Melanotan 1

Status FDA- and EMA-approved (Scenesse) for erythropoietic protoporphyria; not approved for tanning or cosmetic useBest evidence E1Sources checked 2026-09-18

Melanotan 1 (afamelanotide) is FDA- and EMA-approved as Scenesse, a 16 mg implant given once every 60 days for erythropoietic protoporphyria, not for tanning. Tanning and libido effects are real but are not what the drug is approved or tested for as a primary outcome.

Identity

Sequence: 13-amino-acid alpha-MSH analogue with norleucine at position 4 and D-phenylalanine at position 7

What it is

Melanotan 1 is the research-chemical name for afamelanotide, a synthetic 13-amino-acid analogue of alpha-melanocyte-stimulating hormone (alpha-MSH), with norleucine and D-phenylalanine substituted at positions 4 and 7 to extend its stability compared with the natural hormone. Afamelanotide is FDA-approved, under the brand name Scenesse, and EMA-approved since 2014, but not for tanning or cosmetic use: its approved indication is to increase pain-free light exposure in adults with erythropoietic protoporphyria (EPP), a rare genetic disorder in which sunlight exposure causes severe phototoxic pain.

The approved product is a 16 mg subcutaneous implant, administered by a healthcare provider once every 60 days, not an injectable solution the patient administers at home.

The evidence behind the approval

Approval rested on randomized, placebo-controlled Phase 3 trials in EPP patients (conducted in the US and Europe), which measured pain-free time spent in direct sunlight as the primary endpoint, alongside safety monitoring for a rare disease population using a drug whose entire mechanism is increased melanin production.

Tanning and libido effects are real pharmacological consequences of MC1R and MC4R agonism, and are documented in the EPP trial population as expected effects of the drug, but they are not the indication the drug is approved for or tested against as a primary outcome.

What is not established

Efficacy or safety for cosmetic tanning or libido enhancement in a population without EPP. No trial reviewed for this entry tested afamelanotide, or the injectable Melanotan I product circulating outside the approved implant, for those uses as a primary endpoint.

Whether the injectable, self-administered products sold as “Melanotan 1” match the composition, purity or stability of the pharmaceutical-grade implant studied in the pivotal trials. A 2026 stability-profiling study found that afamelanotide degrades under a range of storage and light conditions into at least 14 identifiable degradation products, underscoring that formulation and handling affect what the compound actually is at the point of use.

What is not known

Efficacy or safety for cosmetic tanning or libido enhancement in people without EPP. No trial tested that use as a primary endpoint.

Whether self-administered injectable products sold as “Melanotan 1” match the composition, purity or stability of the pharmaceutical-grade implant actually studied and approved.

Doses used in published research

No published study has administered this compound to a human being, so no dose appears in the literature and none has been established.

Amounts above record what a named source reported administering in a study. They are not a recommendation, not a protocol, and not instructions.

Converting a vial and a syringe into a draw volume is a separate, mechanical question from what amount to use. The reconstitution calculator does that arithmetic for peptide, HCG, and HGH vials.