We are a global biopharmaceutical company committed to developing drugs for the treatment of a range of severe skin disorders.
CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe. In December 2014 the European Commission granted SCENESSE® marketing authorisation under exceptional circumstances for the prevention of phototoxicity in adult patients with EPP. In June 2018 CLINUVEL submitted a new drug application with the US FDA seeking marketing authorisation for SCENESSE®. In January 2019 the FDA set a PDUFA date of 8 July 2019 and granted SCENESSE® a Priority Review. Further trials of SCENESSE® are underway in the pigmentary disorder vitiligo.
Our website has been developed to help share our expertise on the interaction of light and human skin as well as provide a thorough overview of our global drug development programs.