By | 03 November 2023 | 0 Comments

DMD's new drug in development ZYIL1 (Usnoflast) CAS: 2455519-86-3

CAS No.: 2455519-86-3

On October 25, 2023, Zydus announced that it has received permission from the CDSCO in India to initiate a Phase II clinical study of the NLRP3 inhibitor "ZYIL1 (Usnoflast)" in patients with amyotrophic lateral sclerosis (ALS).
According to the Centers for Disease Control and Prevention (CDC), an average of 5,000 new patients are diagnosed with the disease each year in the United States. It is estimated that more than 30,000 people in Europe have amyotrophic lateral sclerosis, while an estimated 75,000 people in India have ALS.The average survival period for ALS patients is about two years from diagnosis.
The Phase II clinical trial will study safety, tolerability, pharmacokinetics and pharmacodynamics in patients with ALS. Baseline change in Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) scores will be measured at Weeks 4, 8, and 12 as the primary endpoint of the trial is a placebo-controlled, randomized, double-blind Phase 2 clinical trial. The trial will also assess key secondary endpoints including slow lung volume (SVC), predictors of loss of function in ALS and nerve fiber levels at Weeks 4 and 12.

ZYIL1 (Usnoflast) is a novel oral small molecule NLRP3 inhibitor. It has been shown to be highly potent in human whole blood assays, inhibiting inflammation induced by the NLRP3 inflammasome.ZYIL1 is distributed in the brain and cerebrospinal fluid of a variety of non-clinical species including mice, rats, and non-human primates.The efficacy of ZYIL1 has been demonstrated in several validated preclinical models of neuroinflammation, Parkinson's disease, inflammatory bowel disease (IBD), and multiple sclerosis (MS).The efficacy of ZYIL1 has been demonstrated in multiple validated preclinical models of neuroinflammation, Parkinson's disease, IBD and multiple sclerosis (MS). models have been demonstrated. The drug candidate ZYIL1 has an acceptable ADME profile with a favorable safety margin. ZYIL1 was found to be safe and well tolerated in Phase I studies [NCT04731324, NCT04972188].

Zydus has established a Phase 2 proof-of-concept in patients with CAPS [NCT05186051] and has published data in Clinical Pharmacology in Drug Development. The U.S. fda has granted orphan drug designation to Zydus' ZYIL1 for the treatment of patients with Cryopyrin-Associated Periodic Syndrome (CAPS), a rare autoinflammatory disease.
CDSCO, Central Drugs Standard Control Organization, is the main body responsible for regulating medical devices. It is the main organization responsible for regulating medical devices.

Leave a Reply

Your email address will not be published.Required fields are marked. *
Verification code