Zydus Receives Approval from WHO International Non-Proprietary Names for Usnoflast as Recommended Name for ZYIL1
(ZYIL1), has an acceptable ADME profile, with a good safety margin. In Phase I studies, ZYIL1 was found to be safe and well-tolerated. 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). Zydus has initiated Phase 2 proof-of-concept study in patients with Ulcerative Colitis. Ulcerative Colitis is characterized by an irregular, chronic immune response that creates inflammation and ulcers in the mucosa of the large intestine or rectum. Usnoflast (ZYIL1) has also received permission from USFDA, to initiate the Phase II clinical study in patients with Parkinson's disease.