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Urinary Tract Infections

28
Pipeline Programs
30
Companies
41
Clinical Trials
2 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
5
1
9
1
8
4
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
583%
Vaccine
117%
+ 53 programs with unclassified modality

On Market (1)

Approved therapies currently available

GSK
BLUJEPAApproved
gepotidacin
GSK
oral2025

Competitive Landscape

34 companies ranked by most advanced pipeline stage

GSK
GSKLONDON, United Kingdom
3 programs
1
GepotidacinPHASE_11 trial
MidazolamPHASE_11 trial
GepotidacinPHASE_31 trial
Active Trials
NCT07371429Not Yet Recruiting20Est. Aug 2027
NCT05760261Completed27Est. Aug 2024
NCT06597344Completed97Est. Mar 2025
Bayer
BayerLEVERKUSEN, Germany
2 programs
2
Cipro XRPhase 41 trial
Cipro XRPhase 41 trial
Active Trials
NCT00481689Completed500Est. Sep 2005
NCT00663806Completed7,614Est. Jul 2003
Oregon Therapeutics
1
ChlorhexidinePhase 41 trial
Active Trials
NCT06598514Active Not Recruiting136Est. Jun 2026
ViiV Healthcare
ViiV HealthcareNC - Durham
8 programs
3
1
4
GepotidacinPhase 3
GepotidacinPhase 3
GepotidacinPhase 3
GepotidacinPhase 3
Candidate UTI vaccine low dose formulation 1Phase 1/2Vaccine
+3 more programs
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
4 programs
2
1
MK0826Phase 3
MK0826, ertapenem sodium /Duration of Treatment: 14 DaysPhase 2
Relebactam 250 mgPhase 2
ErtapenemN/A
MSD
MSDIreland - Ballydine
4 programs
2
1
MK0826Phase 31 trial
MK0826, ertapenem sodium /Duration of Treatment: 14 DaysPhase 21 trial
Relebactam 250 mgPhase 21 trial
ErtapenemN/A1 trial
Active Trials
NCT01173068Unknown60Est. Sep 2014
NCT00451386Completed400Est. Dec 2003
NCT01505634Completed302Est. Jul 2015
+1 more trials
Medpace
MedpaceCINCINNATI, OH
2 programs
1
1
cefepime/AAI101 combinationPhase 31 trial
Cefepime 1G - 2G / AAI101 0.5G - 0.75GPhase 21 trial
Active Trials
NCT03680612Completed45Est. Feb 2018
NCT03687255Completed1,043Est. Feb 2020
Venatorx Pharmaceuticals
1 program
1
Cefepime/VNRX-5133Phase 31 trial
Active Trials
NCT03840148Completed661Est. Dec 2021
Human BioSciences
1
1
Gentamicin SulfatePhase 2/31 trial
GSK3882347Phase 11 trial
Active Trials
NCT04488770Completed61Est. May 2021
NCT03503513Completed23Est. Sep 2023
MerLion Pharmaceuticals
MerLion PharmaceuticalsGermany - Berlin
2 programs
2
FinafloxacinPhase 2Small Molecule1 trial
Finafloxacin 800 mg i.v. once dailyPhase 21 trial
Active Trials
NCT00722735Completed36Est. Apr 2009
NCT01928433Completed225Est. Oct 2015
Colorado Therapeutics
Colorado TherapeuticsCO - Louisville
1 program
1
Catheter insertion with Povidone IodinePhase 21 trial
Active Trials
NCT03101371Completed99Est. Feb 2019
Shionogi
ShionogiJapan - Osaka
1 program
1
CefiderocolPhase 21 trial
Active Trials
NCT02321800Completed452Est. Aug 2016
Genentech
GenentechCA - Oceanside
1 program
1
RO7079901Phase 11 trial
Active Trials
NCT03174795Completed20Est. Dec 2017
Ortho Development
3 programs
LevofloxacinPHASE_3Small Molecule1 trial
LevofloxacinPHASE_3Small Molecule1 trial
levofloxacinPHASE_3Small Molecule1 trial
Active Trials
NCT00258102Completed603Est. Jan 1995
NCT00258089Completed578Est. Jan 1995
NCT00210886Completed1,109Est. Apr 2006
AiCuris
AiCurisGermany - Wuppertal
2 programs
Not ApplicableN/A
Study to Assess Management and Outcomes of Hospitalised Patients With Complicated UTI (RESCUING)N/A1 trial
Active Trials
NCT02641015Completed1,028Est. Aug 2016
Coloplast
ColoplastAustralia - Mulgrave
2 programs
SpeediCathN/A1 trial
urine sampleN/A1 trial
Active Trials
NCT00318591Completed219Est. Oct 2009
NCT03522766Completed30Est. Sep 2019
Locus Biosciences
Locus BiosciencesNC - Morrisville
2 programs
LBP-EC01PHASE_11 trial
LBP-EC01 0.1 x IV dosePHASE_21 trial
Active Trials
NCT04191148Completed36Est. Nov 2020
NCT05488340Recruiting318Est. Dec 2026
Iterum Therapeutics
Iterum TherapeuticsDUBLIN 1, Ireland
2 programs
SulopenemPHASE_11 trial
Sulopenem etzadroxil/probenecidPHASE_31 trial
Active Trials
NCT04700787Withdrawn0Est. Apr 2022
NCT05584657Completed2,229Est. Nov 2023
Next Science
Next ScienceAustralia - Sydney
1 program
BLASTX GelN/A1 trial
Active Trials
NCT03176394Terminated15Est. Oct 2019
Shield Therapeutics
Bladder Stimulation techniqueN/A1 trial
Active Trials
NCT03174834Unknown200Est. Dec 2018
Alliance Pharmaceuticals
1 program
Collect informationN/A1 trial
Active Trials
NCT05458700Unknown16,000Est. Feb 2026
Forte Biosciences
1 program
ContainerN/A1 trial
Active Trials
NCT03131609Completed1,471Est. Sep 2016
Merck & Co.
Merck & Co.RAHWAY, NJ
1 program
ErtapenemN/A
CloudCath
CloudCathCA - San Francisco
1 program
Spectral characteristics assessmentN/A1 trial
Active Trials
NCT04950582Suspended500Est. Jun 2024
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
The Significance of Funguria in Hospitalized PatientsN/A
Innovation Pharmaceuticals
1 program
The Significance of Funguria in Hospitalized PatientsN/A1 trial
Active Trials
NCT00787085Completed919Est. Feb 2006
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
1 program
UrinanlysisN/A1 trial
Active Trials
NCT00583648Withdrawn0Est. Feb 2009
Thermo Fisher Scientific
1 program
Urine PCR testingN/A1 trial
Active Trials
NCT05591911Completed96Est. Aug 2024
Inmunotek
1 program
UromuneN/A1 trial
Active Trials
NCT04173013No Longer Available
Parexel
ParexelMA - Boston
1 program
LBP-EC01 0.1 x IV dosePHASE_2

+4 more companies

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Oregon TherapeuticsChlorhexidine
IBSA Institut Biochimiqueintravesical instillation with HA-CS
BayerCipro XR
BayerCipro XR
GSKGepotidacin
Iterum TherapeuticsSulopenem etzadroxil/probenecid
Venatorx PharmaceuticalsCefepime/VNRX-5133
Medpacecefepime/AAI101 combination
MSDMK0826
Ortho Developmentlevofloxacin
Ortho DevelopmentLevofloxacin
Ortho DevelopmentLevofloxacin
Human BioSciencesGentamicin Sulfate
Locus BiosciencesLBP-EC01 0.1 x IV dose
Colorado TherapeuticsCatheter insertion with Povidone Iodine

Showing 15 of 40 trials with date data

Clinical Trials (41)

Total enrollment: 37,428 patients across 41 trials

Chlorhexidine Lavage for Recurrent Urinary Tract Infection

Start: Dec 2024Est. completion: Jun 2026136 patients
Phase 4Active Not Recruiting
NCT04095572IBSA Institut Biochimiqueintravesical instillation with HA-CS

Alternative Prophylaxis in Female Recurrent Urinary Tract Infections

Start: Oct 2020Est. completion: Jun 202650 patients
Phase 4Recruiting

Study To Evaluate The Efficacy And Safety Of Ciprofloxacin Extended-Release (Cipro® XR) 1000 mg Tablets Given Once Daily For 7 To 14 Days In The Treatment Of Patients 18 Years Or Older With Complicated Urinary Tract Infections Caused By Pseudomonas Aeruginosa And Other Common Uropathogens

Start: May 2004Est. completion: Sep 2005500 patients
Phase 4Completed

A Phase IV Study of Cipro XR in Uncomplicated UTI

Start: Feb 2003Est. completion: Jul 20037,614 patients
Phase 4Completed
NCT06597344GSKGepotidacin

A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis)

Start: Oct 2024Est. completion: Mar 202597 patients
Phase 3Completed
NCT05584657Iterum TherapeuticsSulopenem etzadroxil/probenecid

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

Start: Oct 2022Est. completion: Nov 20232,229 patients
Phase 3Completed

Safety and Efficacy Study of Cefepime/VNRX-5133 in Patients With Complicated Urinary Tract Infections

Start: Aug 2019Est. completion: Dec 2021661 patients
Phase 3Completed
NCT03687255Medpacecefepime/AAI101 combination

Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections

Start: Sep 2018Est. completion: Feb 20201,043 patients
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

A Comparison of the Effectiveness and Safety of Levofloxacin to That of Ciprofloxacin in Treating Complicated Urinary Tract Infection and Acute Pyelonephritis.

Start: Oct 2004Est. completion: Apr 20061,109 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

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

Start: Jan 1993Est. completion: Jan 1995603 patients
Phase 3Completed

Gentamicin Bladder Instillations to Prevent Urinary Tract Infections in Patients With Spinal Cord Injury

Start: Aug 2018Est. completion: Sep 202323 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 2026318 patients
Phase 2Recruiting
NCT03101371Colorado TherapeuticsCatheter insertion with Povidone Iodine

Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion

Start: Oct 2017Est. completion: Feb 201999 patients
Phase 2Completed
NCT03680612MedpaceCefepime 1G - 2G / AAI101 0.5G - 0.75G

Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI

Start: Sep 2017Est. completion: Feb 201845 patients
Phase 2Completed

Phase II Proof of Concept Study in Uncomplicated UTI

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

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

Start: Feb 2015Est. completion: Aug 2016452 patients
Phase 2Completed
NCT01928433MerLion PharmaceuticalsFinafloxacin 800 mg i.v. once daily

Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis

Start: Dec 2012Est. completion: Oct 2015225 patients
Phase 2Completed
NCT01505634MSDRelebactam 250 mg

Safety, Tolerability, and Efficacy of MK-7655 (Relebactam) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone for Treating Complicated Urinary Tract Infection (cUTI) (MK-7655-003)

Start: May 2012Est. completion: Jul 2015302 patients
Phase 2Completed

Finafloxacin 300 mg Twice a Day (b.i.d.) Versus Ciprofloxacin 250 mg Twice a Day (b.i.d) in Patients With Lower Uncomplicated UTI (uUTI)

Start: Oct 2008Est. completion: Apr 200936 patients
Phase 2Completed
NCT00451386MSDMK0826, ertapenem sodium /Duration of Treatment: 14 Days

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
NCT07371429GSKGepotidacin

A Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics

Start: Apr 2026Est. completion: Aug 202720 patients
Phase 1Not Yet Recruiting

Drug Interaction Assessment of GSK3882347 in Healthy Participants Aged 18 to 65 Years

Start: Apr 2023Est. completion: Aug 202427 patients
Phase 1Completed

Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents

Start: Apr 2021Est. completion: Apr 20220
Phase 1Withdrawn

Safety, Tolerability and Pharmacokinetic Investigation of GSK3882347 in Healthy Participants.

Start: Aug 2020Est. completion: May 202161 patients
Phase 1Completed

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

Start: Dec 2019Est. completion: Nov 202036 patients
Phase 1Completed

A Study to Investigate the Pharmacokinetics of RO7079901 and Meropenem in Participants With a Complicated Urinary Tract Infection

Start: Jul 2017Est. completion: Dec 201720 patients
Phase 1Completed

Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)

N/ANo Longer Available

Urine Gene Analysis for Pathogen Detection

Start: Jun 2023Est. completion: Aug 202496 patients
N/ACompleted

POS-cUTI: Study on Complicated Urinary Tract Infections

Start: Oct 2022Est. completion: Feb 202616,000 patients
N/AUnknown
NCT04950582CloudCathSpectral characteristics assessment

In Vitro Analysis of Human Urine With the CloudCath Device

Start: Jun 2021Est. completion: Jun 2024500 patients
N/ASuspended

Evaluation of Urine Samples and Their Relation to Urinary Tract Infection

Start: Mar 2018Est. completion: Sep 201930 patients
N/ACompleted
NCT03174834Shield TherapeuticsBladder Stimulation technique

Bladder Stimulation Technique for Clean Catch Urine Collection in Infants

Start: Sep 2017Est. completion: Dec 2018200 patients
N/AUnknown

Efficacy of BLASTX in Catheter Associated Bacteriuria Versus Standard of Care (SOC)

Start: May 2017Est. completion: Oct 201915 patients
N/ATerminated
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 20161,028 patients
N/ACompleted

Avoiding Bacterial Contamination of Clean Catch Urine Cultures in Ambulatory Patients in the Emergency Department

Start: Sep 2015Est. completion: Sep 20161,471 patients
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

Does Implementing a Urinanylsis Protocol Based on Symptoms Decrease Length of Stay in the Emergency Department?

Start: Feb 2008Est. completion: Feb 20090
N/AWithdrawn

Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections

Start: Apr 2006Est. completion: Oct 2009219 patients
N/ACompleted
NCT00787085Innovation PharmaceuticalsThe Significance of Funguria in Hospitalized Patients

The Significance of Funguria in Hospitalized Patients

Start: Sep 2001Est. completion: Feb 2006919 patients
N/ACompleted

Phase Legend

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

Key Insights

8 late-stage (Phase 3) programs, potential near-term approvals
2 actively recruiting trials targeting 37,428 patients
30 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.