View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
May 1, 2020

Glenmark gets approval to trial favipiravir for Covid-19 in India

Glenmark Pharmaceuticals has received approval from the Drug Controller General of India (DCGI) to evaluate antivirial drug favipiravir in clinical trials to treat patients with Covid-19.

Glenmark Pharmaceuticals has received approval from the Drug Controller General of India (DCGI) to evaluate antivirial drug favipiravir in clinical trials to treat patients with Covid-19.

Free Whitepaper
img

Unlocking the clinical trial potential of Africa

Ongoing improvements around infrastructure, continued investment, and being home to one of the world’s largest working age populations, means that Africa’s role in the clinical trials market has transformed. In this whitepaper, Oximio outlines the dynamics of today’s clinical trial market in Africa, including the key challenges the region is facing and how sponsors can overcome them to unlock the continent’s growing potential.
by Oximio
Enter your details here to receive your free Whitepaper.

Favipiravir is a generic version of Fujifilm Toyama Chemical’s influenza drug Avigan, which holds approval in Japan for treating new influenza virus infections.

Glenmark developed the drug’s API and formulations internally. Following the regulatory approval, the new trial will assess the product in Covid-19 patients with mild to moderate infection.

Around 150 patients will be enrolled for the study. Participants will be given favipiravir plus standard supportive care or only standard supportive care.

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

Glenmark Pharmaceuticals Global R&D executive vice-president Sushrut Kulkarni said: “After having successfully developed the API and the formulations through its in-house R&D team, Glenmark is all geared to immediately begin clinical trials on favipiravir on Covid-19 patients in India.

“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.”

Favipiravir is already in several Covid-19 clinical trials in China, Japan and the US.

Last month, Fujifilm initiated a Phase II study of Avigan (favipiravir) to treat Covid-19 patients in the US. The trial will evaluate the drug’s safety and efficacy as a potential Covid-19 therapy.

The company also commenced a Phase III trial of Avigan for the treatment of Covid-19 patients in Japan.

In addition to treatment studies for Covid-19, Fujifilm is working to boost the production of Avigan to help fight the pandemic.

The drug is produced and distributed upon request by the government of Japan. Avigan was never distributed in the market and is not available at hospitals and pharmacies in Japan or internationally.

Related Companies

Free Whitepaper
img

Unlocking the clinical trial potential of Africa

Ongoing improvements around infrastructure, continued investment, and being home to one of the world’s largest working age populations, means that Africa’s role in the clinical trials market has transformed. In this whitepaper, Oximio outlines the dynamics of today’s clinical trial market in Africa, including the key challenges the region is facing and how sponsors can overcome them to unlock the continent’s growing potential.
by Oximio
Enter your details here to receive your free Whitepaper.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena