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JUN 1 2026
APPROVED · 60 DAYS AGO

Shionogi & Co., Ltd. Xocova (ensitrelvir) $SGIOY

for COVID-19 post-exposure prophylaxis

NDA

FDA approved Xocova (ensitrelvir) as the first oral option for post-exposure prophylaxis of COVID-19, expanding the preventive toolkit beyond vaccines and the high-risk-only monoclonal antibody pemivibart.

About

Xocova (ensitrelvir) is an oral pill that blocks a key protein (3CLpro) the SARS-CoV-2 virus needs to make copies of itself and cause infection. By interfering with this viral machinery right after an exposure, the drug could potentially prevent the infection from taking hold in the body, offering a new prophylactic option beyond vaccines.

Pivotal trial

NCT05605093 Phase 3 terminated NCT05605093

Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi \&; Co

Source: ClinicalTrials.gov

Also in development