SCENESSE
PeakPeptideafamelanotide
NDASUBCUTANEOUSIMPLANTPriority Review
Approved
Oct 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
14
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 15h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SCENESSE (afamelanotide) is a subcutaneous implant approved in 2019 for phototoxic reactions in patients with erythropoietic protoporphyria (EPP). It is a synthetic analog of alpha-melanocyte-stimulating hormone that stimulates melanin production to provide photoprotection. The implant delivers sustained hormone levels over approximately 10 days per dose.
Peak6.5 years to LOE
Product is in peak lifecycle stage with no direct competitors, suggesting stable commercial operations and specialized niche team structure.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (14)
Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients
Started Mar 2024
28 enrolled
Erythropoietic Protoporphyria
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 Vitiligo
Started Oct 2023
200 enrolled
Vitiligo
Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)
Started Mar 2023
6 enrolled
Variegate Porphyria
A Study to Assess the Changes in Pigmentation and Safety of Afamelanotide in Patients With Vitiligo on the Face
Started Oct 2022
6 enrolled
Vitiligo
A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V
Started Mar 2022
6 enrolled
Xeroderma Pigmentosum
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.