Zydus Receives Approval from WHO International Non-Proprietary Names for Usnoflast as Recommended Name for ZYIL1
April 01, 2024 at 03:26 pm IST
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Zydus announced that it 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. 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.
Zydus Lifesciences Limited is an India-based global life sciences company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The Company is engaged in the business of integrated pharmaceutical operations. Its product portfolio includes active pharmaceutical ingredients (API), human formulations, animal health and veterinary, health, and wellness products. Its products include India formulations, Generics and Zydus biologics. The Company's products include Lipaglyn and Bilypsa (Saroglitazar), Ujvira (Trastuzumab emtansine biosimilar), Exemptia (Adalimumab biosimilar), Vivitra (Trastuzumab biosimilar) and Bryxta (Bevacizumab biosimilar). Its Zydus biologics covers various therapeutic areas, such as oncology, autoimmune disease, nephrology, inflammation, rheumatology, hepatology and infectious illnesses, among others. The Company has a global presence and markets its products in the United States, India, Europe and emerging markets.