Clinuvel Pharmaceuticals Ltd is a leading and innovative Australian company focused on the development of SCENESSE® (afamelanotide), its proprietary first-in-class photoprotective drug. Clinuvel has identified a number of groups of patients with a clinical need for photoprotection and one with a need for repigmentation therapy. Currently, Clinuvel is in its final stages to complete testing of SCENESSE® in Phase II and III trials in the United States. Clinuvel’s ongoing focus is to demonstrate the safety and efficacy of SCENESSE®. Clinuvel’s lead compound, SCENESSE® (afamelanotide), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US, Europe and Australia, and has been filed for review by the European Medicines Agency.
Phase I and II human clinical trials using SCENESSE® have demonstrated that the drug is well tolerated and no significant safety concerns have been identified to date.
To maintain global leadership in the development and commercialisation of a melanocortin as the first prescriptive photoprotective pharmaceutical, aimed to assist patients who are most severely affected by light/UV and depigmentation disorders.
Clinuvel aims to be a global leader in pharmaceutical development and excel in further developing and sharing knowledge on all aspects related to photoprotection, environmental factors and related risks, such as skin cancer and light-related skin diseases.
Clinuvel’s objectives are to serve patients, physicians and shareholders in the process of its product development. In the process of building a viable business with a long-term view, the company collaborates with all leading regulatory authorities to best serve and protect stakeholders.