Shionogi Announces Supplemental Approval in Japan for Pediatric Dosage and Administration of XOCOVA to Treat COVID-19

Shionogi & Co., Ltd. announced on June 19, 2026, that it received supplemental approval in Japan for the pediatric dosage and administration of XOCOVA^®^ (ensitrelvir fumaric acid) for treating COVID-19 in pediatric patients aged 6 to under 12 years who weigh at least 20 kg.

The approval also includes newly approved 25 mg tablets, designed for easier administration in younger children, although these tablets have not yet been cross-listed in the standard drug price schedule.

The supplemental approval is based on a Phase 3 clinical trial in Japan in pediatric patients aged 6 to under 12 years with SARS‑CoV‑2 infection, which demonstrated favorable safety and pharmacokinetic profiles comparable to those predicted in adults receiving therapeutic doses.

With this approval, XOCOVA becomes a treatment option for pediatric patients aged 6 years and older weighing at least 20 kg, in addition to its existing indication for adults and pediatric patients aged 12 years and older, broadening its use as an oral anti‑SARS‑CoV‑2 drug regardless of risk factors for progression to severe disease.