FDA
FDA adds Xocova to COVID-19 prevention toolkit
COVID-19 continues to cause substantial morbidity, particularly among older adults and individuals with chronic medical conditions. While vaccines remain the cornerstone of prevention, treatment options specifically intended to prevent illness after a known exposure have been limited.
On May 29, 2026, FDA approved Xocova (ensitrelvir) for post-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older following contact with an individual who has COVID-19. Xocova is the first oral antiviral approved in the United States to help prevent COVID-19 after exposure.
Xocova is a SARS-CoV-2 main protease inhibitor that blocks viral replication during the interval between exposure and symptom onset. The regimen consists of a 5-day oral course, with three tablets taken on day 1, followed by one tablet daily on days 2 through 5.
The approval was based on the phase 3 SCORPIO-PEP trial, which enrolled 2,387 household contacts of individuals with symptomatic COVID-19. More than 99% of participants had evidence of prior vaccination, infection, or both, making the findings particularly relevant to the current population.
Among participants who were uninfected at baseline, Xocova reduced the risk of symptomatic COVID-19 by 67% through day 10 compared with placebo. The study met its primary endpoint and is the first phase 3 trial of an oral antiviral to demonstrate prevention of symptomatic COVID-19 following exposure.
Safety outcomes were similar between groups, with adverse events reported in 15.1% of participants receiving Xocova and 15.5% receiving placebo. The most common adverse events occurring more frequently with Xocova were headache, diarrhea, and cough.
“The FDA approval of Xocova provides an important new approach to preventing COVID-19, which continues to impact lives,” said Frederick Hayden, MD, professor emeritus of Clinical Virology and professor emeritus of Medicine at the University of Virginia. “Ensitrelvir inhibits viral replication, helping protect people who have been exposed to COVID-19 from developing illness. The PEP strategy has the potential to benefit anyone who does not want to get COVID-19. It could be useful not only in household settings but also in other exposure circumstances, such as outbreaks in nursing homes, chronic or acute care facilities and following travel-related exposures.”
Source: Shionogi. (2026, June 1). Press release. Shionogi announces FDA approval of Xocova (ensitrelvir), the first and only oral option to help prevent COVID-19 following exposure