Glenmark Initiates Favipiravir Phase 3 Clinical Trials to Control Effect on COVID-19 Patients, Health News, ET HealthWorld


New Delhi: Glenmark Pharmaceuticals Tuesday said it has started phase 3 clinical trials antiviral drug Favipiravir to check its effectiveness COVID-19 patients in India. The Mumbai-based company had received approval from the Drug Controller General of India (DCGI) last month to conduct clinical trials of Favipiravir antiviral tablets to treat COVID-19 patients.

Glenmark Pharmaceuticals is the first company in the country to initiate Phase 3 clinical trials with Favipiravir for COVID-19 patients in India, it said in a statement.

Clinical trials have begun and over ten leading government and private hospitals are enrolled in the study, it added.

Glenmark estimates the completion of the survey by July / August 2020, it says.

According to the approved clinical trial protocol, 150 subjects with mild to moderate COVID-19 symptoms will be randomized in the study to a 1: 1 ratio of Favipiravir with standard supportive care or standalone standard supportive care.

Treatment duration is a maximum of 14 days and the total study duration is a maximum of 28 days after randomization.

“Several health and medical experts, both inside and outside Glenmark, are eager to see the effect of Favipiravir on COVID-19 cases. We believe the findings will be significant as there is currently no effective treatment of the virus, ”Glenmark Pharmaceuticals Vice President & Head Clinical Development, Global Specialty / Branded Portfolio Monika Tandon said.

The data we get from these trials will point us in a clearer direction in terms of COVID-19 treatment and management, she added.

The company said it aims to start a treatment for COVID-19 patients as soon as possible and to control the spread of the pandemic.

Favipiravir, which is a generic version of Japan-based Fujifilm Toyama Chemicals Avigan, has demonstrated activity against influenza virus and has been approved in Japan for the treatment of new influenza virus infections.


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