Cefiderocol

Overview

Cefiderocol is a cephalosporin antibacterial drug and exerts a mechanism of action similar to other β-lactam antibiotics. Unlike other agents in this category, cefiderocol is a siderophore able to undergo active transport into the bacterial cell through iron channels. It represents a significant addition to antibacterial treatment option as it has proven to be effective in vitro against multidrug resistant strains including extended spectrum β-lactamase producers and carbapenemase producing bacteria. Cefiderocol was granted designation as a Qualified Infectious Disease Product and granted priority review status by the FDA on November 14, 2019. It is indicated for use in complicated urinary tract infections in patients with limited or no alternative treatments available. This indication was supported by a positive clinical trial composed of 448 patients with complicated urinary tract infections which demonstrated a 72.6% rate of symptom resolution and bacterial eradication with cefiderocol compared to 54.6% with the comparator, imipenem/cilastatin. A concern noted in the trial was a 0.3% higher rate of all cause mortality, the cause of which has not been determined.

Background

Indication

Cefiderocol is indicated for the treatment of complicated urinary tract infections with or without pyelonephritis.

Associated Conditions

Complicated Urinary Tract Infection
Nosocomial Pneumonia
Pyelonephritis
Ventilator Associated Bacterial Pneumonia (VABP)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Optimising TREATment for Severe Gram-Negative Bacterial Infections	2025/06/04	NCT07004049	Phase 4	Recruiting	National University of Singapore
A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants	2024/08/09	NCT06547554	Phase 1	Recruiting	Qpex Biopharma, Inc.
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants	2023/10/17	NCT06086626	Phase 2	Completed	Shionogi
Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii	2023/06/28	NCT05922124	Phase 4	Not yet recruiting	Rambam Health Care Campus
Use of Cefiderocol in the Management of Gram-Negative Infections	2023/03/29	NCT05789199	N/A	Completed	Shionogi
A Study to Assess the Effect of Cefiderocol on the Pharmacokinetics (PK) of Midazolam in Healthy Participants	2022/05/27	NCT05395104	Phase 1	Completed	Shionogi
Cefiderocol Plasma Concentrations in Patients Receiving Renal Replacement Therapy	2022/05/13	NCT05373615	Phase 1	Completed	Hartford Hospital
Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis	2022/04/06	NCT05314764	Phase 4	Completed	Hartford Hospital
Cefiderocol PK in Patients on ECMO	2021/08/09	NCT04995835	Phase 1	Completed	Joseph L. Kuti, PharmD
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants	2020/04/06	NCT04335539	Phase 2	Completed	Shionogi

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Fetroja	Shionogi Inc.	59630-266	INTRAVENOUS	1 g in 10 mL	11/19/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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