TOKYO, Jun 19 (Pulse News Wire) – Shionogi & CO.,LTD. (4507.T) announced today that its antiviral drug Zocova (generic name: ensitrelvir fumarate) has received additional approval in Japan for children aged six to twelve years old weighing more than 20 kilograms.
The new dosage regimen includes a smaller tablet size of 25 mg. This approval is based on results from a domestic phase three clinical trial involving 117 patients, which confirmed the safety and efficacy of the treatment. Zocova is now approved for treating mild to moderate cases of COVID-19 in adults and children over 12 years old, as well as for post-exposure prophylaxis in individuals aged six and older who weigh more than 20 kilograms. The expanded approval is expected to contribute to the treatment of a broader patient population, regardless of disease severity.
In related developments, Shionogi's subsidiary, Shionogi Inc., received FDA approval in May 2026 for the prevention of post-COVID exposure in the United States. Additionally, the European Medicines Agency is currently reviewing applications for both treatment and prevention of COVID-19 with Zocova. In Singapore, the drug was granted special import permission through the Special Access Route (SAR) system in November 2023, allowing some medical institutions to use it. Shionogi continues to prioritize research and development efforts aimed at addressing emerging variants and future outbreaks, ensuring timely provision of necessary treatments, vaccines, and preventive measures against infectious diseases.
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