Glenmark Pharmaceuticals Ltd. has become the first company in India to receive approvals for conducting clinical trials of Favipiravir antiviral tablets for Covid-19 treatment, the drugmaker said on Thursday.
After developing the active pharmaceutical ingredients and formulations for the Covid-19 medicine, Glenmark filed the product for clinical trials with the Drug Controller General of India and has now received approval for tests on patients showing mild to moderate symptoms of infection.
"The clinical trial will let us know the efficacy of this molecule on Covid-19 patients. If the clinical trials are successful, Favipiravir could become a potential treatment for Covid-19 patients," Sushrut Kulkarni, executive vice president (Global R&D) at Glenmark, said in a statement.
Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for Covid-19 treatment, Glenmark said.
According to the approved clinical trial protocol, 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 coronavirus outbreak, multiple clinical trials have been initiated on patients in China, Japan and the U.S. Glenmark said its product is a generic version of Japan-based Fujifilm Toyama Chemical Co Ltd's Avigan tablets.
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