Zydus Lifesciences’ Usnoflast (ZYIL1), a novel NLRP3 inhibitor, has received Fast Track Designation from the USFDA for treating ALS. This, alongside Orphan Drug Designation, accelerates development for this serious, unmet medical need.

• ALS affects ~32K in the US & 75K in India.
• Usnoflast is in Phase 2(b) trials, following positive Phase 2(a) data.
• Fast Track offers benefits like priority review & FDA interaction.