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Urinary Tract Infection

14
Pipeline Programs
14
Companies
13
Clinical Trials
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
1
1
7
5
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
2100%
+ 16 programs with unclassified modality

On Market (2)

Approved therapies currently available

Bayer
CIPROApproved
ciprofloxacin
Bayer
oral1997
396K Part D
Merck & Co.
INVANZApproved
ertapenem sodium
Merck & Co.
intramuscular, intravenous2001
14K Part D

Competitive Landscape

14 companies ranked by most advanced pipeline stage

Bayer
BayerLEVERKUSEN, Germany
3 programs
1
2
Cipro XRPhase 41 trial
CiprofloxacinPhase 4Small Molecule1 trial
Cipro XRPhase 31 trial
Active Trials
NCT00668122Completed212Est. Jan 2006
NCT00676533Completed276Est. Jan 2004
NCT00669994Completed180Est. Oct 2003
Merck & Co.
Merck & Co.RAHWAY, NJ
1 program
1
ertapenem sodiumPHASE_3
Dr. Reddy's Laboratories
1 program
1
LevofloxacinPhase 4Small Molecule1 trial
Active Trials
NCT03160807Unknown214Est. Mar 2018
MSD
MSDIreland - Ballydine
2 programs
2
ertapenem sodiumPhase 31 trial
ertapenem sodiumPhase 31 trial
Active Trials
NCT01014013Completed271Est. Feb 2009
NCT00379951Completed107Est. May 2006
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
2 programs
2
ertapenem sodiumPhase 3
ertapenem sodiumPhase 3
ViiV Healthcare
ViiV HealthcareNC - Durham
1 program
1
TBP-PI-HBrPhase 3
Spero Therapeutics
Spero TherapeuticsMA - Cambridge
1 program
1
TBP-PI-HBrPhase 3
NanoVibronix
NanoVibronixIsrael - Nesher
1 program
1
UroSshieldPhase 2/31 trial
Active Trials
NCT00446732Unknown200Est. Jun 2009
Osel
OselCA - Mountain View
1 program
1
Lactin-VPhase 21 trial
Active Trials
NCT00305227Completed100Est. Apr 2012
Bactiguard
BactiguardSweden - Tullinge
1 program
Bactiguard Infection ProtectionN/A1 trial
Active Trials
NCT01054690Completed511Est. Aug 2009
Coloplast
ColoplastAustralia - Mulgrave
1 program
E. coli 83972N/A1 trial
Active Trials
NCT00927316Completed30Est. Dec 2006
Takeda
TakedaTOKYO, Japan
1 program
FlomoxefPHASE_31 trial
Active Trials
NCT02302092Terminated13Est. Dec 2016
DynamiCure
DynamiCureMA - Waltham
1 program
Fosfomycun-trometamolPHASE_31 trial
Active Trials
NCT06822751Not Yet Recruiting138Est. Jun 2029
GSK
GSKLONDON, United Kingdom
1 program
TBP-PI-HBrPHASE_31 trial
Active Trials
NCT06059846Completed1,690Est. Feb 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Dr. Reddy's LaboratoriesLevofloxacin
BayerCiprofloxacin
BayerCipro XR
DynamiCureFosfomycun-trometamol
GSKTBP-PI-HBr
TakedaFlomoxef
MSDertapenem sodium
MSDertapenem sodium
BayerCipro XR
NanoVibronixUroSshield
OselLactin-V
BactiguardBactiguard Infection Protection
ColoplastE. coli 83972

Clinical Trials (13)

Total enrollment: 3,942 patients across 13 trials

NCT03160807Dr. Reddy's LaboratoriesLevofloxacin

Levofloxacin as an Empirical Therapy in Patients With Complicated Urinary Tract Infections

Start: Apr 2017Est. completion: Mar 2018214 patients
Phase 4Unknown
NCT00669994BayerCiprofloxacin

Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Urinary Tract Infections

Start: Jul 2003Est. completion: Oct 2003180 patients
Phase 4Completed
NCT00676533BayerCipro XR

Cipro® XR in Therapeutic Response and Activity (eXtRa) - Assessing Symptom Relief in Urinary Tract Infections

Start: Jun 2003Est. completion: Jan 2004276 patients
Phase 4Completed
NCT06822751DynamiCureFosfomycun-trometamol

FOsfomycin for Male Urinary Tract Infection

Start: Mar 2026Est. completion: Jun 2029138 patients
Phase 3Not Yet Recruiting
NCT06059846GSKTBP-PI-HBr

A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Start: Dec 2023Est. completion: Feb 20251,690 patients
Phase 3Completed
NCT02302092TakedaFlomoxef

An Efficacy and Safety of Flomoxef Versus Cefepime in the Treatment of Participants With Urinary Tract Infections

Start: Dec 2015Est. completion: Dec 201613 patients
Phase 3Terminated
NCT01014013MSDertapenem sodium

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
NCT00379951MSDertapenem sodium

A Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-048)

Start: Jun 2005Est. completion: May 2006107 patients
Phase 3Completed
NCT00668122BayerCipro XR

Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections

Start: Mar 2004Est. completion: Jan 2006212 patients
Phase 3Completed
NCT00446732NanoVibronixUroSshield

The Use of the UroShield Device in Patients With Indwelling Urinary Catheters

Start: Mar 2007Est. completion: Jun 2009200 patients
Phase 2/3Unknown
NCT00305227OselLactin-V

Intravaginal LACTIN-V for Prevention of Recurrent Urinary Tract Infection

Start: Mar 2006Est. completion: Apr 2012100 patients
Phase 2Completed
NCT01054690BactiguardBactiguard Infection Protection

Silver Alloyed Urinary Catheters and Incidence of Catheter Acquired Urinary Tract Infections (UTI)

Start: Oct 2008Est. completion: Aug 2009511 patients
N/ACompleted
NCT00927316ColoplastE. coli 83972

E. Coli 83972 Induced Asymptomatic Bacteriuria (ABU) in Patients With Recurrent Urinary Tract Infections (UTI)

Start: Mar 2003Est. completion: Dec 200630 patients
N/ACompleted

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
14 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.