- subcutaneous implant
Melanotan I (Afamelanotide)
Afamelanotide ([Nle4, D-Phe7]-alpha-MSH)
Melanotan I (Afamelanotide) at a glance
Not on either FDA listHow studies gave it
Placed as a pellet under the skin
Evidence on this page
3 peer-reviewed papers, published 2015 to 2021
FDA compounding lists
It appears on neither of the two FDA compounding tables.
What it is
A synthetic 13 amino acid linear analog of alpha-melanocyte-stimulating hormone (alpha-MSH), approved in the US, EU, and Australia as Scenesse for the prevention of phototoxicity in adults with erythropoietic protoporphyria (EPP). Afamelanotide is a selective MC1R agonist that stimulates eumelanin production independent of UV exposure, providing systemic photoprotection.
Substitutions at positions 4 (norleucine) and 7 (D-phenylalanine) confer approximately 4-fold greater MC1R potency and significantly improved enzymatic stability compared to native alpha-MSH. It is administered as a bioresorbable subcutaneous implant by a healthcare professional.
Published research
Afamelanotide was evaluated in multiple phase II and III clinical trials for EPP. The pivotal phase III trial (Langendonk et al., NEJM 2015) demonstrated a significant increase in pain-free time in direct sunlight (median 69.4 hours vs. 40.8 hours placebo over 6 months, p=0.005). The drug has 4-fold greater MC1R potency than native alpha-MSH with an extended duration of action via bioresorbable implant.
Peak plasma levels (~3.7 ng/mL) occur at ~36 hours post-implant; >90% of drug is released by day 5. The EMA initially restricted use to seasonal months but approved year-round treatment in September 2025. Investigational applications include vitiligo, polymorphic light eruption, and xeroderma pigmentosum.
What the terms on this page mean8 termsHide
- amino acid
- A building block that links with others to form peptides and proteins.
- analog
- A molecule built to copy a natural one with a deliberate change, usually to make it last longer or bind more tightly.
- MSH
- Melanocyte-stimulating hormone, involved in skin pigment and in appetite signalling.
- agonist
- A molecule that binds a receptor and switches it on.
- subcutaneous
- Into the fat layer just under the skin.
- clinical trial
- A study that tests something in people under a written plan, with results recorded.
- placebo-controlled
- Part of the group receives an inactive substitute for comparison.
- plasma
- The clear liquid part of blood, once the cells are taken out.
Compounding status
Not on either FDA list- FDA listing
- Melanotan I (Afamelanotide) appears on neither FDA's category 2 table nor its table of withdrawn nominations.
- What that means
- Absence from both lists is not permission to compound. Section 503A allows a bulk drug substance only where a USP or NF monograph exists, or the substance is a component of an FDA-approved drug product, or it appears on the 503A bulks list.
- Note
- FDA lists Melanotan II among withdrawn nominations. It does not list Melanotan I (afamelanotide), which is a different substance.
Source: Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks, FDA. Content current as of 2026-04-22; read 2026-09-05. This describes what a compounding pharmacy may supply. It is not advice about your own use.
Where this came from3 referencesHide
Each one was resolved at PubMed and confirmed to be the work this page cites. Author, title, journal and year come from the PubMed record, not from the page text.
- Afamelanotide for Erythropoietic Protoporphyria
Langendonk JG, et al.. The New England journal of medicine (2015). PMID 26132941.
- Afamelanotide for prevention of phototoxicity in erythropoietic protoporphyria
Wensink D, Wagenmakers MAEM, Langendonk JG. Expert review of clinical pharmacology (2021). PMID 33507118.
- Afamelanotide: A Review in Erythropoietic Protoporphyria
Kim ES, Garnock-Jones KP. American journal of clinical dermatology (2016). PMID 26979527.
About this page
Reviewed 2026-08-11. This page reports what published studies and FDA documents say. It carries no dose, cycle length or stack, and it does not tell you whether a substance is appropriate for you. Side-effect reports circulating on forums are self-reported rather than measured, so they are not republished here.
See the editorial policy for how corrections are handled.