DelveInsight’s “Urinary Tract Infections Pipeline Insight 2025” report provides comprehensive insights about 38+ companies and 38+ pipeline drugs in the Urinary Tract Infections pipeline landscape. It covers the Urinary Tract Infections Pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Urinary Tract Infections Pipeline Therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
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Key Takeaways from the Urinary Tract Infections Pipeline Report
- On 06 November 2025, Meiji Seika Pharma Co. Ltd conducted a study is a multi-center, randomized, single-blind, parallel-group study to assess the efficacy and safety, when nacubactam is coadministered with cefepime or aztreonam, compared with best available therapy (BAT), in the treatment of patients with cUTI, AP, HABP, VABP, and cIAI, due to Carbapenem Resistant Enterobacterales.
- On 03 November 2025, Locus Biosciences announced a Phase 2 superiority study of LBP-EC01, a recombinant bacteriophage cocktail, with an initial open-label 3-arm pharmacokinetic (PK) lead-in portion of 30 patients to evaluate the optimal dosing regimen to be used in the subsequent 288 patient blinded portion of the study which will be randomized 1:1 comparing LBP-EC01 + antibiotic versus placebo + antibiotic in patients with a history of prior urinary tract infection (UTI) cased by E. coli. All patients will be required to have an active acute uncomplicated UTI at baseline.
- DelveInsight’s Urinary Tract Infections Pipeline report depicts a robust space with 38+ active players working to develop 38+ pipeline therapies for Urinary Tract Infections treatment.
- The leading Urinary Tract Infections Companies such as 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 and others.
- Promising Urinary Tract Infections Therapies such as Gepotidacin, Nitrofurantoin, Fecal microbiota transplant, Ceftaroline fosamil and NXL104 (q8h), Doripenem, Cefiderocol and others
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The Urinary Tract Infections Pipeline Report provides disease overview, pipeline scenario and therapeutic assessment of the key pipeline therapies in this domain. The Urinary Tract Infections Pipeline Report also highlights the unmet needs with respect to the Urinary Tract Infections.
Urinary Tract Infections Overview
Urinary tract infections (UTIs) are a severe public health problem and are caused by a range of pathogens, but most commonly by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterococcus faecalis and Staphylococcus saprophyticus. High recurrence rates and increasing antimicrobial resistance among uropathogens threaten to greatly increase the economic burden of these infections. Clinically, UTIs are categorized as uncomplicated or complicated. Uncomplicated UTIs typically affect individuals who are otherwise healthy and have no structural or neurological urinary tract abnormalities; these infections are differentiated into lower UTIs (cystitis) and upper UTIs (pyelonephritis). Several risk factors are associated with cystitis, including female gender, a prior UTI, diabetes, obesity and genetic susceptibility. Complicated UTIs are defined as UTIs associated with factors that compromise the urinary tract or host defence, including urinary obstruction, urinary retention caused by neurological disease, immunosuppression, renal failure, renal transplantation, pregnancy and the presence of foreign bodies such as calculi, indwelling catheters or other drainage devices. The treatment has varied historically from 3 days to 6 weeks.
Urinary Tract Infections Emerging Drugs Profile
- Tebipenem HBr: Spero Therapeutics
Tebipenem HBr is an investigational drug in the United States being developed for the treatment of complicated urinary tract infection, including pyelonephritis, caused by certain microorganisms, in adult patients who have limited oral treatment options. Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP), Fast Track and Priority Review designations for treatment of complicated urinary tract infection (cUTI), including acute pyelonephritis. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date for June 27, 2022. In March 2022, Spero announced that as part of the FDA’s ongoing review of Spero’s NDA for tebipenem HBr, the FDA had identified deficiencies that precluded the discussion of labeling and post-marketing requirements/commitments at such time. Spero’s LCM with the FDA was in late April 2022.
- Sulopenem etzadroxil: Iterum Therapeutics
Sulopenem is an orally bioavailable, broad-spectrum penem β-lactam antibiotic which is being developed for the treatment of infections caused by multi-drug resistant bacteria. Sulopenem can, however, be administered orally (e.g as a tablet) or by intravenous (IV) infusion. This makes it an attractive option for the treatment of patients with uncomplicated and complicated urinary tract infections (UTI) and complicated intra-abdominal infections (cIAI) caused by susceptible organisms. The IV formulation is intended for the initial treatment of severe infections in a hospital setting, and the oral prodrug will provide the option for IV-to-oral switch, thereby potentially minimizing in-hospital patient stay. The oral prodrug is also intended for the treatment of uncomplicated infections where a patient can tolerate an oral drug in an outpatient setting. The development approach for sulopenem includes its evaluation for the treatment of uUTI, cUTI and cIAI. Qualified Infectious Disease Product (QIDP) designation was granted by the U.S. FDA for both intravenous and oral formulations in the treatment of complicated urinary tract infections (cUTI), uncomplicated urinary tract infections (uUTI) as well as complicated intra-abdominal infections (cIAI).
- Gepotidacin: GlaxoSmithKline
Gepotidacin (GSK2140944) is the first in a new class of antibiotics, called triazaacenaphthylene topoisomerase inhibitors, developed 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 works by selectively interacting with two key 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 conducting a phase III clinical programme investigating gepotidacin, the first in a new chemical class of antibiotics called triazaacenaphthylene bacterial topoisomerase inhibitors, in patients 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 that is being developed for the treatment of 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 used beta-lactam (BL) antibiotic with more than two decades of proven safety and clinical utility against susceptible gram-negative and gram-positive bacteria. Taniborbactam is a beta-lactamase inhibitor (BLI) that, in combination with cefepime, may offer a potential treatment option for patients 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 limiting treatment options. The U.S. Food and Drug Administration (FDA) granted cefepime-taniborbactam Qualified Infectious Disease Product (QIDP) and Fast Track designations for the treatment of 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 trial Cefepime-taniborbactam met 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 patients and 58.0% of meropenem treated patients (treatment difference 11.9; 95% confidence interval (CI), 2.4, 21.6).
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The Urinary Tract Infections Pipeline report provides insights into:-
- The report provides detailed insights about companies that are developing therapies for the treatment of Urinary Tract Infections with aggregate therapies developed by each company for the same.
- It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Urinary Tract Infections Treatment.
- Urinary Tract Infections Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
- Urinary Tract Infections Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
- Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Urinary Tract Infections market.
Urinary Tract Infections Companies
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 and others.
Urinary Tract Infections Pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as,
- Inhalation
- Inhalation/Intravenous/Oral
- Intranasal
- Intravenous
- Intravenous/ Subcutaneous
- NA
- Oral
- Oral/intranasal/subcutaneous
- Parenteral
- Subcutaneous
Urinary Tract Infections Products have been categorized under various Molecule types such as,
- Antibody
- Antisense oligonucleotides
- Immunotherapy
- Monoclonal antibody
- Peptides
- Protein
- Recombinant protein
- Small molecule
- Stem Cell
- Vaccine
From emerging drug candidates to competitive intelligence, the Urinary Tract Infections Pipeline Report covers it all – check it out now @ Urinary Tract Infections Market Drivers and Barriers, and Future Perspectives
Scope of the Urinary Tract Infections Pipeline Report
- Coverage- Global
- Urinary Tract Infections Companies-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 and others.
- Urinary Tract Infections Therapies- Gepotidacin, Nitrofurantoin, Fecal microbiota transplant, Ceftaroline fosamil and NXL104 (q8h), Doripenem, Cefiderocol and others
- Urinary Tract Infections Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
- Urinary Tract Infections Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Stay ahead in Healthcare Research – discover what’s next for the Urinary Tract Infections Treatment landscape in this detailed analysis @ Urinary Tract Infections Emerging Drugs and Major Players
Table of Contents
- 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
- Drug profiles in the detailed report…..
- Late Stage Products (Phase III)
- Gepotidacin: GlaxoSmithKline
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- FL058: Qilu Pharmaceuticals
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- GSK3882347: GlaxoSmithKline
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- ZS05: Zensun (Shanghai) Sci & Tech
- Drug profiles in the detailed report…..
- Inactive Products
- Urinary Tract Infections Key Companies
- Urinary Tract Infections Key Products
- Urinary Tract Infections- Unmet Needs
- Urinary Tract Infections- Market Drivers and Barriers
- Urinary Tract Infections- Future Perspectives and Conclusion
- Urinary Tract Infections Analyst Views
- Urinary Tract Infections Key Companies
- Appendix
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