SCENESSE (afamelanotide)
SCENESSE is indicated for the treatment of Erythropoietic Protoporphyria.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-10-08
- Patent Cliff
- 2033
- Routes
- SUBCUTANEOUS
- Dosage Forms
- IMPLANT
SCENESSE Approval History
What SCENESSE Treats
1 indicationsSCENESSE is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Erythropoietic Protoporphyria
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04525157 results posted | CUV103 | Ph 2 | completed | Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV) |
| NCT04962503 results posted | CUV801 | Ph 2 | completed | A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS) |
| NCT05368857 | CUV151 | Ph 1 | completed | DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers |
| NCT04943159 results posted | CUV100 | Ph 2 | completed | Afamelanotide in Patients Suffering With Acne Vulgaris |
| NCT00979745 results posted | CUV029 | Ph 3 | completed | Phase III Confirmatory Study in Erythropoietic Protoporphyria (EPP) |
| NCT04425746 results posted | CUV025 | Ph 2 | completed | Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium |
| NCT04704713 results posted | CUV032 | Ph 3 | completed | Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE) |
| NCT04578496 results posted | CUV037 | Ph 3 | completed | A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP) |
| NCT01097044 results posted | CUV030 | Ph 2 | completed | Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP) |
| NCT01605136 results posted | CUV039 | Ph 3 | completed | Phase III Confirmatory Study in Erythropoietic Protoporphyria |
| NCT01382589 NSV | CUV101 | Ph 2 | completed | Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo |
| NCT01430195 CUV102 | CUV102 CUV102 | Ph 1 | completed | Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV) |
| NCT00859534 | CUV016 | Ph 2 | completed | Phase II Solar Urticaria (SU) Pilot Study |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SCENESSE FDA Label Details
Indications & Usage
FDA Label (PDF)SCENESSE is indicated for the treatment of Erythropoietic Protoporphyria.
SCENESSE Patents & Exclusivity
Patents (1 active)
Exclusivity
Pro Intelligence Preview
Deep insights for SCENESSE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 1 active patents
Trial Analysis
- • 13 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment