Ensitrelvir Fumaric Acid

Highlights Include an Oral Presentation of New Data from the Global Phase 3 SCORPIO-PEP Study and New Real-World Analysis on Respiratory Tract Infections from the PROVE Observational Study FLORHAM PARK, N.J.--(BUSINESS WIRE)--Shionogi Inc., a New Jersey-based subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.), will present findings from across its broad anti-infective portfolio at IDWeek 2026 (October 21-24, 2026), in Washington, D.C. Data highlights at IDWeek 2026 include an oral presentation featuring a subpopulation analysis from the global Phase 3 SCORPIO-PEP trial, a rapid-fire session focused on ventilator-associated pneumonia isolates from the SENTRY Antimicrobial Surveillance Program and 18 additional presentations across Shionogi’s COVID-19 antiviral and Gram-negative antibiotic programs. “At IDWeek, we build on our legacy as a research-driven company by sharing new data from across our portfolio of marketed products and investigational therapies, while highlighting important milestones, including the FDA approval of XOCOVA and the acceptance of the supplemental New Drug Application for pediatric use of Fetroja,” said Nathan McCutcheon, MBA, President and CEO, Shionogi Inc. “Equally important, IDWeek provides an opportunity to engage with the infectious disease community, deepen our understanding of evolving patient needs, and gain insights that help shape future research efforts and foster meaningful collaborations.” IDWeek attendees can visit Shionogi at Booth #815 to learn more about the company’s infectious disease research and innovation. XOCOVA ® (ensitrelvir) and COVID-19 data presentations: Oral Presentation October 23, 2026 3:15-3:27 PM: Early Pre-Symptomatic Treatment with Ensitrelvir Among PCR-Positive, SARS‑CoV‑2-Exposed and Infected Household Contacts: SCORPIO‑PEP Subpopulation Analysis Poster #2100: Reduction of Infectious SARS-CoV-2 and Viral Titer with Ensitrelvir: A Pooled Analysis of SCORPIO-SR and SCORPIO-HR Trials Poster #2113: Impact of Acute COVID-19 on Underlying Chronic Conditions: Systematic Literature Review Poster #2149: Brain Microstructural Disorganization as a Potential Mechanism of post-COVID-19 Condition and the Onset-suppressive Effects of Ensitrelvir Revealed by Advanced Diffusion MRI–based Translational Research Poster #2143: Ensitrelvir Suppresses Fatigue-like Symptoms Derived from SARS-CoV-2 Infection in Hamsters Fetroja ® (cefiderocol) data presentations: Rapid Fire Session October 24, 2026 12:15-1:30 PM Poster #459: Cefiderocol Activity Across Highly Resistant Pseudomonas aeruginosa Ventilator-Associated Pneumonia Isolates: A Global Surveillance Study of SENTRY 2020-2024 Poster #144: Outcomes of Cefiderocol Treatment in U.S. Patients with Respiratory Tract Infections: Subgroup Analysis of the PROVE Observational Study Poster #93: Clinical Outcomes After Cefiderocol Therapy for Pseudomonas spp. Infections: Results from a Systematic Literature Review Poster #94: Systematic Literature Review of the Clinical Outcomes Associated with Cefiderocol Therapy for Stenotrophomonas maltophilia Infections Poster #141: In vitro Activity of Cefiderocol (FDC) Against a Collection of Infrequently Isolated Gram-Negative Bacterial Isolates from the SENTRY Antimicrobial Surveillance Program Poster #1445: Activity of Cefiderocol Against Carbapenem-Resistant Pseudomonas aeruginosa Encountered in Each of the Different United States Census Bureau Divisions Poster #1465: Activity of cefiderocol against carbapenem-nonsusceptible Gram-negative isolates from skin and soft tissue infections in U.S. and European medical centers collected as part of the SENTRY antimicrobial surveillance program (2020-2024) Poster #160: Activity of Cefiderocol against Metallo-Beta-Lactamase Carrying Pseudomonas aeruginosa of the SENTRY Antimicrobial Surveillance Program (2020-2024) Shionogi will also present preclinical research on xeruborbactam, an investigational beta-lactamase inhibitor, discovered by Qpex Biopharma, Inc., a Shionogi Group Company. For full Prescribing Information for XOCOVA ® (ensitrelvir), including approved indications and Safety Information, please visit For full Prescribing Information for Fetroja ® (cefiderocol), including approved indications and Safety Information, please visit About Shionogi Inc. Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a global research‑driven pharmaceutical company. Since 1878, Shionogi has been developing new treatments to improve patients' lives worldwide. Today in North America, our portfolio of FDA-approved products includes an antibiotic for serious infections caused by susceptible Gram-negative bacteria, an oral antiviral for post-exposure prophylaxis of COVID-19 and a therapy for amyotrophic lateral sclerosis (ALS). Our pipeline programs include investigational treatments across infectious disease, rare disease and additional high‑need therapeutic areas. Together with our subsidiaries Qpex Biopharma Inc. and Shionogi Canada Inc., we are continuing to innovate for patients in the U.S. and worldwide. Learn more at shionogi.com . About Shionogi in Infectious Disease For more than 60 years, Shionogi has discovered and commercialized novel antibiotics. Today, our R&D story extends beyond antibiotics to include novel medications for HIV and influenza. Our global pipeline includes investigational agents to address global health challenges including antimicrobial resistance, COVID-19, influenza, rare fungal diseases and respiratory syncytial virus. As part of our commitment to addressing unmet medical needs, Shionogi partners with several non-governmental organizations to increase equitable access to our medications worldwide. Shionogi and Global Antibiotic Research and Development Partnership (GARDP) have a license and technology transfer agreement and Shionogi and GARDP have a collaboration agreement with the Clinton Health Access Initiative (CHAI) that aim to transform the landscape of access to antibiotics in many low-income countries, most lower middle- and upper middle-income countries, and select high-income countries. Shionogi ranked #2 among large research-based pharmaceutical companies in the Access to Medicine Foundation’s 2026 Antimicrobial Resistance (AMR) Benchmark, a global assessment of how leading pharmaceutical companies are tackling antimicrobial resistance and expanding responsible access to antibiotics worldwide. About Shionogi & Co., Ltd. Shionogi & Co., Ltd. is a 148-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders and cardiovascular diseases. Shionogi’s research and development currently targets two therapeutic areas: infectious diseases and diseases with unmet medical needs in pain/CNS, including Alzheimer’s disease, oncology, rare diseases, and sleep apnea. For more information on Shionogi & Co., Ltd., please visit . Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. Contacts For Further Information: SHIONOGI Website Inquiry Form: U.S. Media: ShionogiCommunications@shionogi.com Shionogi Europe Press Office: pressoffice@shionogi.eu

After an earlier-than-expected FDA green light, Shionogi is rolling out COVID-19 antiviral Xocova with a tagline urging consumers to “make the call” on the pill after exposure. Xocova became the U.S.’s first oral med approved for post-exposure prophylaxis (PEP) of COVID in adults and adolescents aged 12 and older in June after first rolling out in the company’s home country of Japan in 2022. The pill is meant to be taken once-daily over a five-day regimen within 72 hours of coming into contact with someone who has COVID. The mid-summer launch coincides with the COVID-19 summer spike that has occurred in the U.S. every year since 2020, Shionogi points out in a July 28 press release , citing data that signals another COVID summer wave may be already on the way. The company emphasizes the importance of having the med, available at pharmacies, “on hand” and available to take within the 72-hour window following exposure “Taking Xocova to help prevent COVID-19 in the critical window between exposure and symptom onset makes sense for anyone who wants to try 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,” University of California, Irvine, School of Medicine’s Charles Vega, M.D., commented in the release. The company’s new “Got the Call, Make the Call” campaign kicks off its consumer education push and includes a national TV ad and streaming, video and audio amplification. The 90-second TV ad , ‘Hi Mom’, starts with a mother answering a phone call from her sniffling son. He bares bad news: “I have COVID-19, and I think I exposed you and Dad yesterday,” he says. Mom rises from the couch to call her doctor, with one ear toward a phone call with her doctor and the other phone, her son still on the line, pressed to her other ear. Her son, listening to Mom’s end of the conversation with Dr. Warren, suggests she ask about Xocova. The doctor confirms that Xocova is the only prescription pill for people 12 years and older to “help prevent you from getting sick after exposure to COVID-19,” she says, as a graphic displaying the indication bounces on screen. Mom relays this information to her husband as the doctor goes into trial results proving that the drug reduces the risk of symptomatic COVID-19 by 67%. The Dad trails Mom as she paces around the living room on both phone calls while a voiceover lists Xocova’s prescribing information and side effects, continuing as the couple humorously bumps into each other and attempts to share the phone to allow both to listen in. “He’s at high risk,” the Mom says, handing Dad both phones and interrupting his incoming sandwich bite in the process. With the son again saying to ask about Xocova, the scene begins to play again, but this time with the Dad asking the doctor about Xocova as Mom takes the chance to chow down on the sandwich. “You never know when, but when you get the call, make the call,” a different voiceover says at the end of the spot, before an “ask your doctor about Xocova” jingle plays over the sound of a ringing phone. Although COVID’s peak has long been in the rearview, the virus remains highly transmissible and up to 47% of people living with an infected individual could develop the infection as well, according to Shionogi. As the first and only COVID preventative pill, Xocova represents a unique new addition to the COVID landscape, which includes vaccines and treatments such as Pfizer’s Paxlovid and Merck’s Lagevrio.