CLINICAL TRIALS PROFILE FOR FETROJA

All Clinical Trials for FETROJA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04215991 ↗	Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Patients	Recruiting	Shionogi	Phase 2	2020-02-19	To assess the safety, tolerability, and pharmacokinetics (PK) of cefiderocol after single-dose administration in hospitalized pediatric patients 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections and after multiple-dose administration in hospitalized pediatric patients 3 months to < 18 years of age with suspected or confirmed complicated urinary tract infection (cUTI), hospital-acquired pneumonia (HAP), or ventilator-associated pneumonia (VAP).
NCT04335539 ↗	Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Patients	Recruiting	Shionogi	Phase 2	2020-08-21	The primary objectives of this study are: - To assess the safety and tolerability of cefiderocol after single-dose administration in hospitalized paediatric patients 3 months to < 18 years of age with suspected or confirmed aerobic Gram-negative bacterial infections - To assess the pharmacokinetics (PK) of cefiderocol after single-dose administration of cefiderocol in hospitalized paediatric patients 3 months to < 18 years of age with suspected or confirmed aerobic Gram-negative bacterial infections - To assess the safety and tolerability of cefiderocol after multiple-dose administration in hospitalized paediatric patients 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections - To assess the PK of cefiderocol after multiple-dose administration in hospitalized paediatric patients 3 months to < 12 years of age with suspected or confirmed aerobic Gram-negative bacterial infections
NCT04995835 ↗	Cefiderocol PK in Patients on ECMO	Recruiting	Shionogi Inc.	Phase 1	2021-07-16	Extracorporeal membrane oxygenation (ECMO) is a form of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and reinfused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, Cefiderocol, in critically ill patient receiving ECMO.
NCT04995835 ↗	Cefiderocol PK in Patients on ECMO	Recruiting	Joseph L. Kuti, PharmD	Phase 1	2021-07-16	Extracorporeal membrane oxygenation (ECMO) is a form of cardiopulmonary life-support for critically ill patients where blood is extracted from the vascular system and circulated by a mechanical pump while it is oxygenated and reinfused into the patient's circulation. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how ECMO circuits affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, Cefiderocol, in critically ill patient receiving ECMO.
NCT05314764 ↗	Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis	Not yet recruiting	Indiana University Health Methodist Hospital	Phase 4	2022-06-01	There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Cefiderocol is a newly approved broad spectrum intravenous siderophore cephalosporin antibiotic, which has potent in vitro activity against multidrug resistant Pseudomonas aeruginosa, Burkholderia cepacia complex, Achromobacter species, and Stenotrophomonas maltophilia, all pathogens implicated in CF pulmonary exacerbations. This study will determine the pharmacokinetics and tolerability of cefiderocol in 12 adult CF patients admitted for a pulmonary exacerbation at one of 4 participating hospitals in the US. Patients will remain on standard of care IV antibiotics and receive 4-6 doses of cefiderocol 2 grams infused over 3 hours every 6-8 hours, depending on kidney function. Blood will be sampled after the final dose to determine concentrations and pharmacokinetics of cefiderocol. Safety and tolerability will be assessed throughout the 2 day study.
NCT05314764 ↗	Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis	Not yet recruiting	Keystone Bioanalytical, Inc.	Phase 4	2022-06-01	There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients. Cefiderocol is a newly approved broad spectrum intravenous siderophore cephalosporin antibiotic, which has potent in vitro activity against multidrug resistant Pseudomonas aeruginosa, Burkholderia cepacia complex, Achromobacter species, and Stenotrophomonas maltophilia, all pathogens implicated in CF pulmonary exacerbations. This study will determine the pharmacokinetics and tolerability of cefiderocol in 12 adult CF patients admitted for a pulmonary exacerbation at one of 4 participating hospitals in the US. Patients will remain on standard of care IV antibiotics and receive 4-6 doses of cefiderocol 2 grams infused over 3 hours every 6-8 hours, depending on kidney function. Blood will be sampled after the final dose to determine concentrations and pharmacokinetics of cefiderocol. Safety and tolerability will be assessed throughout the 2 day study.

Clinical Trial Conditions for FETROJA

Condition Name

Condition Name for FETROJA
Intervention	Trials
Gram-negative Bacterial Infections	2
Hospital Acquired Pneumonia (HAP)	2
Sepsis	2
Complicated Urinary Tract Infection (cUTI)	2

Condition MeSH

Condition MeSH for FETROJA
Intervention	Trials
Bacterial Infections	3
Pneumonia	3
Communicable Diseases	2
Pneumonia, Ventilator-Associated	2

Clinical Trial Locations for FETROJA

Trials by Country

Trials by Country for FETROJA
Location	Trials
United States	6
Spain	2
Ukraine	2
Estonia	1
Latvia	1

Trials by US State

Trials by US State for FETROJA
Location	Trials
Connecticut	2
Texas	2
Pennsylvania	1
Indiana	1

Clinical Trial Progress for FETROJA

Clinical Trial Phase

Clinical Trial Phase for FETROJA
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for FETROJA
Clinical Trial Phase	Trials
Recruiting	3
Not yet recruiting	2

Clinical Trial Sponsors for FETROJA

Sponsor Name

Sponsor Name for FETROJA
Sponsor	Trials
Shionogi	2
Shionogi Inc.	2
Monaldi Hospital	1

Sponsor Type

Sponsor Type for FETROJA
Sponsor	Trials
Other	12
Industry	4

FETROJA (cefiderocol) Clinical Trials Update, Market Analysis, and Projection

Last updated: May 4, 2026

What is FETROJA and where does it sit clinically?

FETROJA (cefiderocol) is an injectable cephalosporin approved for serious Gram-negative infections. It is positioned around the drug’s “siderophore” entry mechanism into bacterial iron uptake pathways, with clinical use centered on complicated urinary tract infections (cUTI), including pyelonephritis, and hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP) in approved jurisdictions and indications (US approval structure follows label scope). The product’s commercial profile is driven by:

• Broad Gram-negative coverage with emphasis on difficult MDR pathogens.
• Institutional purchasing patterns for IV hospital antibiotics.
• Competitive intensity from other anti-MDR beta-lactams, carbapenems, and combination regimens.

What do the latest clinical trial readouts indicate?

No complete, fully time-stamped “latest update” dataset is provided in the prompt, and producing a verified trial-by-trial update without current registry pull would risk inaccuracies. Under the operating constraints, a complete and accurate response is not possible with the information available.

What is FETROJA’s current market profile?

Market context (institutional IV antibiotic market):

• FETROJA’s demand is concentrated in hospital formularies, infectious disease pathways, and stewardship-controlled use for Gram-negative MDR risk populations.
• The product competes most directly with other “hospital-ready” IV beta-lactams and anti-MDR agents used in similar clinical workflows (empiric escalation to targeted therapy after culture).

Commercial drivers that shape revenue:

• Formulary access and guideline placement in HABP/VABP and cUTI/pyelonephritis pathways.
• MDR Gram-negative epidemiology (incidence of resistant organisms by region and hospital).
• Stewardship restrictions limiting use to high-risk patients or after resistance confirmation.
• Tender pricing and bundled hospital contracting, which often determines net price more than list price.

Commercial constraints that shape revenue:

• Class competition and switching based on local antibiogram patterns.
• Shorter duration of therapy and rapid de-escalation once susceptibilities return.
• Higher use scrutiny for broad Gram-negative agents.

How big is the addressable market and what is the forecast logic?

A full market sizing and projection requires live inputs (current annual prescriptions/treated cases, regional approvals, and competitor shares). The prompt does not include those data, and a complete, accurate projection cannot be produced without them.

What is the competitive landscape and where does FETROJA fit?

FETROJA’s competitive set in serious Gram-negative infections typically includes:

• New-generation cephalosporin/beta-lactam options and anti-MDR agents used in hospital settings for cUTI/pyelonephritis and HABP/VABP.
• Carbapenems and combination regimens used when stewardship or local resistance profiles favor broader coverage.
• Later-line agents used for resistant phenotypes where cephalosporin susceptibility is compromised.

A decision-grade projection depends on:

• Indication-level share by setting (ICU pneumonia vs non-ICU pneumonia vs cUTI/pyelo).
• Resistance-adjusted utilization (how often cefiderocol is culture-directed vs empiric).
• Contracting impact (net price vs list, rebating structure, and tender schedules).

Those elements require current market data not included in the prompt.

Key Takeaways

• FETROJA (cefiderocol) is an IV hospital antibiotic focused on serious Gram-negative infections with demand shaped by MDR epidemiology and stewardship-controlled institutional access.
• A trial-by-trial “latest clinical update” and a numeric market projection cannot be produced accurately from the information provided in the prompt without a verifiable data set.
• For investment and R&D planning, the revenue outlook is primarily governed by formulary access, guideline uptake, resistance-driven targeting, and net pricing under hospital contracting.

FAQs

1. What infections is FETROJA used for?
   In approved markets, FETROJA is used for serious Gram-negative infections, including cUTI (with pyelonephritis) and HABP/VABP, per label indication structure.

2. Why does cefiderocol have commercial differentiation?
   Its clinical differentiation is tied to bacterial iron uptake-mediated entry, supporting activity against certain resistant Gram-negative phenotypes used in hospital settings.

3. What drives inpatient demand for FETROJA?
   MDR risk selection, stewardship pathways, culture-directed therapy rates, and formulary access determine utilization more than outpatient demand.

4. What usually limits market expansion for new IV antibiotics?
   Stewardship restrictions, payer/hospital tender dynamics, and rapid de-escalation once susceptibility results are available.

5. Can a reliable market forecast be done without current registry and market share inputs?
   Not to decision-grade standards. Accurate projections require up-to-date clinical activity (trial readouts, labeling changes) and current market share/epidemiology and pricing inputs.

References

[1] FDA. “FETROJA (cefiderocol) prescribing information.” U.S. Food and Drug Administration.
[2] European Medicines Agency (EMA). “Fetroja (cefiderocol).” European public assessment and product information.