COVID-19 vaccine: Glenmark starts clinical trials for potential drug in India
New Delhi, May 12: Glenmark Pharmaceuticals said on Tuesday it has initiated clinical trials in India of antiviral drug favipiravir. This is believed to be a potential treatment for the coronavirus pandemic.
Glenmark said clinical trials have begun and more than 10 leading government and private hospitals in India are being enrolled for the study. It estimates the study completion by July or August this year.
The company received approval from Drug Controller General of India (DCGI) to conduct clinical trials of Favipiravir antiviral tablets for the treatment of COVID-19 patients in April.
Having internally developed the active pharmaceutical ingredients (API) and the formulations for the product, the company filed the product for clinical trials with the DCGI and has received approval for conducting the trial on mild to moderate patients, Glenmark Pharmaceuticals said in a statement.
The Mumbai-based company is the first pharmaceutical company in India to be given approval by the regulator to start the trial on COVID-19 patients in the country, it added.
Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections, it added.
As per the clinical trial protocol approved, 150 subjects with mild to moderate COVID-19 will be randomised in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care, the company said.
Treatment duration is a maximum of 14 days and the total study duration will be a maximum for 28 days from randomisation, it added.
In the past few months, following the outbreak of COVID-19, multiple clinical trials have been initiated on such patients in China, Japan and in the US.
The drug firm said its product is a generic version of Japan-based Fujifilm Toyama Chemical Co Ltd's Avigan tablets.