Glenmark Pharma begins phase 3 clinical trial on antiviral tablet

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

Favipiravir is a generic version of Avigan of Fujifilm Toyama Chemical Co. Ltd (Japan), a subsidiary of Fujifilm Corporation. Clinical trials have commenced and over ten leading government & private hospitals in India are being enrolled for the study. Glenmark estimates study completion by July or August, 2020.

Through its well-developed R&D department, Glenmark has successfully developed API and the formulations for the product. 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.

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 car. The treatment duration will be of maximum 14 days and the total study duration will be for around 28 days from randomisation.

On Tuesday, in the early morning session, the stock of Glenmark Pharma was up by 2.3 per cent to Rs 342.95 from its previous close of Rs 335.40 on BSE.