melanocortin-1 receptor agonist
Afamelanotide
Answer
Afamelanotide is authorised or registered in the US, the EU, the UK, Canada and Australia: 5 of the 10 registers read. Highest trial phase: Phase 2. It has 28 registered trials, 1 of them running. Brand names on the FDA label register: Scenesse.
RegulatorTrial register10 regulators' registers, read 2026-09-03 to 2026-10-03 · ClinicalTrials.gov and EU CTIS, read 2026-10-03
Not medical, legal or regulatory advice.
28 trials by status
Trial registerClinicalTrials.gov and EU CTIS · read 2026-10-03 · 12 trials have posted results
Trials first submitted per year
Trial registerClinicalTrials.gov first-submitted date, last 10 years · read 2026-10-03. 9 trials carry no first-submitted date (EU CTIS publishes none, or the year is outside this range).
Status by jurisdiction
World map| Where | Status | Register | Read |
|---|---|---|---|
| United States | FDA-approved | FDA, openfda | 2026-10-03 |
| European Union | Authorised | EMA, ema | 2026-10-03 |
| United Kingdom | Authorised | MHRA, uk-mhra | 2026-10-03 |
| Canada | Authorised | Health Canada, ca-dpd | 2026-10-03 |
| Australia | Registered | TGA, au-artg | 2026-10-03 |
| Switzerland | Not on the register | Swissmedic, ch-swissmedic | 2026-09-03 |
| Brazil | Not on the register | ANVISA, br-anvisa | 2026-09-03 |
| Serbia | Not on the register | ALIMS, rs-alims | 2026-09-03 |
| Singapore | Not on the register | HSA, sg-hsa | 2026-09-03 |
| Turkey | Not on the register | TITCK, tr-titck | 2026-09-03 |
An EU decision applies in the 30 territories the EU register covers: its member states, and Iceland, Liechtenstein and Norway. A dashed tile has no register read for this peptide.
Side effects
Trial registerCHANGE ALERTS
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One email when the status of Afamelanotide changes on the register. You confirm your address first.
REGISTERED TRIALS
Newest 10 of 28 trials
| NCT06388642 | Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients completed · register updated 2026-07-27 |
|---|---|
| 2023-505907-21-00 | A Mechanistic Study to Evaluate Impact of Afamelanotide in Aqueous Solution on Ultraviolet Radiation-Induced DNA Damage and DNA Re no status recorded · register updated 2025-12-22 |
| NCT06109649 | A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Pat running, but no longer enrolling · register updated 2025-07-08 |
| NCT05854784 | Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP) completed · register updated 2025-04-27 |
| 2023-507311-35-00 | A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients with Erythropoietic Protoporphyria (EPP). no status recorded · register updated 2024-11-04 |
| 2022-500919-40-01 | A Phase IIa, Open Label, Proof of Concept Study to Evaluate the Safety of Aqueous Afamelanotide Solution in Patients with acute Ar no status recorded · register updated 2024-10-15 |
| 2022-502207-30-01 | A Proof of Concept, Phase IIa, Open Label Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients with Early Parkin no status recorded · register updated 2024-06-17 |
| NCT04525157 | Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV) completed · register updated 2023-09-22 |
| NCT05370235 | A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V last verified some time ago; the register no longer confirms its status · register updated 2023-09-21 |
| 2022-502207-30-00 | A Phase IIa, Open Label Study to Evaluate the Safety of Afamelanotide in Patients with Early Parkinson's Disease no status recorded · register updated 2023-08-07 |
WEEKLY
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New trials, approvals and enforcement actions. One email a week.