USFDA grants Fast Track Designation to Zydus Usnoflast for amyotrophic lateral sclerosis
Usnoflast (ZYIL1) is a novel, oral small molecule NLRP3 inhibitor.;
Written By : Ruchika Sharma
Published On 2025-05-28 09:48 GMT | Update On 2025-05-28 09:48 GMT
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Ahmedabad: Zydus, a discovery-based, global pharmaceutical company, has announced that the USFDA has granted ‘Fast Track Designation’ to Usnoflast, a novel oral NLRP3 inhibitor, for the treatment of amyotrophic lateral sclerosis (ALS).
A drug that receives Fast Track Designation from the USFDA is eligible for accelerated approval and priority review, if the relevant criteria are met. The purpose of Fast Track Designation is to get important new drugs to the patients faster.
Speaking on the development, Chairman of Zydus Lifesciences Limited, Pankaj Patel, said, “This ‘Fast Track Designation’ in addition to the previous ‘Orphan Drug Designation’ granted by the USFDA underlines the urgent need to develop treatments to address Amyotrophic Lateral Sclerosis (ALS), which is a fatal neurodegenerative disease. Zydus is committed to unlocking new frontiers in neuroscience and develop Usnoflast for patients with ALS.”
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