Drug Approval | May 29, 2025
Zydus receives USFDA ‘Fast Track Designation’ for novel oral inhibitor ‘Usnoflast’
Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA
Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA
The company is committed to unlocking new frontiers in neuroscience and developing Usnoflast for patients with ALS
ALS patients experience neuroinflammation and rapid neurodegeneration
ALS is a rare, progressive and fatal neurodegenerative disease, with an average life expectancy of 3 to 5 years from the time of symptom onset
Usnoflast (ZYIL1) is a novel oral small molecule NLRP3 inhibitor discovered at Zydus
The company reported revenue from operations at Rs. 6,573.7 crore, up 6 per cent YoY
This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo
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