Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) will present new data at IDWeek 2026 that reinforce the role of Fetroja®/Fetcroja® (cefiderocol), an innovative siderophore cephalosporin, in serious Gram-negative infections.
Cefiderocol data highlights at IDWeek will include new U.S. real-world data demonstrating improved clinical outcomes with early cefiderocol treatment versus salvage therapy in critically ill patients with respiratory infections caused by carbapenem-resistant Gram-negative bacteria. Shionogi will also present global surveillance data showing cefiderocol maintained greater than 90% CLSI susceptibility against highly resistant P. aeruginosa VAP isolates despite resistance to other newer beta-lactam/beta-lactamase inhibitor (BL/BLI) combinations, and a systematic literature review summarizing the published evidence supporting the use of cefiderocol in vulnerable high-risk patients with infections caused by S. maltophilia.1-3
Cefiderocol is approved in the U.S. for the treatment of adult patients with complicated urinary tract infections (cUTIs), including pyelonephritis, and hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain susceptible Gram-negative bacteria. See Fetroja U.S. full indications and important safety information below in the About Cefiderocol section.4
PROVE Data Support Early Cefiderocol Use in Critically Ill Patients with Carbapenem-Resistant Respiratory Infections
PROVE (Retrospective Cefiderocol Chart Review) is an international, retrospective, observational medical chart review study conducted between November 2020 and July 2024 in more than 1,000 patients in the U.S. and Europe.1,5 The subgroup analysis that will be presented at IDWeek evaluated 266 U.S. patients treated with cefiderocol for respiratory tract infections caused by Gram-negative bacteria, of which 89.5% (n=238) were resistant to carbapenem antibiotics.1
In the study, 59.4% of patients (n=158) were male, 35% of patients (n=93) had chronic pulmonary disease and nearly all patients (96.6%) had one or more risk factors for carbapenem-resistant Gram-negative bacteria infections.1 The median hospital stay for these patients was 42.0 days, and almost three-quarters of patients (74.8%) were in the intensive care unit, and two-thirds (65.4%) received organ support and/or mechanical ventilation (66.2%).1
Cefiderocol was administered for a median duration of 9.0 days (IQR: 7.0–14.0), and most patients (72.9%) received cefiderocol once the pathogen and susceptibility profile were known.1 The majority (66.5%) of infections were monomicrobial, and the most frequently observed pathogens were P. aeruginosa (34.2%; n=91) and Acinetobacter baumannii (19.2%; n=51).1
In this subgroup analysis of 266 patients, the overall clinical response rate was 76.7% (n=204), for patients receiving cefiderocol.1 Clinical response was achieved in 78.9% (n=153/194) of patients treated after the pathogen and its antibiotic susceptibility were known, 80.0% (n=24/30) of patients who started cefiderocol empirically prior to pathogen identification and 63.4% (n=26/41) of patients who received cefiderocol after a prior antibiotic regimen had failed.1
“We conducted this sub analysis because hospital-acquired respiratory tract infections caused by carbapenem-resistant Gram-negative bacteria are difficult to treat, and delayed antibiotic treatment can be associated with increased morbidity and mortality,” said Amy L. Carr, PharmD, BCIDP at AdventHealth Orlando. “These real-world findings provide important insight into the treatment of critically ill patients with respiratory infections caused by carbapenem-resistant Gram-negative bacteria. Notably, the use of cefiderocol earlier in the treatment course was associated with higher clinical response rates than when cefiderocol was used after a prior antibiotic regimen had failed.”
As Antimicrobial Resistance Among P. Aeruginosa Continues to Increase and Treatment Options Become More Limited, SENTRY Global Antimicrobial Surveillance Program Data Presented During a Rapid-Fire Session Reinforce Cefiderocol’s In Vitro Activity Against Isolates from Patients with Ventilator-Associated Pneumonia (VAP)
The SENTRY Antimicrobial Surveillance Program monitors pathogen prevalence and antimicrobial susceptibility patterns worldwide.2,6 Surveillance programs like SENTRY track how bacterial resistance evolve over time and across regions, offering critical early warnings of emerging strains and helping guide clinical treatment decisions.2,6
Shionogi will present SENTRY Surveillance Program data evaluating cefiderocol against 1,400 global P. aeruginosa isolates collected from patients with VAP in the U.S. and Europe between 2020-2024.2 P. aeruginosa is a leading cause of VAP and a significant driver of mortality in critically ill patients.2
The study compared cefiderocol with four commonly prescribed BL/BLI combinations. Cefiderocol demonstrated in vitro activity against P. aeruginosa, showing high susceptibility across the different breakpoint interpretive criteria (CLSI 99.5%, EUCAST 98.9%, FDA 97.9%).2 Susceptibility to cefiderocol remained consistently high among highly resistant subsets, including BL/BLI-non-susceptible isolates (91.4% to 96.0% susceptible by CLSI criteria) and isolates harboring the VIM (Verona integron-encoded metallo-beta-lactamase), NDM (New Delhi metallo-beta-lactamase), and IMP (imipenemase) enzymes, whereas BL/BLI combinations generally exhibited low susceptibility (30.4% to 41.8% susceptible by CLSI criteria).2
These findings add to a growing body of evidence supporting the use of cefiderocol as a treatment for VAP caused by P. aeruginosa*, particularly in settings where resistance to BL/BLI combinations may limit treatment options, including infections caused by difficult-to-treat MBL-producing strains.2 Cefiderocol maintained high susceptibility against a contemporary global collection of P. aeruginosa VAP isolates, including highly resistant phenotypes where cross-resistance among commonly used comparator BL/BLI agents was observed.2
“As resistance among P. aeruginosa isolates continues to increase, clinicians need treatment options that retain activity against difficult-to-treat Gram-negative pathogens,” said Christine Slover, Vice President, Medical Affairs, Shionogi Inc. “This analysis provides contemporary insight into susceptibility trends among isolates from patients with ventilator-associated pneumonia, including evidence of cross-resistance across commonly used beta-lactam/beta-lactamase inhibitor combinations. Findings such as these help inform our understanding of the evolving resistance landscape and activity against difficult-to-treat pathogens.”
*In vitro activity does not necessarily correlate with clinical efficacy.
New Systematic Literature Review Highlights the Body of Evidence Supporting Cefiderocol for the Treatment of Infections Caused by S. maltophilia
Shionogi will also present findings from a systematic literature review of 45 published case reports and cohort studies examining clinical outcomes associated with cefiderocol for the treatment of infections caused by S. maltophilia, an opportunistic Gram-negative bacterium intrinsically resistant to many antibiotics and associated with significant morbidity and mortality in severely ill and immunosuppressed patients with limited treatment options.3,7-9
Results showed a clinical response in 71.4% of patients described in case reports (35/49), with favorable microbiological and clinical outcomes reported across a range of invasive S. maltophilia infections.3 These findings add to the published clinical evidence for cefiderocol in S. maltophilia infections. The 2026 AMR Guidance lists cefiderocol as the preferred treatment for invasive S. maltophilia infections, noting that this preference is based largely on animal model data, as clinical outcomes data remain limited.10
U.S. INDICATIONS
Fetroja® (cefiderocol) is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex.
Fetroja is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens.
USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fetroja and other antibacterial drugs, Fetroja should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Fetroja is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of Fetroja.
WARNINGS AND PRECAUTIONS
Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections
An increase in 28-day all-cause mortality was observed in Fetroja-treated nosocomial pneumonia, bloodstream infections, or sepsis patients compared to those treated with best available therapy (BAT) in a clinical study (NCT02714595). Most BAT regimens contained colistin. All-cause mortality remained higher in patients treated with Fetroja than in patients treated with BAT through Day 49.
Generally, deaths were in patients with infections caused by Gram-negative organisms, including non-fermenters such as Acinetobacter baumannii complex, Stenotrophomonas maltophilia, and Pseudomonas aeruginosa, and were the result of worsening or complications of infection, or underlying comorbidities. The cause of the increase in mortality has not been established.
Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP.
Hypersensitivity Reactions
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Hypersensitivity was observed with Fetroja. Before Fetroja is instituted, inquire about previous hypersensitivity to cephalosporins, penicillins, or other beta-lactam drugs. If an allergic reaction occurs, discontinue Fetroja.
Clostridioides difficile-associated Diarrhea (CDAD)
CDAD has been reported with nearly all systemic antibacterial agents, including Fetroja. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, antibacterial drugs not directed against C. difficile may need to be discontinued.
Seizures and Other Central Nervous System (CNS) Adverse Reactions
Cephalosporins, including Fetroja, have been implicated in triggering CNS adverse reactions such as seizures. Encephalopathy, coma, asterixis, and neuromuscular excitability have been reported with cephalosporins, particularly in patients with a history of epilepsy and/or when recommended dosages of cephalosporins were exceeded due to renal impairment. Adjust Fetroja dosing based on creatinine clearance. If focal tremors or seizures occur, evaluate patients to determine whether Fetroja should be discontinued.
Development of Drug-Resistant Bacteria
Prescribing Fetroja in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
ADVERSE REACTIONS
The most common adverse reactions occurring in ≥2% of patients receiving Fetroja in the cUTI trial were: diarrhea (4%), infusion site reactions (4%), constipation (3%), rash (3%), candidiasis (2%), cough (2%), elevations in liver tests (2%), headache (2%), hypokalemia (2%), nausea (2%), and vomiting (2%). The most common adverse reactions occurring in ≥4% of patients receiving Fetroja in the HABP/VABP trial were: elevations in liver tests (16%), hypokalemia (11%), diarrhea (9%), hypomagnesemia (5%), and atrial fibrillation (5%).
Please click here for Full U.S. Prescribing Information for Fetroja® (cefiderocol).
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- and 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 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 & 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 and CNS disorders. Shionogi’s research and development currently targets two therapeutic areas: infectious diseases and diseases with unmet medical needs, including rare diseases, allergy/inflammation, oncology, hearing loss, and sleep apnea. For more information on Shionogi & Co., Ltd., please visit https://www.shionogi.com/global/en.
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 |
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1 Carr A, et al. Outcomes of Cefiderocol Treatment in US Patients with Respiratory Tract Infections: Subgroup Analysis of the PROVE Observational Study. Poster presented at IDWeek 2026. Poster #144. |
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2 Nguyen ST, et al. SENTRY Poster Cefiderocol Activity Across Highly Resistant Pseudomonas aeruginosa Ventilator-Associated Pneumonia Isolates: A Global Surveillance Study of SENTRY 2020–2024. Poster presented at IDWeek 2026. Poster #459. |
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3 Martin A, et al. Systematic Literature Review of the Clinical Outcomes Associated with Cefiderocol Therapy for Stenotrophomonas maltophilia Infections. Poster presented at IDWeek 2026. Poster #94. |
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4 Fetroja Prescribing Information. Available from: https://www.shionogi.com/content/dam/shionogi/si/products/pdf/fetroja.pdf. Accessed October 7, 2026. |
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5 Clancy CJ, Cornely OA, Marcella SW, et al. Effectiveness and safety of cefiderocol in clinical practice for treatment of patients with Gram-negative bacterial infections: US interim results of the PROVE study. Infection and Drug Resistance. 2024 Dec 31:4427-43. doi: 10.2147/IDR.S475462 |
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6 JMI Laboratories [Internet]. SENTRY Antimicrobial Surveillance Program. Available from: https://www.jmilabs.com/sentry-surveillance-program/. Accessed October 7, 2026. |
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7 Chen L, et al. Assessment of the relative benefits of monotherapy and combination therapy approaches to the treatment of hospital-acquired Stenotrophomonas maltophilia pneumonia: a multicenter, observational, real-world study. Ann Intensive Care. 2023;13:47. doi: 10.1186/s13613-023-01144-7 |
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8 Puech B, et al. Effect of antibiotic therapy on the prognosis of ventilator-associated pneumonia caused by Stenotrophomonas maltophilia. Ann Intensive Care. 2021;11(1):160. doi: 10.1186/s13613-021-00950-1 |
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9 Mojica MF, et al. Treatment approaches for severe Stenotrophomonas maltophilia infections. Curr Opin Infect Dis. 2023;36(6):572–584. doi: 10.1097/QCO.0000000000000975 |
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10 Infectious Disease Society of America [Internet]. IDSA 2026 Guidance on the Treatment of Antimicrobial Resistant Gram-Negative Infections. Available from: https://www.idsociety.org/practice-guideline/amr-guidance/. Accessed October 7, 2026. |
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