CLINUVEL Pharmaceuticals (ASX:CUV) has taken a significant step toward expanding its product portfolio, confirming it is planning to lodge a European regulatory submission for its second pharmaceutical product, NEURACTHEL Instant, by mid-2026.
The company says the move will mark a pivotal moment in its strategy to build a broader suite of melanocortin-based therapies, underpinned by newly validated manufacturing processes that clear a critical path to market.
The announcement follows the successful validation of end-to-end Good Manufacturing Practice (GMP) processes for the new branded generic formulation of adrenocorticotropic hormone (ACTH). CLINUVEL and its European manufacturing partner have completed three consecutive GMP batches supported by stability data, confirming a reproducible production process suitable for regulatory approval. The product is now available for clinical use once approved.
The company plans to pursue national approvals in selected European markets with established demand for ACTH therapies, a strategy designed to accelerate entry and allow a scalable rollout. ACTH is approved in the United States for 19 conditions, including infantile spasms and acute exacerbations of multiple sclerosis, and CLINUVEL is positioning NEURACTHEL Instant as a high-quality, reliable formulation for patients and clinicians managing neurological, endocrinological, and inflammatory disorders.
Chief Scientific Officer Dr Dennis Wright said the filing milestone reflects years of work to minimise development and regulatory risk. “We have methodically de-risked the manufacturing and regulatory process, giving us great confidence as we finalise the dossier,” he said.
The company is simultaneously investing in commercial and regulatory infrastructure across Europe and the United States to support the NEURACTHEL Instant launch and future peptide-based therapies. Its broader development program includes new delivery platforms for ACTH and other melanocortins to address high unmet medical needs.
NEURACTHEL Instant represents CLINUVEL’s continued push beyond its flagship product SCENESSE and deeper into systemic, specialty-care markets. If approved, it would be the company’s first ACTH product and its second commercial therapy, signalling the next phase of diversification for the Melbourne-headquartered biopharmaceutical group.