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Fetroja (CEFIDEROCOL)
Fetroja works by binding to penicillin-binding proteins on bacterial cell walls, inhibiting cell wall synthesis and ultimately leading to bacterial cell death.
Fetroja (Cefiderocol) is a cephalosporin antibacterial drug developed by Shionogi Inc. It is a small molecule that targets a wide range of Gram-negative bacterial infections, including urinary tract infections caused by Escherichia coli, Klebsiella, and Pseudomonas. Fetroja was FDA-approved in 2019 for various indications, including pyelonephritis and urinary tract infections. The commercial status of Fetroja is patented, with no generic manufacturers available. Key safety considerations include potential side effects such as infusion site reactions and increased risk of Clostridioides difficile infection.
At a glance
| Generic name | CEFIDEROCOL |
|---|---|
| Sponsor | Shionogi |
| Drug class | Cephalosporin Antibacterial |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2019 |
| Annual revenue | 300 |
Mechanism of action
FETROJA is an antibacterial drug [see Microbiology (12.4)].
Approved indications
- Bacterial urinary infection
- Escherichia coli urinary tract infection
- Gram-Negative Bacterial Infections
- Proteus urinary tract infection
- Pseudomonas urinary tract infection
- Pyelonephritis
- Urinary tract infection caused by Klebsiella
- Urinary tract infectious disease
Common side effects
- Diarrhea
- Infusion site reactions
- Constipation
- Rash
- Candidiasis
- Cough
- Elevations in liver tests
- Headache
- Hypokalemia
- Nausea
- Vomiting
- Atrial fibrillation
Key clinical trials
- Impact of Siderophore Genes on Cefiderocol Susceptibility in Carbapenem Resistant Hypervirulent Klebsiella Pneumoniae
- Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries (PHASE4)
- A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants (PHASE2)
- A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants (PHASE2)
- Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex (PHASE2)
- A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants (PHASE1)
- A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal Impairment (PHASE1)
- Cefiderocol vs Best Available Therapy for Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex Infections: A Target Trial Emulation
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |