Zydus Lifesciences' Usnoflast Gets USFDA Fast Track for ALS Treatment

Key Highlights:

• Usnoflast receives USFDA Fast Track Designation for ALS.
• Phase 2(a) trial in India completed; Phase 2(b) U.S. trial approved.
• Q3 FY25 net profit surges 29.62% YoY to ?1,023.5 crore.

Zydus Lifesciences has announced that its novel oral NLRP3 inhibitor, Usnoflast (ZYIL1), has received Fast Track Designation from the U.S. Food and Drug Administration (USFDA) for the treatment of Amyotrophic Lateral Sclerosis (ALS).

The designation aims to accelerate the development and review of drugs that address serious conditions and unmet medical needs, offering benefits such as priority review, accelerated approval, and more frequent FDA interactions.

Also read: Balancing Innovation and Affordability in Medical Solutions for India

ALS, a progressive neurodegenerative disorder, affects about 32,000 people in the U.S., with an average survival of two to five years post-diagnosis. The disease is marked by neuroinflammation, rapid neurodegeneration, and eventual respiratory failure. Zydus has completed a Phase 2(a) randomized, double-blind, placebo-controlled trial involving 24 ALS patients across seven Indian sites, and has now secured FDA approval to begin a Phase 2(b) trial in the U.S.

Usnoflast, a novel chemical entity, had earlier received Orphan Drug Designation (ODD), providing incentives like tax credits and potential seven-year marketing exclusivity upon approval. It is also being studied in other neuroinflammatory conditions including Parkinson’s disease, IBD, and MS.