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

1,119

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

OBJECTIVES:

Drug-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.

METHODS:

CRE 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.

RESULTS:

Among 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.

CONCLUSION:

The 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 ; Yilmaz, Mesut ; Mataracı-Kara, Emel ; Özer, Bekir

OBJECTIVES:

This research examines the combined in vitro effectiveness of cefiderocol with other antibiotics against carbapenem-resistant and -susceptible Pseudomonas aeruginosa obtained from Intensive Care Units.

METHODS:

Forty 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.

RESULTS:

Colistin 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.

CONCLUSION:

The 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.

06 May 2025·Microbiology Spectrum

Global molecular epidemiology of the incomplete CirA protein related to cefiderocol resistance in Klebsiella pneumoniae : a genome-based study

Article

Author: Zong, Zhiyong ; Feng, Yu ; Long, Haiyan

ABSTRACT:

CirA is an iron transporter comprising 657 amino acids in Klebsiella pneumoniae, and incomplete CirA alone leads to reduced susceptibility to cefiderocol. We performed a genome-based analysis to study the prevalence of incomplete CirA in K. pneumoniae through analyzing all genomes of this species ( n = 55,517, as of 26 October 2023) available in NCBI. We detected incomplete CirA in 633 (1.27%) genomes with the corresponding strains collected since 1911, across 44 countries on six continents, and mostly ( n = 563, 88.94%) from humans. Notably, 77 (12.16%) genomes had incomplete CirA in combination with β-lactamases (NDM-1, NDM-5, NDM-7, or KPC-3 plus SHV-11) known to confer cefiderocol resistance. We identified 189 variants of incomplete CirA, including two particularly common ones, a 362-amino-acid remnant due to frameshift by a deletion at cirA nucleotide position 1,083 (116/633, 18.33%) and a 562-amino-acid remnant due to premature stop resulting from a mutation at nucleotide position 1,684 (71/633, 11.22%). The 362-amino-acid remnant was mainly found in ST26 (39/116), ST34 (36/116), and ST359 (31/116) strains. The 562-amino-acid remnant was almost exclusive to ST86 (69/71), particularly related to the hypervirulent capsule type K2. Clonal outbreaks (ST26 in USA, ST34 in UK, and ST86 in Vietnam) and cross-border transmission (ST34 in UK and Portugal) were observed. However, this study has limitations, as the analyzed publicly available K. pneumoniae assemblies are biased, and only mutations resulting in incomplete CirA were considered. In conclusion, K. pneumoniae with incomplete CirA is a global concern, highlighting the urgent need for heightened vigilance and further studies.

IMPORTANCE:

Cefiderocol is a critically important antimicrobial agent against multidrug-resistant organisms including carbapenem-resistant Klebsiella pneumoniae . We performed a genome-mining study and found incomplete CirA (an iron transporter), which is related to cefiderocol resistance, in a small proportion (1.27%) of publicly available K. pneumoniae genomes. However, K. pneumoniae strains with incomplete CirA are globally distributed and have been present for over a century, well before the clinical use of cefiderocol. One hundred eighty-nine incomplete CirA variants were identified, suggesting multifactorial causes. Almost all publicly available genomes of ST26, ST34, and ST86 K. pneumoniae strains with incomplete CirA have a wide geographic distribution, pointing to the potential existence of particular lineages prone to develop resistance to cefiderocol. Clonal outbreaks and cross-border transmission of strains with incomplete CirA were detected. Incomplete CirA was associated with the hypervirulent K2-ST86 lineage or high-risk multidrug resistance ST16 clone, posing an increased threat or challenge to treatment and infection control.

News (Medical) associated with Cefiderocol Sulfate Tosylate

07 May 2025

·www.shionogi.com

Announcement of Agreement on Company Split (Simplified Absorption-Type Split) of Japan Tobacco Inc.'s Pharmaceutical Business and Acquisition of Shares of Akros Pharma Inc. by Shionogi Inc. (Making it a Subsidiary)

OSAKA, Japan, May 7, 2025 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi" or the “Company”) today announced that at the Board of Directors meeting held on May 7, 2025, it resolved to succeed to the pharmaceutical business of Japan Tobacco Inc. (Headquarters: Minato-ku, Tokyo; President: Masamichi Terabatake; hereinafter referred to as "Japan Tobacco") (hereinafter referred to as "JT Pharmaceutical Business" or the "Business to be Split") through a company split (simplified absorption-type split) (hereinafter referred to as the "Absorption-Type Split") and to acquire all issued shares of Akros Pharma Inc. (a 100% sub-subsidiary of Japan Tobacco, headquartered in New Jersey, USA; hereinafter referred to as "Akros") by Shionogi Inc., a group company of Shionogi in the USA (hereinafter referred to as the "Share Acquisition"), and has entered into an agreement (hereinafter referred to as the "Agreement") regarding the same. In connection with the Agreement, the Company also resolved at the Board of Directors meeting held today to conduct a tender offer (hereinafter referred to as the "Tender Offer") for the common shares of Torii Pharmaceutical Co., Ltd. (hereinafter referred to as "Torii Pharmaceutical"), a consolidated subsidiary of Japan Tobacco, to make Torii Pharmaceutical a wholly-owned subsidiary of the Company (hereinafter referred to as the "Full Ownership"). For details on the Tender Offer, please refer to the "Notice of Commencement of Tender Offer for Shares of Torii Pharmaceutical Co., Ltd. (Securities Code: 4551)" released today. I. Purpose of the Absorption-Type Split and Share Acquisition (hereinafter referred to as the "Transaction") Shionogi's basic policy (SHIONOGI Group Heritage) is to always provide the best medicine (healthcare solutions) necessary to protect people's health. The Company engages in research and development, manufacturing, and sales activities of prescription drugs, over-the-counter drugs, and diagnostic agents. In 2020, the Company set forth the Vision (SHIONOGI Group Vision) that aims to achieve by 2030, "Creating the Future of Healthcare with a New Platform," and formulated the medium-term management plan Shionogi Transformation Strategy 2030 (STS2030) to realize this Vision. The Company is transforming into a Healthcare as a Service (HaaS) company that provides various healthcare services tailored to customer needs, not limited to the provision of prescription drugs, to comprehensively address the problems faced by patients and society worldwide. From fiscal 2020 to fiscal 2022, the Company aimed to contribute to the early end of the COVID-19 pandemic by providing not only therapeutic drugs but also total care solutions for COVID-19, including detection (epidemic prediction), prevention, diagnosis, and mitigation of severe cases. As a result, the Company obtained domestic approval for the COVID-19 therapeutic drug Xocova at an unprecedented speed, advancing its drug discovery capabilities. Additionally, the Company expanded its product and service offerings beyond prescription drugs, including its first vaccine and wastewater epidemiology survey service. Based on the achievements and lessons learned from these efforts, the path to realizing the SHIONOGI Group Vision became clearer, leading to the revision of STS2030 in 2023 and the start of STS2030 Revision. In STS2030 Revision, the three years from fiscal 2023 to fiscal 2025 are positioned as STS Phase 2, with the basic policy of global top-line growth centered on the infectious disease area and fostering growth drivers through aggressive investment, accelerating growth through transformation. In research and development, the Company focuses on high-impact infectious diseases and high-impact QOL diseases as priority areas. In infectious diseases, the Company has developed many innovative new drugs, such as the anti-HIV drugs (dolutegravir and cabotegravir), the for multidrug-resistant Gram-negative bacterial infections (cefiderocol), and the anti-influenza virus drug Xofluza, based on its strong foundation in small molecule drug discovery (creating drugs with molecular weights ranging from tens to hundreds). The Company aims to solve the problems faced by patients and society worldwide by further strengthening and expanding its strong foundation in small molecule drug discovery. On the other hand, JT Pharmaceutical Business has been engaged in research and development of prescription drugs since entering the business in 1987, aiming to create first-in-class small molecule drugs through stable research and development investment. Currently, under the business purpose of "valuing science, technology, and human resources and contributing to patients' health," Japan Tobacco conducts research and development, while Torii Pharmaceutical handles manufacturing, sales, and promotion activities, building an integrated value chain and maximizing synergies within the group. JT Pharmaceutical Business focuses on three priority research and development areas: cardiovascular, renal, and muscle, "immunology and inflammation, and central nervous system, with strengths in rapid clinical development through specialization on research and development in the small molecule drug discovery and collaboration between domestic and international research and development bases. To deliver new drugs created in-house to patients as early as possible, JT Pharmaceutical Business actively engages in out-licensing and partnerships with global mega-pharma companies, in addition to promoting in-house development. Shionogi has been considering collaboration with JT Pharmaceutical Business and Torii Pharmaceutical to realize the Vision of "Creating the Future of Healthcare with a New Platform" in STS2030 Revision. As a result of these considerations, the Company concluded that by adding the capabilities of JT Pharmaceutical Business, which has strengths in small molecule drug discovery and development , it would be possible to accelerate the advancement of promising pipeline projects and increase the responsiveness and efficiency of business operations through collaboration with the Company's pharmaceutical manufacturing functions. The Company proposed to Japan Tobacco the acquisition of JT Pharmaceutical Business and the full ownership of Torii Pharmaceutical, and after subsequent discussions, reached the Agreement. The Company believes that the Transaction will create a leading company that delivers innovative pharmaceuticals from Japan to the world, contributing to the health of patients and people worldwide, and contributing to the realization of a sustainable and healthy society. The Company also believes that the Transaction will provide opportunities for the employees of JT Pharmaceutical Business (including group companies) to continue to thrive with peace of mind. II. Overview of the Absorption-Type Split i. Summary of the Absorption-Type Split (1) Date (1) Date of Board Resolution for Agreement May 7, 2025 (2) Date of Agreement May 7, 2025 (3) Date of Board Resolution for Absorption-Type Split Agreement September, 2025 (planned) (4) Date of Absorption-Type Split Agreement September, 2025 (planned) (5) Effective Date of Absorption-Type Split December, 2025 (planned) (Note 1): The Absorption-Type Split falls under the simplified absorption-type split stipulated in Article 796, Paragraph 2 of the Companies Act for the Company, and Article 784, Paragraph 2 of the Companies Act for Japan Tobacco. Therefore, it will be carried out without the approval resolution of the shareholders' meeting. (Note 2): The schedule may be changed as necessary, considering the need for responses to approvals, registrations, notifications, etc., from relevant authorities, circumstances, and other various factors. (2) Method of Absorption-Type Split The Company will be the succeeding company, and Japan Tobacco will be the splitting company. (3) Allocation of Consideration The Company will pay 5,397 million yen to Japan Tobacco as consideration for the Absorption-Type Split. (4) Handling of Stock Acquisition Rights and Bonds with Stock Acquisition Rights Not applicable. (5) Increase or Decrease in Capital Due to Absorption-Type Split Not applicable. (6) Rights and Obligations to be Succeeded The Company will succeed to the assets, liabilities, and contractual rights and obligations related to the Absorption-Type Split, except for those separately specified in the Absorption-Type Split Agreement. (7) Prospects for Debt Performance The Company believes that there are no issues with performance of the debts that will become due after the effective date of the Absorption-Type Split. ii. Allocation of Consideration and Basis for the Absorption-Type Split (1) Basis and Reason for Allocation of Consideration The allocation of consideration was agreed upon after comprehensive discussions between both companies, taking into account the performance status and future prospects of the business to be split. (2) Matters Related to Calculation The Company has not obtained a valuation report from a valuation institution in connection with the Absorption-Type Split. (3) Prospect of Delisting and Its Reason Since the consideration involves the exchange of money, there is no prospect of delisting. (4) Measures to Ensure Fairness Not applicable. However, the Company has appointed Nishimura & Asahi Law Office as the legal advisor for the Absorption-Type Split and has received legal advice on various procedures, decision-making methods, and processes related to the Absorption-Type Split. Nishimura & Asahi Law Office does not have any significant interests that should be disclosed in relation to the Absorption-Type Split and is not a related party to the Company or Japan Tobacco. (5)Measures to Avoid Conflicts of Interest Not applicable. (Unit: million yen, unless otherwise specified.) i. Overview of JT Pharmaceutical Business (1) Content of JT Pharmaceutical Business Research and development of prescription drugs (2) Business Performance of JT Pharmaceutical Business Fiscal year ended December 2024 Net sales ¥44,942 million (3) Items and Amounts of Assets and Liabilities of the JT Pharmaceutical Business to be Succeeded (as of December 31, 2024) The assets (excluding shares of Torii Pharmaceutical and Akros) and liabilities, as well as other rights and obligations belonging to the JT pharmaceutical business, As stipulated in the absorption-type split agreement will be succeeded by our company. Assets Liabilities field book value field book value Current Assets ¥8,588 million Current Assets ¥5,448 million Fixed Liabilities ¥37,832 million Fixed Liabilities ¥9,875 million Total ¥46,420 million Total ¥15,323 million Note: The above amounts are calculated based on the balance sheet as of December 31, 2024, and the actual amounts to be succeeded will be adjusted for any increases or decreases up to the effective date. ii. Status After the Absorption-Type Split (1) Name of Company Shionogi & Co., Ltd. Japan Tobacco Inc. (2) Location 1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan 1-1, Toranomon 4-chome, Minato-ku, Tokyo (3) Representative Isao Teshirogi, Ph.D., Representative Director, President and CEO Masamichi Terabatake, President, Chief Executive Officer and Representative Director　 (4) Business Description Research, development, manufacturing and distribution of pharmaceuticals, diagnostic reagents and medical devices, etc. Manufacture, sale, import, etc., of manufactured tobacco (5) Paid-in Capital ¥21,279 million ¥100,000 million (6) Fiscal Year-End March 31 December 31 (7) Net Assets It is not confirmed at this time It is not confirmed at this time (8) Total Assets It is not confirmed at this time It is not confirmed at this time iii. Overview of Accounting Treatment For the accounting treatment related to the Absorption-Type Split, we plan to apply IFRS 3 'Business Combinations' and use the purchase method, with our Company as the acquiring entity. The amount of goodwill generated from this Absorption-Type Split is currently undecided, and we will inform you as soon as it is determined. iv. Future Outlook We are currently assessing the impact of this Absorption-Type Split on our consolidated performance, and will inform you as soon as it is determined. v. Other Noteworthy Matters The Agreement is contingent upon the absence of any factors hindering the execution of the stock acquisition, such as the issuance of a cease and desist order, based on the results of the Japan Fair Trade Commission's review of the notification under Article 10, Paragraph 2 of the Act on Prohibition of Private Monopolization and Maintenance of Fair Trade. II. Overview of this Stock Acquisition i. Overview of Our U.S. Subsidiary (Shionogi Inc.) Acquiring the Shares (1) Name of Company Shionogi Inc. (2) Location 400 Campus Drive, Florham Park, NJ 07932, USA (3) Representative President and Chief Executive Officer Nathan McCutcheon (4) Business Description Development, manufacturing, and sales of pharmaceuticals (5) Paid-in Capital 12 USD (as of March 31, 2024) (6) Date of Founding August 2008 (7) Major Shareholders and Shareholding Ratios Shionogi (100%) ii. Overview of the Subsidiary to be Acquired (1) Name of Company Akros Pharma Inc. (2) Location 302 Carnegie Center, Suite 300, Princeton, NJ 08540 (3) Job Title and Name of Representative President＆CEO Teppei Higuchi (4) Business Description Clinical development, joint research, and exploration of new technology projects overseas (5) Paid-in Capital 1,000 USD (as of December 31, 2024) (6) Date of Founding January 1999 (7) Net Assets 23,776 thousand USD (as of December 31, 2024) (8) Total Assets 32,986 thousand USD (as of December 31, 2024) (9) Major Shareholders and Shareholding Ratios JT AMERICA INC. (100%) ※ JT AMERICA INC. is a wholly owned subsidiary of Japan Tobacco Inc. (10) Relationship between Shionogi and said company Capital Relationship None. Personal Relationship None. Transactional Relationship None. Status as Related Party None. iii. Overview of the Counterparty in the Stock Acquisition (1) Name of Company JT AMERICA INC. (2) Location 112 W. 34th Street, 18th Floors, New York, NY 10120 (3) Job Title and Name of Representative President & CEO Toshimitsu Eguchi (4) Business Description Holding company functions in the U.S. for non-tobacco and non-food businesses (5) Paid-in Capital 51 thousand USD (as of December 31, 2024) (6) Date of Founding May 1988 (7) Net Assets 141,447 thousand USD (as of December 31, 2024) (8) Total Assets 142,125 thousand USD (as of December 31, 2024) (9) Major Shareholders and Ownership Ratios Japan Tobacco Inc.(100％) (10) Relationship between Shionogi and said company Capital Relationship None. Personal Relationship None. Business Relationship None. Related Party Relationship None. iv. Number of Shares to be Acquired, Acquisition Price, and the Status of Shareholding Before and After the Acquisition * The acquisition price has been converted at an exchange rate of 1 USD = 151.55 JPY (based on the average rate over the past six months). v. Date vi. Future Outlook We are currently assessing the impact of this stock acquisition on Shionogi’s consolidated financial results for the fiscal year ending March 2026. If it becomes necessary to revise the performance forecast, Shionogi will promptly disclose the information. For Further Information, Contact: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html

AcquisitionLicense out/in

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

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	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, Inc.	14 Nov 2019
Urinary Tract Infections	United States	Shionogi, Inc.	14 Nov 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hospital acquired bacterial pneumonia	Phase 3	United States	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Japan	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Belgium	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Canada	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Czechia	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Estonia	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	France	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Georgia	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Germany	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Hungary	Shionogi, Inc.	24 Oct 2017

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	icmpixzthi(rympgaajeg) = pcccsifhaa sogirjoiqs (urbdldfxen ) 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)	krfxxqgagl(qulwujbopl) = muokfoheyg vffsdoacjq (tiffiflheo )	Positive	24 Mar 2025
				Cefiderocol (Burkholderia cepacia complex)	krfxxqgagl(qulwujbopl) = zbkhrmwrgx vffsdoacjq (tiffiflheo )
NCT05395104 (CTgov)	Phase 1	-	14	Cefiderocol+Midazolam	sikbshzwez(vzypfhukag) = eehldujqoe iadlfqqgqr (kitshvjzfj, 45.3) View more	-	14 Dec 2023
NCT03032380 (APEKS-NP, Pubmed) Manual	Phase 3	Healthcare-Associated Pneumonia	-	Linezolid+Cefiderocol	fgtiobdmdu(lpkhullwsb) = ygwkitbopy zqsmjdgeur (tqueernodc ) View more	Non-inferior	13 Jan 2022
				Linezolid+meropenem	fgtiobdmdu(lpkhullwsb) = xjifokltic zqsmjdgeur (tqueernodc ) View more
NCT02714595 (CREDIBLE-CR, Pubmed \| Lancet Infect Dis) Manual	Phase 3	Infectious Diseases	152	cefiderocol	lwxsvofaxq(aksqbualrr) = tzawdndods lwgdvmaohk (xoyhfwhflt, 23.2 - 65.5) View more	Similar	01 Feb 2021
				best available therapy	lwxsvofaxq(aksqbualrr) = inzmzycjvw lwgdvmaohk (xoyhfwhflt, 17.7 - 71.1) View more
NCT03032380 (APEKS-NP, CTgov)	Phase 3	Hospital acquired bacterial pneumonia \| Ventilator associated bacterial pneumonia	300	Cefiderocol+Linezolid (Cefiderocol)	fbzzuluoxh = mxvdexcfcf kyqdwvzoqq (ixjvhspmtz, qnptzltevt - qsmwmbnsef) View more	-	13 Nov 2020
				Meropenem+Linezolid (Meropenem)	fbzzuluoxh = ioniygaxxp kyqdwvzoqq (ixjvhspmtz, ctlcosjpuf - fhlfsnqdju) View more
NCT03862040 (CTgov)	Phase 1	Pneumonia, Bacterial	7	Standard of Care Antibiotic+Cefiderocol	ffgyqhjijj(rhydiohljs) = blfsxohohe ttkrojbbdo (phxqbaflvi, ypftvobkjy - xcmalqluij) View more	-	05 Nov 2020
NCT02321800 (Pubmed) Manual	Phase 2	Urinary Tract Infections Gram-negative	452	Cefiderocol	enuqdajroc(eeyoqyhriv) = pietnsbbsk blxzspvssm (xhhjaehvjc ) View more	Positive	01 Dec 2018
				imipenem-cilastatin	enuqdajroc(eeyoqyhriv) = isdhqvbquo blxzspvssm (xhhjaehvjc ) View more

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