Afamelanotide
SCENESSE
SCENESSE is an FDA-approved afamelanotide implant for a narrowly defined EPP use. Seller-labelled Melanotan I research vials are not this implant and do not share its approval.
FDA's review describes it as an alpha-MSH analog.
The application was approved on October 8, 2019.
The approved presentation is an implant, not a research vial.
The use is tied to phototoxic reactions from erythropoietic protoporphyria.
Resolve the application before the claim.
- Brand
- SCENESSE
- Active ingredient
- Afamelanotide
- US application
- NDA 210797
- Company named in current label
- CLINUVEL INC.
- Dosage form
- Implant
- Route
- Subcutaneous
- Approval record
- SCENESSE NDA approved October 8, 2019
- Label record updated
- May 2026
What this approval covers - and what it does not.
This summary stays intentionally high level. Use the current full prescribing information for complete warnings, contraindications, adverse reactions, and instructions.
The exact approved record
The current US label covers increasing pain-free light exposure in adults with a history of phototoxic reactions from erythropoietic protoporphyria, or EPP.
Open current label ↗An ingredient match is not product equivalence
Approval belongs to the SCENESSE implant reviewed under NDA 210797. It does not transfer to seller-labelled Melanotan I, cosmetic-tanning products, research vials, or any other presentation using a related ingredient or alias.
Read the category guide →SCENESSE across 42 countries.
This record starts with the exact US FDA medicine identity. The global and state maps keep authorization, presentation, prescription route, market status, pharmacy, and seller records separate.
Compare SCENESSE by country →Compare SCENESSE by US state →The questions behind the medicine search.
Answers are based on the dated FDA and DailyMed records below. They are educational reporting, not a diagnosis, prescription, or treatment recommendation.
Are afamelanotide, Scenesse, and Melanotan I the same product?
No. Afamelanotide is the active ingredient in the SCENESSE implant. Melanotan I is commonly used in research-market naming, but a seller-labelled vial is not the FDA-approved implant and does not inherit NDA 210797's product evidence or label.
What is Scenesse FDA approved for?
SCENESSE is approved to increase pain-free light exposure in adults with a history of phototoxic reactions from EPP. That narrow product-specific use should not be generalized to tanning, other conditions, or unrelated products.
Why is the implant presentation important?
Route and dosage form are part of product identity. A product with a related name but a different presentation is not approval-equivalent. Peptide Local therefore keeps the SCENESSE implant record separate from the Melanotan I research-listing board.
Use the current full prescribing information and a licensed clinician or pharmacist for medicine-specific decisions. Do not substitute a research product, investigational program, or unapproved seller listing for an FDA-approved product.
Open safety and verification resources →