Shionogi Announces U.S. Availability of XOCOVA® (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following Exposure*｜ 塩野義製薬

Release

2026/07/29

Shionogi Announces U.S. Availability of XOCOVA® (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following Exposure*

Once-daily oral XOCOVA is now available by prescription for adults and adolescents 12 years of age and older1

In a global clinical trial, XOCOVA significantly reduced the risk of symptomatic COVID-19 by 67% following exposure to an infected individual, compared to placebo2

XOCOVA availability comes ahead of anticipated summer surge in COVID-19 cases3

OSAKA, Japan, July 29, 2026 – Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced the U.S. availability of XOCOVA® (ensitrelvir), an oral antiviral approved for post-exposure prophylaxis (PEP) of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID‑192. XOCOVA is now available in the United States through Shionogi Inc., Shionogi’s U.S. subsidiary.

XOCOVA offers a new approach to help prevent COVID-19 by blocking viral replication during the critical window between exposure and COVID-19 symptom onset.4,5 XOCOVA is taken once daily, with three 125 mg tablets (375 mg) taken at the same time on the first day, followed by one 125 mg tablet on days two to five. XOCOVA should be taken as soon as possible and within 72 hours following contact with an individual who has COVID‑19.1

“With XOCOVA, we have a novel oral option to help prevent COVID-19 after exposure and it is available just in time for the annual late summer spike,” said Charles Vega, MD, FAAFP, Health Sciences Clinical Professor, University of California, Irvine, School of Medicine. “Taking XOCOVA to help prevent COVID-19 in the critical window between exposure and symptom onset makes sense for anyone who wants to avoid illness, and it could be especially beneficial for older adults and individuals with health conditions that may put them at higher risk for severe illness. Now, in addition to recommending my patients stay updated with vaccinations, I’ll be talking to them about XOCOVA, so they are ready to act quickly in the event of an exposure.”

The U.S. has experienced a COVID-19 summer spike every year since 2020.3 Biobot Analytics, a wastewater intelligence company with continuous and longitudinal data on pathogens from wastewater, reports that SARS-CoV-2 levels are beginning to rise, providing an early, population-level signal that another COVID-19 summer wave may be taking shape.6 Scenario modeling from The Centers for Disease Control and Prevention indicates there may be increased COVID-19 activity in regions (South and West) which did not experience a substantial level of COVID-19 activity during the most recent winter months.3

“Post-exposure prophylaxis, or PEP for short, has been used successfully with influenza as well as HIV and other sexually transmitted infections, and it has the potential to help reduce the burden of COVID-19,” said David Wohl, MD, Professor of Medicine, The University of North Carolina at Chapel Hill, School of Medicine. “The availability of XOCOVA means that now, for the first time, there’s an oral option that can help prevent COVID-19 after exposure. Since XOCOVA must be taken within 72 hours of exposure, having it on hand can help ensure it is taken within the critical window between exposure and COVID-19 symptom onset.”

Having XOCOVA on hand can help appropriate patients be prepared in the event of a COVID-19 exposure. Before taking XOCOVA, individuals should review the dosing and administration instructions and check the expiration date on the blister pack. They should also speak with a healthcare professional if there are any changes to their medications (including prescription and over-the-counter medicines), vitamins or supplements and verify they are not pregnant or are not breastfeeding.

In the United States, Shionogi Inc. is supporting the availability of XOCOVA through professional and consumer education initiatives and partnerships with national and regional pharmacies to help ensure product availability.

In the United States, Shionogi Inc. offers a commercial co-pay program for XOCOVA that helps eligible, commercially insured patients with out-of-pocket costs.

For the U.S. market, all components of XOCOVA are produced in the U.S., including active pharmaceutical ingredient production, drug product formulation, packaging, quality control, release testing, supply chain management and distribution.

The Ongoing Impact of COVID-19

COVID-19 remains highly transmissible, driven by Omicron and its subvariants, and up to 47% of people living with an infected individual may develop COVID-19.7 The U.S. Centers for Disease and Control and Prevention estimates that between October 1, 2025, and July 4, 2026, there were...