Zydus Cadila gets permission from DCGI for phase-1 clinical trial of novel molecule ZYIL1

PTI, Dec 7, 2020, 12:29 PM IST

New Delhi: Drug firm Zydus Cadila on Monday said it has received permission from Drugs Controller General of India (DCGI) to initiate phase-1 clinical trial of its novel molecule ZYIL1, indicated for use as an inhibitor for inflammation condition ”NLRP3”.

In a regulatory filing, Zydus Cadila said “it has received permission to initiate the phase 1 clinical trial of ZYIL1, a novel oral small molecule NLRP3 inhibitor candidate. NLRP3 inflammasomes are involved in the inflammation process”.

This harmful inflammation within the body leads to the onset and development of various kinds of diseases, including Acute Respiratory Distress Syndrome (ARDS), auto-immune diseases, inflammatory diseases, cardiovascular diseases, metabolic disorders, Gastro-intestinal diseases (inflammatory bowel disease), renal diseases and CNS diseases, the company added.

Pankaj R Patel, Chairman, Cadila Healthcare said: “We will study the safety, tolerability, pharmacokinetics and pharmacodynamics of ZYIL1 in this phase I clinical trial in healthy human volunteers. We are committed to developing these pioneering novel treatments to the clinic for the patients in need.”

Last month, Zydus Cadila had filed the investigational new drug application for ZYIL1, positioned for management of critically ill COVID-19 patients.

Shares of Cadila Healthcare were trading 1.85 per cent higher at Rs 479.70 apiece on BSE.