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Zydus Lifesciences bags approval for ‘Usnoflast’

The approval has been received from the WHO International Non-proprietary Names

Zydus, a leading discovery-based, global pharmaceutical company, has received approval from WHO International Non-proprietary Names (INN) for ‘Usnoflast’ as the recommended name for ZYIL1. The INN system aims to provide healthcare professionals with a unique and universal designated name for each pharmaceutical substance.

Usnoflast (ZYIL1) is a novel oral small molecule NLRP3 inhibitor discovered at Zydus. Studies have demonstrated that ZYIL1 is highly potent in human whole blood assay and can suppress inflammation caused by the NLRP3 inflammasome. ZYIL1 was found distributed in the brain and CSF of various nonclinical species including mice, rats and non-human primates. The efficacy of Usnoflast (ZYIL1) has been established in several validated pre-clinical models of neuroinflammation, Parkinson’s disease, Inflammatory Bowel Disease (IBD) and Multiple Sclerosis (MS). The candidate, Usnoflast (ZYIL1), has an acceptable ADME profile, with a good safety margin. In Phase I studies, ZYIL1 was found to be safe and well-tolerated [NCT04731324, NCT04972188].

Pankaj Patel, Chairman, Zydus Lifesciences, said, “In keeping with our mission of creating healthier communities globally, we discovered the novel oral NLRP3 inhibitor ‘Usnoflast’ with potential to provide “Pipeline-in-a-pill” treatment owing to the number of different patient populations NLRP3 mechanism can target. We are currently conducting clinical development in indications including rare autoinflammatory diseases, neurological diseases like Amyotrophic Lateral Sclerosis (ALS), Parkinson’s Disease, as well as Ulcerative Colitis.”

 

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