Ensitrelvir suppresses SARS-CoV-2 by selectively inhibiting the 3CL protease. Credit: visuals3Dde from Pixabay.

Taiwan Shionogi, a subsidiary of the Japanese pharmaceutical company Shionogi, has filed an application with the Taiwan Food and Drug Administration (TFDA) to obtain emergency use authorisation (EUA) for ensitrelvir fumaric acid (ensitrelvir).

The TFDA has accepted the application for EUA to use the drug for the treatment of Covid-19 patients.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Taiwan Shionogi will work with the regulator to secure the EUA for ensitrelvir in Taiwan as soon as possible.

Shionogi stated that the EUA filing is based on the data obtained from Phase III of the pivotal Phase II/III SCORPIO-SR trial, which was conducted in South Korea, Vietnam and Japan.

In Phase III of the trial, ensitrelvir is claimed to be the first antiviral agent to demonstrate clinical symptomatic efficacy for five typical Omicron-related symptoms, and antiviral efficacy in patients who are predominantly vaccinated and have mild to moderate Covid-19 infection.

Phase IIb/III of the Phase II/III trial is currently being conducted in Asia, chiefly in Japan. It targets Covid-19 patients who were asymptomatic or only had mild symptoms.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Ensitrelvir, known as Xocova in Japan, is an oral antiviral drug which suppresses the duplication of SARS-CoV-2 by selectively inhibiting the 3CL protease. It was co-created by Shionogi and Hokkaido University. 

In November 2022, the Japanese Ministry of Health, Labour and Welfare (MHLW) granted emergency regulatory approval to ensitrelvir to treat SARS-CoV-2 infection.

In early April 2023, ensitrelvir received Fast Track designation from the US Food and Drug Administration (FDA).