Clinuvel Pharmaceuticals Ltd
Clinuvel Pharmaceuticals Limited is a specialty pharmaceutical company.
The business
Clinuvel Pharmaceuticals Limited is a specialty pharmaceutical company. It is focused on developing and commercializing treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders, as well as healthcare solutions for specialized populations. Its lead therapy, SCENESSE (afamelanotide 16mg), is approved for commercial distribution in Europe, the United States of America, Israel, and Australia as the first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). It has operations in Europe, Singapore, and the United States of America. It develops and manufactures NEURACTHEL (adrenocorticotropic hormone) in different formulations, to target neurological, endocrinological, and degenerative disorders. Its pharmaceutical product, PRENUMBRA, has been developed, and its use is to be expanded in the clinic from stroke to Parkinson's.
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Latest news
Clinuvel Pharmaceuticals reaches patient recruitment milestone ahead of Phase III Scenesse vitiligo trial
Clinuvel Pharmaceuticals (ASX: CUV) has recruited more than 200 patients for a Phase III trial (CUV105) of its breakthrough Scenesse (afamelanotide 16mg) repigmentation therapy to treat vitiligo. The company is conducting the randomised 20-week trial at 37 sites across North America, Africa and Europe, with 57% of patients enrolled in the US. The last patient […]
Clinuvel reports breakthrough against UV damage in skin DNA repair study using afamelanotide
Specialty pharmaceutical group Clinuvel Pharmaceuticals (ASX: CUV) has received promising outcomes from the final set of results from a study evaluating the DNA-repair capacity of its afamelanotide candidate. For the general population, and specifically for individuals with fair skin types who sunburn easily, the results indicate that afamelanotide can reduce oxidative damage and inflammatory reactions […]
Clinuvel Pharmaceuticals offers up novel drug to combat rare genetic disease following FDA approval
Clinuvel Pharmaceuticals (ASX: CUV) has been given the all-clear to market its afamelanotide drug (brand-named Scenesse) by the US Food and Drug Administration (FDA). The drug was already approved by the European Medicines Agency in 2014 and constitutes the company’s lead compound that combats phototoxicity. The regulatory path to approval has taken over a decade, […]
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