Cefiderocol sulfate tosylate is under clinical development by Shionogi and currently in Phase III for Enterobacteriaceae Infections. According to GlobalData, Phase III drugs for Enterobacteriaceae Infections have an 80% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Cefiderocol sulfate tosylate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Cefiderocol sulfate tosylate overview

Cefiderocol sulfate tosylate (Fetroja, Fetcroja) belongs to cephalosporins, acts as antibacterial agent. It is formulated as powder for concentrate for solution for intravenous route of administration. Fetroja is indicated in patients 18 years of age or older who have limited or no alternative treatment options for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, and indicated for the treatment of infections due to aerobic Gram-negative organisms (complicated urinary tract infections including pyelonephritis, complicated intra-abdominal infections, hospital-acquired pneumonia including ventilator associated pneumonia) in adults (18 years or older) with limited treatment options.

Cefiderocol sulfate tosylate (S-649266, GSK-2696266, S-649266D, GSK-2696266D) is under development for the treatment of multidrug resistant pseudomonas aeruginosa (MDRP), multidrug resistant Acinetobacter baumannii (MDRA), carbapenem resistant Enterobacteriaceae (CRE) such as carbapenem resistant Klebsiella pneumoniae, hospital acquired pneumonia (HAP), ventilator associated pneumonia (VAP), healthcare-associated pneumonia (HCAP), bloodstream infections or sepsis caused by carbapenem-resistant gram-negative pathogens. It is administered intravenously as powder for solution. S-649266 is a cephalosporin and targets penicillin-binding protein.

Shionogi overview

Shionogi focuses on the research, development, manufacturing, and marketing of pharmaceutical products, diagnostic reagents, and medical devices. It develops innovative products and services in collaboration with its partners. The company offers prescription drugs, over-the-counter (OTC) drugs, and diagnostic products for the therapeutic areas including metabolic disorders, infectious diseases, pain/central nervous system (CNS), and cancer. It offers contract development and manufacturing facilities including all stages from drug development to commercial manufacturing. The company operates a network of subsidiaries, branches, sales offices manufacturing plants, and research laboratories across Japan, China, Taiwan; North America and Europe. Shionogi is headquartered in Osaka, Japan.

For a complete picture of Cefiderocol sulfate tosylate’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.