Shionogi has announced the US availability of XOCOVA (ensitrelvir), an oral antiviral approved by the US Food and Drug Administration (FDA) for post-exposure prophylaxis (PEP) of COVID-19 in adults and adolescents aged 12 years and older following contact with someone who has COVID-19. The FDA approved XOCOVA in May 2026, making it the first and only oral option authorized in the US for preventing COVID-19 after exposure.
The drug is designed to block SARS-CoV-2 viral replication during the period between exposure and the potential development of COVID-19 symptoms. According to Shionogi, XOCOVA is intended to provide an option for people who have recently been exposed to the virus and want to reduce their risk of developing symptomatic disease.
XOCOVA is administered once daily over five days. Patients take three 125 mg tablets, totaling 375 mg, at the same time on the first day, followed by one 125 mg tablet daily on days two through five. The treatment should be started as soon as possible and within 72 hours after contact with an individual who has COVID-19.
The availability of XOCOVA comes as the US continues to monitor seasonal changes in COVID-19 activity. Shionogi cited wastewater surveillance data and federal modeling indicating that SARS-CoV-2 activity may increase during the summer period, particularly in parts of the country that had lower levels of activity during the previous fall and winter. The company is positioning the therapy as an additional tool for people seeking protection after an identified exposure.
Post-exposure prophylaxis has been used in other infectious diseases, and the FDA approval of XOCOVA extends this approach to an oral antiviral for COVID-19. Shionogi said the availability of the drug could give appropriate patients an option that can be taken quickly after exposure rather than waiting until symptoms develop.
The FDA’s approval was based on clinical evidence supporting the use of ensitrelvir for post-exposure prevention. XOCOVA is already approved in Japan, where Shionogi has developed the drug as part of its broader antiviral portfolio. In March 2026, Japan approved an expanded indication for XOCOVA for COVID-19 post-exposure prophylaxis based on results from the global Phase 3 SCORPIO-PEP study.
Shionogi is now working to expand access to XOCOVA across the US through a network of national and regional pharmacies. Selected retail pharmacies will stock the product, while pharmacies that do not keep it on hand will be able to order it through Shionogi’s wholesale distribution partners.
The company has also introduced a commercial copay program for eligible patients with commercial insurance. According to Shionogi, qualifying patients may pay as little as $0 per prescription fill, subject to the program’s eligibility requirements.
The Japanese pharmaceutical company is supporting the US launch with professional and consumer education efforts aimed at increasing awareness of the new post-exposure prevention option. Shionogi is also emphasizing the importance of having access to the medicine quickly because the treatment must be started within 72 hours of exposure.
Patients considering XOCOVA are advised to review dosing instructions and the expiration date on the product packaging before use. Shionogi also recommends that individuals discuss changes in prescription medicines, over-the-counter products, vitamins or supplements with a healthcare professional because of the potential for drug interactions. Pregnancy and breastfeeding status should also be reviewed before taking the medicine.
Another notable aspect of the US launch is that Shionogi says all components of XOCOVA are produced in the United States. This includes active pharmaceutical ingredient manufacturing, drug product formulation, packaging, quality control, release testing and supply chain and distribution activities.
The launch gives Shionogi a new position in the US COVID-19 prevention market at a time when treatment and prevention strategies are evolving beyond vaccines and symptomatic management. While vaccination remains an important public health measure, the availability of an oral post-exposure antiviral provides another potential layer of protection for eligible individuals following contact with the virus.
XOCOVA’s US launch also expands the global commercial footprint of ensitrelvir, which has been developed by Shionogi as an oral antiviral targeting SARS-CoV-2. The company will now focus on making the medicine accessible to eligible patients while building awareness among healthcare professionals and consumers about its use after COVID-19 exposure.
As the US continues to experience periodic increases in COVID-19 activity, Shionogi’s latest move places XOCOVA among the newer pharmaceutical options being used to address the changing needs of COVID-19 prevention. The product’s uptake will depend on awareness, timely access following exposure and continued evaluation of the role of post-exposure antiviral therapy in managing COVID-19.