Shionogi Completes Acquisition of All Rights to RADICAVA (edaravone)
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced that we have completed the transfer of all rights for RADICAVA (edaravone), including intellectual property rights and sales rights, in major countries and regions to our company from Tanabe Pharma Corporation. Transfer of rights in additional countries and regions is forthcoming. The acquisition and integration of RADICAVA team members, programs and platforms adds to ongoing strategic investments in rare disease and establishes Shionogi as a commercially viable rare disease company ready to introduce new treatments to patients with unmet medical needs.
Shionogi Announces First Patients Enrolled in Global Phase 2 Clinical Trial in Adults with Late-Onset Pompe Disease
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced the first patients were enrolled in Esprit, a global Phase 2 clinical trial evaluating S-606001, an investigational drug for the treatment of late-onset Pompe disease (LOPD).
Shionogi Expands Rare Disease Presence with Planned Acquisition of Global Rights to Tanabe Pharma Corporation’s RADICAVA ORS® (edaravone) and IV RADICAVA
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced that its Board of Directors, at a meeting held on December 22, 2025, resolved to acquire a newly established company that Tanabe Pharma Corporation (Head Office: Osaka, Japan; Chief Executive Officer: Akihisa Harada; hereafter “Tanabe Pharma”) will create to hold the rights to RADICAVA ORS® (edaravone) and IV RADICAVA. Tanabe Pharma plans to form this new entity, and Shionogi intends to purchase 100% of its shares. The agreement between Shionogi and Tanabe Pharma was signed this afternoon. As part of the transaction, a new business company established by Tanabe for RADICAVA in the U.S. will become a wholly owned subsidiary of Shionogi Inc.
IDWeek 2025: Shionogi Presents Real-World and Surveillance Data Reinforcing Role of Cefiderocol Across Range of Patient Populations and Difficult-to-Treat Infections
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) presents new data at IDWeek 2025, demonstrating broad activity of Fetroja®/Fetcroja® (cefiderocol) across infection types and adult patient populations. Results from the PROVE (Retrospective Cefiderocol Chart Review) study showed the effectiveness of earlier appropriate cefiderocol use in real-world settings, while data from the SENTRY Antimicrobial Surveillance Program further demonstrated the susceptibility of a broad range of clinically significant Gram-negative (GN) pathogens to cefiderocol.1,2,3,4,5
Shionogi to Present New Data from Anti-Infective Portfolio at IDWeek
Shionogi Inc., a United States subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.), will share 17 scientific presentations from across its anti-infective programs at IDWeek 2025 (October 19-22, 2025) in Atlanta, Georgia.
FDA Accepts Shionogi’s Ensitrelvir NDA as the First Oral Therapy for the Prevention of COVID-19 Following Exposure
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) from Shionogi Inc., a New Jersey-based subsidiary of Shionogi, for ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622), an investigational oral antiviral for the prevention of COVID-19 following exposure to an infected individual. The FDA has set an action date of June 16, 2026 under the Prescription Drug User Fee Act (PDUFA).
Late-Breaking at CROI 2025: SCORPIO-PEP Phase 3 Trial: Ensitrelvir is the First and Only COVID-19 Oral Antiviral to Demonstrate Prevention of COVID-19 as Post Exposure Prophylaxis
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) delivered a late-breaking scientific oral presentation at the Conference of Retroviruses and Opportunistic Infections (CROI) 2025, including new data from its global, double-blind, randomized, placebo-controlled Phase 3 study, Stopping COVID-19 pRogression with early Protease InhibitOr treatment – Post-Exposure Prophylaxis (SCORPIO-PEP) assessing ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”) as oral post-exposure prophylaxis. SCORPIO-PEP is the first and only Phase 3 study of a COVID-19 oral antiviral as a post-exposure prophylaxis to meet the primary endpoint of preventing COVID-19.*
Shionogi and Jordan’s Guardian Angels Announce First-Ever Human Drug Study for Jordan’s Syndrome, an Ultra-Rare Genetic Neurodevelopmental Disorder
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, PhD.; hereinafter “Shionogi”) and Jordan’s Guardian Angels announced a research collaboration between their organizations and the first-ever clinical trial evaluating an investigational drug for PPP2 syndrome type R5D (Houge-Janssens syndrome 1, HJS1), commonly referred to as Jordan's Syndrome.
Shionogi Receives Award Through BARDA's Rapid Response Partnership Vehicle to Advance Long-Acting Formulation of S-892216, an Antiviral for COVID-19 Pre-Exposure Prophylaxis in At-Risk Populations
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced Shionogi Inc., a New Jersey-based subsidiary of Shionogi, has been awarded a $375 million project agreement through the Rapid Response Partnership Vehicle (RRPV), to advance the development of S-892216, a 3CL protease inhibitor, as a long-acting injectable for COVID-19 pre-exposure prophylaxis.
IDWeek 2024: Shionogi Presents Largest Global Real-World Evidence Study of Cefiderocol Demonstrating Strong Clinical Response Rates Across Seriously Ill Patients
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President & CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announces new data at IDWeek 2024 from PROVE (Retrospective Cefiderocol Chart Review), the largest global real-world evidence study of Fetroja®/Fetcroja® (cefiderocol), an innovative siderophore cephalosporin, for the treatment of seriously ill adult patients with certain Gram-negative (GN) bacterial infections, the majority of which were carbapenem-resistant (CR).
Shionogi Continues Global Commitment to Advances in Infectious Disease with Key Data Presentations from Its Expanding Product Portfolio at IDWeek 2024
Shionogi Inc., the United States subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.) will have 22 scientific presentations across the company’s infectious disease portfolio at IDWeek 2024 (October 16-19, 2024) in Los Angeles, California.
Shionogi Provides Updates on Zatolmilast, an Investigational Drug for Fragile X Syndrome, Including Recent Changes to Study Protocol to Increase Access for Participants and Families
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced progress on the development program for zatolmilast (BPN14770), an investigational drug for Fragile X syndrome (FXS), the leading cause of inherited intellectual disabilities, like autism spectrum disorder.1 Zatolmilast was discovered by Tetra Therapeutics Inc., (hereafter “Tetra”), which was acquired by Shionogi in 2020.
Shionogi Expands Global Infectious Disease and Antimicrobial Research Operations to U.S. to Address Current and Emerging Health Threats
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced the company is responding to the urgent global need for additional antimicrobial research and development by establishing its first discovery laboratory in the U.S., in San Diego, California.
Shionogi & Co., Ltd. and Maze Therapeutics, Inc. Announce Exclusive Worldwide License Agreement for MZE001, a Novel Therapeutic Candidate for the Treatment of Pompe DiseaseShionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) and Maze Therapeutics, Inc. (Head Office: South San Francisco, California, USA; Chief Executive Officer: Jason Coloma, Ph.D.; hereafter “Maze”) announced the companies have completed an exclusive worldwide license agreement for the rights to MZE001, an investigational oral glycogen synthase 1 (GYS1) inhibitor that aims to address Pompe disease by limiting disease-causing glycogen buildup.
ESCMID Global 2024: Shionogi presents real-world data demonstrating efficacy of Fetcroja® / Fetroja® (cefiderocol) in critically ill patients with certain difficult-to-treat bacterial infections
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President & CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announces new data from the largest European real-world evidence study (PERSEUS) of Fetroja®/Fetcroja® (cefiderocol), an innovative siderophore cephalosporin, for the treatment of critically ill patients with carbapenem-resistant (CR) Gram-negative (GN) bacterial infections at the 34th ESCMID Global (formerly ECCMID) in Barcelona, 27–30 April, 2024.
Shionogi Announces New Phase 3 Data Showing Early Resolution of Many Common COVID-19 Symptoms in JAMA Network Open
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) announced the first peer-reviewed publication of the Phase 3 portion of its pivotal, double-blind, randomized, placebo-controlled Phase 2/3 study (SCORPIO-SR) in patients with mild to moderate COVID-19 in Japan, South Korea and Vietnam in JAMA Network Open. The trial met its primary and key secondary endpoints, making ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”) the first antiviral agent to show both clinical symptom improvement and antiviral effect in a predominantly vaccinated population with Omicron infection regardless of risk factors.*
Shionogi Strengthens Regulatory Leadership with the Appointment of Dr. Ramón Polo as Senior Vice President, Head of Regulatory Affairs
Shionogi Inc., a U.S. subsidiary of Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.; hereinafter “Shionogi”), announced the appointment of Ramón Polo, MBA, PharmD, Ph.D. as Senior Vice President, Head of Regulatory Affairs.
Shionogi Presents New Ensitrelvir COVID-19 Data Supporting Effectiveness in Real-World and Clinical Settings at IDWeek 2023
Shionogi Inc., a United States subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.) will present new real-world and clinical data at IDWeek 2023 reinforcing the potential of ensitrelvir, its investigational oral antiviral, to treat the symptoms of COVID-19.
IDWeek 2023: Shionogi Presents New Real-World Evidence Demonstrating Effectiveness of Earlier Treatment with Fetroja® (cefiderocol) in Appropriate Patients
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that it will present real-world evidence (RWE) suggesting treatment with Fetroja® (cefiderocol) is effective in treating Gram-negative infections and that appropriate patients who received Fetroja earlier (within 6-20 days of index culture) had lower in-hospital all-cause mortality (IHACM) than those receiving it later (>20 days).1 The data are being presented at IDWeek 2023, which is taking place in Boston, October 11-15.
Zatolmilast, an Investigational Treatment for Fragile X Syndrome, Receives Rare Pediatric Disease Designation from the U.S. FDA
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced the U.S. Food and Drug Administration (FDA) has granted Tetra Therapeutics Inc. (hereafter "Tetra"), a Shionogi Group Company, Rare Pediatric Disease Designation for zatolmilast (BPN14770), an investigational treatment being studied for Fragile X syndrome (FXS), a leading cause of inherited intellectual disability and autism.
Shionogi Presents New Ensitrelvir Clinical and Real-World Data Reinforcing Potential Across COVID-19 Populations at ESWI 2023
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") will present two late-breaking posters at the European Scientific Working Group on Influenza and other Respiratory Viruses’ (ESWI), 9th Influenza Conference, highlighting data suggesting the potential of its investigational oral antiviral ensitrelvir on symptoms associated with long COVID and in high-risk COVID-19 hospitalized patients with significant co-morbidities who did not respond to first-line treatment with remdesivir.
Critical agreement paves way for new model to accelerate access to important antibiotics for serious bacterial infections
A new agreement is poised to accelerate antibiotic access for tens of thousands of patients in regions with the highest rates of antimicrobial resistance (AMR). The Global Antibiotic Research & Development Partnership (GARDP) and India-based Orchid Pharma Ltd (Orchid) have signed a sublicense agreement to manufacture cefiderocol, an antibiotic to treat certain Gram-negative infections. This agreement is a critical step in an ambitious project by Shionogi & Co. Ltd. (Shionogi), GARDP, and the Clinton Health Access Initiative (CHAI) that aims to provide access to cefiderocol in a number of predominantly low- and middle- income countries, pending local authorization or national regulatory approval.
IDWeek 2023: Shionogi and Qpex Biopharma, Inc. Continue Longstanding Commitment to Addressing Unmet Needs in Infectious Disease
Shionogi Inc., the United States subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.), announced the upcoming presentation of new data at IDWeek 2023 (October 11-15, 2023) on its investigational oral antiviral for COVID-19, ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”), and Fetroja® (cefiderocol), an antibiotic marketed under the brand name Fetcroja® in Europe.
Shionogi Further Extends Infectious Disease Innovation Platform with Planned Acquisition of Qpex Biopharma, Inc.
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that Shionogi Inc., a New Jersey-based subsidiary of Shionogi, has entered into a definitive agreement pursuant to which Shionogi Inc. will acquire Qpex Biopharma, Inc. (Head Office: San Diego; President & CEO: Michael Dudley; hereafter "Qpex"), a privately held clinical stage pharmaceutical company with expertise in antimicrobial research and development. Following the completion of the acquisition, which is subject to customary closing conditions, Qpex will become a wholly owned subsidiary of Shionogi Inc.
Shionogi Enrolls the First Participant in Japan in its Global Phase 3 Trial of Ensitrelvir for the Prevention of Symptomatic SARS-CoV-2 Infection
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) today announced the first participant has been enrolled in Japan in its global Phase 3 study, Stopping COVID-19 pRogression with early Protease InhibitOr treatment – Post Exposure Prophylaxis (SCORPIO-PEP). The study will evaluate the safety and efficacy of the novel COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”) for the prevention of symptomatic SARS-CoV-2 infection in study participants exposed to household contacts who are symptomatic and tested positive for SARS-CoV-2, when compared to placebo. The first participant is expected to be enrolled in the U.S. in July. In addition, Shionogi also announced that it has filed for full approval of ensitrelvir in Japan.
ECCMID 2023: Shionogi Announces Real-World Evidence Demonstrating the Efficacy of Fetcroja® / Fetroja® (cefiderocol) Against Some of the Most Difficult-to-Treat Gram-Negative Bacterial Pathogens
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announces key data for Fetcroja® (cefiderocol), an innovative siderophore cephalosporin, to be presented at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), April 15-18, 2023, including new real-world evidence demonstrating its efficacy against some of the most difficult-to-treat Gram-negative bacterial infections.
Shionogi Receives U.S. FDA Fast Track Designation for Ensitrelvir Fumaric Acid, an Investigational Oral Antiviral for COVID-19
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for their investigational COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”). FDA Fast Track designation is designed to facilitate the development and expedite the review of potential new therapies that treat serious conditions and fulfill an unmet medical need.
Shionogi Presents Pivotal Ensitrelvir Fumaric Acid Phase 3 Data and Exploratory Long COVID Data at CROI
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today, at the 30th Conference on Retroviruses and Opportunistic Infections (CROI), presented further results from the Phase 3 part of the pivotal SCORPIO-SR trial (Phase 2/3 study) conducted in Japan, South Korea, and Vietnam (hereafter, the “Study”) of the novel COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”). Shionogi also presented exploratory data from the Study evaluating the potential effect of ensitrelvir on the symptoms of long COVID.
Shionogi Presents Real-World Evidence Showing Strong Efficacy with Fetroja® (cefiderocol) Against Treatment Resistant Bacterial Infections at IDWeek 2022
Shionogi Inc., the United States subsidiary of Shionogi & Co., Ltd., announced that new Fetroja® (cefiderocol) data will be presented at IDWeek 2022 including new real-world evidence demonstrating Fetroja’s strong efficacy against some of the most difficult-to-treat Gram-negative bacterial infections.
Shionogi, GARDP and CHAI Announce Landmark License and Collaboration Agreements to Treat Bacterial Infections by Expanding Access to Cefiderocol in 135 Countries
Shionogi & Co., Ltd. (Shionogi) and the Global Antibiotic Research and Development Partnership (GARDP) have today announced the execution of a license and technology transfer agreement and, with the Clinton Health Access Initiative (CHAI), a collaboration agreement that aim to significantly transform the landscape of access to antibiotics for countries around the world.
Shionogi Announces Strategic Re-Organization of U.S. Executive Leadership
Shionogi Inc., the United States subsidiary of Shionogi & Co., Ltd. based in New Jersey, has announced a strategic executive leadership re-organization and expansion of the company’s Executive Committee with the following changes effective July 1, 2022:
New Data for Shionogi’s COVID-19 Once-Daily Oral Antiviral S-217622 Show Rapid Virus Clearance
Shionogi & Co., Ltd. (hereafter “Shionogi”) today announced new results from two late-breaking presentations of S-217622 at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Lisbon, 23 – 26 April. S-217622 is an investigational 3CL protease inhibitor that was studied for once-daily oral administration in mainly vaccinated patients (~85%), with no risk factors for severe complications, within five days of COVID-19 symptom onset.
Shionogi Presents the Results of COVID-19 Therapeutic Agent at ISIRV-WHO Virtual Conference
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.; hereafter "Shionogi") presented results from non-clinical studies and from the Japanese Phase 1 clinical trial of S-217622, an investigational oral antiviral drug for COVID-19, caused by the novel coronavirus (SARS-CoV-2), at the International Society for Influenza and Other Respiratory Virus Diseases (ISIRV)-World Health Organization (WHO) Virtual Conference.
Shionogi to Present In Vitro and Real-World Data at IDWeek 2021 Demonstrating Activity of FETROJA® (cefiderocol) Against Gram-Negative Pathogens
Shionogi & Co., Ltd. (hereafter “Shionogi”) today announces that 11 abstracts on FETROJA® (cefiderocol) will be shared at IDWeek. The meeting will take place virtually from Sept. 29 – Oct. 3, 2021.
Shionogi Strengthens U.S. Executive Leadership Team to Support Growth
Shionogi Inc., a pharmaceutical company with a significant focus on infectious diseases, announced today the expanded leadership roles of executive vice president Nathan McCutcheon and senior vice president Gianine Esposito.
