Fetroja

(Cefiderocol)

ApprovedSmall molecule

Shionogi

Fetroja is one of 134 small molecule programs targeting Bacterial Pneumonia. It is currently in Approved.

Indications

Total Trials

Active Trials

133

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Bacterial PneumoniaActive, not recruiting

PneumoniaActive, not recruiting

Gram-Negative Bacterial InfectionsActive, not recruiting

Cystic FibrosisActive, not recruiting

Urinary Tract InfectionActive, not recruiting

Bacterial PneumoniaPhase 1

Active, not recruiting

PneumoniaPhase 3

Active, not recruiting

Gram-Negative Bacterial InfectionsApproved

Active, not recruiting

Cystic FibrosisApproved

Active, not recruiting

Urinary Tract InfectionPhase 2

Active, not recruiting

Competition

Competitive Landscape

547 competitors in Pneumonia

#DrugCompanyPhaseTrials

Fetroja

Shionogi

Approved

1 2

Prevacid

Takeda

Preclinical

1 3

Innohep

Alnylam Pharmaceuticals

Preclinical

1 4

Acanya

Pfizer

Preclinical

1 5

Avlosulfon

AAlmirall, S.A.

Preclinical

4 6

Zantac 150

CChattem

Preclinical

2 7

Gantanol

CConrado Roberto Hoffmann Filho

Preclinical

2 8

Mucinex

AAultman Health Foundation

Preclinical

1 9

Cancidas

FFresenius Kabi Oncology Ltd.

Preclinical

1 10

Pepcid

KKenvue Brands

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Post-ApprovalRecruiting

Ampicillin

NCT05922124

Q1 2027

Post-ApprovalRecruiting

Acute

NCT07465432

Q4 2028

Post-ApprovalRecruiting

Gram-Negative Bacterial Infections

NCT07004049

Clinical

Trials by Indication[1]

Pediatric2 trials

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants

Completed· Shionogi logo

Shionogi·Phase 2·NCT04335539·53 enrolled

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants

Completed· Shionogi logo

Shionogi·Phase 2·NCT04215991·91 enrolled

Midazolam1 trial

A Study to Assess the Effect of Cefiderocol on the Pharmacokinetics (PK) of Midazolam in Healthy Participants

Completed· Shionogi logo

Shionogi·Phase 1·NCT05395104·14 enrolled

Infants1 trial

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants

Completed· Shionogi logo

Shionogi·Phase 2·NCT06086626·30 enrolled

Pneumonia1 trial

Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens

Completed· Shionogi logo

Shionogi·Phase 3·NCT03032380·300 enrolled

Cystic Fibrosis1 trial

Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis

Completed·HHartford Hospital·Phase 4·NCT05314764·10 enrolled

12 more indications

Urinary Tract Infection1 trial

A Study of Efficacy and Safety of Intravenous Cefiderocol (S-649266) Versus Imipenem/Cilastatin in Complicated Urinary Tract Infections

Completed· Shionogi logo

Shionogi·Phase 2·NCT02321800·452 enrolled

Bacterial Pneumonia1 trial

Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial Pneumonia

Terminated· Shionogi logo

Shionogi·Phase 1·NCT03862040·7 enrolled

ECMO1 trial

Cefiderocol PK in Patients on ECMO

Completed·JJoseph L. Kuti, PharmD·Phase 1·NCT04995835·5 enrolled

Ampicillin1 trial

Cefiderocol and Ampicillin-sulbactam vs. Colistin +/- Meropenem for Carbapenem Resistant A. Baumannii

Recruiting·RRambam Health Care Campus·Phase 4·NCT05922124·734 enrolled

Bacterial Infections1 trial

Expanded Access to Cefiderocol for the Intravenous Treatment of Severe Gram Negative Bacterial Infections

Approved for marketing· Shionogi logo

Shionogi··NCT03780140

Renal Replacement Therapy1 trial

Cefiderocol Plasma Concentrations in Patients Receiving Renal Replacement Therapy

Completed·HHartford Hospital·Phase 1·NCT05373615·14 enrolled

Severe Infection1 trial

Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens

Completed· Shionogi logo

Shionogi·Phase 3·NCT02714595·152 enrolled

Infections1 trial

Use of Cefiderocol in the Management of Gram-Negative Infections

Completed· Shionogi logo

Shionogi··NCT05789199·314 enrolled

Treatment1 trial

RCT Cefiderocol vs BAT for Treatment of Gram Negative BSI

Completed·TThe University of Queensland·Phase 2·NCT03869437·513 enrolled

Adult1 trial

A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants

Completed·QQpex Biopharma, Inc.·Phase 1·NCT06547554·60 enrolled

Acute1 trial

Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries

Recruiting·UUniversity of Tennessee·Phase 4·NCT07465432·12 enrolled

Gram-Negative Bacterial Infections1 trial

Optimising TREATment for Severe Gram-Negative Bacterial Infections

Recruiting·NNational University of Singapore·Phase 4·NCT07004049·600 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 14, 2019

FETROJA

NDA NDA209445

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Cefiderocol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Cefiderocol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Cefiderocol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA209445). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Fetroja. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Shionogi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Shionogi

Patent Landscape[5]

Patent Cliff

Nov 14, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9238657Nov 14, 2033

10004750Sep 3, 2035

9949982Sep 3, 2035

Fetroja

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q1 2027

Q4 2028

Trials by Indication[1]

Pediatric2 trials

Midazolam1 trial

Infants1 trial

Pneumonia1 trial

Cystic Fibrosis1 trial

Urinary Tract Infection1 trial

Bacterial Pneumonia1 trial

ECMO1 trial

Ampicillin1 trial

Bacterial Infections1 trial

Renal Replacement Therapy1 trial

Severe Infection1 trial

Infections1 trial

Treatment1 trial

Adult1 trial

Acute1 trial

Gram-Negative Bacterial Infections1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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