Approved & therapeutic
Afamelanotide
Scenesse, Melanotan I, Melanotan-1
Afamelanotide is a synthetic analogue of alpha-melanocyte stimulating hormone, approved in the US to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria. It is delivered as a slow-release implant placed under the skin by a trained professional. It is the same molecule sold in grey markets as "Melanotan I".
Also known as: Scenesse, Melanotan I, Melanotan-1, MT-1, Melanotan 1, CUV1647
- Status
- Afamelanotide is approved by the U.S. FDA and has official prescribing information.
- Evidence
- Approved labeling. Official prescribing information exists, based on clinical trials in people.
- Half-life
- The implant releases over approximately two months; afamelanotide itself is cleared from plasma within about 12 hours of implant depletion.
- How it's taken
- Subcutaneous implant inserted by a healthcare professional
- Mechanism
- Melanocortin receptor
- Pathways
- Melanocortin
How Afamelanotide works
Afamelanotide is a potent MC1R agonist. MC1R activation in melanocytes shifts melanin synthesis toward eumelanin, increasing skin pigmentation independently of ultraviolet exposure. In erythropoietic protoporphyria that increased eumelanin is thought to absorb and scatter the visible light that triggers phototoxic reactions, extending tolerated light exposure.
What research has looked at
- Approval was based on increased duration of pain-free time spent in direct sunlight in adults with erythropoietic protoporphyria — a condition for which there had previously been no approved treatment.
- Pigmentation develops without ultraviolet exposure, which is the mechanistic basis for its use in a photosensitivity disorder.
- The implant provides sustained exposure over approximately two months rather than requiring frequent self-injection.
Evidence level: Approved labeling. Official prescribing information exists, based on clinical trials in people. These are areas studied or reported, not promised effects.
Reported side effects and risks
- Generalised skin darkening is expected and is the pharmacological effect, not an adverse event; it includes darkening of existing naevi and freckles.
- The label requires twice-yearly full-body skin examinations, because increased pigmentation can obscure detection of skin cancer. Afamelanotide is not a sunscreen and does not remove the need for photoprotection.
- Implant-site reactions, nausea, headache, fatigue, dizziness and back pain were reported in trials.
- Grey-market use of this molecule for cosmetic tanning is unapproved, is typically self-injected rather than implanted, and carries the additional risks of unregulated sourcing, non-sterile compounding and unknown purity. Any changing pigmented lesion warrants dermatological assessment.
- Melanotan II is a different, non-selective molecule with a substantially different risk profile — see that entry. The two are frequently confused.
Sources
- FDA approved-drug listing for afamelanotide · U.S. Food & Drug Administration
- DailyMed prescribing information for afamelanotide · NIH · DailyMed
- PubMed research on afamelanotide erythropoietic protoporphyria · NIH · National Library of Medicine
- DrugBank record for afamelanotide · DrugBank
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Afamelanotide FAQ
What is Afamelanotide?
Afamelanotide is a synthetic analogue of alpha-melanocyte stimulating hormone, approved in the US to increase pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria. It is delivered as a slow-release implant placed under the skin by a trained professional. It is the same molecule sold in grey markets as "Melanotan I".
How does Afamelanotide work?
Afamelanotide is a potent MC1R agonist. MC1R activation in melanocytes shifts melanin synthesis toward eumelanin, increasing skin pigmentation independently of ultraviolet exposure. In erythropoietic protoporphyria that increased eumelanin is thought to absorb and scatter the visible light that triggers phototoxic reactions, extending tolerated light exposure.
Is Afamelanotide FDA approved?
Yes. Afamelanotide is approved by the U.S. FDA and has official prescribing information. Evidence level: approved labeling. Official prescribing information exists, based on clinical trials in people.
What is the half-life of Afamelanotide?
Reported half-life: The implant releases over approximately two months; afamelanotide itself is cleared from plasma within about 12 hours of implant depletion.
How is Afamelanotide taken?
Subcutaneous implant inserted by a healthcare professional.
What side effects have been reported with Afamelanotide?
Reported in the sources: Generalised skin darkening is expected and is the pharmacological effect, not an adverse event; it includes darkening of existing naevi and freckles; The label requires twice-yearly full-body skin examinations, because increased pigmentation can obscure detection of skin cancer. Afamelanotide is not a sunscreen and does not remove the need for photoprotection; Implant-site reactions, nausea, headache, fatigue, dizziness and back pain were reported in trials; Grey-market use of this molecule for cosmetic tanning is unapproved, is typically self-injected rather than implanted, and carries the additional risks of unregulated sourcing, non-sterile compounding and unknown purity. Any changing pigmented lesion warrants dermatological assessment; Melanotan II is a different, non-selective molecule with a substantially different risk profile — see that entry. The two are frequently confused.
Educational summary compiled from the sources listed above. Not medical advice. Peptide Vault does not sell, source or recommend any compound. Talk to a qualified clinician before starting or changing anything.