Glenmark Pharma begins its phase 3 trial of generic antiviral drug Favipiravir 

According to the government's registry, so far, nine sites for the study have been selected, with six hospitals in Maharashtra, two in Gujarat and the All India Institute of Medical Sciences in Chhattisgarh.

Glenmark is the first company in India to initiate Phase-3 clinical trials on Favipiravir for COVID-19 patients in India, it said. Glenmark Pharmaceuticals has initiated Phase-3 clinical trials in India on antiviral tablet Favipiravir, for which it received approval from India’s drug regulator DCGI in late April, the company has said in a statement.

Drug Controller General of India V.G. Somani had in late April approved Glenmark’s plan to conduct phase 3 trials on the use of the drug. Clinical trials have commenced and over 10 leading government & private hospitals in India are being enrolled for the study, the company said in an exchange filing.

About 150 patients with mild to moderate covid-19 will be enrolled in 10 hospitals for the randomized, open-label study, except patients with severe COVID-19, like those requiring ventilator support, will not be included in the trials.

“Our effort is to launch a treatment for COVID-19 patients as soon as possible and control the spread of the pandemic. We will do all it takes to ensure accessibility of the product across the country if the clinical trials are successful," quoted Sujesh Vasudevan, Glenmark’s President for Formulations Business in India, Middle East and Africa.

Clinical trials have commenced and over 10 leading government & private hospitals in India are being enrolled for the study. Glenmark estimates that the study would complete by July/August 2020. It has developed the API and the formulations for the product through its in-house R&D team.