Complicated Urinary Tract Infections Clinical Pipeline, 12+ Companies Driving the Next Wave of Innovation | Spero Therapeutics, Iterum Therapeutics, Venatorx Pharmaceuticals, Nabriva Therapeutics

The market for Complicated Urinary Tract Infections is rapidly evolving, driven by groundbreaking research and innovative therapeutic advancements.

DelveInsight's 'Complicated Urinary Tract Infections Pipeline Insight 2024' 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 Complicated Urinary Tract Infections emerging 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 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 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.

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Complicated Urinary Tract Infections Overview
Urinary tract infections (UTIs) are among the most common bacterial infections, affecting both the lower urinary tract (cystitis, prostatitis) and the upper urinary tract (pyelonephritis, renal abscess, perinephric abscess). The distinction between complicated and uncomplicated UTIs is based on structural or functional abnormalities in the urinary tract, which can elevate the risk of treatment failure and severe complications. Various factors contribute to complicated UTIs, including foreign bodies, urinary stones, obstructions, neurogenic bladder, kidney transplantation, immunosuppression, and pregnancy. Complications of urinary tract infection can be severe, leading to bacteremia, sepsis, perinephric abscess, renal impairment, and, in extreme cases, emphysematous pyelonephritis.

Accurate diagnosis relies on obtaining a high-quality urine specimen, but if complicated urinary tract infection symptoms are evident, treatment should not be delayed. In severe cases, blood cultures can be useful in confirming the diagnosis and ruling out contamination. Imaging techniques such as ultrasound and CT scans are sometimes essential, particularly for detecting perinephric abscess, urinary retention, hydronephrosis, or obstructive pyelonephritis in septic patients. Because urinary tract infection complications can escalate to life-threatening sepsis and multiorgan involvement, resuscitation often takes priority over definitive treatment. Patients with severe sepsis may require aggressive fluid resuscitation and immediate administration of broad-spectrum antibiotics in emergency settings.

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Complicated Urinary Tract Infection Treatment Analysis: Drug Profile
Tebipenem Pivoxil Hydrobromide: Spero Therapeutics
Spero Therapeutics is developing tebipenem pivoxil hydrobromide (tebipenem HBr) as an oral antibiotic for the treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis (AP). The therapy aims to help patients avoid hospitalization by enabling treatment at home or facilitating an early transition from intravenous (IV) therapy to oral medication. In September 2020, Spero completed the Phase III ADAPT-PO trial, a groundbreaking study that was the first to compare an entirely oral regimen against an IV-only regimen for cUTI treatment. This global, randomized, placebo-controlled trial assessed the safety and efficacy of tebipenem HBr in hospitalized adult patients with cUTI or AP. The results demonstrated that oral tebipenem HBr was statistically non-inferior to IV ertapenem, supporting its potential as an effective oral treatment option.

If approved, tebipenem HBr would be the first oral carbapenem antimicrobial to receive marketing authorization in the United States. The drug has already been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for cUTI and AP treatment. Following discussions with the FDA during a recent Type A meeting, Spero Therapeutics plans to conduct an additional Phase III trial to support its regulatory submission.

Sulopenem: Iterum Therapeutics
Sulopenem is a broad-spectrum penem β-lactam antibiotic with oral bioavailability, developed to combat infections caused by multi-drug-resistant bacteria. Originally discovered in Pfizer Inc.'s laboratories during the 1980s, sulopenem was initially available only as an intravenous (IV) formulation. Following extensive preclinical studies and human trials, Iterum Therapeutics advanced the development of an oral formulation, which was evaluated in Phase I and Phase II trials.

In May 2022, Iterum Therapeutics announced its meeting with the FDA on May 5, 2022, to discuss its proposed plan for an additional Phase III clinical trial. This trial is intended to support the potential resubmission of its New Drug Application (NDA) for oral sulopenem etzadroxil-probenecid ("oral sulopenem") for the treatment of 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

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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
• Parenteral
• Intravenous
• Subcutaneous
• 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: Tebipenem Pivoxil Hydrobromide, Cefepime-zidebactam, Cefepime/Taniborbactam, Cefepime/Enmetazobactam, OP0595, 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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This release was published on openPR.