A Multicenter, Single-arm, Open-label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Cefiderocol in Hospitalized Pediatric Patients from Birth to less than 3 Months of Age with Suspected or Confirmed Aerobic Gram-negative Bacterial Infections

Start Date01 Nov 2024

Sponsor / Collaborator

Shionogi, Inc.

NCT06547554

/ RecruitingPhase 1

A Phase 1, Randomized, Double-blind, Placebo-controlled, Drug-drug Interaction, Pharmacokinetic, and Safety Study of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants

A phase 1, randomized, double blind, placebo controlled drug-drug interaction, pharmacokinetics and safety study of cefiderocol in combination with xeruborbactam in healthy adult participants

Start Date04 Sep 2024

Sponsor / Collaborator

Qpex Biopharma, Inc.

[+2]

NCT05922124

/ Not yet recruitingPhase 4IIT

Cefiderocol and Ampicillin-sulbactam vs. Colistin or Colistin-meropenem for Carbapenem Resistant Acinetobacter Baumannii Bacteremia or Hospital-acquired Pneumonia: Controlled Clinical Study With Historical Controls (CASCADE)

Patients with bloodstream infections, hospital acquired pneumonia or ventilator-associated pneumonia caused by carbapenem-resistant Acinetobacter baumannii (CRAB) treated with cefiderocol combined with ampicillin sulbactam will be compared to patients treated treated with colistin alone or colistin combined with meropenem.

Start Date30 May 2024

Sponsor / Collaborator

Rambam Health Care Campus

[+2]

100 Clinical Results associated with Cefiderocol Sulfate Tosylate

100 Translational Medicine associated with Cefiderocol Sulfate Tosylate

100 Patents (Medical) associated with Cefiderocol Sulfate Tosylate

1,125

Literatures (Medical) associated with Cefiderocol Sulfate Tosylate

01 Dec 2025·Molecular Biology Reports

Prevalence of New Delhi Metallo-β-lactamase (blaNDM) gene in a selected population of drug-resistant clinical isolates

Article

Author: Latif, Kunza ; Ahmed, Iftikhar ; Hyder, Muhammad Zeeshan ; Saeed, Muhammad ; Shafiq, Muhammad ; Ahmad, Aftab

OBJECTIVESDrug-resistant Enterobacterales carrying carbapenem-resistant genes cause severe infections in clinical settings worldwide. Among these, the New Dehli Metallo-β-lactamase (bla_NDM) gene is significantly prevalent and associated with high morbidity. This study was designed to investigate the susceptibility profiling of Carbapenem-Resistant-Enterobacterales (CRE), prevalence of bla_NDM and its variants, and associated risk factors.METHODSCRE isolates from a tertiary care hospital, in Islamabad, Pakistan, were identified and the susceptibility testing was performed using disc diffusion method. MICs were determined for imipenem, tigecycline, and colistin through E-strips and microbroth dilution method respectively. For molecular characterization and typing of the bla_NDM gene, PCR products were sequenced, and the phylogenetic analysis was performed using MEGA ver 6.0 software.RESULTSAmong 5,134 clinical samples, 42.13% (n = 2,163) yielded pathogens including 42.58% (n = 921) Enterobacterales. On further screening, 39.52% (n = 364) of Enterobacterales were identified as CRE. The bla_NDM gene was detected in 75.27% (n = 274) in CRE isolates, comprising bla_NDM-1 (44%), bla_NDM-5 (53%), and bla_NDM-7 (3%) variants. Tigecycline (86.7%) and colistin (100%) were most effective antimicrobial agents with MICs ranging from 0.064 to 8 and 0.125-1 µg/ml respectively. bla_NDM-1-harboring bacteria exhibited high antimicrobial resistance compared to bla_NDM-5 and bla_NDM-7. Cefiderocol was 75.6% and ceftazidime/avibactam with aztreonam was 97.08% effective against bla_NDM-harboring bacteria. The phylogenetic analysis indicated that bla_NDM variants showed close genetic relationships and homology to the previously described sequences in GenBank databases having diverse connection with worldwide sequences.CONCLUSIONThe high prevalence of bla_NDM in our study has of great concern for clinical practice and public health. Clinicians are left with few therapeutic options. However, ceftazidime/avibactam with aztreonam may show therapeutic success. Continuous surveillance is crucial to monitorgenetic variations of continuously evolving bla_NDM gene, which is essential for effective clinical management.

01 Jul 2025·Microbial Pathogenesis

An assessment of cefiderocol's synergistic effects with eravacycline, colistin, meropenem, levofloxacin, ceftazidime/avibactam, and tobramycin against carbapenem-resistant and -susceptible Pseudomonas aeruginosa

Article

Author: Özbek-Çelik, Berna ; Özer, Bekir ; Mataracı-Kara, Emel ; Yilmaz, Mesut

OBJECTIVESThis research examines the combined in vitro effectiveness of cefiderocol with other antibiotics against carbapenem-resistant and -susceptible Pseudomonas aeruginosa obtained from Intensive Care Units.METHODSForty unique P. aeruginosa isolates were evaluated for their minimum inhibitory concentrations (MICs) using broth microdilution. All the isolates were evaluated for carbapenemase resistance genes. The bactericidal and synergistic effects of cefiderocol, alone or in conjunction with other antimicrobials, were assessed using time-kill curve experiments.RESULTSColistin had the lowest MIC₅₀/MIC₉₀ value of 1/2 mg/L, with cefiderocol following at 0.5/4 mg/L against the tested strains. Cefiderocol, levofloxacin, tobramycin, and meropenem showed bactericidal activity against various isolates. In carbapemase-producing P. aeruginosa strains, almost half of them were carrying bla_VIM. Moreover, the most effective synergistic interactions were seen with combinations of cefiderocol and eravacycline, cefiderocol and meropenem, and cefiderocol and levofloxacin against four out of eight strains at 1xMIC concentrations after 24 h. Additionally, we observed synergistic effects when cefiderocol was used with colistin, tobramycin, and ceftazidime/avibactam against three of the eight isolates. Antagonism against the analyzed P. aeruginosa strains was not found.CONCLUSIONThe findings of this study indicate that combining cefiderocol enhances its synergistic efficacy against both carbapenem-resistant and susceptible P. aeruginosa strains. This suggests that combination therapy could serve as a potential alternative for treating resistant P. aeruginosa infections.

01 Jun 2025·Journal of Infection and Public Health

Genomic approach to evaluate the intrinsic antibacterial activity of novel diazabicyclooctanes (zidebactam and nacubactam) against clinical Escherichia coli isolates from diverse clonal lineages in the United Arab Emirates

Article

Author: Alshamsi, Maitha ; Alzaabi, Abdulrahman ; Al-Marzooq, Farah ; Oommen, Seema ; Alsaadi, Abdullah ; Almansoori, Hamad ; Aleissaee, Omar ; Aldhaheri, Rauda ; Daoud, Lana ; Collyns, Timothy ; Ahmad, Amna ; Ahli, Hafsa ; Ghazawi, Akela

BACKGROUNDThe spiking rise in the prevalence of multidrug-resistant (MDR) pathogens necessitates discovering new antimicrobial agents. This study aims to investigate the intrinsic activity of two novel diazabicyclooctane (DBO) β-lactamase inhibitors, zidebactam and nacubactam, against diverse MDR Escherichia coli isolates from the United Arab Emirates. We aimed to correlate their antibacterial efficacy with the genomic characteristics of the strains.METHODSThis study investigated 73 E. coli strains and tested them for susceptibility to different antibiotics, including DBOs. PCR screening for carbapenemase and major β-lactamase genes was done. The strains were then grouped according to phenotypic and genotypic profiles. Whole-genome sequencing was employed to characterize the genetic landscape and clonality of selected 32 strains. Additionally, time-kill studies were conducted to confirm the bactericidal activity of DBOs.RESULTSZidebactam demonstrated superior efficacy compared to nacubactam, primarily due to its higher affinity for penicillin-binding protein 2 (PBP2). Notably, zidebactam alone exhibited the most potent in vitro activity, outperforming both traditional β-lactams and novel antibiotics like cefiderocol. DBOs maintained effectiveness against strains harboring various resistance determinants, including NDM-5, OXA-181, CTX-M-15, SHV-12, CMY, and DHA. Genomic analysis revealed multiple mutations in PBP1-3, with PBP2 mutations correlating with DBO susceptibility variations. Importantly, DBOs remained highly effective against isolates with PBP mutations, even those belonging to high-risk clonal lineages (ST167, ST410, ST131). Time-kill studies confirmed the bactericidal activity of DBOs, with only one strain showing reduced susceptibility (MIC: 4 µg/ml).CONCLUSIONSThis study provides compelling evidence for the potential of DBOs, particularly zidebactam, as novel antibacterial agents. Their unique characteristics and broad-spectrum activity position them as promising candidates for future antibiotic development. While the inclusion of DBO therapies in the antibiotic arsenal could significantly impact MDR pathogen treatment, realizing their full potential requires further research, clinical evaluation, and vigilant monitoring of resistance mechanisms through integrated genomic approaches.

News (Medical) associated with Cefiderocol Sulfate Tosylate

08 Apr 2025

·www.shionogi.com

ESCMID Global 2025: Shionogi presents real-world data demonstrating better clinical outcomes when Fetcroja® / Fetroja® (cefiderocol) is used as empiric or documented therapy as compared to salvage therapy for the treatment of Gram-negative bacterial

· Data from five European countries demonstrates the effectiveness of cefiderocol against Gram-negative pathogens considered as high or critical priorities by the WHO, including high rates of clinical cure and day 28 survival across patients with limited treatment options.1,2 · New European cohort data from the largest real-world evidence study of cefiderocol indicates a lower clinical cure rate trend among patients who received cefiderocol as salvage therapy compared with patients who received documented or empirical treatment.3 OSAKA, Japan, 8th April , 2025 – Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President & CEO: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) presents new European data from its largest real-world evidence study of Fetroja®/Fetcroja® (cefiderocol), an innovative siderophore cephalosporin at the 35th Congress of the European Society of Clinical Microbiology and Infectious Diseases in Vienna on 11th-15th April 2025. The PROVE (Retrospective Cefiderocol Chart Review) study is a five-year international, retrospective, observational medical chart review study, conducted between November 2020 and July 2024 designed to describe the efficacy and safety of real-world cefiderocol use in adult patients with serious Gram-negative (GN) bacterial infections.1 Analysis of the European cohort found a higher clinical cure rate trend among patients who received cefiderocol for a documented infection (67.4%) or as empiric therapy (64.6%) as compared to those who received it as salvage therapy (58.2%).3 Professor Oliver Cornely, Director of Translational Research, University of Cologne, said: “These data suggest a trend towards worse clinical outcomes when the use of cefiderocol to treat Gram-negative bacterial infections is reserved as a last line treatment option compared with those who received the treatment earlier. This trend may offer clinicians new evidence to justify the early and effective use of cefiderocol in patients with suspected resistant infections.” The study analysed data from 567 patients hospitalised with confirmed GN bacterial infections, who were treated with cefiderocol for the first time for ≥72 hours across Spain, France, Italy, Germany and the United Kingdom.1 Carbapenem resistance rate was >70% among patients enrolled in the study.1 55.9% of patients were critically ill in the intensive care unit and 41.3% were receiving organ support at the point of cefiderocol initiation.1 Respiratory tract infection (RTI) was the most frequent infection site, reported in over 50% patients (299), followed by urinary tract infection in over 12% of patients (73).1 Patients in the study receiving cefiderocol across all pathogens achieved an overall clinical cure rate of 65.3%.1 The most frequent pathogens observed were Pseudomonas aeruginosa (41.3%), Acinetobacter baumannii (15.0%), and Enterobacterales (14.6%)1, which are identified as priority pathogens by the World Health Organisation2. A clinical cure rate of 73.1% was observed among patients with a Pseudomonas aeruginosa infection.1 Takuko Sawada, Board Director and Vice Chair, Shionogi & Co Ltd., said: “Antimicrobial resistance is one of the most pressing global health challenges of this century, resulting in the deaths of millions of people around the world each year. In order to support better patient outcomes, it is imperative that clinicians have access to the innovative treatments they need for appropriate use with the right patient at the right time. We remain committed to the research and development of essential medicines that will help tackle the growing threat of drug-resistant infection.” - Ends – About Shionogi & Co. Ltd. Shionogi & Co., Ltd. is a 147-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, cardiovascular diseases and gastroenterology. Shionogi’s research and development currently target two therapeutic areas: infectious diseases, and pain/CNS disorders. For more information on Shionogi & Co., Ltd., please visit https://www.shionogi.com/global/en. About Shionogi in AMR Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for more than 60 years. Shionogi is proud to be one of the few large pharmaceutical companies that continues to focus on R&D in anti-infectives. About Cefiderocol 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.1 In the US, cefiderocol is commercially available under the brand name Fetroja® for the treatment of 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.2 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.3 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. For Further Information, Contact: 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 References [1] Fetcroja® Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/fetcroja-epar-product-information_en.pdf . Accessed: March 2024. [2] Fetroja® Prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209445s000lbl.pdf. Accessed: March 2024. [3] Press release on November 30, 2023. Regarding the Acquisition of Manufacturing and Marketing Approval for the New Siderophore Cephalosporin Antibiotic FetrojaⓇ(cefiderocol) Intravenous Infusion 1g vial in Japan

Clinical ResultDrug Approval

02 Apr 2025

·www.shionogi.com

Exclusive Licensing Agreement with Link Healthcare, a Clinigen Company for Cefiderocol in Australia and New Zealand

OSAKA, Japan, April 2 , 2025 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereinafter "Shionogi") is pleased to announce that it has entered into an exclusive licensing agreement with Link Medical Products Pty Ltd (hereinafter "Link"), part of Clinigen, the global specialty pharmaceutical services group (Senior Vice President - JAPAC: Dr. Varun Sethi; hereinafter "Clinigen") for the development and commercialization of cefiderocol in Australia and New Zealand. The Therapeutic Goods Administration (TGA) regulatory authority in Australia accepted the market authorisation application for cefiderocol in December 2024 and the application is under evaluation1. Under the terms of the agreement, Link will in-license cefiderocol from Shionogi and obtain exclusive rights for its development and commercialization in Australia and New Zealand. Shionogi will receive an upfront payment, milestone payments based on development progress, and royalties from Link. Shionogi is committed to research and development of innovative treatments for infectious diseases for the benefit of patients around the world and to helping tackle urgent global health challenges such as antimicrobial resistance (AMR). About Cefiderocol 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 options2. In the U.S., cefiderocol is 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 (HABP/VABP) and complicated urinary tract infections (cUTIs) caused by certain susceptible Gram-negative microorganisms3. 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 species4. Cefiderocol is listed on the World Health Organization's Essential Medicines List5, and preparations are underway through a collaborative agreement with The Global Antibiotic Research and Development Partnership (GARDP) and Clinton Health Access Initiative (CHAI) to improve access to this antibacterial agent for patients in low- and middle-income countries 6. About AMR Antimicrobial resistance (AMR), the phenomenon where bacteria acquire resistance to antibiotics, is one of the most significant global public health threats facing humanity and requires urgent action. AMR has been referred to as a "silent pandemic”, and without countermeasures, it is projected to result in over 10 million deaths annually by 20507,8 Click here to learn more about our efforts to address drug resistance. About Link Medical Products Pty Ltd For almost 30 years, Link Healthcare, part of the Clinigen Group, has played a vital role in the Australasian healthcare landscape as a trusted partner providing ethical and compliant pathways to both registered and unregistered medicines. With a team of 58 employees, Link Healthcare offers specialised pharmaceutical services across the product lifecycle, from clinical through to commercial, supporting pharmaceutical and biotech companies and healthcare professionals to address unmet patient needs. For more information on Link Healthcare, a Clinigen Company visit: https://www.linkhealthcare.com.au About Clinigen Clinigen is a global, specialist pharmaceutical services company focused on providing ethical access to medicines. Its mission is to accelerate access to medicines for patients in every corner of the globe. The Group supports pharmaceutical and biotech companies across the medical product lifecycle, from clinical through to commercial and operates from sites in North America, Europe, Africa and the Asia Pacific. Clinigen has more than 1,100 employees across five continents in 15 countries and provides access in more than 130 countries every year. For more information on Clinigen, please visit http://www.clinigen.com. Reference: 1. Acceptance of a New Drug Application for the Gram-Negative Bacterial Infection Treatment, Cefiderocol, in Australia｜ SHIONOGI 2. Fetcroja® Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/fetcroja-epar-product-information_en.pdf. Accessed: March 2024. 3. Fetroja® Prescribing information. Available at: Full U.S. Prescribing Information for Fetroja® (cefiderocol). Accessed August 2024. 4. Press release on November 30, 2023. Regarding the Acquisition of Manufacturing and Marketing Approval for the New Siderophore Cephalosporin Antibiotic FetrojaⓇ(cefiderocol) Intravenous Infusion 1g vial in Japan 5. WHO Model List of Essential Medicines - 23rd list, 2023. WHO Model List of Essential Medicines - 23rd list, 2023 Accessed: April 2024 6. Press release on June 15, 2022 Shionogi, GARDP and CHAI announce landmark license and collaboration agreements to treat bacterial infections by expanding access to cefiderocol in 135 countries 7. Global antimicrobial resistance forum launched to help tackle common threat to planetary health 8. O’Neill J. ‘Tackling Drug-Resistant Infections Globally: Final Report and Recommendations’. Review on Antimicrobial Resistance. May 2016. Retrieved from https://amr-review.org/sites/default/files/160525_Final%20paper_with%20cover.pdf 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. For Further Information, Contact: SHIONOGI Website Inquiry Form : https://www.shionogi.com/global/en/contact.html U.S. Media: ShionogiCommunications@shionogi.com Shionogi Europe press office: press@shionogi.eu

License out/inDrug Approval

21 Feb 2025

·www.shionogi.com

Approval for "Fetroja®"(cefiderocol) in South Korea

OSAKA, Japan, February 21, 2025 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") is pleased to announce that JEIL PHARMACEUTICAL CO., LTD. (Headquarters: Seoul, South Korea; President: Suk Je Sung ; hereinafter "JEIL"), its partner in South Korea1, has obtained marketing approval from the South Korean regulatory authorities for the gram-negative bacterial infection treatment "Fetroja®"(cefiderocol) (hereafter "Fetroja"). Fetroja®/Fetcroja® (cefiderocol), an innovative siderophore cephalosporin, for the treatment of critically ill patients with carbapenem-resistant (CR) Gram-negative (GN) bacterial infections. In South Korea, based on the results of three global clinical trials (a Phase 2 trial [APEKS-cUTI] in patients with complicated urinary tract infections, a Phase 3 trial in patients with carbapenem-resistant gram-negative bacterial infections [CREDIBLE-CR], and a Phase 3 trial in patients with nosocomial pneumonia [APEKS-NP])2-4, JEIL received marketing approval. Antimicrobial resistance (AMR), the phenomenon where bacteria acquire resistance to antibiotics, is one of the most significant global public health threats facing humanity and requires urgent action. AMR has been referred to as a "silent pandemic," and without countermeasures, it is projected to result in over 10 million deaths annually by 20505. However, available treatment options remain limited, making this an area of high unmet medical need. With this approval, Fetroja will be a new treatment option for patients in South Korea suffering from infections caused by multidrug-resistant. Shionogi has identified "Protecting people from the threat of infectious diseases" as a material issue (materiality) to address, and is working toward achieving comprehensive care for infectious diseases. We are committed to protecting the health of people by delivering the necessary infectious disease treatments to patients around the world as quickly as possible, in order to contribute to the successful management of global challenges such as COVID-19 and AMR. About Shionogi in AMR Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for more than 60 years. Shionogi is proud to be one of the few large pharmaceutical companies that continues to focus on R&D in anti-infectives. Click here to learn more about our efforts to address drug resistance. About Cefiderocol 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 options6. In the U.S., cefiderocol is 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 (HABP/VABP) and complicated urinary tract infections (cUTIs) caused by certain susceptible Gram-negative microorganisms7. 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 species8. Cefiderocol is listed on the World Health Organization's Essential Medicines List9, and preparations are underway through a collaborative agreement with The Global Antibiotic Research and Development Partnership (GARDP) and Clinton Health Access Initiative (CHAI) to improve access to this new antibacterial agent for patients in many low- and middle-income countries and high- and middle-income countries10. About JEIL PHARMACEUTICAL CO., LTD. Founded in 1959 and listed on KOSPI since 1988, JEIL has consistently contributed to the growth and development of South Korea’s pharmaceutical industry by developing and supplying high-quality medicines. Today, JEIL collaborates with pharmaceutical companies worldwide and is recognized as an advanced pharmaceutical company that adheres to international business practices. Reference: 1. Press release on July28, 2022 Execution of Sublicense Agreement with JEIL for New Siderophore Cephalosporin Antibacterial Drug Cefiderocol in South Korea 2. Press release on January 12, 2017 3. Press release on October 2, 2019 4. Press release on November 15, 2019 5. O’Neill J. ‘Tackling Drug-Resistant Infections Globally: Final Report and Recommendations’. Review on Antimicrobial Resistance. May 2016. Retrieved from https://amr-review.org/sites/default/files/160525_Final%20paper_with%20cover.pdf 6. Fetcroja® Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/fetcroja-epar-product-information_en.pdf. Accessed: March 2024. 7. Fetroja® Prescribing information. Available at: https://www.shionogi.com/content/dam/shionogi/si/products/pdf/fetroja.pdf Accessed: April 2024. 8. Press release on November 30, 2023. Regarding the Acquisition of Manufacturing and Marketing Approval for the New Siderophore Cephalosporin Antibiotic FetrojaⓇ(cefiderocol) Intravenous Infusion 1g vial in Japan 9. WHO Model List of Essential Medicines - 23rd list, 2023. WHO Model List of Essential Medicines - 23rd list, 2023 Accessed: April 2024 10. Press release on June 15, 2022 Shionogi, GARDP and CHAI announce landmark license and collaboration agreements to treat bacterial infections by expanding access to cefiderocol in 135 countries 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. For Further Information, Contact: SHIONOGI Website Inquiry Form : https://www.shionogi.com/global/en/contact.html

Phase 3Drug ApprovalLicense out/inClinical Result

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.

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Indication	Country/Location	Organization	Date
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
Klebsiella Infections	United States	Shionogi, Inc.	25 Sep 2020
Pneumonia, Ventilator-Associated	United States	Shionogi, Inc.	25 Sep 2020
Serratia Infections	United States	Shionogi, Inc.	25 Sep 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	European Union	Qualicaps Netherlands BV	23 Apr 2020
Gram-Negative Bacterial Infections	Norway	Qualicaps Netherlands BV	23 Apr 2020
Pyelonephritis	United States	Shionogi, Inc.	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
Gram-Negative Bacterial Infections	NDA/BLA	Australia	Shionogi & Co., Ltd.	03 Dec 2024
Complicated urinary tract infection	Preclinical	United Kingdom	Shionogi, Inc.	07 Sep 2016
Complicated urinary tract infection	Preclinical	Taiwan Province	Shionogi, Inc.	07 Sep 2016
Complicated urinary tract infection	Discovery	Turkey	Shionogi, Inc.	07 Sep 2016
Complicated urinary tract infection	Discovery	Brazil	Shionogi, Inc.	07 Sep 2016
Complicated urinary tract infection	Discovery	Spain	Shionogi, Inc.	07 Sep 2016
Complicated urinary tract infection	Discovery	United States	Shionogi, Inc.	07 Sep 2016
Complicated urinary tract infection	Discovery	Thailand	Shionogi, Inc.	07 Sep 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05789199 (PERSEUS study, Pubmed \| Eur J Clin Microbiol Infect Dis)	Not Applicable	Gram-Negative Bacterial Infections	261	Cefiderocol	brieyvgepp(qwmcspplab) = cxkncbshgl mzxhbzgavk (rrtynfgawh ) View more	Positive	25 Mar 2025
NCT05789199 (PERSEUS study, Pubmed \| Eur J Clin Microbiol Infect Dis)	Not Applicable	Stenotrophomonas Maltophilia Bacteremia Gram-negative bacteria	-	Cefiderocol (Stenotrophomonas maltophilia)	(tkggypxhme) = rlxmkyikwh uajnltefzz (liavuhxbky )	Positive	24 Mar 2025
				Cefiderocol (Burkholderia cepacia complex)	(tkggypxhme) = iyozhuslzp uajnltefzz (liavuhxbky )
NCT05395104 (CTgov)	Phase 1	-	14	Cefiderocol+Midazolam	geqzcqvnhk(lxcjnmdsae) = xtobwyspnf czqfnrghkq (omuowfxter, lnzqmeybzt - hxfgqiljvt) View more	-	14 Dec 2023
NCT03032380 (APEKS-NP, Pubmed) Manual	Phase 3	Healthcare-Associated Pneumonia	-	Linezolid+Cefiderocol	(tzoilnyxup) = wpsmhuzcah fvadnqmhqf (bwzhveiykn ) View more	Non-inferior	13 Jan 2022
				Linezolid+meropenem	(tzoilnyxup) = slrpvrzvsh fvadnqmhqf (bwzhveiykn ) View more
NCT02714595 (CREDIBLE-CR, Pubmed \| Lancet Infect Dis) Manual	Phase 3	Infectious Diseases	152	cefiderocol	(wfgpspfnrn) = zmqtfqsguo mbutrvgewx (hppnrgbenb, 23.2 - 65.5) View more	Similar	01 Feb 2021
				best available therapy	(wfgpspfnrn) = vdvhbwtbcu mbutrvgewx (hppnrgbenb, 17.7 - 71.1) View more
NCT03032380 (APEKS-NP, CTgov)	Phase 3	Hospital acquired bacterial pneumonia \| Pneumonia, Ventilator-Associated \| Hospital-acquired pneumonia \| Ventilator associated bacterial pneumonia	300	Cefiderocol+Linezolid (Cefiderocol)	mwwuwbpmyg(ccfhnnozvv) = xxsvizroyc wrrepusyir (ovjrxymvoe, twfevmwspc - qorjtrforb) View more	-	13 Nov 2020
				Meropenem+Linezolid (Meropenem)	mwwuwbpmyg(ccfhnnozvv) = bftabcgjos wrrepusyir (ovjrxymvoe, netfaeyabl - qrletrhlpa) View more
NCT03862040 (CTgov)	Phase 1	Pneumonia, Bacterial	7	Standard of Care Antibiotic+Cefiderocol	evoxzrzxew(ckibcxfgyc) = raeuztfylu xmjzvxtxrm (htspdvexhy, cednkxoaaq - maioigoemw) View more	-	05 Nov 2020
NCT02321800 (Pubmed) Manual	Phase 2	Urinary Tract Infections Gram-negative	452	Cefiderocol	epuxduxjks(patuztekhb) = syykgeqoil ofgiqksdyz (ybynjihyvh ) View more	Positive	01 Dec 2018
				imipenem-cilastatin	epuxduxjks(patuztekhb) = qxksuufifk ofgiqksdyz (ybynjihyvh ) View more

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