Glenmark begins Phase-3 clinical trials on antiviral drug Favipiravir for COVID-19 patients in India

Company estimates that the study would be completed by August

May 12, 2020 11:10 am | Updated 05:41 pm IST - MUMBAI

Photo for representation.

Photo for representation.

Glenmark Pharmaceuticals has initiated Phase-3 clinical trials in India on antiviral tablet Favipiravir, for which it received approval from India’s drug regulator DCGI in late April, the company has said in a statement.

Glenmark is the first company in India to initiate Phase-3 clinical trials on Favipiravir for COVID-19 patients in India, it said.

Also read:Coronavirus | When will a COVID-19 vaccine be ready?

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 10 leading government & private hospitals in India are being enrolled for the study.

Also read:Coronavirus | Key ICMR panel on vaccines dissolved

Glenmark estimates that the study would complete by July/August 2020. It has developed the 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.

Monika Tandon, vice-president & head, clinical development, global specialty/branded portfolio, Glenmark Pharmaceuticals Ltd., said, “Several health and medical experts, both in and outside of Glenmark are eager to see the effect that Favipiravir has on COVID-19 cases.”

“We believe the study results will be significant as there is currently no effective treatment for the virus,” she added.

“The data we get from these trials will point us in a clearer direction with regard to COVID-19 treatment and management,” Ms. Tandon said.

Sujesh Vasudevan, president, India Formulations, Middle East and Africa, Glenmark Pharmaceuticals Ltd. said “Our effort is to launch a treatment for COVID-19 patients as soon as possible and control the spread of the pandemic.”

“We will do all it takes to ensure accessibility of the product across the country if the clinical trials are successful,” he said.

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.

Treatment duration is a maximum of 14 days and the total study duration will be a maximum of 28 days from randomisation.

0 / 0
Sign in to unlock member-only benefits!
  • Access 10 free stories every month
  • Save stories to read later
  • Access to comment on every story
  • Sign-up/manage your newsletter subscriptions with a single click
  • Get notified by email for early access to discounts & offers on our products
Sign in


Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.

We have migrated to a new commenting platform. If you are already a registered user of The Hindu and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.