The CLINUVEL Group

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®. 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.

Latest Company Announcements

06 July 2018

Change in Director's Interest Notice

Change in Director's Interest Notice

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04 July 2018

Change in substantial holding

Change in substantial holding

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25 June 2018

CLINUVEL COMPLETES SCENESSE® FDA FILING

Historic New Drug Application for the use of SCENESSE® in rare metabolic disorder EPP

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22 June 2018

Trading Halt


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01 June 2018

Appendix 3B

Appendix 3B

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23 May 2018

NICE MAINTAINS ITS POSITION NOT TO RECOMMEND SCENESSE® FOR REIMBURSEMENT

CLINUVEL PHARMACEUTICALS LTD today announced that the English National Institute of Health and Care Excellence (NICE) maintained its position not to recommend CLINUVEL’s drug SCENESSE® (afamelanotide 16mg) for reimbursement in England.

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