European Commission Approves Shionogi's Zokovea (ensitrelvir)
核心洞察
Shionogi received European Commission marketing authorization for Zokovea (搜索) (ensitrelvir) for post-exposure prophylaxis of COVID-19 (搜索) in adults and adolescents aged 12 years and older.
The approval makes Zokovea (搜索) the first oral antiviral authorized in the EU for COVID-19 (搜索) post-exposure prophylaxis, based on the Phase 3 SCORPIO-PEP trial.
In SCORPIO-PEP, ensitrelvir cut the risk of symptomatic COVID-19 (搜索) through Day 10 by 67% versus placebo, with adverse event rates of 15.1% and 15.5%.
The European Commission has granted marketing authorization for Zokovea (搜索) (ensitrelvir) for post-exposure prophylaxis (PEP) of COVID-19 (搜索) in adults and adolescents aged 12 years and older, Shionogi announced. The decision makes Zokovea the first oral antiviral authorized in the EU for COVID-19 post-exposure prophylaxis, based on a search of the European Commission Union Register of medicinal products and European Medicines Agency records conducted in August 2026.
The authorization is supported by the global Phase 3 SCORPIO-PEP trial, a multicenter, randomized, double-blind, placebo-controlled study in household contacts of people with COVID-19 (搜索), run from June 2023 to September 2024. Among 2,041 household contacts with a central laboratory-confirmed negative SARS-CoV-2 test at baseline, treatment started within 72 hours of symptom onset in the infected household member reduced the risk of symptomatic COVID-19 through Day 10 by 67% versus placebo (ensitrelvir n=1,030; placebo n=1,011). Adverse event rates were similar between groups, at 15.1% for ensitrelvir and 15.5% for placebo, with headache, diarrhea and cough the most common events reported more frequently than placebo. Results were published in the New England Journal of Medicine on May 14, 2026.
Ensitrelvir is a SARS-CoV-2 main protease (搜索) inhibitor created through joint research between Hokkaido University and Shionogi. Outside the EU it is marketed as Xocova in Japan and the United States, and is approved in Japan for COVID-19 (搜索) treatment and, in Japan and the United States, for post-exposure prophylaxis in adults and adolescents aged 12 years and older. Xocova received emergency regulatory approval in Japan in November 2022 and full approval in March 2024 for COVID-19 treatment, with a supplemental approval in June 2026 covering pediatric patients aged 6 to under 12 years weighing at least 20 kg.
Source: Shionogi