Melanocortin-1 receptor agonist peptide · Fact sheet
Afamelanotide
Also known as Scenesse · Melanotan I · NDP-alpha-MSH
Afamelanotide is approved as the Scenesse implant to increase pain-free light exposure in adults with erythropoietic protoporphyria. That disease-specific approval does not validate cosmetic tanning products labeled Melanotan I or other formulations.
What is Afamelanotide?
It is a modified alpha-melanocyte-stimulating-hormone analog that acts at melanocortin-1 receptors.
Afamelanotide, Melanotan II and bremelanotide are distinct molecules and products.
Benefits & claims
Interest spans phototoxic disease and pigmentation. The useful clinical outcome is reduced light-related pain in EPP, not a cosmetic tanning score.
What the evidence supports
- The EPP trials demonstrated disease-specific light-exposure benefits.
- Vitiligo research combined afamelanotide with narrowband UV-B, so results cannot be assigned to an unspecified peptide alone.
- Approved EPP use does not establish safe cosmetic tanning or replace sun-protection precautions.
Research areas
- Erythropoietic protoporphyria
- Investigational vitiligo combinations
Dosage & frequency
Product-specific label informationThe Scenesse label specifies an adult EPP implant schedule; it is not a general afamelanotide injection or tanning regimen.
Scenesse 16 mg implant
Adults with a history of phototoxic reactions from erythropoietic protoporphyria
- Amount
- One implant containing 16 mg afamelanotide
- Frequency
- Every two months
- Route studied or labeled
- Subcutaneous implant administered by a trained healthcare professional
The label requires product-specific administration expertise and twice-yearly full-body skin examinations. This summary omits procedural details and does not establish another formulation or a fixed treatment duration.
How to read these amounts
An approved regimen belongs to a specific product, indication, and population. A study regimen describes what researchers tested; it does not establish a prescription or a safe self-use protocol. Products, routes, and formulations are not interchangeable. A prescriber uses the full label and individual clinical circumstances.
Personal accounts may describe amounts, schedules and outcomes beyond clinical research. They do not establish a regimen. Read the reported experiences
Formulations, interactions & practical context
- Identity and pharmacology
- It is a modified alpha-melanocyte-stimulating-hormone analog that acts at melanocortin-1 receptors.
Formulation differences
- Afamelanotide, Melanotan II and bremelanotide are distinct molecules and products.
Interactions & precautions
- The reviewed sources do not establish a comprehensive human interaction profile for this exact substance or combination.
What is still unresolved
- Benefit and safety outside the approved implant and population
- Long-term outcomes in other pigmentary disorders
- Equivalence of nonstandard products
Side effects & risks
- The label includes serious hypersensitivity reactions, including anaphylaxis.
- Darkening of existing moles or freckles and other pigmentary changes require skin monitoring; implant-site reactions, nausea and other adverse effects occur.
This is a summary of the cited evidence, not a complete product label. A lack of human safety data does not establish safety.
Clinical research
Strong human evidence for approved usesTwo randomized EPP trials found longer pain-free light exposure and improved quality of life. Small vitiligo combination studies address a separate investigational use.
Studies
Two randomized EPP implant trials.
Investigational combination with narrowband UV-B for vitiligo.
Personal experiences
Reports describe what someone noticed. They cannot establish cause, typical results, or how often a side effect happens. Amounts and schedules describe the individual account, not an effective or safe dose. Product identity and strength may be unverified, and missing details are left explicit.
No attributable personal accounts were found in the sources reviewed.
Approval status
Scenesse is FDA approved to increase pain-free light exposure in adults with a history of phototoxic reactions from EPP. Its implant-specific approval does not extend to general tanning, powders or other delivery products.
Approved uses
- Scenesse implant to increase pain-free light exposure in adults with EPP-associated phototoxic reactions.
FDA approved for a specific product and use
Approval covers the labeled product, use and population. A trial phase does not establish success; a stopped program is not ongoing research.
Open questions
- Benefit and safety outside the approved implant and population
- Long-term outcomes in other pigmentary disorders
- Equivalence of nonstandard products
Summary
Approved EPP use does not establish safe cosmetic tanning or replace sun-protection precautions.
Sources
Medical evidence and regulatory sources are listed here. Personal reports are linked separately in the experiences section.
- nihScenesse prescribing information
Current U.S. implant labeling, EPP indication, schedule, hypersensitivity and skin-monitoring warnings.
- pubmedAfamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial.
Investigational combination with narrowband UV-B for vitiligo.