Complicated Urinary Tract Infection Pipeline and Clinical Trials 2025: EMA, PDMA, FDA Approval, Medication, NICE Approval, IND, NDA Approvals, Therapies, MOA, ROA and Companies by DelveInsight

(Albany, United States) "Complicated Urinary Tract Infection (UTI) Pipeline Insight 2025" report by DelveInsight provides a comprehensive analysis of the ongoing clinical development activities and growth prospects across the Complicated Urinary Tract Infection Therapeutics Market.

As per DelveInsight's assessment, globally, about 12+ key pharma and biotech companies are working on 12+ pipeline drugs in the Complicated Urinary Tract Infection therapeutics landscape based on different Routes of Administration (ROA), Mechanism of Action (MOA), and molecule types. Several of the therapies are in the advanced stages of clinical development and are expected to launch in the coming years.

The report provides a detailed description of the Complicated Urinary Tract Infection drugs, including the mechanism of action, type, stage, route of administration, molecule type, clinical studies, inactive pipeline products, and NDA approvals (if any). The report also covers commercial and clinical activities of the pipeline products from the pre-clinical developmental phase to the marketed stage. Additionally, it presents the ongoing developments in the therapeutics segment, including collaborations, licensing, mergers & acquisitions (M&A), funding, designations, and other product-related details.

Get a Detailed Overview of the Complicated Urinary Tract Infection Clinical Trial Activities and Regulatory Developments in the domain @
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Key Takeaways from the Complicated Urinary Tract Infections Pipeline Report
• DelveInsight's Complicated Urinary Tract Infections Pipeline analysis depicts a robust space with 12+ active players working to develop 12+ pipeline drugs for Complicated Urinary Tract Infection treatment.
• The leading Complicated Urinary Tract Infections companies include Spero Therapeutics, Iterum Therapeutics, Venatorx Pharmaceuticals, Inc., Nabriva Therapeutics, Allecra Therapeutics, Wockhardt, MerLion Pharmaceuticals, and others are evaluating their lead assets to improve the Complicated Urinary Tract Infection treatment landscape.
• Key Complicated Urinary Tract Infections pipeline therapies in various stages of development include Tebipenem Pivoxil Hydrobromide, Cefepime-zidebactam, Cefepime/Taniborbactam, Cefepime/Enmetazobactam, OP0595, XNW4107, and others.
• In March 2025, GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis.
In February 2025, AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved EMBLAVEOTM (aztreonam and avibactam), as the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic. It is approved in combination with metronidazole, for patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI), including those caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. Gram-negative bacterial infections are among the most challenging for healthcare professionals to control due to high antimicrobial resistance (AMR).2 When AMR develops, medicines intended to treat these infections become ineffective, increasing the risk of morbidity and mortality.
• In November 2024, Sulopenem received FDA approval for the treatment of uncomplicated urinary tract infections (uUTI) after two successful phase 3 trials. The SURE 1 trial compared a 5-day course of sulopenem to a 3-day course of ciprofloxacin.
• In October 2024, Iterum Therapeutics plc announced FDA approval for ORLYNVAH (sulopenem etzadroxil and probenecid) to treat uncomplicated urinary tract infections (uUTIs) caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited oral antibacterial options.

Complicated Urinary Tract Infection (UTI) Pipeline Analysis
The report provides insights into:
• The report provides detailed insights into the key companies that are developing Complicated Urinary Tract Infection therapies.
• The report also evaluates different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Complicated Urinary Tract Infection treatment.
• It analyzes the key companies involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• It navigates the emerging Complicated Urinary Tract Infection 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 in the Complicated Urinary Tract Infection treatment market.

Learn More about the Clinical and Commercial Development Activities in the Complicated Urinary Tract Infection Therapeutics Domain @
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Complicated Urinary Tract Infections Overview:
Complicated Urinary Tract Infections (cUTIs) refer to infections of the urinary tract that occur in individuals with structural or functional abnormalities, catheter use, immunosuppression, or other comorbidities. Complicated Urinary Tract Infections typically involve the bladder (cystitis) or kidneys (pyelonephritis) and are often resistant to standard treatments. Complicated Urinary Tract Infections are more common in hospitalized or elderly patients and can lead to serious complications if not promptly treated.

Complicated Urinary Tract Infections are commonly caused by bacteria such as Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa. Complicated Urinary Tract Infections often require urine culture tests and imaging to confirm diagnosis. Complicated Urinary Tract Infections demand targeted antibiotic therapy based on susceptibility results. Complicated Urinary Tract Infections may also necessitate the removal of underlying obstructions or indwelling catheters. Complicated Urinary Tract Infections differ from uncomplicated UTIs in terms of etiology, clinical presentation, and management. Complicated Urinary Tract Infections can be recurrent and need long-term monitoring.

Complicated Urinary Tract Infections treatment often includes broad-spectrum antibiotics like carbapenems or aminoglycosides. Complicated Urinary Tract Infections pose a rising global concern due to antimicrobial resistance. Complicated Urinary Tract Infections must be managed with a multidisciplinary approach to improve patient outcomes and reduce hospitalization rates.

Complicated Urinary Tract Infection (UTI) Therapeutics Analysis
Around 12 noteworthy companies are actively involved in the development of therapies for Complicated Urinary Tract Infections (cUTIs). Notably, Spero Therapeutics stands out among these, with its cUTI drug candidates progressing to the most advanced stage, Phase III.

Complicated Urinary Tract Infection (UTI) Companies in the Therapeutics Market Include:
Spero Therapeutics (NASDAQ: SPRO), Iterum Therapeutics (NASDAQ: ITRM), Venatorx Pharmaceuticals, Inc. (Private), Nabriva Therapeutics (NASDAQ: NBRV), Allecra Therapeutics (Private), Wockhardt (NSE: WOCKPHARMA), MerLion Pharmaceuticals (Private), and others. are notable contributors in the field of Complicated Urinary Tract Infection therapeutics, each playing a crucial role in the advancement and development of treatments within the Complicated Urinary Tract Infection market..

Emerging and Marketed Complicated Urinary Tract Infection (UTI) Therapies Covered in the Report Include:
• Tebipenem Pivoxil Hydrobromide: Spero Therapeutics
• Sulopenem: Iterum Therapeutics
And Man Others

Get an in-depth Assessment of the Emerging Therapies and Complicated Urinary Tract Infection Companies Actively Working in the Market @
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The Report Covers the Emerging Complicated Urinary Tract Infection Therapies Under Different Phases of Clinical Development Like -
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued and inactive candidates

Route of Administration
Complicated 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
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical

Molecule Type
Products have been categorized under various Molecule types such as
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

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Table of Content
1. Report Introduction
2. Executive Summary
3. Complicated Urinary Tract Infection Current Treatment Patterns
4. Complicated Urinary Tract Infection - DelveInsight's Analytical Perspective
5. Therapeutic Assessment
6. Complicated Urinary Tract Infection Late-Stage Products (Phase-III)
7. Complicated Urinary Tract Infection Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Complicated Urinary Tract Infection Discontinued Products
13. Complicated Urinary Tract Infection Product Profiles
14. Complicated Urinary Tract Infection Companies
15. Complicated Urinary Tract Infection Drugs
16. Dormant and Discontinued Products
17. Complicated Urinary Tract Infection Unmet Needs
18. Complicated Urinary Tract Infection Future Perspectives
19. Complicated Urinary Tract Infection Analyst Review
20. Appendix
21. Report Methodology

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