Urinary Tract Infections Pipeline Analysis 2025: Emerging Clinical Studies

DelveInsight's "Urinary Tract Infections Pipeline Analysis 2025" delivers extensive intelligence on over 38 pharmaceutical firms and more than 38 investigational medications within the Urinary Tract Infections development arena. The analysis encompasses profiles of Urinary Tract Infections therapeutic candidates, spanning both clinical and preclinical phases. Additionally, it includes evaluation of Urinary Tract Infections Pipeline Therapeutics by product category, developmental phase, administration method, and molecular classification. The report also spotlights dormant development programs in this therapeutic area.

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Primary Highlights from the Urinary Tract Infections Pipeline Analysis

On November 6, 2025, Meiji Seika Pharma Co. Ltd initiated a multi-center, randomized, single-blind, parallel-group investigation to evaluate the efficacy and safety profile when nacubactam is co-administered with cefepime or aztreonam, relative to best available therapy (BAT), for managing patients with cUTI, AP, HABP, VABP, and cIAI, attributed to Carbapenem Resistant Enterobacterales.
On November 3, 2025, Locus Biosciences revealed a Phase 2 superiority investigation of LBP-EC01, a recombinant bacteriophage cocktail, featuring an initial open-label 3-arm pharmacokinetic (PK) lead-in segment of 30 participants to determine the optimal dosing protocol for the subsequent 288 participant blinded segment of the investigation which will be randomized 1:1 comparing LBP-EC01 + antibiotic versus placebo + antibiotic in individuals with a medical history of prior urinary tract infection (UTI) caused by E. coli. All participants will require an active acute uncomplicated UTI at baseline.
DelveInsight's Urinary Tract Infections Pipeline analysis reveals a dynamic field featuring more than 38 engaged entities advancing over 38 investigational treatments for Urinary Tract Infections management.
Major Urinary Tract Infections pharmaceutical firms include Wockhardt, GlaxoSmithKline, Iterum Therapeutics, Spero Therapeutics, VenatoRx Pharmaceuticals, Helperby Therapeutics, Spexis, LUCA Biologics, Seed Health, Inc., Aelin Therapeutics, Omnix Medical, Inmunotek S.L., Sinovent Pty Ltd., Qilu Pharmaceuticals, Entasis Therapeutics, Adaptive Phage Therapeutics, Locus Biosciences, Nabriva Therapeutics, Utility Therapeutics, Zensun (Shanghai) Sci & Tech, Fedora Pharmaceuticals, Osel Inc., Evofem Biosciences, Enlivex, Fimbrion Therapeutics, Rebiotix, MerLion Pharmaceuticals, Allecra Therapeutics, Lakewood Amedex, Sumitomo Dainippon Pharma, Sihuan Pharmaceuticals, SuperTrans Medical, and Asieris Pharmaceuticals, among additional organizations.
Notable Urinary Tract Infections investigational medications include Gepotidacin, Nitrofurantoin, Fecal microbiota transplant, Ceftaroline fosamil and NXL104 (q8h), Doripenem, Cefiderocol, among others.

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Urinary Tract Infections Background

Urinary tract infections (UTIs) represent a significant public health challenge and result from various pathogens, most frequently by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterococcus faecalis and Staphylococcus saprophyticus. Elevated recurrence rates and growing antimicrobial resistance among uropathogens pose risks of substantially increasing the economic impact of these infections. Clinically, UTIs are classified as uncomplicated or complicated. Uncomplicated UTIs generally affect individuals who are otherwise healthy and lack structural or neurological urinary tract abnormalities; these infections are distinguished into lower UTIs (cystitis) and upper UTIs (pyelonephritis). Multiple risk factors correlate with cystitis, encompassing female gender, a previous UTI, diabetes, obesity and genetic predisposition. Complicated UTIs are characterized as UTIs linked with factors that compromise the urinary tract or host defense mechanisms, including urinary obstruction, urinary retention resulting from neurological disease, immunosuppression, renal failure, renal transplantation, pregnancy and the presence of foreign materials such as calculi, indwelling catheters or other drainage devices. Treatment approaches have ranged historically from 3 days to 6 weeks.

Urinary Tract Infections Investigational Drug Profiles

Tebipenem HBr: Spero Therapeutics

Tebipenem HBr is an experimental medication in the United States under development for managing complicated urinary tract infection, including pyelonephritis, caused by specific microorganisms, in adult individuals who have restricted oral treatment alternatives. Tebipenem HBr has received Qualified Infectious Disease Product (QIDP), Fast Track and Priority Review designations for managing complicated urinary tract infection (cUTI), including acute pyelonephritis. The FDA established a Prescription Drug User Fee Act (PDUFA) target action date for June 27, 2022. In March 2022, Spero disclosed that during the FDA's ongoing evaluation of Spero's NDA for tebipenem HBr, the FDA had identified deficiencies that prevented the discussion of labeling and post-marketing requirements/commitments at that time. Spero's LCM with the FDA occurred in late April 2022.

Sulopenem etzadroxil: Iterum Therapeutics

Sulopenem is an orally bioavailable, broad-spectrum penem β-lactam antibiotic under development for managing infections caused by multi-drug resistant bacteria. Sulopenem can be administered orally (e.g., as a tablet) or through intravenous (IV) infusion. This makes it an appealing option for managing patients with uncomplicated and complicated urinary tract infections (UTI) and complicated intra-abdominal infections (cIAI) caused by susceptible organisms. The IV formulation is designed for the initial management of severe infections in a hospital environment, and the oral prodrug will offer the option for IV-to-oral transition, thereby potentially reducing in-hospital patient duration. The oral prodrug is also designed for managing uncomplicated infections where a patient can tolerate an oral medication in an outpatient environment. The development strategy for sulopenem encompasses its evaluation for managing uUTI, cUTI and cIAI. Qualified Infectious Disease Product (QIDP) designation was awarded by the U.S. FDA for both intravenous and oral formulations in managing complicated urinary tract infections (cUTI), uncomplicated urinary tract infections (uUTI) as well as complicated intra-abdominal infections (cIAI).

Gepotidacin: GlaxoSmithKline

Gepotidacin (GSK2140944) is the inaugural member of a novel antibiotic class, termed triazaacenaphthylene topoisomerase inhibitors, created at GSK in 2007 with a novel "dual targeting" mechanism of action (MOA) and oral formulation. Its MOA is distinct from any currently approved antibiotic. Gepotidacin functions by selectively interacting with two critical bacterial enzymes, DNA gyrase and topoisomerase IV (type II topoisomerases), responsible for bacterial replication. The novel MOA confers activity against most target pathogens resistant to established antibiotics, including fluoroquinolones. GlaxoSmithKline is executing a phase III clinical program investigating gepotidacin, the inaugural member of a novel chemical class of antibiotics termed triazaacenaphthylene bacterial topoisomerase inhibitors, in individuals with uncomplicated urinary tract infection (uUTI, also known as acute cystitis) and urogenital gonorrhoea (GC).

Cefepime-taniborbactam: Venatorx Pharmaceuticals

Cefepime-taniborbactam is Venatorx's beta-lactam / beta-lactamase inhibitor (BL/BLI) combination antibiotic under development for managing complicated urinary tract infections (cUTIs) and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). Cefepime, a fourth-generation cephalosporin, is a widely utilized beta-lactam (BL) antibiotic with over two decades of demonstrated safety and clinical utility against susceptible gram-negative and gram-positive bacteria. Taniborbactam is a beta-lactamase inhibitor (BLI) that, combined with cefepime, may provide a potential therapeutic option for individuals with serious bacterial infections caused by difficult-to-treat drug resistant gram-negative bacteria, most notably carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant Pseudomonas aeruginosa (CRPA). Many of these organisms are also multidrug-resistant (MDR), further restricting treatment alternatives. The U.S. Food and Drug Administration (FDA) awarded cefepime-taniborbactam Qualified Infectious Disease Product (QIDP) and Fast Track designations for managing cUTI and HABP/VABP. The FDA and the EMA approved Venatorx's initial Pediatric Study Plan (iPSP) and Pediatric Investigation Plan (PIP), respectively, for cefepime-taniborbactam. In a Phase III clinical investigation, Cefepime-taniborbactam achieved the primary efficacy endpoint of statistical noninferiority (NI) to meropenem in the microITT population at TOC with composite microbiologic and clinical success occurring in 70.0% of cefepime-taniborbactam treated individuals and 58.0% of meropenem treated individuals (treatment difference 11.9; 95% confidence interval (CI), 2.4, 21.6).

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The Urinary Tract Infections Pipeline Analysis Offers Intelligence On:

The analysis delivers detailed intelligence regarding pharmaceutical companies developing therapeutics for Urinary Tract Infections management, including cumulative therapies created by each organization for this indication.
It evaluates various therapeutic candidates categorized into early-phase, mid-phase, and late-phase development for Urinary Tract Infections Treatment.
Urinary Tract Infections pharmaceutical firms engaged in targeted therapeutic development with corresponding active and inactive (dormant or terminated) initiatives.
Urinary Tract Infections investigational medications classified by developmental phase, administration method, target receptor, monotherapy or combination therapy, distinct mechanism of action, and molecular classification.
Comprehensive analysis of partnerships (company-to-company collaborations and company-to-academia partnerships), licensing arrangements, and funding particulars for future progression of the Urinary Tract Infections market.

Urinary Tract Infections Pharmaceutical Firms

Wockhardt, GlaxoSmithKline, Iterum Therapeutics, Spero Therapeutics, VenatoRx Pharmaceuticals, Helperby Therapeutics, Spexis, LUCA Biologics, Seed Health, Inc., Aelin Therapeutics, Omnix Medical, Inmunotek S.L., Sinovent Pty Ltd., Qilu Pharmaceuticals, Entasis Therapeutics, Adaptive Phage Therapeutics, Locus Biosciences, Nabriva Therapeutics, Utility Therapeutics, Zensun (Shanghai) Sci & Tech, Fedora Pharmaceuticals, Osel Inc., Evofem Biosciences, Enlivex, Fimbrion Therapeutics, Rebiotix, MerLion Pharmaceuticals, Allecra Therapeutics, Lakewood Amedex, Sumitomo Dainippon Pharma, Sihuan Pharmaceuticals, SuperTrans Medical, and Asieris Pharmaceuticals, among additional organizations.

The Urinary Tract Infections Pipeline analysis presents therapeutic evaluation of investigational medications by Administration Method. Products are classified under multiple administration routes including:

Inhalation
Inhalation/Intravenous/Oral
Intranasal
Intravenous
Intravenous/ Subcutaneous
NA
Oral
Oral/intranasal/subcutaneous
Parenteral
Subcutaneous

Urinary Tract Infections products are classified under various molecular categories including:

Antibody
Antisense oligonucleotides
Immunotherapy
Monoclonal antibody
Peptides
Protein
Recombinant protein
Small molecule
Stem Cell
Vaccine

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Scope of the Urinary Tract Infections Pipeline Analysis

Coverage: Global
Urinary Tract Infections Pharmaceutical Firms: Wockhardt, GlaxoSmithKline, Iterum Therapeutics, Spero Therapeutics, VenatoRx Pharmaceuticals, Helperby Therapeutics, Spexis, LUCA Biologics, Seed Health, Inc., Aelin Therapeutics, Omnix Medical, Inmunotek S.L., Sinovent Pty Ltd., Qilu Pharmaceuticals, Entasis Therapeutics, Adaptive Phage Therapeutics, Locus Biosciences, Nabriva Therapeutics, Utility Therapeutics, Zensun (Shanghai) Sci & Tech, Fedora Pharmaceuticals, Osel Inc., Evofem Biosciences, Enlivex, Fimbrion Therapeutics, Rebiotix, MerLion Pharmaceuticals, Allecra Therapeutics, Lakewood Amedex, Sumitomo Dainippon Pharma, Sihuan Pharmaceuticals, SuperTrans Medical, and Asieris Pharmaceuticals, among additional organizations.
Urinary Tract Infections Investigational Treatments: Gepotidacin, Nitrofurantoin, Fecal microbiota transplant, Ceftaroline fosamil and NXL104 (q8h), Doripenem, Cefiderocol, among others.
Urinary Tract Infections Therapeutic Evaluation by Product Category: Monotherapy, Combination, Mono/Combination
Urinary Tract Infections Therapeutic Evaluation by Clinical Phases: Discovery, Preclinical, Phase I, Phase II, Phase III

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* Introduction

* Executive Summary

* Urinary Tract Infections: Overview

* Pipeline Therapeutics

* Therapeutic Assessment

* Urinary Tract Infections - DelveInsight's Analytical Perspective

* Late Stage Products (Preregistration)

* Tebipenem HBr: Spero Therapeutics