Glenmark Pharmaceuticals has begun phase 3 of clinical trials on antiviral Favipiravir in India, becoming the first company in the country to do so.
Glenmark had obtained approval from the Drug Controller General of India late in April, news agency ANI reported. Favipiravir is a generic version of Avigan of Fujifilm Toyama Chemical Co Ltd in Japan, a subsidiary of Fujifilm Corporation.
"Clinical trials have commenced and over 10 leading government and private hospitals in India are being enrolled for the study. Glenmark estimates study completion by July or August," it said in a statement on Tuesday.
Glenmark has successfully developed the active pharma ingredient (API) and the formulations for the product through its in-house R&D team. Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections.
The molecule if commercialised will be marketed under the brand name FabiFlu in India.
"Several health and medical experts both in and outside of Glenmark are eager to see the effect that Favipiravir has on Covid-19 cases," Monika Tandon, Vice President and Head of Clinical Development, Global Specialty/Branded Portfolio at Glenmark Pharmaceuticals was quoted as saying by ANI.
"We believe the study results will be significant as there is currently no effective treatment for the virus. The data we get from these trials will point us in a clearer direction with regard to Covid-19 treatment and management," she said.
Glenmark was the first pharmaceutical company in India to be given approval by the regulator to start the trial on Covid-19 patients in India. As per 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 agency said.
Treatment duration is a maximum of 14 days and the total study duration will be a maximum of 28 days from randomisation.