ESCMID Global 2026: Shionogi Presents New Real-World Data Highlighting Clinical Effectiveness of Fetroja®/Fetcroja® (cefiderocol) in MBL-Producing Enterobacterales Infections

Real-world evidence study carried out in Spain demonstrates 68% clinical cure rate at day 14, and 83% overall survival at day 28, for patients infected with highly resistant metallo-beta lactamase (MBL)-producing pathogens¹

Carbapenem-resistant Enterobacterales pathogens are considered by the World Health Organization to be one of the most critical health threats²

OSAKA, Japan--(BUSINESS WIRE)--Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) presents new real-world data evaluating Fetroja^®/Fetcroja^® (cefiderocol), an innovative siderophore cephalosporin, in adults with confirmed MBL-producing Enterobacterales infections at the 36th Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in Munich, 17th-21st April, 2026.¹

Cefiderocol is for the treatment of seriously ill adult patients with complicated urinary tract infections (cUTIs) and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by certain Gram-negative bacterial infections.³ See Fetroja U.S. full indications and important safety information below in the About Cefiderocol section.

The CIRCE study was a retrospective, observational, multicenter chart review study conducted in Spain between January 2023 and April 2025, designed to describe the effectiveness and safety of real-world cefiderocol use in 232 adult patients with infections caused by MBL-producing Enterobacterales.¹

The analysis found 68% of patients who received cefiderocol were considered clinically cured at day 14 and 82% of patients achieved clinical response at day 14.¹ The overall rates of survival at days 14 and 28 were 90% and 83%, respectively, in this population.¹ At baseline, 29% of patients were immunosuppressed, 27% were in intensive care and 13% presented with septic shock.¹ Drug associated adverse events were collected through routine chart review with no new identified safety signals beyond the established safety profile of cefiderocol.¹

MBL-producing Enterobacterales inactivate almost all beta-lactam antibiotics, including carbapenems - agents typically reserved for severe or high-risk infections, thereby limiting therapeutic options.^1,4,5 In the CIRCE study, the most frequently identified pathogens were carbapenem-resistant Klebsiella pneumoniae and Enterobacter spp. respectively,¹ both classified by the World Health Organization as critical priority pathogens due to their high levels of resistance to currently available therapies.²

“MBL-producing Enterobacterales infections represent a significant and growing clinical challenge worldwide, particularly in critically ill patients where treatment options are limited,” said Dr. Ricard Ferrer, Head of the Intensive Care Department at Vall d’Hebron Hospital in Barcelona, Spain. “These data support the clinical effectiveness of cefiderocol in adult patients with these infections, contributing further real-world evidence to inform future treatment considerations in practice.”

Among patients with available follow-up cultures, microbiological eradication rates were reported as 85% in bloodstream infections and 82% in urinary tract infections (UTIs).¹ Approximately half of patients received cefiderocol based on susceptibility testing.¹

Additional data presented at ESCMID 2026 evaluated the in vitro* activity of cefiderocol against more than 4,000 Stenotrophomonas maltophilia clinical isolates collected through the multinational SIDERO-WT (2014–2019) and SENTRY (2020–2024) surveillance programmes.⁶ Across this 10-year period, there was no significant change in cefiderocol susceptibility observed before or after market introduction.⁶ Stenotrophomonas maltophilia is an opportunistic pathogen with high intrinsic resistance to multiple antimicrobial classes, often limiting treatment options in high-risk patients.⁶

Data presented at the same congress reinforced cefiderocol’s effectiveness against Stenotrophomonas maltophilia, with a subgroup analysis of 119 patients from the PROVE study demonstrating clinical cure in approximately two-thirds of patients, the majority of whom were critically ill and receiving care in intensive care units.⁷

“Antimicrobial resistance continues to threaten effective treatment of serious Gram-negative infections globally,” said Mark Hill, Global Head of Medical Affairs, Shionogi & Co. Ltd. “These data add to the growing body of evidence supporting cefiderocol in resistant pathogens and underscores the importance of sustained investment in innovation and evidence generation in antimicrobials.”

*In vitro activity does not necessarily correlate with clinical efficacy.

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 target 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 https://www.shionogi.com/global/en.

About Shionogi in Infectious Disease

Over the past 70 years, Shionogi has discovered and commercialized six 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’s ongoing efforts to address current and emerging health threats includes a U.S.-based drug discovery laboratory in the U.S. with Qpex Biopharma, Inc., a Shionogi Group Company. Through Qpex, we are advancing a robust portfolio of potential best-in-class, clinical-stage antimicrobial compounds. Learn more about the Qpex lab here.

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 Cefiderocol

In the U.S., cefiderocol is commercially available under the brand name Fetroja^® and is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia and complicated urinary tract infections caused by certain susceptible Gram-negative microorganisms.³ In Europe, cefiderocol is commercially available under the brand name Fetcroja^® for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.⁸ In Japan, cefiderocol is commercially available under the brand name Fetroja^® and received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare for various infections caused by strains resistant to carbapenem antibiotics among sensitive strains of Escherichia coli, Citrobacter species, Klebsiella pneumoniae, Enterobacter species, Serratia marcescens, Proteus species, Morganella morganii, Pseudomonas aeruginosa, Burkholderia species, Stenotrophomonas maltophilia, and Acinetobacter species.

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).

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.

¹ Boán, J., Aguado, J. M., Soriano-Cuesta, C., Martínez-Sagasti, F., Vidart, N., Hidalgo-Tenorio, C., Sequera, S., Garcia, L., Longshaw, C., & González Calvo, A. J. (2026, April 17–21). Real-world efficacy of cefiderocol for treatment of infections caused by metallo-beta-lactamase-producing Enterobacterales in Spain [Conference poster]. ESCMID Global 2026, Munich, Germany.
² World Health Organisation. WHO Bacterial Priority Pathogens List, 2024. Available at: https://iris.who.int/server/api/core/bitstreams/1a41ef7e-dd24-4ce6-a9a6-1573562e7f37/content. Accessed: March 2026.
³ Fetroja^® Prescribing information. Available at: https://www.shionogi.com/content/dam/shionogi/si/products/pdf/fetroja.pdf. Accessed March 2026.
⁴ Vázquez-Ucha, J.C. et al. (2023) ‘Activity of aztreonam in combination with novel β-lactamase inhibitors against metallo-β-lactamase-producing Enterobacterales’, Journal of Global Antimicrobial Resistance. Available at: https://www.sciencedirect.com/science/article/abs/pii/S0924857923000262 Accessed March 2026.
⁵ Paudel R, et al. Carbapenemase producing Gram negative bacteria. Journal of Infection and Public Health. 2024. Available at: https://www.sciencedirect.com/science/article/abs/pii/S0732889324001998 Accessed March 2026.
⁶ Yamano, Y., Longshaw, C., Nguyen, S. T., Maher, J. M., Mendes, R. E., Hackel, M., Yamashiro, S., & DeJong, E. (2026, April 17–21). Activity of cefiderocol against Stenotrophomonas maltophilia clinical isolates collected in multi-national antimicrobial surveillance studies SIDERO-WT (2014–2019) and SENTRY (2020–2024) [Conference poster]. ESCMID Global 2026, Munich, Germany.
⁷ Timsit, J.-F., Torre-Cisneros, J. de la, Machuca, I., Kobci, M., Henriksén, A. S., Gill, K., & Nguyen, S. T. (2026, April 17–21). Real-world cefiderocol outcomes in the treatment of Stenotrophomonas spp. infections: Data from the PROVE study [Conference poster]. ESCMID Global 2026, Munich, Germany.
⁸ Fetcroja^® Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/fetcroja-epar-product-information_en.pdf. Accessed: March 2026.

For Further Information:
SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html
Shionogi Europe Press Office: pressoffice@shionogi.eu
U.S. Media Contact: ShionogiCommunications@shionogi.com