Urinary Tract Infections

13
Pipeline Programs
10
Companies
25
Clinical Trials
2 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
0
3
0
5
3
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
4100%
+ 11 programs with unclassified modality

On Market (2)

Approved therapies currently available

J&
LEVAQUINApproved
levofloxacin
Johnson & Johnson
oral2004
J&
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINERApproved
levofloxacin
Johnson & Johnson
injection1996

Competitive Landscape

10 companies ranked by most advanced pipeline stage

J&
Johnson & JohnsonNEW BRUNSWICK, NJ
1 program
1
1
LevofloxacinPhase 3Small Molecule1 trial
Active Trials
NCT00258089Completed578Est. Jan 1995
IBSA Institut Biochimique
IBSA Institut BiochimiqueSwitzerland - Lugano-Pazzallo
1 program
1
intravesical instillation with HA-CSPhase 41 trial
Active Trials
NCT04095572RecruitingEst. Jun 2026
OD
3 programs
3
LevofloxacinPhase 3Small Molecule
LevofloxacinPhase 3Small Molecule
levofloxacinPhase 3Small Molecule
Iterum Therapeutics
Iterum TherapeuticsDUBLIN 1, Ireland
2 programs
1
1
Sulopenem etzadroxil/probenecidPhase 31 trial
SulopenemPhase 11 trial
Active Trials
NCT04700787WithdrawnEst. Apr 2022
NCT05584657CompletedEst. Nov 2023
Locus Biosciences
Locus BiosciencesNC - Morrisville
2 programs
1
1
LBP-EC01 0.1 x IV dosePhase 21 trial
LBP-EC01Phase 11 trial
Active Trials
NCT04191148CompletedEst. Nov 2020
NCT05488340RecruitingEst. Dec 2026
Mission Therapeutics
Mission TherapeuticsUK - Cambridge
1 program
1
MPC-SHRCPhase 21 trial
Active Trials
NCT03129295Unknown200Est. Sep 2017
Mission Pharmacal
Mission PharmacalTX - San Antonio
1 program
1
MPC-SHRCPhase 2
C
ColoplastAustralia - Mulgrave
2 programs
SpeediCathN/A1 trial
urine sampleN/A1 trial
Active Trials
NCT00318591CompletedEst. Oct 2009
NCT03522766CompletedEst. Sep 2019
M&
Merck & Co.RAHWAY, NJ
1 program
ErtapenemN/A5 trials
Active Trials
NCT01159379Unknown30Est. Dec 2011
NCT01203046Completed56Est. Oct 2011
NCT01173068Unknown60Est. Sep 2014
+2 more trials
AiCuris
AiCurisGermany - Wuppertal
1 program
Study to Assess Management and Outcomes of Hospitalised Patients With Complicated UTI (RESCUING)N/A1 trial
Active Trials
NCT02641015CompletedEst. Aug 2016

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
IBSA Institut Biochimiqueintravesical instillation with HA-CS
Merck & Co.Ertapenem
Merck & Co.Ertapenem
Merck & Co.Ertapenem
Merck & Co.Ertapenem
Iterum TherapeuticsSulopenem etzadroxil/probenecid
Merck & Co.Ertapenem
Merck & Co.Ertapenem
Merck & Co.Ertapenem
Merck & Co.Ertapenem
Merck & Co.Ertapenem
Merck & Co.Ertapenem
Merck & Co.Ertapenem
Johnson & JohnsonLevofloxacin
Merck & Co.Ertapenem

Showing 15 of 25 trials with date data

Clinical Trials (25)

Total enrollment: 3,836 patients across 25 trials

NCT04095572IBSA Institut Biochimiqueintravesical instillation with HA-CS

Alternative Prophylaxis in Female Recurrent Urinary Tract Infections

Start: Oct 2020Est. completion: Jun 2026
Phase 4Recruiting

Safety of Ertapenem in Beta-lactam Allergic Patients.

Start: Jan 2011Est. completion: Dec 201130 patients
Phase 4Unknown

Pharmacokinetics (PK) of Ertapenem Intravenous (IV) Bolus Versus Standard Infusion

Start: Aug 2010Est. completion: Oct 201012 patients
Phase 4Completed

Ertapenem Pharmacokinetics in Patients in Continuous Ambulatory Peritoneal Dialysis

Start: Jun 2009Est. completion: May 20107 patients
Phase 4Completed

A Study to Evaluate Ertapenem Versus It's Comparator in the Treatment of Complicated Intra-abdominal Infections in Adults (0826-050)(COMPLETED)

Start: Jan 2004Est. completion: Sep 2004134 patients
Phase 4Completed
NCT05584657Iterum TherapeuticsSulopenem etzadroxil/probenecid

Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women

Start: Oct 2022Est. completion: Nov 2023
Phase 3Completed

Clinical Trial to Study the Safety and Effectiveness of MK0826 and Other Antibiotic Therapy in Patients With Complicated Urinary Tract Infection (0826-054)

Start: Dec 2008Est. completion: Jun 20096 patients
Phase 3Terminated

Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)

Start: Apr 2008Est. completion: Feb 2009271 patients
Phase 3Completed

To Evaluate the Treatment Effect of an Anti-Infective Agent for Different Kinds of Infections (0826-052)

Start: Jul 2005Est. completion: Jan 200630 patients
Phase 3Completed

A Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection Following Colorectal Surgery as Compared to a Marketed Drug Approved for This Indication (0826-039)

Start: Apr 2002Est. completion: Mar 2005952 patients
Phase 3Completed

A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)

Start: Dec 2001Est. completion: Jun 2003300 patients
Phase 3Completed

Ertapenem Sodium vs. Piperacillin/Tazobactam in the Treatment of Complicated Intra-Abdominal Infections (0826-037)

Start: Sep 2001Est. completion: May 2004300 patients
Phase 3Completed

Comparative Study of Ertapenem Versus Another Antibiotic in the Treatment of Diabetic Foot Infections in Adults (0826-034)

Start: Apr 2001Est. completion: Apr 2004400 patients
Phase 3Completed

A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Complicated Urinary Tract Infections

Start: Jun 1993Est. completion: Jan 1995578 patients
Phase 3Completed

Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days

Start: Dec 2010Est. completion: Oct 201156 patients
Phase 2/3Completed
NCT05488340Locus BiosciencesLBP-EC01 0.1 x IV dose

A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)

Start: Jul 2022Est. completion: Dec 2026
Phase 2Recruiting

Phase II Proof of Concept Study in Uncomplicated UTI

Start: Apr 2017Est. completion: Sep 2017200 patients
Phase 2Unknown

An Investigational Agent for the Treatment of Complicated Intra-Abdominal Infections or Acute Pelvic Infections (0826-038)

Start: Mar 2002Est. completion: Jan 2004100 patients
Phase 2Completed

Ertapenem Study in Pediatric Patients Who Have Urinary Tract Infections, Skin Infections or Community-acquired Pneumonia (0826-036)

Start: Jan 2002Est. completion: Dec 2003400 patients
Phase 2Completed

Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents

Start: Apr 2021Est. completion: Apr 2022
Phase 1Withdrawn

Safety, Tolerability, and PK of LBP-EC01 in Patients With Lower Urinary Tract Colonization Caused by E. Coli

Start: Dec 2019Est. completion: Nov 2020
Phase 1Completed

Evaluation of Urine Samples and Their Relation to Urinary Tract Infection

Start: Mar 2018Est. completion: Sep 2019
N/ACompleted
NCT02641015AiCurisStudy to Assess Management and Outcomes of Hospitalised Patients With Complicated UTI (RESCUING)

Study to Assess Management and Outcomes of Hospitalised Patients With Complicated UTI (RESCUING)

Start: Dec 2015Est. completion: Aug 2016
N/ACompleted

An Observational Study of Ertapenem in Outpatient Parenteral Antibiotic Therapy (OPAT) for Complicated Urinary Tract Infections.

Start: Aug 2010Est. completion: Sep 201460 patients
N/AUnknown

Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections

Start: Apr 2006Est. completion: Oct 2009
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

5 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 3,836 patients
10 companies competing in this space