Melanotan 1 vs Melanotan 2: Approval, Evidence and Risks
Melanotan I vs Melanotan II at a glance
| Fact | Melanotan I | Melanotan II |
|---|---|---|
| Also known as | Melanotan I, MT-I, Afamelanotide, [Nle4-D-Phe7]-alpha-MSH | Melanotan II, MT-II |
| What it is | Alpha-MSH analogue ([Nle4-D-Phe7]-alpha-MSH); approved as afamelanotide | Synthetic alpha-MSH analogue (unapproved tanning peptide) |
| Evidence level | Approved drug (in at least one market) | Early human trials |
| Approved products | Scenesse (afamelanotide) (EU, 2014); Scenesse (afamelanotide) (US, 2019); Scenesse (afamelanotide) (UK); Scenesse (afamelanotide) (CA); Scenesse (afamelanotide) (AU) | None |
| United States | Afamelanotide 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 | Not FDA-approved; the nomination of melanotan II for pharmacy (503A) compounding was withdrawn after FDA flagged potential safety risks, and FDA plans to consult its compounding advisory committee on it before the end of February 2027 [13][11][24].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 Kingdom | Afamelanotide is licensed as Scenesse in Great Britain [15]. | No UK-licensed medicine containing melanotan II appears in the MHRA products database [20]. |
| European Union | Afamelanotide 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]. |
| Canada | Scenesse (afamelanotide) is listed with Approved status [16]. | No product containing melanotan II appears in Health Canada's Drug Product Database [23]. |
| Australia | Afamelanotide 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 track | 38 vendors | 60 vendors |
| Our lab tests | None yet | None yet |
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.