Zydus Lifesciences gets WHO INN approval for 'Usnoflast' as recommended name for ZYIL1

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]. ALS affects approximately 31,000 people in the U.S.A. and on average 5,000 new patients are diagnosed every year with this disease in USA as per statistics from Centers for Disease Control and Prevention (CDC). More than 30,000 people are estimated to be living with ALS in Europe (European Union and United Kingdom), while India has an estimated 75,000 people living with ALS. People living with ALS have a median survival of approximately two years from diagnosis.

Zydus has initiated Phase 2 proof-of-concept study in patients with Ulcerative Colitis [CTRI/2024/02/062456]. Ulcerative Colitis is characterized by an irregular, chronic immune response that creates inflammation and ulcers in the mucosa of the large intestine or rectum. In 2023, the prevalence of ulcerative colitis was estimated to be 5 million cases around the world, and the incidence is increasing worldwide [The Lancet, (2023), 402, 10401, 571-584, DOI : https://doi.org/10.1016/S0140-6736(23)00966-2]. Usnoflast (ZYIL1) has also received permission from USFDA, to initiate the Phase II clinical study in patients with Parkinson’s disease. It is estimated that there are more than 8.5 mn people in the world suffering from Parkinson’s disease, with 1 mn suffering from the disease in the USA. Each year 90,000 new cases of Parkinson’s disease are reported in the USA. Analysts estimate that the treatment costs of Parkinson’s disease amounts to almost USD 52 billion every year, and by 2037 this disease is estimated to touch U.S. $80 billion every year.

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