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Scenesse (AFAMELANOTIDE)
Scenesse (afamelanotide) is a small molecule drug developed by Clivunel Inc, targeting the melanocyte-stimulating hormone receptor. It is FDA-approved since 2019 for the treatment of erythropoietic protoporphyria, a rare genetic disorder. Scenesse is a patented product with no generic manufacturers available. Key safety considerations include the potential for skin darkening and increased risk of melanoma. As a patented product, its commercial status is subject to ongoing patent protection.
At a glance
| Generic name | AFAMELANOTIDE |
|---|---|
| Sponsor | Clivunel Inc |
| Drug class | afamelanotide |
| Target | Melanocyte-stimulating hormone receptor |
| Modality | Recombinant protein |
| Therapeutic area | Rare Disease |
| Phase | FDA-approved |
| First approval | 2019 |
Approved indications
- Erythropoietic protoporphyria
Common side effects
- Implant site reaction
- Nausea
- Oropharyngeal pain
- Cough
- Fatigue
- Skin hyperpigmentation
- Dizziness
- Melanocytic nevus
- Respiratory tract infection
- Somnolence
- Non-acute porphyria
- Skin irritation
Key clinical trials
- Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients (PHASE1,PHASE2)
- 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 (PHASE3)
- Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP) (PHASE2)
- Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV) (PHASE2)
- A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V (PHASE2)
- A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP) (PHASE2)
- A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS) (PHASE2)
- DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Scenesse CI brief — competitive landscape report
- Scenesse updates RSS · CI watch RSS
- Clivunel Inc portfolio CI