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Also known as Afamelanotide and NB-UVB Light
Afamelanotide · 2 trials · 2 indications
Blood samples will be collected for analysis of afamelanotide plasma concentrations and understand what the maximum concentration in plasma is.
Blood samples will be collected for analysis of afamelanotide plasma concentrations.
Analysis of UV photoproducts from skin samples.
Analysis of UV photoproduct repair mechanisms from skin samples.
| Arm | Type | Description |
|---|---|---|
| Afamelanotide 16 mg implant | EXPERIMENTAL | - |
| Afamelanotide | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Afamelanotide 16mg implant | DRUG | afamelanotide 16mg implant will be administered to each patient during the study. |
| Afamelanotide | DRUG | Up to 10 adult healthy volunteers will be enrolled in this study in which small areas of their skin will be exposed to UVR and skin samples taken. UV-induced DNA damage and repair will be analysed. |
Inclusion Criteria: * EPP patients aged between 12 and 70 years * BMI between 15 and 30 kg/m2 * \>50 kg Exclusion Criteria: * Any personal or direct family history of melanoma * Any significant history of allergy and/or sensitivity to any of the contents of study drug product or lignocaine or oth...
Afamelanotide is being evaluated as a skin DNA repair therapy in healthy volunteers, and is also studied for erythropoietic protoporphyria and vitiligo. It is an investigational small molecule in dermatology, developed by Clinuvel Pharmaceuticals Limited (CUVL).
Afamelanotide is a small molecule being studied for its effects on skin DNA repair and in conditions like vitiligo and erythropoietic protoporphyria. Its specific molecular target is not disclosed in available clinical trial information.
Afamelanotide is developed by Clinuvel Pharmaceuticals Limited, traded as American Depositary Shares under the ticker CUVL. The company is conducting clinical trials to evaluate the drug for skin-related conditions.
Afamelanotide is in Phase 1 clinical development for skin DNA repair and erythropoietic protoporphyria, and Phase 3 for vitiligo. It is investigational and not yet approved by regulatory authorities.
Afamelanotide has been studied in NCT05368857, a completed Phase 1 trial in healthy volunteers in the United Kingdom, and NCT06388642, a completed Phase 1 pharmacokinetic trial in erythropoietic protoporphyria patients. NCT06109649 is an active Phase 3 trial comparing SCENESSE and NB-UVB light versus NB-UVB alone in vitiligo.
Afamelanotide is also known as SCENESSE, as referenced in the vitiligo trial NCT06109649. The drug is being evaluated under this brand name in combination with narrow-band ultraviolet light therapy.