Zydus Gets USFDA Fast Track Nod for ALS Drug Usnoflast

29 May 2025 , 10:53 AM

Zydus Lifesciences Ltd. has announced that the experimental drug developed by the company, Usnoflast, has been granted the Fast Track Designation by the US Food and Drug Administration (US FDA) for use of the drug in treating amyotrophic lateral sclerosis (ALS).

Fast Track Designation is given to drugs that are intended to treat serious conditions and or fill an unmet medical need. It provides benefits such as faster approval, priority review and a more open line of communication with the F.D.A.

Usnoflast is an oral NLRP3 inhibitor specifically designed for the treatment of neuroinflammation associated with ALS, a debilitating and fatal neurodegenerative disease. Zydus noted the designation would facilitate faster development and review timelines.

Notice of this Clinical Trial Activation follows Orphan Drug Designation (ODD) granted to Usnoflast by USFDA, which provides incentives including tax credits enabling clinical testing, access to various fees and for a term of seven years after marketing has been authorized.

“Having both designations underscores how critical it is to bring effective treatments for As to people living with this disease,” ALS Association Chairman Pankaj Patel said. The illness is usually fatal, with progressive paralysis resulting in death two to five years after the first symptoms develop.

Zydus has done a Phase 2(a) double-blind, placebo control trial with 24 ALS patients at seven sites in India. It has already received USFDA approval to start a Phase 2(b) trial in ALS patients in the U.S.

According to Zydus, pre-clinical studies have demonstrated the promise of Usnoflast in the treatment of neuroinflammation, Parkinson’s disease, multiple sclerosis and inflammatory bowel disease.

ALS strikes an estimated 32,000 Americans with some 5,000 new diagnoses each year. ALS afflicts more than 30,000 people in Europe and there are about 75,000 patients in India, company data showed. Clinical advancement of the drug candidate and other regulatory steps have enhanced the position of Zydus in the global neurodegenerative disease treatment sphere.”