Japanese Company Says New Oral COVID-19 Drug Ensitrelvir Achieves Primary Endpoint

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Japanese pharmaceutical company Shionogi’s new oral COVID-19 drug has achieved the primary endpoint in a clinical trial, the company announced in September.

From February to July, Shionogi conducted a clinical trial with 1,821 people to evaluate ensitrelvir fumaric acid (S-217622), the oral drug the company developed in February. The subjects were not at risk for other diseases and had been vaccinated.

The endpoint for the clinical trial was the resolution of the five symptoms characteristic of the Omicron virus strain—stuffy or runny nose, sore throat, cough, feeling hot or feverish, and low energy or tiredness—according to a statement by the company.

Japan’s Minister of Health, Labour and Welfare Katsunobu Kato wearing a face mask speaks during a budget committee meeting at the lower house of parliament in Tokyo, Japan, on April 28, 2020. (Tomohiro Ohsumi/Getty Images)

Ensitrelvir—an inhibitor of 3CL protease, the main protease found in coronavirus—inhibits a different site from the spike protein targeted by the messenger RNA (mRNA) vaccines. It does not induce mutations in the spike protein and can inhibit the 3CL protease that is used to replicate the virus after it enters the cell. Ensitrelvir is the first non-peptide inhibitor clinically available for the treatment of COVID-19, according to the study, which was published in the Journal of Medicinal Chemistry in March, with Hokkaido University.

Katsunobu Kato, Japan’s Minister of Health, Labour, and Welfare, told the Senate Budget Committee on Oct. 20 that the public has high expectations for domestically produced therapeutic drugs.

“We will proceed with the review quickly, taking into account an emergency approval,” he said. “The data is being submitted in order regarding the results announced by [Shionogi].”

Zheng Jie, a medical doctor at the University of Tokyo, said that current drugs for the treatment of COVID-19 have significant side effects.

“The clinical data of the new drug developed by Shionogi is very meaningful,” Zheng told The Epoch Times on Nov. 13. “If approved by the regulatory authorities, it will be the first oral COVID-19 drug developed successfully in Japan.”

The Japanese government said in June that they had agreed with Shionogi in March that if the company receives emergency approval the government will purchase doses for one million people.

According to Japan’s Ministry of Health, Labour, and Welfare, as of November 2022, over 630 million people worldwide have been confirmed infected with COVID-19 and more than 6.6 million have died. The number of infected people in Japan is more than 22 million and 47,000 people have died.