Zydus Cadila gets approval from Mexican authority to test COVID-19 drug
The company said it will conduct a study to evaluate the efficacy and safety of Desidustat tablets for the management of COVID-19 patients.
Drug firm Zydus Cadila on Monday said it has received approval from Mexico's regulatory authority Cofepris to test one of its lead research candidate Desidustat in the management of COVID-19.
"Clinical and regulatory development of Desidustat in COVID-19 is being executed in Mexico by Avant Sant Research Center S.A. de C.V., a leading contract research organisation headquartered in Monterrey, Mexico," Cadila Healthcare said in a regulatory filing.
The company said it will conduct a study to evaluate the efficacy and safety of Desidustat tablets for the management of COVID-19 patients.
"As a part of the study, 100 mg tablets of Desidustat will be administered for a period of 14 days along with recommended standard care during the trial," the company added.
Zydus Cadila Chairman Pankaj R Patel said, At Zydus, we have been stepping up our efforts to fight the COVID-19 pandemic through therapeutic drugs, diagnostics, and vaccines. With Desidustat we will study a novel approach for management of COVID-19."
Zydus had initiated two phase-III trials of Desidustat.
Last week, Zydus, a part of the Cadila Healthcare group, had received approval from Indian authorities to start human trials for its COVID-19 vaccine contender — the second Indian pharmaceutical firm to get such nod amid a surge in novel coronavirus infections worldwide.
ZyCoV-D, developed at the company's Vaccine Technology Centre in Ahmedabad, has now received permission from the Drug Controller General of India (DCGI) - Central Drugs Standard Control Organisation (CDSCO) to initiate Phase I/II human clinical trials in India, Cadila Healthcare said in a regulatory filing.
Shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 363.40 a piece on BSE, 0.78 percent lower against their previous close.
(Disclaimer: Additional background information has been added to this PTI copy for context)
Edited by Kanishk Singh