Is Melanotan-1 approved?

As afamelanotide (Scenesse), yes — in the EU and US, for erythropoietic protoporphyria. The approval covers a specific implant formulation, a specific rare indication and supervised clinical use.

What did the Melanotan-1 trial measure?

Pain-free time in direct sunlight in people with erythropoietic protoporphyria. The randomised trial reported a median of 69.4 hours against 40.8 on placebo.

How is Melanotan-1 different from Melanotan-2?

Selectivity. Melanotan-1 acts at MC1R, the pigmentation receptor. Melanotan-2 binds MC1R, MC3R, MC4R and MC5R, which is why it appears in appetite and sexual arousal literatures as well — and why its harm literature looks very different.

Does the approval mean it is safe for tanning?

No. The evidence was generated in a population for whom sunlight is disabling, using a supervised implant formulation. Nothing published supports extending that risk/benefit judgement to cosmetic use.

Is the material supplied here the approved medicine?

No. It is supplied as a laboratory reagent for in-vitro research, with a certificate of analysis, and not for human or veterinary use.

Research guides

Melanotan-1 (afamelanotide): what the research says

Approved in the EU and US as Scenesse for a rare light-sensitivity disorder. What the trial measured, and why the approval is narrower than it sounds.

Available in the catalogue

Supplied as research material. Sizes and pricing are on the product page. Availability is not a statement about what a compound does.

MELANOTAN-1
Cosmetic & Dermal

Melanotan-1 is the compound in this catalogue with the clearest regulatory status and the most commonly misread one. It is an approved medicine. The approval covers a specific formulation, a specific indication and a rare disease population, and none of those qualifications survive the journey into most summaries of it.

What the molecule is

A synthetic analogue of α-melanocyte-stimulating hormone with two amino acid substitutions that make it far more stable than the natural hormone. Published as afamelanotide, marketed as Scenesse, and written in the older literature as [Nle4-D-Phe7]-α-MSH.

Selectivity is what separates it from Melanotan-2

It is selective for MC1R, the melanocortin receptor on pigment cells, where it drives production of eumelanin — the darker pigment that absorbs ultraviolet light. That selectivity is the entire difference between this molecule and Melanotan-2, which binds MC1R, MC3R, MC4R and MC5R indiscriminately. The two are routinely discussed as if they were grades of the same thing. They are not, and the safety literatures attached to them look completely different as a result.

What the trial actually tested

The randomised controlled trial was conducted in people with erythropoietic protoporphyria, an inherited disorder in which sunlight causes severe pain. The endpoint was pain-free time in direct sunlight, and the trial reported a median of 69.4 hours against 40.8 on placebo.

That is a real result in a population for whom sunlight is disabling. It is not a study of cosmetic tanning, and the long-term observational work that followed — a 115-patient cohort, a German post-authorisation safety study, and an observational study of liver markers — is likewise all in the protoporphyria population under clinical supervision.

What studies reported

Each entry states what a study examined and the model it used. Nothing below describes an outcome for a person.

Everything below is drawn from published research, and each entry names the model the study used. Approval status varies by compound and by country, and nothing described here is supplied as a medicine or for use in a person.

Langendonk et al. (2015)New England Journal of Medicine · 373(1):48–59
Reported a median 69.4 pain-free hours in direct sunlight versus 40.8 on placebo, in participants with erythropoietic protoporphyria.
human, randomised controlled Source
Biolcati et al. (2015)British Journal of Dermatology · 172(6):1601–12
Long-term observational follow-up of patients with erythropoietic protoporphyria, reporting on sustained use over an extended period.
human, long-term observational, 115 patients Source
Minder et al. (2021)Therapeutic Advances in Rare Disease · 2:26330040211065453
An observational study of Swiss patients reporting changes in liver markers during treatment, examining effects beyond pigmentation.
human, observational cohort Source

Adverse and null findings reported

Harms, tolerability observations, and trials that did not meet their endpoint. A negative result is a finding and is listed here rather than omitted.

Homey et al. (2025)Photodermatology, Photoimmunology & Photomedicine · 41(2):e13012
A German cohort study designed to investigate short- and long-term safety alongside clinical effectiveness in patients with erythropoietic protoporphyria — post-authorisation safety data rather than an efficacy result.
human, observational cohort study Source

What the research does not establish

An absence cannot be cited, so these are stated plainly. They are the part of the picture that silence would otherwise hide.

Every published study is in erythropoietic protoporphyria. No randomised trial has tested the compound in people without that disorder, and the risk/benefit judgement that supported the approval does not transfer to a cosmetic context.
The approved product is a controlled-release implant administered under medical supervision, which is not the same thing as the molecule supplied as a reagent. A trial of the authorised formulation is not evidence about anything else.
Because it drives pigmentation, the question of what it does to existing pigmented lesions is an obvious one. Clinical monitoring for skin lesions accompanies authorised use; the published trial programme was not designed to answer the question at population scale.
Long-term outcome data beyond the observational cohorts is limited, and those cohorts are supervised patients rather than general users.
Material supplied here is a research reagent, not the authorised medicine, and carries none of its regulatory guarantees.

Common questions

Is Melanotan-1 approved?: As afamelanotide (Scenesse), yes — in the EU and US, for erythropoietic protoporphyria. The approval covers a specific implant formulation, a specific rare indication and supervised clinical use.
What did the Melanotan-1 trial measure?: Pain-free time in direct sunlight in people with erythropoietic protoporphyria. The randomised trial reported a median of 69.4 hours against 40.8 on placebo.
How is Melanotan-1 different from Melanotan-2?: Selectivity. Melanotan-1 acts at MC1R, the pigmentation receptor. Melanotan-2 binds MC1R, MC3R, MC4R and MC5R, which is why it appears in appetite and sexual arousal literatures as well — and why its harm literature looks very different.
Does the approval mean it is safe for tanning?: No. The evidence was generated in a population for whom sunlight is disabling, using a supervised implant formulation. Nothing published supports extending that risk/benefit judgement to cosmetic use.
Is the material supplied here the approved medicine?: No. It is supplied as a laboratory reagent for in-vitro research, with a certificate of analysis, and not for human or veterinary use.

Compounds covered

The reference page for each compound this article discusses.

Melanotan-1

Melanotan-2 (MT-II): what the research says
No controlled efficacy trial has ever been published. The indexed literature is dominated by dermatology case reports of naevi after injection.
PT-141 (bremelanotide): what the research says
Approved in the US as Vyleesi, with two phase 3 trials and a published safety programme. The mechanism is neural at MC4R, not vascular like PDE5 inhibitors.
How to store research peptides
Lyophilised peptides at -20°C, reconstituted at 2–8°C, ambient in transit. Why the dry cake tolerates shipping, and what actually degrades a vial.

About this article

Everything reported here comes from published research, and each finding names the model the study used — cell culture, rat, or human. Findings in one model do not transfer to another, most of the work described is preclinical, and none of it is a claim that a compound is safe or effective for any purpose. Nothing on this page describes doses, routes of administration, or use in a person.

Approval status varies by compound and by country. A few of the substances described are the active ingredient of medicines authorised in the EU; most have no marketing authorisation anywhere and have never been assessed by a regulator. Neither is supplied as a medicine here. All material supplied by ASSAY is sold for in-vitro laboratory research only, and is not a drug, food, cosmetic or medical device, and not for human or veterinary use.

All guides