Pharmaceutical
Division

R&D

CLINUVEL has focussed its R&D on melanocortins, associated hormones and peptides, polymers, and technological expertise to be applied for human use. At this stage, the Company is working to translate its technologies to products for specific patients and broader audiences.

Following two decades of collecting safety data from the human use of systemically administered melanocortins, CLINUVEL is able to expand the therapeutic potential of melanocortins and, in particular, SCENESSE^® (afamelanotide 16mg) in a number of genetic, metabolic, and life-threatening disorders.

CLINUVEL’s lead product SCENESSE^® is approved as a prescriptive pharmaceutical therapy for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP) in Europe, the USA and Australia. Further details on SCENESSE^® can be found here.

Clinical trials are planned or underway in a number of acute and life-threatening disorders. Access details on our DNA Repair Program and CNS Program as part of this Strategic Update.

CLINUVEL’s Research, Development and Innovation Centre, VALLAURIX Laboratories in Singapore, is focussed on both prescriptive pharmaceutical solutions and OTC products.

PRÉNUMBRA^®, the second prescriptive, a non-solid afamelanotide formulation, was unveiled in 2020 as part of the life cycle management of the novel molecule. This liquid formulation is intended to address patients with critical disorders who lack therapeutic alternatives.

CLINUVEL is expanding its pharmaceutical pipeline of melanocortins with CUV9900, phimelanotide and parvysmelanotide for systemic and topical use (transdermal), and these form the next generation of melanocortins.

As part of its overall portfolio, CLINUVEL intends to launch a minimum of two pharmaceutical and four OTC product lines.