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Shionogi Still Hopeful For Xocova In US Despite Phase III Fail

Missed Primary Endpoints

 
• By Lisa Takagi

Despite sales success in Japan and a fast track designation in the US, Shionogi’s oral COVID-19 therapeutic has missed statistical significance in a global Phase III trial in patients with mild to moderate symptoms.

Shionogi's Xocova faced a thick wall of P3 failure before its NDA filing in the US after a huge commercial success in Japan.
Xocova faces US Phase Phase III failure after commercial success in Japan • Source: Shutterstock

A global Phase III clinical trial with Shionogi & Co. Ltd.’s oral COVID-19 therapeutic Xocova (ensitrelvir) for non-hospitalized patients has missed its primary endpoint, the Japanese firm announced on 13 May.

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