Clinuvel Pharmaceuticals Limited announced an update on its commercial development of the analogue adrenocorticotropic hormone (ACTH), part of CLINUVEL's portfolio of melanocortin products. The Company will launch a range of ACTH products under the trade names NEURACTHEL® Instant and NEURACTHEL® Modified-release for patients with neurological, endocrinological, and degenerative disorders, with plans to file a regulatory drug master file (DMF) for ACTH in the second half of 2023. CLINUVEL is currently pursuing the development of three melanocortin-based pharmaceutical product lines globally: NEURACTHEL®, PRÉNUMBRA®, and SCENESSE®.

Working closely with exclusive manufacturing partners, CLINUVEL completed method and process development work throughout H2 2022, including the establishment of critical process parameters serving the commercial product manufacturing. In the coming months work is planned for on production of the ACTH drug substance under current Good Manufacturing Practices (cGMP) standards at commercial scale, characterisation of the drug substance, and overall evaluation stability. Data from validation batches support the filing of a DMF with global regulatory authorities laying the foundation for the submission of marketing authorisation applications.