Japanese pharmaceutical company Shionogi has enrolled the first participant in its global Phase 3 trial of Ensitrelvir, an oral antiviral designed to prevent symptomatic SARS-CoV-2 infection. The study will evaluate the drug's safety and efficacy in preventing infection among people exposed to household contacts who have tested positive for COVID-19. Approximately 2,200 participants across North America, South America, Europe, Africa and Asia will be recruited for the double-blind placebo-controlled study. Ensitrelvir received emergency regulatory approval from Japan's Ministry of Health in November 2022 and was granted Fast Track designation by the US Food and Drug Administration in April 2023. The randomized, double-blind, placebo-controlled global study is expected to recruit around 2,200 participants across five continents.
Keywords: Shionogi, Ensitrelvir, SARS-CoV-2 infection, Phase 3 trial, prevention
Shionogi & Co., Ltd. announced that it has filed for full approval of ensitrelvir in Japan and enrolled the first participant in Japan for its global Phase 3 study named Stopping COVID-19 pRogression with early Protease InhibitOr treatment – Post Exposure Prophylaxis (SCORPIO-PEP