Product Description
Cefiderocol (CFDC), a novel siderophore cephalosporin possessed unique drug delivery systems and stability to beta-lactamases, has the potential to become first-line therapy for most aggressive MDR Gram-negative pathogens infection. (Sourced from: https://www.frontiersin.org/articles/10.3389/fmed.2021.741940/full)
Mechanisms of Action: PBP Binder
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Austria | Belgium | Croatia | Czech | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | Ireland | Italy | Latvia | Lithuania | Netherlands | Norway | Poland | Portugal | Slovakia | Spain | Sweden | United Kingdom | United States
Approved Indications: Gram-Negative Bacterial Infections | Urinary Tract Infections | Nephritis | Pyelonephritis
Known Adverse Events: Headache | Candidiasis | Hypokalemia | Constipation | Diarrhea
Company: Shionogi
Company Location: OSAKA M0 541-0045
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Belgium, Estonia, Georgia, Greece, Hungary, Latvia, Lithuania, Malaysia, Mexico, Panama, Philippines, Russia, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United States
Active Clinical Trial Count:
Highest Development Phases
Phase 2: Communicable Diseases|Gram-Negative Bacterial Infections|Intraabdominal Infections|Pneumonia|Pneumonia, Bacterial|Pneumonia, Ventilator-Associated|Sepsis|Urinary Tract Infections
Phase 1: Acute Kidney Injury|Healthy Volunteers|Pyelonephritis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
QPEX-400 | P1 |
Recruiting |
Pneumonia, Ventilator-Associated|Pyelonephritis|Pneumonia, Bacterial|Urinary Tract Infections |
2025-12-01 |
|
1904R2136 | P2 |
Recruiting |
Communicable Diseases|Gram-Negative Bacterial Infections |
2024-12-31 |
24% |
HHC-2022-0045 | P1 |
Completed |
Acute Kidney Injury |
2024-11-20 |
|
1704R2133 | P2 |
Completed |
Pneumonia, Bacterial|Urinary Tract Infections|Communicable Diseases|Gram-Negative Bacterial Infections |
2024-09-17 |