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Drug

Cefiderocol

In clinical development
ClassBacterial penicillin-binding protein inhibitorEmerging researchLate-stage development

Also known as Fetroja.

RxNorm2265702ChEMBLCHEMBL3989974ATCJ01DI04UNIISZ34OMG6E8
2
Research papers
3
Active clinical trials
7
Protein targets
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Cefiderocol and Ampicillin-sulbactam vs. Colistin or Colistin-meropenem for Carbapenem Resistant Acinetobacter Baumannii Bacteremia or Hospital-acquired Pneumonia: Controlled Clinical Study With Historical Controls (CASCADE)

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries

Clinical trial2026-03-12Results expected Q1 2027 · ClinicalTrials.gov

A Single Arm, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Paediatric Subjects 3 Months to <18 Years of Age With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections

Clinical trial2026-02-27Results posted · ClinicalTrials.gov

A Phase 1, Randomized, Double-blind, Placebo-controlled, Drug-drug Interaction, Pharmacokinetic, and Safety Study of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants

Clinical trial2025-10-27Completed · ClinicalTrials.gov

TREAT-GNB [CR-GNB]

Clinical trial2025-06-04Results expected Q4 2028 · ClinicalTrials.gov

A Multicenter, Single-arm, Open-label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Cefiderocol in Hospitalized Pediatric Patients From Birth to < 3 Months of Age With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections

Clinical trial2025-03-31Completed · ClinicalTrials.gov

Population Pharmacokinetics of Cefiderocol During Acute Pulmonary Exacerbations in Adult Patients With Cystic Fibrosis

Clinical trial2024-12-11Completed · ClinicalTrials.gov

Effect of Continuous Renal Replacement Therapy and Residual Renal Clearance on Cefiderocol Pharmacokinetics in Critically Ill Adult Patients

Clinical trial2024-11-20Completed · ClinicalTrials.gov

An Open-label Study With a Nonrandomized Single-dose Phase in Subjects With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections Followed by a Randomized, Multiple-dose, Active-controlled Phase in Subjects With Suspected or Confirmed Complicated Urinary Tract Infection (cUTI), Hospital-acquired Bacterial Pneumonia (HABP) or Ventilator-associated Bacterial Pneumonia (VABP) to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Subjects 3 Months to < 18 Years of Age

Clinical trial2024-09-17Completed · ClinicalTrials.gov

Ex Vivo Sequestration and Pharmacokinetics of Cefiderocol in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)

Clinical trial2024-09-01Completed · ClinicalTrials.gov

New Antibiotics for Multidrug-Resistant Bacterial Strains: Latest Research Developments and Future Perspectives.

Research2021-05-02Molecules (Basel, Switzerland)

Cefiderocol versus imipenem-cilastatin for the treatment of complicated urinary tract infections caused by Gram-negative uropathogens: a phase 2, randomised, double-blind, non-inferiority trial.

Research2018-10-25The Lancet. Infectious diseases

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Cefiderocol
Aliases & brands
Fetroja
RxNorm CUI
2265702
ChEMBL ID
CHEMBL3989974
ATC codes
J01DI04
UNII
SZ34OMG6E8
Primary mechanism
Bacterial penicillin-binding protein inhibitor

Pharmacology & targets

7 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

D-alanyl-D-alanine carboxypeptidase DacB
dacB · P24228
INHIBITORBacterial penicillin-binding protein inhibitor
Peptidoglycan D,D-transpeptidase FtsI
ftsI · P0AD68
INHIBITORBacterial penicillin-binding protein inhibitor
Penicillin-binding protein 1A
mrcA · P02918
INHIBITORBacterial penicillin-binding protein inhibitor
Penicillin-binding protein 1B
mrcB · P02919
INHIBITORBacterial penicillin-binding protein inhibitor
D-alanyl-D-alanine carboxypeptidase DacA
dacA · P0AEB2
INHIBITORBacterial penicillin-binding protein inhibitor
Peptidoglycan D,D-transpeptidase MrdA
mrdA · P0AD65
INHIBITORBacterial penicillin-binding protein inhibitor
D-alanyl-D-alanine carboxypeptidase DacC
dacC · P08506
INHIBITORBacterial penicillin-binding protein inhibitor

Clinical trials

16 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
16
registered trials across all phases
LATEST COMPLETION 2025
3
Active studies
3
Recruiting
6
Late-stage (III+)
12
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 16
Phase 15Phase 25Phase 32Phase 44

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

TREAT-GNB [CR-GNB]

RecruitingPH IVNational University of Singaporen=6002028

Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries

RecruitingPH IVUniversity of Tennesseen=122027

Cefiderocol and Ampicillin-sulbactam vs. Colistin or Colistin-meropenem for Carbapenem Resistant Acinetobacter Baumannii Bacteremia or Hospital-acquired Pneumonia: Controlled Clinical Study With Historical Controls (CASCADE)

RecruitingPH IVRambam Health Care Campusn=7342026

Population Pharmacokinetics of Cefiderocol During Acute Pulmonary Exacerbations in Adult Patients With Cystic Fibrosis

CompletedPH IVHartford Hospitaln=102024

A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens

CompletedPH IIIShionogin=1522019

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1, Randomized, Double-blind, Placebo-controlled, Drug-drug Interaction, Pharmacokinetic, and Safety Study of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants

CompletedPH IQpex Biopharma, Inc.n=602025

A Multicenter, Single-arm, Open-label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Cefiderocol in Hospitalized Pediatric Patients From Birth to < 3 Months of Age With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections

CompletedPH IIShionogin=302025

Population Pharmacokinetics of Cefiderocol During Acute Pulmonary Exacerbations in Adult Patients With Cystic Fibrosis

CompletedPH IVHartford Hospitaln=102024

Effect of Continuous Renal Replacement Therapy and Residual Renal Clearance on Cefiderocol Pharmacokinetics in Critically Ill Adult Patients

CompletedPH IHartford Hospitaln=142024

An Open-label Study With a Nonrandomized Single-dose Phase in Subjects With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections Followed by a Randomized, Multiple-dose, Active-controlled Phase in Subjects With Suspected or Confirmed Complicated Urinary Tract Infection (cUTI), Hospital-acquired Bacterial Pneumonia (HABP) or Ventilator-associated Bacterial Pneumonia (VABP) to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Subjects 3 Months to < 18 Years of Age

CompletedPH IIShionogin=912024

Ex Vivo Sequestration and Pharmacokinetics of Cefiderocol in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)

CompletedPH IJoseph L. Kuti, PharmDn=52024

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20182021
Major research themes2
Drug Design1Drug Resistance, Multiple, Bacterial1
Journals, researchers & institutions
Top journals
  • Molecules (Basel, Switzerland)1
  • The Lancet. Infectious diseases1
Leading researchers
  • Ariyasu M1
  • Echols R1
  • Ferreira JCA1
  • Machida M1
  • Nagata TD1
  • Portsmouth S1
  • Pregnolato M1
  • Taccani M1
Leading institutions
free-text, unnormalised
  • Jahn Ferenc Dél-Pesti Hospital1
  • University of Pavia1

Related drugs

7 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Delafloxacin

Studied across 2 of the same disease areas as Cefiderocol in the shared literature.

2 shared diseases1 shared paper
Eravacycline

Studied across 2 of the same disease areas as Cefiderocol in the shared literature.

2 shared diseases1 shared paper
Meropenem

Studied across 2 of the same disease areas as Cefiderocol in the shared literature.

2 shared diseases1 shared paper
Plazomicin

Studied across 2 of the same disease areas as Cefiderocol in the shared literature.

2 shared diseases1 shared paper
Pretomanid

Studied across 2 of the same disease areas as Cefiderocol in the shared literature.

2 shared diseases1 shared paper
Sisomicin

Studied across 2 of the same disease areas as Cefiderocol in the shared literature.

2 shared diseases1 shared paper
Vaborbactam

Studied across 2 of the same disease areas as Cefiderocol in the shared literature.

2 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials