Shionogi & Co announced that the FDA has approved XOCOVA (ensitrelvir), an oral antiviral, for post-exposure prophylaxis (PEP) of COVID‑19 in adults and adolescents 12 years and older following contact with an individual who has COVID‑19. The approval, which came ahead of the June 16, 2026 PDUFA action date, makes XOCOVA the first oral option cleared to help prevent COVID‑19 after exposure in the current U.S. treatment landscape. XOCOVA is given as a five-day regimen: three tablets on day one and one tablet daily on days two through five.
Frederick Hayden, MD, Richardson Professor Emeritus of Clinical Virology and Professor Emeritus of Medicine at the University of Virginia School of Medicine, said the approval offers an additional approach to preventing COVID‑19, which can become severe and can worsen chronic conditions or contribute to long COVID even when initially mild or moderate. He noted that ensitrelvir inhibits viral replication and can help protect exposed individuals from developing illness, and suggested that post-exposure prophylaxis could be useful in households as well as in settings such as nursing homes, chronic and acute care facilities, and following travel-related exposures.
The FDA decision is based on results from SCORPIO‑PEP, described as the only Phase 3 study of an oral antiviral to meet its primary endpoint of preventing symptomatic COVID‑19 after exposure to an infected individual. In the trial, XOCOVA reduced the risk of symptomatic COVID‑19 by 67% through day 10 compared with placebo in uninfected individuals following exposure (ensitrelvir n=1,030; placebo n=1,011). Overall, the drug was generally well tolerated, with adverse event rates of 15.1% in the XOCOVA group (n=1,190) and 15.5% in the placebo group (n=1,187). The most common adverse events (occurring in at least 1% of the XOCOVA group and more frequently than placebo) were headache, diarrhea, and cough. No cases of altered taste (dysgeusia) were attributed to XOCOVA in the trial. Results from SCORPIO‑PEP were published in the New England Journal of Medicine on May 14, 2026.
Nathan McCutcheon, president and CEO of Shionogi Inc., said XOCOVA is the first oral option shown in clinical trials to help prevent symptomatic COVID‑19 after exposure among participants regardless of vaccination status or prior infection. He described the approval as the latest step in Shionogi’s antiviral portfolio, which includes agents for HIV and influenza, and said XOCOVA provides an opportunity for people who have been exposed to COVID‑19 to act early to help protect themselves.
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