Complicated Urinary Tract Infections Pipeline | 12+ Companies Driving the Next Wave of Treatment Innovations

The Complicated Urinary Tract Infections market rapidly evolves with cutting-edge research and breakthrough therapies driven by leading companies like Nabriva Therapeutics, Allecra Therapeutics, Wockhardt, and MerLion Pharmaceuticals. These innovators are revolutionizing treatment approaches and shaping the future of Complicated Urinary Tract Infections care, offering new hope for patients worldwide.

DelveInsight's 'Complicated Urinary Tract Infections Pipeline Insight 2025' report provides comprehensive global coverage of pipeline Complicated Urinary Tract Infections therapies in various stages of clinical development. Major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Complicated Urinary Tract Infections pipeline domain.

For emerging Complicated Urinary Tract Infections drugs, the Complicated Urinary Tract Infections pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.

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 Infections 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 Infections treatment landscape.
• Key Complicated Urinary Tract Infections pipeline therapies in various stages of development include Cefepime/enmetazobactam, Cefepime/taniborbactam, Cefepime/zidebactam, Nacubactam and cefepime or aztreonam, Tebipenem Poxil Hydrobromide, Imipenem/Cilastatin, XNW4107, and others.
• In October 2024, Iterum Therapeutics received FDA approval for ORLYNVAH Trademark (sulopenem etzadroxil and probenecid) to treat uUTIs caused by E. coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited oral antibacterial options. This approval marks Iterum's first FDA-approved product and introduces a new treatment option for resistant uUTIs.
• In January 2024, TILITY therapeutics announced the FDA's acceptance of its New Drug Application (NDA) for PIVYA (pivmecillinam) for the treatment of uncomplicated UTIs, a significant step in addressing the rising demand for new antibiotic treatments.

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Complicated Urinary Tract Infections Overview
Urinary tract infections (UTIs) are the most common bacterial infections, affecting both the lower urinary tract (cystitis, prostatitis) and the upper urinary tract (pyelonephritis, renal abscess, perinephric abscess). UTIs are classified as complicated or uncomplicated based on structural or functional abnormalities that may increase the risk of treatment failure and severe complications. Risk factors for complicated UTIs include urinary tract obstructions, stones, neurogenic bladder, kidney transplants, immunosuppression, pregnancy, and the presence of foreign bodies. These conditions heighten the risk of complications such as bacteremia, sepsis, renal impairment, perinephric abscess, and emphysematous pyelonephritis.

Accurate diagnosis relies on obtaining a high-quality urine sample, though treatment should not be delayed if clinical symptoms strongly indicate a UTI. In more severe cases, blood cultures can help confirm the diagnosis and differentiate true infections from contamination. Imaging techniques such as ultrasound and CT scans are valuable for detecting complications like perinephric abscesses, hydronephrosis, urinary retention, and obstructive pyelonephritis in critically ill patients. Given that UTIs can escalate to life-threatening sepsis and multiorgan involvement, immediate resuscitation may be necessary before definitive treatment. Severely septic patients often require aggressive fluid resuscitation and broad-spectrum antibiotics administered promptly in emergency settings.

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Complicated Urinary Tract Infections Treatment Analysis: Drug Profile
Tebipenem Pivoxil Hydrobromide: Spero Therapeutics
Spero Therapeutics is developing tebipenem HBr (formerly SPR994) as an oral antibiotic for complicated urinary tract infections (cUTI) and acute pyelonephritis (AP), aiming to reduce hospitalizations and facilitate home-based treatment. In September 2020, the drug completed the pivotal Phase III ADAPT-PO trial, the first to compare an all-oral regimen with an all-IV regimen for cUTI. Results showed tebipenem HBr was statistically non-inferior to IV ertapenem. If approved, it would be the first oral carbapenem in the U.S. The FDA has granted it Qualified Infectious Disease Product (QIDP) and Fast Track designations. Following FDA feedback, Spero will conduct an additional Phase III trial for regulatory submission.

Sulopenem: Iterum Therapeutics
Sulopenem is a broad-spectrum, orally available penem β-lactam antibiotic initially developed by Pfizer in the 1980s as an IV formulation. Iterum later advanced its oral version, completing preclinical and Phase I/II trials. In May 2022, the company met with the FDA to discuss an additional Phase III trial required to support the resubmission of its NDA for oral sulopenem etzadroxil-probenecid in uncomplicated urinary tract infections (uUTI).

Key Complicated Urinary Tract Infections Therapies and Companies
• Tebipenem Pivoxil Hydrobromide (SPR994): Spero Therapeutics
• Cefepime-zidebactam (WCK-5222): Wockhardt
• Cefepime/Taniborbactam: Venatorx Pharmaceuticals
• Cefepime/Enmetazobactam: Allecra Therapeutics
• OP0595 (nacubactam): Meiji Seika Pharma/Fedora Pharmaceuticals
• XNW4107 (Imipenem/Cilastatin): Evopoint Pharmaceuticals
• Sulopenem: Iterum Therapeutics

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Complicated Urinary Tract Infections Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

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

By Molecule Type
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Scope of the Complicated Urinary Tract Infections Pipeline Report
• Coverage: Global
• Key Complicated Urinary Tract Infections Companies: Spero Therapeutics, Iterum Therapeutics, Venatorx Pharmaceuticals, Inc., Nabriva Therapeutics, Allecra Therapeutics, Wockhardt, MerLion Pharmaceuticals, and others.
• Key Complicated Urinary Tract Infections Pipeline Therapies: Cefepime/enmetazobactam, Cefepime/taniborbactam, Cefepime/zidebactam, Nacubactam and cefepime or aztreonam, Tebipenem Poxil Hydrobromide, Imipenem/Cilastatin, XNW4107, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Complicated Urinary Tract Infections Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Complicated Urinary Tract Infections Pipeline Therapeutics
6. Complicated Urinary Tract Infections Pipeline: Late-Stage Products (Phase III)
7. Complicated Urinary Tract Infections Pipeline: Late-Stage Products (Phase III)
8. Complicated Urinary Tract Infections Pipeline: Mid-Stage Products (Phase II)
9. Complicated Urinary Tract Infections Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

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About DelveInsight
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This release was published on openPR.