Targeted Versus Standard Peri-operative Antibiotic Prophylaxis in Patients Colonized With Carbapenemase-producing Enterobacterales Undergoing Liver Transplantation: a Stepped Wedge Cluster Randomization Trial

This is a multicenter stepped-wedge cluster randomized trial, conducted over a 2-year period at three hospitals. The trial is structured into four phases, each lasting six months. During phase 1 (pre-rollout), all hospitals will use standard antibiotic prophylaxis for all patients. In each of phases 2 to 4, one hospital will switch to targeted antibiotic prophylaxis, so that by phase 4 all hospitals will be using it. The order in which hospitals switch is determined by computer-generated randomization performed centrally by an independent statistician, ensuring each hospital has an equal chance of switching at any given phase and minimizing selection bias.
The goal of this clinical trial is to learn whether targeted antibiotic prophylaxis works better than standard antibiotic prophylaxis at preventing infections in liver transplant patients who carry resistant bacteria called CPE (carbapenemase-producing Enterobacterales). It will also learn about the effects of these antibiotics on gut bacteria.
The main questions it aims to answer are:
* Does targeted antibiotic prophylaxis reduce the number of CPE infections occurring in the first two weeks after liver transplant, compared to standard prophylaxis?
* How do targeted and standard antibiotic prophylaxis affect the gut microbiome after transplant?
* Is there a link between achieving optimal antibiotic blood levels and the risk of developing an infection after transplant?
Researchers will compare targeted antibiotic prophylaxis (chosen based on the specific bacteria each patient carries) to standard antibiotic prophylaxis (used routinely at each hospital) to see which approach better prevents infection.
This study does not involve the administration of any drugs or instrumental examinations beyond those already part of standard clinical care at each center. However, additional blood tests will be performed by collecting one extra blood sample (and a bile sample, if the patient has a Kehr's tube, which is a drain placed in the bile duct after surgery) during blood draws already scheduled as part of routine clinical practice, in order to measure drug levels in the blood. Stool samples will also be collected specifically for the study to investigate the gut microbiome.

Start Date01 Oct 2026

Sponsor / Collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

CTIS2024-516232-10-00

/ RecruitingPhase 4IIT

Defining Antibiotic Levels in Intensive care patients (DALI-2) protocol - A multi-national pharmacokinetic/pharmacodynamic cohort study to determine whether contemporary antibiotic dosing for critically ill patients achieves therapeutic exposures.

Start Date31 Jul 2026

Sponsor / Collaborator

Centre Hospitalier Universitaire de Nimes

NCT07431307

/ Not yet recruitingPhase 2

A Two-part Phase IIb Randomized, Multicenter, Open-label Comparative Study to Firstly Evaluate the Safety and Efficacy Trial of BV100 in Combination With Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol Versus Best Available Therapy in Patients With Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia and Bloodstream Infection, Suspected or Confirmed to be Due to Carbapenem-resistant Acinetobacter Baumannii Calcoaceticus Complex (CRABC), and Secondly to Evaluate the Pharmacokinetics of BV100 in Combination With Low Dose Polymyxin B Plus Cefideroc

This Phase IIb study aims to evaluate the safety and efficacy of BV100 in combination with low dose polymyxin B plus ceftazidime/avibactam or cefiderocol in patients with suspected or confirmed CRABC infections. The study is divided into two parts (Part A and Part B), recruiting in parallel. Approximately 10 subjects will be recruited in Part B, with enrollment ending once Part A enrollment is complete (at least 30 patients randomized to all of the three groups). Eligible patients, who have given informed consent, will be enrolled, and pre-treatment microbiology samples submitted to a local laboratory.

Start Date01 Jul 2026

Sponsor / Collaborator

BioVersys AG

100 Clinical Results associated with Cefiderocol Sulfate Tosylate

100 Translational Medicine associated with Cefiderocol Sulfate Tosylate

100 Patents (Medical) associated with Cefiderocol Sulfate Tosylate

1,158

Literatures (Medical) associated with Cefiderocol Sulfate Tosylate

01 Dec 2026·MEDICAL MICROBIOLOGY AND IMMUNOLOGY

Human ex vivo comparison of Escherichia coli and Pseudomonas aeruginosa lipopolysaccharide–induced immune responses and cefiderocol effects in whole blood

Article

Author: Pracher, Lena ; Eberl, Sabine ; Zeitlinger, Markus ; Weber, Maria ; Jorda, Anselm

Abstract:

Immune dysregulation is central in bacterial sepsis with lipopolysaccharide (LPS) of gram-negative bacteria acting as a key component in innate immune activation. Modulation of the host response by potential immunomodulatory agents may confer benefits. This ex vivo study compared cytokine responses induced by E. coli and P. aeruginosa LPS and evaluated the impact of cefiderocol on LPS-induced immune activation in human whole blood. Whole blood from ten healthy volunteers was stimulated ex vivo with E. coli or P. aeruginosa LPS in the presence or absence of cefiderocol and incubated for 4 h at 37 °C. Plasma concentrations of TNF-α, IL-1β, IL-6, IL-10, IFN-α, IFN-γ, and IL-8 were quantified at 0 h, 2 h, and 4 h using a multiplex immunoassay. Cytokine release was significantly higher after E. coli LPS stimulation than with P. aeruginosa LPS across all analytes. Mean TNF-α area under the curve (AUC₀–₄) was 2379 pg*h/mL with cefiderocol vs 1936 pg*h/mL without (percent difference 18.2% [95% CI, 5.9–31.4]) after E. coli LPS stimulation, and 278 pg/mL vs 242 pg*h/mL (12.9% [4.3–21.5]) after P. aeruginosa LPS stimulation. For IL-6, cefiderocol slightly increased AUC₀–₄ following E. coli LPS stimulation (4584 vs 3635 pg*h/mL; 20.7% [8.3–33.0]) but not with P. aeruginosa LPS (184 vs 201 pg*h/mL; − 9.3% [− 53.7–35.2]). IL-1β, IL-10, IFN-α, IFN-γ, and IL-8 levels were mostly unaffected by cefiderocol. Cefiderocol did not suppress cytokine release in human whole blood. In this study, E. coli LPS elicited a stronger immune response than P. aeruginosa LPS.

01 Nov 2026·INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

Molecular and epidemiological characteristics of cefiderocol-resistant Klebsiella pneumoniae: Insights from genomic analysis

Review

Author: Li, Yi ; Li, Chunhua ; Jia, Xun ; Li, Dan ; Zhang, Jie ; Long, Shanshan ; Mao, Huinan ; Yang, Jing

OBJECTIVE:

To characterize reported cefiderocol (FDC)-resistant Klebsiella pneumoniae through a systematic review and reanalysis of available whole-genome sequencing (WGS) data.

METHODS:

PubMed, Embase, and Web of Science were searched for original reports of FDC-resistant K. pneumoniae. Epidemiological, susceptibility, molecular, and available WGS data were extracted and reanalysed. Iron-related disruptive events were compared between high- and lower-minimum inhibitory concentration (MIC) groups among eligible non-outbreak isolates.

RESULTS:

Seventy-five studies reported 779 FDC-resistant K. pneumoniae isolates from 24 countries or regions. Forty-four studies provided WGS data, yielding 145 non-duplicate genomes. The WGS subset comprised 31 sequence types (STs), most commonly ST147, ST16, ST512, and ST307. Carbapenemase genes were detected in 143 genomes, most frequently blaNDM (71/145, 49.0%), blaKPC (65/145, 44.8%), and blaOXA-48-like (31/145, 21.4%); 31 genomes (21.4%) carried carbapenemase genes from two groups. Iron uptake- or regulation-related disruptive events were identified in 59 isolates (40.7%). Among 71 non-outbreak isolates with MIC data, these events were more frequent in the high-MIC group than in the lower-MIC group (78.3% vs. 22.9%; odds ratio = 12.1, 95% confidence interval 3.82-36.18; P < 0.0001), and disruption involving two or more iron-related genes was observed only in the high-MIC group. Among isolates with available data, resistance to ceftazidime-avibactam (105/129, 81.4%) and ceftolozane-tazobactam (75/75, 100%) was frequent, whereas aztreonam-avibactam resistance was detected in 4 of 60 isolates (6.7%).

CONCLUSIONS:

Available WGS data indicate that reported FDC-resistant K. pneumoniae isolates are genetically diverse, commonly carry complex β-lactamase backgrounds, and harbour candidate iron-related genomic alterations associated with higher FDC MICs.

01 Oct 2026·INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

Comment on "A multicenter, randomized, double-blind, imipenem/cilastatin-controlled clinical study of cefiderocol for the treatment of complicated urinary tract infections caused by gram-negative pathogens in Chinese adults"

Letter

Author: Li, Qiuqiong ; Luo, Hong ; Chai, Liying

News (Medical) associated with Cefiderocol Sulfate Tosylate

10 Sep 2026

·www.shionogi.com

Approval for Cefiderocol in Australia

OSAKA, Japan, September 7 2026 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced today that it has received marketing authorization from the Therapeutic Goods Administration (TGA) in Australia for cefiderocol, a siderophore cephalosporin developed by Shionogi for the treatment of carbapenem-resistant Gram-negative bacterial infections. This marketing authorization is based on the results of three global clinical trials of cefiderocol conducted to date: the Phase 2 APEKS-cUTI study in patients with complicated urinary tract infections (cUTI), the Phase 3 CREDIBLE-CR study in patients with carbapenem-resistant Gram-negative bacterial infections, and the Phase 3 APEKS-NP study in patients with hospital-acquired pneumonia.1-3 The TGA has approved cefiderocol for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia due to proven or strongly suspected carbapenem-resistant aerobic Gram-negative organisms in adults with limited treatment options. Shionogi has entered into a license agreement with Link Medical Products Pty Ltd (Head Office: New South Wales, Australia; hereafter “Link”) for the development and commercialization of cefiderocol in Australia and New Zealand.4 Following the marketing authorization in Australia, Shionogi will work with Link to improve access to this novel antibacterial agent for patients who need it. Antimicrobial resistance (AMR), often referred to as a “silent pandemic,” is one of the major global public health threats facing humanity and is an urgent global challenge that requires immediate action. In 2021, AMR was estimated to have been directly responsible for 1.14 million deaths worldwide, and it is projected that more than 39 million people could die from AMR by 2050 unless action is taken through international collaboration.5-7 At the same time, treatment options remain limited, making AMR one of the areas with a significant unmet medical need. Cefiderocol is active against Gram-negative bacteria, including a range of multidrug-resistant bacteria that have become difficult to treat due to the acquisition of antimicrobial resistance, and the marketing authorization is expected to provide a new treatment option for patients with these infections. Shionogi has identified “Protect People from the Threat of Infectious Diseases” as one of its material issues and is advancing initiatives toward realizing total care for infectious diseases. To contribute to the successful global response to AMR, Shionogi will continue its efforts to deliver anti-infective medicines needed to protect people’s health to patients around the world. For more information on Shionogi’s initiatives to address AMR, please visit Address the problem of antimicrobial resistance (AMR). About Cefiderocol Cefiderocol is an antibacterial agent that effectively penetrates the outer membrane of Gram-negative bacteria, including multidrug-resistant bacteria, to exert its antibacterial activity. The APEKS-cUTI is a global, double-blind, parallel-group Phase 2 study, the CREDIBLE-CR is a global, open-label, parallel-group phase 3 study, the APEKS-NP is a global, double-blind, parallel-group Phase 3 study. Cefiderocol is marketed in multiple countries and regions, including the United States, Japan, Europe, Taiwan, and South Korea. Cefiderocol is included in the World Health Organization (WHO) Model List of Essential Medicines and plays an important role globally as a treatment option for infections caused by antimicrobial-resistant bacteria. To improve access to this novel antibacterial agent for patients in need across many low- and middle-income countries, Shionogi is also advancing initiatives through a tripartite agreement with the Global Antibiotic Research and Development Partnership (GARDP) and the Clinton Health Access Initiative (CHAI).8 The application for marketing authorization in Australia was accepted by the Australian authorities in December 2024.9 Cefiderocol is not currently listed on the Pharmaceutical Benefits Scheme. For more information about cefiderocol in Australia, healthcare professionals and consumers should consult the Consumer Medicine Information. Cefiderocol is included in the Black Triangle Scheme and subject to additional monitoring. Healthcare professionals are asked to report suspected adverse events to the TGA.10 It is recommended that cefiderocol should be used after consultation with a physician with appropriate experience in the management of infectious diseases. About Link Medical Products Pty Ltd For over 30 years, LINK Healthcare, part of Clinigen, has been a trusted partner to healthcare professionals, hospitals, pharmaceutical and biotechnology companies across Australia and New Zealand. Providing specialised services across the product lifecycle, from clinical development through to commercialisation, LINK enables ethical and compliant access to registered and unregistered medicines. 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. References: 1. Press release on January 12, 2017 2. Press release on October 2, 2019 3. Press release on November 15, 2019 4. Press release on April 2, 2025 5. GBD 2021 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance 1990-2021: a systematic analysis with forecasts to 2050. Lancet. 2024 Sep 28;404(10459):1199-1226. doi: 10.1016/S0140-6736(24)01867-1. Epub 2024 Sep 16. PMID: 39299261. 6. World Health Organization (WHO), “Antimicrobial resistance,” 16 July 2026. 7. Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet 2022; 399: 629–55. 8. Press release on June 15, 2022 9. Press release on December 3, 2024 10. Report an adverse event or safety problem | Therapeutic Goods Administration (TGA) For Further Information: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html

Phase 3License out/inDrug Approval

09 Sep 2026

·www.biospace.com

Shionogi to Showcase Advancements Across its Infectious Disease Portfolio at IDWeek 2026

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

License out/inPhase 3Qualified Infectious Disease Product

02 Sep 2026

·www.businesswire.com

Shionogi Announces U.S. Government Procurement of Fetroja ® (cefiderocol) Through BARDA's Project BioShield to Support National Preparedness for Drug-Resistant Bacterial Threats

Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that the Biomedical Advanced Research and Development Authority (BARDA) has exercised a $36.9 million procurement option, under Project BioShield funding, from its April 2026 contract with Shionogi Inc., a New Jersey-based subsidiary of Shionogi, to procure Fetroja® (cefiderocol) as a critical countermeasure against difficult-to-treat Gram-negative bacterial infections and pathogens that present a high-priority biothreat to national health security. The order exercises the first of several procurement and related options under the contract, with initial funding of $119 million and multiyear options for a total of up to $482 million. Other projects under the contract include establishing a U.S. drug product manufacturing site for Fetroja, advancing Fetroja for the treatment of infections caused by high-priority biothreat pathogens and expanding the utility of Fetroja for HABP/VABP in pediatric patients through a U.S. Food and Drug Administration (FDA) Supplemental New Drug Application (sNDA). This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50126C00004. Fetroja is approved in the U.S. for the treatment of adult patients with cUTIs, including pyelonephritis and HABP/VABP caused by certain susceptible Gram-negative bacteria. 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 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 most low-, lower middle- and upper middle-income countries, and select high-income countries. Shionogi ranked second 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. 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. 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, and CNS disorders. 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. The content above comes from the network. if any infringement, please contact us to modify.

License out/inDrug Approval

100 Deals associated with Cefiderocol Sulfate Tosylate

External Link

KEGG	Wiki	ATC	Drug Bank
D11013	Cefiderocol Sulfate Tosylate	J01D	DB14879

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hospital acquired bacterial pneumonia	Australia	Link Medical Products Pty Ltd.	14 Aug 2026
Ventilator associated bacterial pneumonia	Australia	Link Medical Products Pty Ltd.	14 Aug 2026
Complicated urinary tract infection	South Korea	Jeil Pharmaceutical Co., Ltd.	18 Feb 2025
Infectious Diseases	Japan	Shionogi Pharma, Inc.	30 Nov 2023
Hospital-acquired pneumonia	United States	Shionogi, Inc.	25 Sep 2020
Hospital-acquired pneumonia	United States	Shionogi & Co., Ltd.	25 Sep 2020
Klebsiella Infections	United States	Shionogi, Inc.	25 Sep 2020
Klebsiella Infections	United States	Shionogi & Co., Ltd.	25 Sep 2020
Pneumonia, Ventilator-Associated	United States	Shionogi, Inc.	25 Sep 2020
Pneumonia, Ventilator-Associated	United States	Shionogi & Co., Ltd.	25 Sep 2020
Serratia Infections	United States	Shionogi, Inc.	25 Sep 2020
Serratia Infections	United States	Shionogi & Co., Ltd.	25 Sep 2020
Gram-Negative Bacterial Infections	European Union	Qualicaps Netherlands BV	23 Apr 2020
Gram-Negative Bacterial Infections	Iceland	Qualicaps Netherlands BV	23 Apr 2020
Gram-Negative Bacterial Infections	Liechtenstein	Qualicaps Netherlands BV	23 Apr 2020
Gram-Negative Bacterial Infections	Norway	Qualicaps Netherlands BV	23 Apr 2020
Pyelonephritis	United States	Shionogi & Co., Ltd.	14 Nov 2019
Pyelonephritis	United States	Shionogi, Inc.	14 Nov 2019
Urinary Tract Infections	United States	Shionogi & Co., Ltd.	14 Nov 2019
Urinary Tract Infections	United States	Shionogi, Inc.	14 Nov 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Complicated intra-abdominal infection	Phase 3	China	Ping An Shionogi Co., Ltd.	21 Nov 2022
Carbapenem Resistant Bacterial Infection	Phase 3	China	Ping An Shionogi Co., Ltd.	16 Sep 2022
Sepsis	Phase 3	United States	Shionogi, Inc.	07 Sep 2016
Sepsis	Phase 3	Japan	Shionogi, Inc.	07 Sep 2016
Sepsis	Phase 3	Brazil	Shionogi, Inc.	07 Sep 2016
Sepsis	Phase 3	Croatia	Shionogi, Inc.	07 Sep 2016
Sepsis	Phase 3	France	Shionogi, Inc.	07 Sep 2016
Sepsis	Phase 3	Germany	Shionogi, Inc.	07 Sep 2016
Sepsis	Phase 3	Greece	Shionogi, Inc.	07 Sep 2016
Sepsis	Phase 3	Guatemala	Shionogi, Inc.	07 Sep 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04335539 (PEDI-CEFI, CTgov)	Phase 2	Gram-Negative Bacterial Infections \| Complicated intra-abdominal infection \| Pneumonia, Ventilator-Associated ... View more	53	cefiderocol (Single-Dose Phase: Cohort 1 (12 to <18 Years))	yemadyqkiv = xeqrhndeiw rirriyfsff (hrkozuevph, sqwfjtqowe - adobepikbc) View more	-	27 Feb 2026
				cefiderocol (Single-Dose Phase: Cohort 2 (6 to <12 Years))	yemadyqkiv = wgdnadqmxx rirriyfsff (hrkozuevph, rgtfrksvqd - ujqjdmvsqj) View more
NCT05789199 (PERSEUS study, Pubmed \| Eur J Clin Microbiol Infect Dis)	Not Applicable	Gram-Negative Bacterial Infections	261	Cefiderocol	zdujyjbywe(kxwrbbgehl) = wgwhznkqqw pnxqkfciru (vpjovbnayd ) View more	Positive	25 Mar 2025
NCT05789199 (PERSEUS study, Pubmed \| Eur J Clin Microbiol Infect Dis)	Not Applicable	Chronic Kidney Diseases Gram-negative bacteria	-	Cefiderocol (Stenotrophomonas maltophilia)	onnbdhwtpb(wgiqmneqnd) = nbpdamxjjs yfqvanqslv (gyjjpswaas )	Positive	24 Mar 2025
				Cefiderocol (Burkholderia cepacia complex)	onnbdhwtpb(wgiqmneqnd) = fwolpzxxxf yfqvanqslv (gyjjpswaas )
NCT05395104 (CTgov)	Phase 1	-	14	Cefiderocol+Midazolam	tmtniqpgye(shvlnarlkk) = qwnplivdal hvpxggcjsn (rilfhrtnyz, 45.3) View more	-	14 Dec 2023
NCT03032380 (APEKS-NP, Pubmed \| Eur J Clin Microbiol) Manual	Phase 3	Healthcare-Associated Pneumonia	-	Linezolid+Cefiderocol	ftqvpzclgq(ejavpglmtg) = meibfnjwjs ftekxbbgfx (zyjxcxzyqv ) View more	Non-inferior	13 Jan 2022
				Linezolid+meropenem	ftqvpzclgq(ejavpglmtg) = awmyswfovd ftekxbbgfx (zyjxcxzyqv ) View more
NCT02714595 (CREDIBLE-CR, Pubmed \| Lancet Infect Dis) Manual	Phase 3	Infectious Diseases	152	cefiderocol	wvyxhormxz(tttmevwaxz) = krtvspgczq hxkqhqolpq (qrvonqknsa, 23.2 - 65.5) View more	Similar	01 Feb 2021
				best available therapy	wvyxhormxz(tttmevwaxz) = umcieqylfo hxkqhqolpq (qrvonqknsa, 17.7 - 71.1) View more
NCT02321800 (APEKS-cUTI, Pubmed)	Phase 2	Complicated lower urinary tract infection	371	Cefiderocol	iemcnevmdp(odhtcsliqs) = yimwdnurnt ryszyqayuu (lywxesbcyj )	-	01 Jan 2021
				Imipenem-cilastatin	iemcnevmdp(odhtcsliqs) = xxkvuciney ryszyqayuu (lywxesbcyj )
NCT03032380 (APEKS-NP, CTgov)	Phase 3	Hospital acquired bacterial pneumonia \| Ventilator associated bacterial pneumonia	300	Cefiderocol+Linezolid (Cefiderocol)	dhzvpjaolh = sjhkwppodj asgajldscs (rrrybiytzy, lgioktyyfg - jzxkdeekcx) View more	-	13 Nov 2020
				Meropenem+Linezolid (Meropenem)	dhzvpjaolh = bicvqunmmy asgajldscs (rrrybiytzy, ihokkmhcwi - bbgzqzuolx) View more
NCT03862040 (CTgov)	Phase 1	Pneumonia, Bacterial	7	Standard of Care Antibiotic+Cefiderocol	yjtfialpec(nonqhsboyx) = jsjkpchkmp zocngxdtrc (hfprptjtoq, xqrwwyeegn - hlqonvogid) View more	-	05 Nov 2020
NCT02321800 (Pubmed) Manual	Phase 2	Urinary Tract Infections Gram-negative	452	Cefiderocol	nnxegefbgy(cvvdocpnjq) = yhnxxpnynt mrgkqgjdaq (bfkepwhkdd ) View more	Positive	01 Dec 2018
				imipenem-cilastatin	nnxegefbgy(cvvdocpnjq) = kevgidokho mrgkqgjdaq (bfkepwhkdd ) View more

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