Melanotan I (Afamelanotide)

How does Melanotan I work?

Melanotan I (afamelanotide) is a synthetic analogue of α-melanocyte-stimulating hormone (α-MSH) that agonizes the melanocortin-1 receptor (MC1R). MC1R activation drives synthesis of eumelanin — the dark, photoprotective form of melanin — in the epidermis. In erythropoietic protoporphyria (EPP), that increased eumelanin is what reduces the disease's phototoxic reaction.

1. MC1R Agonism. Afamelanotide is a synthetic α-MSH analogue that binds and activates the melanocortin-1 receptor (MC1R) on epidermal melanocytes.
2. Eumelanin Synthesis (Melanogenesis). MC1R activation stimulates synthesis of eumelanin, the dark and photoprotective form of melanin, in the epidermis.
3. Photoprotection in EPP. In EPP, accumulated protoporphyrin IX drives a phototoxic reaction on light exposure. Increased epidermal eumelanin absorbs light and reduces that reaction — the mechanistic basis for the approved indication, increasing pain-free light exposure.
4. Analogue Design. The [Nle4, D-Phe7] substitutions define the analogue (also called NDP-α-MSH), distinguishing it from native α-MSH while preserving melanocortin activity.

What is Melanotan I researched for?

Melanotan I's strongest evidence is the clinical program behind its approved indication: erythropoietic protoporphyria (EPP). The FDA (NDA 210797, 2019) and EMA (2014) approvals rest on Clinuvel's randomized, double-blind trials CUV029, CUV030, and CUV039. Beyond EPP, the molecule's MC1R-driven eumelanin synthesis underlies research into photoprotection and polymorphic light eruption.

1. Erythropoietic Protoporphyria (EPP) — Approved Indication. The FDA (NDA 210797, October 2019) and EMA (2014) approvals for EPP rest on Clinuvel's randomized, double-blind clinical program (CUV029, CUV030, CUV039), which evaluated increases in pain-free light exposure.
2. Photoprotection / Eumelanin Synthesis. Afamelanotide's MC1R-driven eumelanin synthesis is the basis for its photoprotective research applications.
3. Polymorphic Light Eruption. Afamelanotide has been studied as a photoprotective agent in polymorphic light eruption.

How is Melanotan I dosed?

There are two very different answers depending on which material is meant. The approved drug Scenesse has an FDA/EMA-approved clinical regimen for EPP. Research-grade MT-1 has no validated research-use dose.

For the approved drug Scenesse, an FDA- and EMA-approved regimen exists for EPP: a 16 mg controlled-release subcutaneous implant administered by a healthcare professional every 2 months under prescription. No other dosing figures are reproduced here — the implant is administered clinically, not self-injected. For research-grade 'Melanotan I' / MT-1, there is no validated research-use dose; it is unapproved material handled in the laboratory. Researchers reconstitute lyophilized powder with bacteriostatic or sterile water (see storage below); any volume chosen is a generic handling convenience, not a dosing recommendation. Prof. Peptide deliberately does not publish an injectable mg schedule for research-grade MT-1 — none has been validated, and the research material is not the approved drug.

What are the side effects of Melanotan I?

The two materials must be kept separate. For the approved drug Scenesse, the documented adverse-effect profile is established in the FDA/EMA labeling and the NIH LiverTox monograph — those sources, not this page, are authoritative for the drug's safety. A predictable pharmacodynamic effect of MC1R agonism is increased skin pigmentation (darkening), consistent with the eumelanin-synthesis mechanism. For research-grade MT-1 used outside the approved indication, human safety is not established. This is unapproved, Research Use Only material and is not intended for human consumption; nothing here should be read as human-use guidance.

How should Melanotan I be stored?

1. Research-grade Melanotan I / MT-1 (lyophilized powder): store cold and desiccated, protected from light. Freeze at -20°C for long-term storage; 2–8°C is acceptable short-term.
2. Reconstitute with bacteriostatic or sterile water for injection. Add the water slowly down the inside wall of the vial and swirl gently — do not shake.
3. Reconstituted solution: refrigerate at 2–8°C and keep protected from light.
4. Protect from light at all times; store in original packaging.
5. Discard if the solution is cloudy, discolored, or contains particles.
6. The approved drug Scenesse is a controlled-release subcutaneous implant administered and stored by healthcare professionals per its FDA/EMA labeling, not these research-handling notes.

What are the limitations of Melanotan I research?

This is the most important section to read carefully. The approval is narrow, cosmetic use is unapproved and discouraged, and the research-grade material is a different thing entirely from the approved drug.

Where to source Melanotan I

Scenesse (afamelanotide) is a prescription implant administered by a healthcare professional for EPP. The 'Melanotan I' / MT-1 sold by specialty peptide vendors is unapproved, research-grade material for laboratory use only — not the approved drug. Quality varies across vendors; verify a Certificate of Analysis before purchase.

Melanotan I FAQ

References

1. U.S. Food and Drug Administration. Scenesse (afamelanotide) — NDA 210797; approval October 2019; indicated to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). (FDA approval; cited by name, no URL added.)
2. European Medicines Agency. Scenesse (afamelanotide) — EU marketing authorization for EPP, 2014. (EMA approval; cited by name, no URL added.)
3. Clinuvel Pharmaceuticals. Erythropoietic protoporphyria clinical program: randomized, double-blind trials CUV029, CUV030, and CUV039. (Clinical program; cited by name, no URL added.)
4. NIH LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. Afamelanotide monograph, Bookshelf ID NBK602608. (NIH LiverTox; cited by name, no URL added.)
5. Chemical identifiers: PubChem CID 16154396 (Afamelanotide); CAS 75921-69-6; DrugBank DB04931; UNII QW68W3J66U. (Cited by name/ID, no URL added.)

Published Studies