Shionogi files in Japan to expand pediatric use of COVID-19 antiviral

Japanese drugmaker Shionogi (TYO: 4507) has filed a supplemental application in Japan to broaden the use of its oral antiviral Xocova (ensitrelvir), aiming to include children as young as six who weigh at least 20 kilograms.

Developed in collaboration with Hokkaido University, the molecule targets the 3CL protease enzyme—an essential component in the coronavirus life cycle. Though still considered investigational outside of Japan and Singapore, the drug has shown promise as both a treatment and preventative option.

The treatment is used to treat COVID-19 in patients aged 12 and older. The new submission requests approval of a 25mg tablet designed for easier administration in younger children and is supported by positive data from a Phase III trial in Japan.