Neurizon Therapeutics Limited has announced it has commenced manufacturing the first registration batch of NUZ-001 tablets, marking what it described as a significant milestone in its pathway toward regulatory submission and commercialisation.
According to the company’s ASX announcement, the manufacturing is being undertaken by Catalent Inc, a leading global contract development and manufacturing organisation, using full-scale commercial processes compliant with US Food and Drug Administration (FDA) and International Council for Harmonisation (ICH) guidelines.
Neurizon said the initial batch, produced at a 1:10 scale of the planned 1.4 million-tablet commercial run, will support stability studies, Chemistry, Manufacturing and Controls (CMC) requirements for the planned New Drug Application (NDA) submission, and validation of commercial-scale manufacturing.
The ASX-listed company stated it is the first of three planned registration batches to be produced over the coming months.
In the announcement, Managing Director and Chief Executive Officer Dr Michael Thurn said the commencement of Good Manufacturing Practice (GMP) manufacturing was a “critical milestone” for the NUZ-001 program.
“It reflects the advanced stage of our development program and our confidence in NUZ-001 as a potentially effective treatment for people living with ALS and related neurodegenerative diseases,” Dr Thurn said.
“This progress is further underpinned by our exclusive global licensing agreement with Elanco Animal Health, which significantly de-risks the supply chain and enhances our commercial scalability.”
The company said manufacturing is taking place at Catalent’s certified GMP facility, which operates under both US and international regulatory standards.
Once complete, the batches will undergo long-term and accelerated stability testing to determine product shelf-life and generate data to support the NDA dossier.
Head of Manufacturing Dr Herbert Brinkman said in the ASX announcement that the start of production represented “a major milestone” for the company’s regulatory pathway.
“With this step, we have commenced a key regulatory requirement for the NDA and made significant progress toward ensuring commercial readiness for NUZ-001,” Dr Brinkman said.
According to Neurizon’s statement, NUZ-001 is being developed for the treatment of Amyotrophic Lateral Sclerosis (ALS) and is designed to target pathological mechanisms such as TDP-43 protein aggregation and impaired autophagy.
The company said the therapy has shown favourable oral bioavailability, central nervous system penetration, and a strong safety profile in earlier studies.
Neurizon confirmed that it plans to begin participation in the Phase 2/3 HEALEY ALS Platform Trial in the fourth quarter of 2025, pending FDA clearance to lift the current clinical hold.
The company said this manufacturing milestone demonstrates its readiness to progress NUZ-001 through the next stages of clinical development and toward potential global market access.
The content of this article is based on information supplied by Neurizon Therapeutics Limited. For more information, please refer to the official company announcement and communications from Neurizon. Please consult a licensed and/or registered professional in this area before making any decisions based on the content of this article.
