About CLINUVEL

Our Work

Clinuvel's SCENESSE® (afamelanotide 16mg implant)CLINUVEL is developing new drugs to improve the lives of individuals with severe skin disorders. Our lead technologies, SCENESSE® (afamelanotide 16mg) and CUV9900, are from a new class of drugs, known as melanocortins, which are based on the naturally occurring hormone α-MSH.

Alpha-Melanocyte Stimulating Hormone (α-MSH) is a naturally occurring hormone released by skin cells in response to ultraviolet radiation (UVR) following exposure to sunlight or artificial sources of UV. α-MSH activates melanin, a brown pigment which provides skin with colour and protection from UV/light (photoprotection). SCENESSE® is a first-in-class dermatological drug being developed solely by CLINUVEL. The active ingredient in SCENESSE® is afamelanotide, a chemical analogue of α-MSH which activates melanin in the skin. This mimics the skin’s natural protective umbrella against UVR and sunlight. SCENESSE® is delivered as a subcutaneous, dissolving implant approximately the size of a rice grain. Increased pigmentation of the skin appears after two days and lasts up to two months.

CLINUVEL has identified groups of patients with a high clinical need for photoprotection and one disorder with a need for repigmentation therapy. CLINUVEL has completed testing of SCENESSE® in Phase II and III trials in Australia and Europe for the orphan disease erythropoietic protoporphyria (EPP). In February 2012 a marketing authorisation application for SCENESSE® was filed for review by the European Medicines Agency for EPP.

A Phase II study of the SCENESSE® in EPP was completed in the USA in 2011, with a Phase III completed in 2013. A Phase IIb study of the drug is also underway in Singapore in the common pigmentary disorder vitiligo. An earlier study in vitiligo showed the drug was well tolerated and may assist in repigmenting skin as an adjunct therapy to narrowband ultraviolet B.

In addition to our drug development program, CLINUVEL has developed an extensive online resource library, the Science of Skin, focused on the interactions between skin, light and melanin. This project, in evolution since 2007, has expanded beyond our site to include interactive content across Youtube, Twitter and Facebook.

The team at CLINUVEL is excited by the potential of SCENESSE® to improve the conditions and lives of people living with these various disorders. We are currently employing all our in-house knowledge and expertise to make its approval and administration a reality.

Latest Company Announcements

16 October 2017

CLINUVEL Newsletter - October 2017

I am addressing you during quite a turbulent period, when our teams are preparing various dossiers to meet regulatory obligations in Europe and the US

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10 October 2017

CLINUVEL CONFIRMS AGM DATE

CLINUVEL PHARMACEUTICALS LTD today announced it will hold its 2017 Annual General Meeting of shareholders on Tuesday 28 November 2017

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04 October 2017

ELIE ISHAG TO RETIRE FROM CLINUVEL BOARD

CLINUVEL today announced that Mr Elie Ishag has advised that he will not stand for re-election as Non-Executive Director of CLINUVEL at the Company’s 2017 Annual General Meeting

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19 September 2017

CLINUVEL PROVIDES UPDATE ON SCENESSE® FDA FILING

CLINUVEL PHARMACEUTICALS LTD today announced an update on its submission of the New Drug Application (NDA) for CLINUVEL’s drug SCENESSE® (afamelanotide 16 mg) to the US Food and Drug Administration (FDA).

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06 September 2017

Appendix 3B

Appendix 3B - New issue announcement

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30 August 2017

Appendix 4E - Preliminary Final Report 2016/17

Appendix 4E - Preliminary Final Report 2016/17

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