Melanotan 1 vs Melanotan 2: Approval, Evidence and Risks

By Editorial team. Updated Oct 15, 2026. Awaiting expert review

Melanotan I vs Melanotan II at a glance

FactMelanotan IMelanotan II
Also known asMelanotan I, MT-I, Afamelanotide, [Nle4-D-Phe7]-alpha-MSHMelanotan II, MT-II
What it isAlpha-MSH analogue ([Nle4-D-Phe7]-alpha-MSH); approved as afamelanotideSynthetic alpha-MSH analogue (unapproved tanning peptide)
Evidence levelApproved drug (in at least one market)Early human trials
Approved productsScenesse (afamelanotide) (EU, 2014); Scenesse (afamelanotide) (US, 2019); Scenesse (afamelanotide) (UK); Scenesse (afamelanotide) (CA); Scenesse (afamelanotide) (AU)None
United StatesAfamelanotide is approved as the Scenesse implant (October 2019) [8].Not FDA-approved; the nomination of melanotan II for pharmacy (503A) compounding was withdrawn after FDA flagged potential safety risks, and FDA plans to consult its compounding advisory committee on it before the end of February 2027 [13][11][24].
United KingdomAfamelanotide is licensed as Scenesse in Great Britain [15].No UK-licensed medicine containing melanotan II appears in the MHRA products database [20].
European UnionAfamelanotide is centrally authorized as Scenesse (December 2014) [7].No medicine containing melanotan II is authorized in the EU, according to EMA's central and Article 57 product data [21][22].
CanadaScenesse (afamelanotide) is listed with Approved status [16].No product containing melanotan II appears in Health Canada's Drug Product Database [23].
AustraliaAfamelanotide is Schedule 4 (prescription-only) and Scenesse is registered [17][18].Schedule 4 (prescription-only) in Australia's Poisons Standard [17].
Sport (WADA)Not named on the 2026 Prohibited List [19].Not named on the 2026 Prohibited List; its section S0 bans any pharmacological substance with no current approval for human therapeutic use [19].
Vendors we track38 vendors60 vendors
Our lab testsNone yetNone yet
Regulatory rows summarize official sources, checked Oct 15, 2026; rules change, so follow the numbered sources. Not legal or medical advice, and we don't publish dosing or usage instructions.

Melanotan I and melanotan II are both synthetic analogues of alpha-melanocyte-stimulating hormone (alpha-MSH), and both were first tested in small human studies for skin tanning [2, 3]. After that, their paths split. Melanotan I is the same molecule as afamelanotide [2, 14], the active ingredient of an approved prescription implant for a rare light-sensitivity disorder [4, 7, 8]. Melanotan II never became an approved medicine [13], and much of what is known about it comes from case reports of harm after unregulated use [9, 11].

What each one is

Melanotan I (MT-1) is [Nle4-D-Phe7]-alpha-MSH: a linear peptide that keeps the 13-amino-acid length of alpha-MSH with two amino acids changed [2, 1]. Under the name afamelanotide it is the active ingredient of Scenesse, and it acts on the melanocortin-1 receptor (MC1R) [4].

Melanotan II (MT-2) is shorter and ring-shaped: a cyclic, lactam-bridged peptide of seven amino acids based on part of the alpha-MSH sequence [3, 1]. It is a non-selective melanocortin receptor agonist, and its reported effects in humans include sexual arousal as well as darker skin [5]. It was tested clinically for erectile dysfunction as well as tanning [1], and the approved drug bremelanotide was developed from it (see PT-141 vs melanotan 2) [1].

How the evidence compares

Melanotan I has the stronger human record, largely because it was developed into a medicine. An early study in three men found significant tanning with minimal side effects, mainly occasional stomach upset and facial flushing [2]. As afamelanotide, it was then tested in two randomized, placebo-controlled trials in people with erythropoietic protoporphyria, a painful light-sensitivity disorder: patients given the implant could spend longer in direct sunlight without pain, and adverse events were mostly mild [6].

Melanotan II’s early human research included a 1996 pilot study in three men [3]. It produced skin darkening, along with nausea, fatigue, drowsiness and spontaneous erections [3]. Since then, unregulated use has produced case reports of harm, including a melanoma in a young woman who used it alongside sunbeds [10] and a kidney (renal) infarction [5]. FDA cites published case reports of melanoma, posterior reversible encephalopathy syndrome, sympathomimetic toxidrome and priapism [11].

The unregulated versions of both carry similar warnings. A dermatology review links unregulated use of melanotan I and II with changes in existing moles and new atypical moles, and counts four case reports of melanoma arising from existing moles during or shortly after use [9]. It notes that conclusive evidence of a causal link is lacking [9].

Regulation and sport

Afamelanotide has been authorized in the EU as Scenesse since December 2014 and approved by FDA since October 2019 [7, 8]. Melanotan II has never been approved by FDA [13], which lists it among compounding substances that may present significant safety risks [11]; the table above shows each market and sport.

Quality risks when buying

Scenesse is a biodegradable, controlled-release implant [4]. Products sold online as melanotan I or II are unregulated, and the UK medicines regulator has warned about their potential impurity and about the risk of blood-borne viruses from shared needles [12]. The dermatology review above also raises questions about how such products are prepared [9]. Because the two compounds are different molecules sold under similar names [1], an independent lab report should confirm which one a vial contains by its molecular mass, not just its purity.

Our guides explain how to read a peptide COA, how to check a peptide vendor and what “research use only” means.

More on each

See the melanotan I overview and the melanotan II overview for each compound’s full sources. We track current listings on the melanotan I price page and the melanotan II price page.

Frequently asked questions

Are melanotan 1 and melanotan 2 the same thing?

No. Melanotan I is a linear 13-amino-acid analogue of alpha-MSH that acts on the melanocortin-1 receptor. Melanotan II is a shorter, ring-shaped seven-amino-acid analogue that acts on several melanocortin receptors.

Is melanotan 1 approved?

Yes, under the name afamelanotide. It is the active ingredient of Scenesse, an implant authorized in the EU in 2014 and approved in the US in 2019 for erythropoietic protoporphyria. Products sold online as melanotan I are unregulated and are not Scenesse.

Is melanotan 2 approved anywhere?

No. It never became an approved medicine, and FDA lists it among compounding substances that may present significant safety risks, citing published case reports of melanoma and other serious events.

What are the risks of unregulated melanotan?

Case reports link unregulated melanotan I and II with changes in existing moles and new atypical moles, and a few with melanoma, although a causal link has not been proven. Regulators have also warned about impure products and about shared needles.

Sources

  1. Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization. Peptides (2006). Accessed Oct 15, 2026
  2. Skin pigmentation and pharmacokinetics of melanotan-I in humans. Biopharmaceutics & Drug Disposition (1997). Accessed Oct 15, 2026
  3. Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study. Life Sciences (1996). Accessed Oct 15, 2026
  4. Afamelanotide: A Review in Erythropoietic Protoporphyria. American Journal of Clinical Dermatology (2016). Accessed Oct 15, 2026
  5. Melanotan II: a possible cause of renal infarction: review of the literature and case report. CEN Case Reports (2020). Accessed Oct 15, 2026
  6. Afamelanotide for Erythropoietic Protoporphyria. New England Journal of Medicine (2015). Accessed Oct 15, 2026
  7. Scenesse: EPAR (marketing authorisation 22 December 2014). European Medicines Agency. Accessed Oct 15, 2026
  8. Drugs@FDA: NDA 210797 (Scenesse), original approval 8 October 2019. U.S. Food and Drug Administration. Accessed Oct 15, 2026
  9. Risks of unregulated use of alpha-melanocyte-stimulating hormone analogues: a review. International Journal of Dermatology (2017). Accessed Oct 15, 2026
  10. Melanoma associated with the use of melanotan-II. Dermatology (2014). Accessed Oct 15, 2026
  11. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (content current as of 22 April 2026). U.S. Food and Drug Administration. Accessed Oct 15, 2026
  12. Melanotropic peptides: more than just 'Barbie drugs' and 'sun-tan jabs'? British Journal of Dermatology (2010). Accessed Oct 15, 2026
  13. Drugs@FDA: FDA-Approved Drugs (database searched by active ingredient). U.S. Food and Drug Administration. Accessed Oct 15, 2026
  14. Evaluation of the immunogenicity of the synthetic alpha-MSH analogue afamelanotide ([Nle4-D-Phe7]-alpha-MSH, Scenesse) in erythropoietic protoporphyria patients. Skin Pharmacology and Physiology (2015). Accessed Oct 15, 2026
  15. MHRA Products: licensed-medicine search for "afamelanotide". Medicines and Healthcare products Regulatory Agency (UK). Accessed Oct 14, 2026
  16. Drug Product Database: Scenesse (DIN 02569825), status Approved. Health Canada. Accessed Oct 14, 2026
  17. Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026 (F2026L01327, registered 30 September 2026). Federal Register of Legislation, Australian Government. Accessed Oct 14, 2026
  18. Scenesse. healthdirect Australia. Accessed Oct 14, 2026
  19. World Anti-Doping Code International Standard: Prohibited List 2026 (in force 1 January 2026). World Anti-Doping Agency. Accessed Oct 14, 2026
  20. MHRA Products: licensed-medicine search for "melanotan". Medicines and Healthcare products Regulatory Agency (UK). Accessed Oct 14, 2026
  21. EMA medicines data: centrally authorised human medicines (export of 14 October 2026). European Medicines Agency. Accessed Oct 14, 2026
  22. EMA Article 57 product data: medicines authorised in the EU/EEA (data as of 9 October 2026). European Medicines Agency. Accessed Oct 14, 2026
  23. Drug Product Database online query (searched by active ingredient). Health Canada. Accessed Oct 14, 2026
  24. Meeting of the Pharmacy Compounding Advisory Committee (to be held before the end of February 2027). U.S. Food and Drug Administration. Accessed Oct 14, 2026