FDA Approves Xocova as First Oral Therapy for COVID-19 Prevention

On September 11, 2026, the U.S. Food and Drug Administration (FDA) approved Shionogi’s Xocova (ensitrelvir) as the first oral therapy for post-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older. This decision marks a shift in how the virus is managed, moving from emergency response toward long-term endemic strategies. The approval rested on data from the Phase III Scorpio-Pep trial, which showed a 67% reduction in the risk of symptomatic infection among people who had been exposed to the virus.

The Scorpio-Pep trial included 2,387 participants who were uninfected at the start of the study but lived with someone who had symptomatic COVID-19. These individuals began treatment within 72 hours of exposure. Results showed that Xocova effectively blocked the onset of symptoms, making it the first oral antiviral recognized for preventive use. Frederick Hayden, MD, a specialist in clinical virology, highlighted the significance of the move, stating that it provides a crucial new approach to preventing COVID-19. By inhibiting viral replication, the drug prevents those exposed to the virus from becoming ill.

Researchers found the safety profile of Xocova to be favorable, with side effects occurring at similar rates in both the treatment and placebo groups. Developed through a partnership between Shionogi and Hokkaido University, the medication is taken as a five-day oral regimen: three tablets on the first day, followed by one tablet daily for the four days that follow. While the drug is already approved in Japan for both treatment and prevention, its U.S. approval is currently focused on post-exposure prophylaxis, a vital tool as the virus remains a public health concern.

The rollout of Xocova comes as the CDC reports high levels of COVID-19 activity in the United States, with millions of infections and thousands of hospitalizations recorded in recent months. This oral therapy offers a new way to manage the virus, particularly for people who know they have been exposed. As the global response to COVID-19 continues to evolve, the approval of Xocova stands as a milestone in the effort to establish reliable preventive measures.