Clinuvel Pharmaceuticals has announced its aim to file its second pharmaceutical product, Neuracthel Instant, with a European regulatory authority by mid-2026. Neuracthel Instant is a generic injectable adrenocorticotropic hormone (ACTH) formulation. Clinuvel Pharmaceuticals is a global biopharmaceutical company focused on developing and commercialising treatments for patients with genetic, metabolic, and other life-threatening disorders, with a focus on skin diseases. Their lead drug, Scenesse, is approved for erythropoietic protoporphyria (EPP) in various markets.
The submission will be made through a national procedure, a deliberate decision intended to expedite market entry. This announcement comes after the validation of the end-to-end Good Manufacturing Practice (GMP) processes for the formulation, marking a significant step forward in the drug’s development and regulatory pathway. The company is working to ensure that all manufacturing and quality control standards meet the stringent requirements for pharmaceutical approval.
