For a history of phototoxic reactions from erythropoietic protoporphyria (EPP). Sold as Scenesse. Every FDA application for this active ingredient.
As of Nov 13, 2026, FDA lists 1 application for Afamelanotide (sold as Scenesse), first approved Oct 8, 2019, with 0 new uses approved and 0 published complete response letters.
| Study | Phase | Status | Posted |
|---|---|---|---|
| A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients With VitiligoVitiligo · Clinuvel, Inc. | Phase 3 | Active, not recruiting | Oct 31, 2023 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Oct 8, 2019 | ScenesseNDA 210797 · New molecular entity | Clivunel Inc | 1 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
