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Complicated Urinary Tract Infection

10
Pipeline Programs
11
Companies
12
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
3
0
7
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

11 companies ranked by most advanced pipeline stage

Pfizer
PfizerNEW YORK, NY
2 programs
1
1
Ceftazidime - AvibactamPhase 31 trial
NXL104/ceftazidimePhase 21 trial
Active Trials
NCT00690378Completed137Est. Jul 2010
NCT01644643Completed345Est. Sep 2014
Wockhardt
WockhardtNJ - Parsippany
2 programs
2
Cefepime-zidebactamPhase 3
WCK 4282Phase 31 trial
Active Trials
NCT03630081Unknown1,004Est. Feb 2026
Meiji Seika Pharma
Meiji Seika PharmaJapan - Tokyo
2 programs
2
co-administration of cefepime and nacubactamPhase 31 trial
co-administration of cefepime and nacubactamPhase 31 trial
Active Trials
NCT05887908Completed614Est. Nov 2024
NCT05905055Completed126Est. Sep 2025
Medpace
MedpaceCINCINNATI, OH
1 program
1
Cefepime-zidebactamPhase 31 trial
Active Trials
NCT04979806Completed530Est. Nov 2024
Spero Therapeutics
Spero TherapeuticsMA - Cambridge
1 program
1
TBPM-PI-HBrPhase 31 trial
Active Trials
NCT03788967Completed1,372Est. May 2020
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
1 program
1
Ceftolozane/TazobactamPhase 2
MSD
MSDIreland - Ballydine
1 program
1
Ceftolozane/TazobactamPhase 21 trial
Active Trials
NCT03230838Completed134Est. Dec 2020
QIAGEN
QIAGENGermany - Hilden
1 program
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMRN/A1 trial
Active Trials
NCT06824129Active Not Recruiting1,500Est. Sep 2026
Iterum Therapeutics
Iterum TherapeuticsDUBLIN 1, Ireland
1 program
Sulopenem Etzadroxil/ProbenecidN/A1 trial
Active Trials
NCT04682834No Longer Available
Merck & Co.
Merck & Co.RAHWAY, NJ
1 program
CXA-101PHASE_21 trial
Active Trials
NCT00921024Completed129Est. Mar 2010
Qilu Pharmaceutical
Qilu PharmaceuticalChina - Jinan
1 program
Meropenem- FL058PHASE_21 trial
Active Trials
NCT05060419Unknown150Est. Aug 2022

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
WockhardtWCK 4282
Meiji Seika Pharmaco-administration of cefepime and nacubactam
Meiji Seika Pharmaco-administration of cefepime and nacubactam
MedpaceCefepime-zidebactam
Spero TherapeuticsTBPM-PI-HBr
PfizerCeftazidime - Avibactam
Qilu PharmaceuticalMeropenem- FL058
MSDCeftolozane/Tazobactam
Merck & Co.CXA-101
PfizerNXL104/ceftazidime
QIAGENClinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR

Clinical Trials (12)

Total enrollment: 6,041 patients across 12 trials

NCT03630081WockhardtWCK 4282

Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Start: Jan 2024Est. completion: Feb 20261,004 patients
Phase 3Unknown
NCT05905055Meiji Seika Pharmaco-administration of cefepime and nacubactam

P3 Study to Assess Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy for Adults With Infection Due to Carbapenem Resistant Enterobacterales

Start: Sep 2023Est. completion: Sep 2025126 patients
Phase 3Completed
NCT05887908Meiji Seika Pharmaco-administration of cefepime and nacubactam

Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis

Start: May 2023Est. completion: Nov 2024614 patients
Phase 3Completed
NCT04979806MedpaceCefepime-zidebactam

Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Start: Aug 2022Est. completion: Nov 2024530 patients
Phase 3Completed
NCT03788967Spero TherapeuticsTBPM-PI-HBr

Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Start: Jun 2019Est. completion: May 20201,372 patients
Phase 3Completed
NCT01644643PfizerCeftazidime - Avibactam

Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens

Start: Jan 2013Est. completion: Sep 2014345 patients
Phase 3Completed
NCT05060419Qilu PharmaceuticalMeropenem- FL058

Meropenem-FL058 Phase 2 Study in the Treatment of Complicated Urinary Tract Infections

Start: Oct 2021Est. completion: Aug 2022150 patients
Phase 2Unknown
NCT03230838MSDCeftolozane/Tazobactam

MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)

Start: Apr 2018Est. completion: Dec 2020134 patients
Phase 2Completed
NCT00921024Merck & Co.CXA-101

Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections

Start: Jun 2009Est. completion: Mar 2010129 patients
Phase 2Completed
NCT00690378PfizerNXL104/ceftazidime

Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections

Start: Nov 2008Est. completion: Jul 2010137 patients
Phase 2Completed
NCT04682834Iterum TherapeuticsSulopenem Etzadroxil/Probenecid

Expanded Access Use of Sulopenem Etzadroxil/Probenecid for Complicated Urinary Tract Infection

N/ANo Longer Available
NCT06824129QIAGENClinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR

Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR

Start: Dec 2025Est. completion: Sep 20261,500 patients
N/AActive Not Recruiting

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

7 late-stage (Phase 3) programs, potential near-term approvals
11 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.