At a glance
- Afamelanotide (Melanotan I) is an FDA-approved drug, marketed as Scenesse (first approval: October 8, 2019).
- PubMed lists 123 publications mentioning it, including 5 randomized controlled trials and 4 animal-only studies.
- ClinicalTrials.gov lists 23 registered studies testing it (1 active).
- FDA's adverse event system (FAERS) holds 19 reports mentioning it; 15 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA210797 | SCENESSE | Approved, marketed | October 8, 2019 | CLIVUNEL INC |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Acute impact of afamelanotide on UVR erythemal and melanogenic responses in healthy humans in vivo: an exploratory study.
- A Review of Randomized Controlled Trials for Vitiligo Therapies Published Between 2013 and 2023.
- Heterochiral co-assembly of β-strands and hairpins affords stereocomplexed peptide hydrogels for drug delivery.
- Insights into Tanning Biology and Tanning Products.
- New and currently investigated pharmacotherapies for the erythropoietic protoporphyrias: spotlight on dersimelagon and bitopertin.
- Afamelanotide improves quality of life and light tolerance in Austrian erythropoietic protoporphyria patients.
- Adjunctive use of Polypodium leucotomos extract in patients with erythropoietic protoporphyria: An exploratory study.
- Congenital Erythropoietic Porphyria with Persistent Severe Biochemical Abnormalities and a Non-Mutilating Clinical Course: A Case Report.
- Investigation of the stability profile of therapeutic α-MSH analogue: Insights from liquid chromatography-high resolution mass spectrometry analysis of afamelanotide.
- From darkness to light: Case report on afamelanotide-treatment in a 9-year-old child with erythropoietic protoporphyria.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 23
- Active
- 1
- With posted results
- 12
Conditions studied
Show 13 more studies
All 23 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 19
- Serious
- 15
- With death outcome
- 2
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.