
Urinary Tract Infections - Pipeline Insight, 2024
Description
Urinary Tract Infections - Pipeline Insight, 2024
DelveInsight’s, “Urinary Tract Infections - Pipeline Insight, 2024,” report provides comprehensive insights about 38+ companies and 38+ pipeline drugs in Urinary Tract Infections pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Geography Covered
- Global coverage
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, sexual activity, vaginal infection, 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. There are excellent cure rates with “mini-dose therapy” which involves three days of treatment. The FDA has approved fosfomycin as a single-dose therapy for uncomplicated UTIs caused by E coli. Adjunctive therapy with phenazopyridine for several days may help provide additional symptom relief.
""Urinary Tract Infections - Pipeline Insight, 2024"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Urinary Tract Infections pipeline landscape is provided which includes the disease overview and Urinary Tract Infections treatment guidelines. The assessment part of the report embraces, in depth Urinary Tract Infections commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Urinary Tract Infections collaborations, licensing, mergers and acquisition, funding, designations and other product related details.
Report Highlights
- In January 2022, Spero Therapeutics announced that the US FDA has accepted for Priority Review the New Drug Application for tebipenem HBr (tebipenem pivoxil hydrobromide) for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible microorganisms.
- In May 2022, Evofem Biosciences reported post-hoc analysis data from the Phase III AMPOWER clinical trial where Phexxi (lactic acid, citric acid, and potassium bitartrate) was shown to lower urinary tract infections (UTIs) in women.
This segment of the Urinary Tract Infections report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.
Urinary Tract Infections Emerging Drugs
- Tebipenem HBr: Spero Therapeutics
- Sulopenem etzadroxil: Iterum Therapeutics
In September 2021, Company held a Type A meeting with the US Food and Drug Administration (FDA) during the third quarter of 2021 to discuss the steps required for potential resubmission of the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTI). In July 2021, the Company announced that it had received a Complete Response Letter (CRL) from the FDA requesting additional data to support approval of oral sulopenem for the treatment of adult women with a uUTI. Based on the current operating plan and subject to final determination of the design and planned conduct of additional clinical and potential nonclinical development for sulopenem, the Company believes that it is well positioned financially to fund its operations into the second half of 2023.
- Gepotidacin: GlaxoSmithKline
- Cefepime-taniborbactam: Venatorx Pharmaceuticals
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).
Further product details are provided in the report……..
Urinary Tract Infections: Therapeutic Assessment
This segment of the report provides insights about the different Urinary Tract Infections drugs segregated based on following parameters that define the scope of the report, such as:
- Major Players in Urinary Tract Infections
- Phases
- 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
- Route of Administration
- Inhalation
- Inhalation/Intravenous/Oral
- Intranasal
- Intravenous
- Intravenous/ Subcutaneous
- NA
- Oral
- Oral/intranasal/subcutaneous
- Parenteral
- Subcutaneous
- Molecule Type
- Antibody
- Antisense oligonucleotides
- Immunotherapy
- Monoclonal antibody
- Peptides
- Protein
- Recombinant protein
- Small molecule
- Stem Cell
- Vaccine
- Product Type
Urinary Tract Infections: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Urinary Tract Infections therapeutic drugs key players involved in developing key drugs.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Urinary Tract Infections drugs.
Urinary Tract Infections Report Insights
- Urinary Tract Infections Pipeline Analysis
- Therapeutic Assessment
- Unmet Needs
- Impact of Drugs
- Pipeline Product Profiles
- Therapeutic Assessment
- Pipeline Assessment
- Inactive drugs assessment
- Unmet Needs
Current Treatment Scenario and Emerging Therapies:
- How many companies are developing Urinary Tract Infections drugs?
- How many Urinary Tract Infections drugs are developed by each company?
- How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Urinary Tract Infections?
- What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Urinary Tract Infections therapeutics?
- What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for Urinary Tract Infections and their status?
- What are the key designations that have been granted to the emerging drugs?
- 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
- Asieris Pharmaceuticals
- Cefepime-zidebactam
- Gepotidacin
- Sulopenem etzadroxil
- Tebipenem Pivoxil Hydrobromide
- Phexxi
- HY-009B2
- Lactin-V
- Nacubactam
- VMSC-04
- MV140
- ZS05
- VNRX-5133
- XNW4107
- Fosfomycin intravenous
- Pivmecillinam Oral
- etx0282
- GSK3882347
- LBP-EC01
- Meropenem-FL058
- RBX2660
- Finafloxacin
- Cefepime/enmetazobactam
- Nu-8
- Benapenem
- STM001
- APL-1501
Table of Contents
120 Pages
- Introduction
- Executive Summary
- Urinary Tract Infections: Overview
- Causes
- Mechanism of Action
- Signs and Symptoms
- Diagnosis
- Disease Management
- Pipeline Therapeutics
- Comparative Analysis
- Therapeutic Assessment
- Assessment by Product Type
- Assessment by Stage and Product Type
- Assessment by Route of Administration
- Assessment by Stage and Route of Administration
- Assessment by Molecule Type
- Assessment by Stage and Molecule Type
- Urinary Tract Infections – DelveInsight’s Analytical Perspective
- Late Stage Products (Preregistration)
- Comparative Analysis
- Tebipenem HBr: Spero Therapeutics
- Product Description
- Research and Development
- Product Development Activities
- Drug profiles in the detailed report…..
- Late Stage Products (Phase III)
- Comparative Analysis
- Gepotidacin: GlaxoSmithKline
- Product Description
- Research and Development
- Product Development Activities
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- Comparative Analysis
- FL058: Qilu Pharmaceuticals
- Product Description
- Research and Development
- Product Development Activities
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- Comparative Analysis
- GSK3882347: GlaxoSmithKline
- Product Description
- Research and Development
- Product Development Activities
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Comparative Analysis
- ZS05: Zensun (Shanghai) Sci & Tech
- Product Description
- Research and Development
- Product Development Activities
- Drug profiles in the detailed report…..
- Inactive Products
- Comparative Analysis
- 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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