Clinuvel Pharmaceuticals Update on SCENESSE® in Vitiligo
Key points
- Topline results of CUV105 study expected in December 2026
- CUV107 Phase III study planned to start in November 2026
- SCENESSE® and NB-UVB to be evaluated for repigmentation in vitiligo patients
Full summary
Clinuvel Pharmaceuticals Ltd announced an update on the clinical and regulatory path for its drug SCENESSE® (afamelanotide) used with adjuvant narrowband ultraviolet B (NB-UVB) phototherapy to treat vitiligo patients with darker skin. The company is completing its first late-stage study, CUV105, which has enrolled 210 patients globally and is expected to release topline results in December 2026. The study evaluates the ability of SCENESSE® with adjunct NB-UVB to repigment vitiligo patients over a 20-week treatment period. The European Medicines Agency (EMA) reviewed the CUV107 protocol in April 2026, and the pivotal Phase III CUV107 study is planned to start in November 2026 with a 12-month recruitment period.
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