Clinuvel's lead compound, Scenesse (afamelanotide), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the USA and Europe.
In December 2014, the European Commission granted Scenesse marketing authorization under exceptional circumstances for the prevention of phototoxicity in adult patients with EPP.
In June 2018, the company submitted a new drug application with the US Food and Drug Administration seeking marketing authorization for Scenesse.
Further trials of Scenesse are underway in the pigmentary disorder vitiligo.
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