Glenmark Pharmaceuticals Ltd said Tuesday it has started phase 3 clinical trials in India for its generic antiviral drug favipiravir to treat mild to moderate covid-19 and expects to complete the study by August.
Drug controller general of India V.G. Somani had in late April approved Glenmark’s plan to conduct the trials.
More than 10 leading government and private hospitals have been enrolled for the trials, the company said in a regulatory exchange filing.
Favipiravir is a generic version of Avigan of Japan’s Fujifilm Toyama Chemical Co. Ltd, a subsidiary of Fujifilm Corp. Favipiravir has shown some early promise in treating mild to moderate covid-19, and trials of the broad-spectrum antiviral drug are taking place in various countries, including Japan and the US.
About 150 patients with mild to moderate covid-19 will be enrolled in 10 hospitals for the randomized, open-label study.
“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,” Sujesh Vasudevan, Glenmark’s president for formulations business in India, West Asia and Africa, said.
The trial process has so far commenced in nine hospitals—six in Maharashtra, two in Gujarat and the All India Institute of Medical Sciences in Chhattisgarh, according to the Union government’s clinical trial registry.
