMID 23914578.
  39. Langan EA, Rhodes LE (2011). Melanotropic peptides: what exactly is meant by melanotan? Acta Dermato-Venereologica 91(3):377. PMID 21547334 · DOI 10.2340/00015555-1130
  40. Breindahl T, Evans-Brown M, Hindersson P, McVeigh J, Bellis M, Stensballe A, Kimergard A (2015). Identification and characterization by LC-UV-MS/MS of melanotan II skin-tanning products sold illegally on the Internet. Drug Testing and Analysis 7(2):164-72. PMID 24771717 · DOI 10.1002/dta.1655
  41. Therapeutic Goods Administration (Australia). Safety alert: Melanotan II tanning peptide products found to be inconsistently dosed, August 2026. https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/melanotan-ii-tanning-peptide-products-found-be-inconsistently-dosed
  42. Therapeutic Goods Administration (Australia). Melanotan — illegal therapeutic goods. Names both Melanotan I and Melanotan II; not listed in the Australian Register of Therapeutic Goods, not assessed for quality, safety or efficacy, treated as prescription-only medicines; import for personal use requires a prescription from a doctor registered in Australia; warns of infection risk from self-injection. https://www.tga.gov.au/melanotan-illegal-therapeutic-goods
  43. Langan EA, Nie Z, Rhodes LE (2010). Melanotropic peptides: more than just 'Barbie drugs' and 'sun-tan jabs'? British Journal of Dermatology 163(3):451-455. PMID 20545686. DOI 10.1111/j.1365-2133.2010.09891.x. Cited here as the secondary source for the British regulator's warning about blood-borne viruses and product contamination; the original press release was not retrievable on 6 September 2026.
  44. Drugs@FDA / openFDA, NDA 210797 (afamelanotide implant): original approval 8 October 2019, submission class Type 1 new molecular entity, priority review, orphan property; labelling supplement approved 12 August 2024. Retrieved 6 September 2026. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22afamelanotide%22
  45. Health Canada, Drug Product Database: afamelanotide implant, DIN 02569825, drug code 107203, status Approved with status date 9 July 2026, schedule Prescription, no original market date recorded. Retrieved 6 September 2026. https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=107203
  46. National Institute for Health and Care Excellence. Highly specialised technologies guidance HST27: afamelanotide for treating erythropoietic protoporphyria. Published 26 July 2023. Chapters 1 and 3. https://www.nice.org.uk/guidance/hst27
  47. US Food and Drug Administration. Warning letter of 30 August 2007 to Melanocorp, Inc., Hendersonville, Tennessee, announced publicly on 5 September 2007. The subsequent debarment document, Docket No. FDA-2015-N-4169, records continued distribution, a criminal conviction under 18 U.S.C. 371 and a permanent debarment. https://www.fda.gov/media/128834/download
  48. Bundesinstitut für Arzneimittel und Medizinprodukte. Press release 14/10 of 28 October 2010, advising strongly against obtaining and cosmetically using melanotan-containing products from indeterminate internet sources, and noting risks to the cardiovascular system, the digestive tract and skin colour. The agency confirmed to Stiftung Warentest on 11 July 2026 that the warning still stands. https://www.bfarm.de/SharedDocs/Pressemitteilungen/DE/2010/pm14-2010.html
  49. Laegemiddelstyrelsen (Danish Medicines Agency). Warning against the product Melanotan, 8 August 2008 (English version 11 August 2008). Repeated on 20 June 2011. https://laegemiddelstyrelsen.dk/en/pharmacies/medicines-imported-from-abroad/warnings-against-products/warning-against-the-product-melanotan/
  50. Therapeutic Goods (Poisons Standard — June 2026) Instrument 2026, authorised version F2026L00633, registered 28 May 2026. Schedule 4 entry AFAMELANOTIDE; index entry 'AFAMELANOTIDE — cross reference: MELANOCYTE STIMULATING HORMONE, MELANOTAN I — Schedule 4'; separate Schedule 4 entry for MELANOTAN II.
  51. World Anti-Doping Agency, Prohibited List 2026, in force from 1 January 2026. Full-text check of the official document on 6 September 2026 returned no match for afamelanotide, melanotan or melanocortin, in either the list or the monitoring programme. Wording of class S0 quoted. https://www.wada-ama.org/en/prohibited-list

Further reading

Last reviewed: September 2026

Take myPeptides with you

Track doses, plans and progress on your phone — end-to-end encrypted.

Open in app App Store Join the beta

This article is for informational purposes only and does not replace medical advice. myPeptides gives no dosing recommendations.