Zydus Lifesciences secures Orphan Drug Designation for Usnoflast to treat ALS

23 Jan 2025 Evaluate

The USFDA has granted Orphan Drug Designation (ODD) to Zydus Lifesciences’ Usnoflast, a novel oral NLRP3 inhibitor, for the treatment of amyotrophic lateral sclerosis (ALS). The USFDA's Office of Orphan Drug Products grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States.

Orphan drug designation by USFDA for Usnoflast, provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and a potential seven-year marketing exclusivity upon FDA approval.

Usnoflast (ZYIL1) is a novel, oral small molecule NLRP3 inhibitor. Usnoflast has been studied in several pre-clinical models of neuroinflammation, Parkinson’s disease, Inflammatory Bowel Disease (IBD) and Multiple Sclerosis (MS). The USFDA has earlier granted Zydus an ‘Orphan Drug Designation’ for Usnoflast to treat patients with Cryopyrin Associated Periodic Syndrome (CAPS), a rare auto-inflammatory disease.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.


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