Cefiderocol sulfate tosylate is under clinical development by Shionogi & and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Cefiderocol sulfate tosylate’s likelihood of approval (LoA) and phase transition for Gram-Negative Bacterial Infections took place on 07 Jul 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Cefiderocol sulfate tosylate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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 & (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.

Quick View Cefiderocol sulfate tosylate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Cefiderocol sulfate tosylate
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Genito Urinary System And Sex Hormones
  • Infectious Disease
Key Developers
Highest Development Stage
  • Marketed

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.