WHO INN approves ‘Usnoflast’ as recommended name for ZYIL1 from Zydus

Zydus Lifesciences 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 pharma 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].

Zydus was the first to establish the Phase 2 proof-of-concept in Cryopyrin-associated periodic syndromes (CAPS) patients [NCT05186051], and published the Phase 2 results in ‘Clinical Pharmacology in Drug Development’. The USFDA has granted Zydus an ‘Orphan Drug Designation’ for Usnoflast (ZYIL1) to treat patients with Cryopyrin Associated Periodic Syndrome (CAPS), a rare auto-inflammatory disease.

Usnoflast (ZYIL1) is under Phase 2 clinical trial in patients with Amyotrophic Lateral Sclerosis (ALS) [ClinicalTrials.gov Identifier: NCT05981040].

Zydus has initiated Phase 2 proof-of-concept study in patients with Ulcerative Colitis [CTRI/2024/02/062456].

Usnoflast (ZYIL1) has also received permission from USFDA, to initiate the Phase II clinical study in patients with Parkinson’s disease.