This “Acute Pyelonephritis - Pipeline Insight, 2024” report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Acute Pyelonephritis 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.
Symptoms
Symptoms usually include fever, flank pain, nausea, vomiting, burning on urination, increased frequency, and urgency. The 2 most common symptoms are usually fever and flank pain. Acute pyelonephritis can be divided into uncomplicated and complicated. Complicated pyelonephritis includes pregnant patients, patients with uncontrolled diabetes, kidney transplants, urinary anatomical abnormalities, acute or chronic kidney failure, as well as immunocompromised patients, and those with hospital-acquired bacterial infections. It is important to make a distinction between complicated and uncomplicated pyelonephritis, as patient management and disposition depend on it.
Pathophysiology
E. coli is the most common bacteria causing acute pyelonephritis due to its unique ability to adhere to and colonize the urinary tract and kidneys. E.coli has adhesive molecules called P-fimbriae, which interact with receptors on the surface of uroepithelial cells. Kidneys infected with E. coli can lead to an acute inflammatory response which can cause scarring of the renal parenchyma. Though the mechanism in which renal scarring occurs is still poorly understood, it has been hypothesized that the adhesion of bacteria to the renal cells disrupts the protective barriers, which leads to localized infection, hypoxia, ischemia, and clotting in an attempt to contain the infection.
Treatment
Nonsteroidal anti-inflammatory drugs (NSAIDs) work well to treat both pain and fever associated with acute pyelonephritis. The initial selection of antibiotics will be empiric and should be based on the local antibiotic resistance. Antibiotic therapy should then be adjusted based on the results of the urine culture. Most uncomplicated cases of acute pyelonephritis will be caused by E. coli, for which patients can be treated with oral cephalosporins or TMP-SMX for 14 days. Complicated cases of acute pyelonephritis require intravenous (IV) antibiotic treatment until there are clinical improvements. Examples of IV antibiotics include piperacillin-tazobactam, fluoroquinolones, meropenem, and cefepime.
Acute Pyelonephritis- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Acute Pyelonephritis pipeline landscape is provided which includes the disease overview and Acute Pyelonephritis treatment guidelines. The assessment part of the report embraces, in depth Acute Pyelonephritis 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, Acute Pyelonephritis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.
Spero’s lead product candidate, tebipenem HBr, is being developed as the first oral carbapenem antibiotic for use in complicated urinary tract infection and acute pyelonephritis. In September 2020, tebipenem HBr completed a pivotal Phase III trial, ADAPT-PO, for the treatment of c UTI including acute pyelonephritis (AP). If approved, tebipenem HBr would be the first oral carbapenem antimicrobial to receive marketing approval in the United States. Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of c UTI andAcutePyelonephritis.
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 (c UTIs) and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). The drug completed its Phase III trial and expected New Drug Application submission thisyear.
CERTAIN-1: A Phase III Study of Cefepime-Taniborbactam Efficacy and Safety in the Treatment of Complicated Urinary Tract Infections (c UTI), including Acute Pyelonephritis (AP) was conducted in which cefepime-taniborbactam met the prospectively defined non-inferiority primary endpoint of composite microbiologic and clinical response versus meropenem at the TOC visit (70.6% response rate for cefepime-taniborbactam versus 58.0% for meropenem). Cefepime-taniborbactam demonstrated a safety profile consistent withmeropenem.
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Geography Covered
- Global coverage
Acute Pyelonephritis: Understanding
Acute Pyelonephritis: Overview
Acute pyelonephritis is a bacterial infection causing inflammation of the kidneys and is one of the most common diseases of the kidney. Pyelonephritis occurs as a complication of an ascending urinary tract infection (UTI) which spreads from the bladder to the kidneys and their collecting systems.Symptoms
Symptoms usually include fever, flank pain, nausea, vomiting, burning on urination, increased frequency, and urgency. The 2 most common symptoms are usually fever and flank pain. Acute pyelonephritis can be divided into uncomplicated and complicated. Complicated pyelonephritis includes pregnant patients, patients with uncontrolled diabetes, kidney transplants, urinary anatomical abnormalities, acute or chronic kidney failure, as well as immunocompromised patients, and those with hospital-acquired bacterial infections. It is important to make a distinction between complicated and uncomplicated pyelonephritis, as patient management and disposition depend on it.
Pathophysiology
E. coli is the most common bacteria causing acute pyelonephritis due to its unique ability to adhere to and colonize the urinary tract and kidneys. E.coli has adhesive molecules called P-fimbriae, which interact with receptors on the surface of uroepithelial cells. Kidneys infected with E. coli can lead to an acute inflammatory response which can cause scarring of the renal parenchyma. Though the mechanism in which renal scarring occurs is still poorly understood, it has been hypothesized that the adhesion of bacteria to the renal cells disrupts the protective barriers, which leads to localized infection, hypoxia, ischemia, and clotting in an attempt to contain the infection.
Treatment
Nonsteroidal anti-inflammatory drugs (NSAIDs) work well to treat both pain and fever associated with acute pyelonephritis. The initial selection of antibiotics will be empiric and should be based on the local antibiotic resistance. Antibiotic therapy should then be adjusted based on the results of the urine culture. Most uncomplicated cases of acute pyelonephritis will be caused by E. coli, for which patients can be treated with oral cephalosporins or TMP-SMX for 14 days. Complicated cases of acute pyelonephritis require intravenous (IV) antibiotic treatment until there are clinical improvements. Examples of IV antibiotics include piperacillin-tazobactam, fluoroquinolones, meropenem, and cefepime.
Acute Pyelonephritis- Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Acute Pyelonephritis pipeline landscape is provided which includes the disease overview and Acute Pyelonephritis treatment guidelines. The assessment part of the report embraces, in depth Acute Pyelonephritis 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, Acute Pyelonephritis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.
Report Highlights
The companies and academics are working to assess challenges and seek opportunities that could influence Acute Pyelonephritis R&D. The therapies under development are focused on novel approaches to treat/improve Acute Pyelonephritis.Acute Pyelonephritis Emerging Drugs Chapters
This segment of the Acute Pyelonephritis 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.Acute Pyelonephritis Emerging Drugs
Tebipenem pivoxil: Spero TherapeuticsSpero’s lead product candidate, tebipenem HBr, is being developed as the first oral carbapenem antibiotic for use in complicated urinary tract infection and acute pyelonephritis. In September 2020, tebipenem HBr completed a pivotal Phase III trial, ADAPT-PO, for the treatment of c UTI including acute pyelonephritis (AP). If approved, tebipenem HBr would be the first oral carbapenem antimicrobial to receive marketing approval in the United States. Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of c UTI andAcutePyelonephritis.
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 (c UTIs) and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). The drug completed its Phase III trial and expected New Drug Application submission thisyear.
CERTAIN-1: A Phase III Study of Cefepime-Taniborbactam Efficacy and Safety in the Treatment of Complicated Urinary Tract Infections (c UTI), including Acute Pyelonephritis (AP) was conducted in which cefepime-taniborbactam met the prospectively defined non-inferiority primary endpoint of composite microbiologic and clinical response versus meropenem at the TOC visit (70.6% response rate for cefepime-taniborbactam versus 58.0% for meropenem). Cefepime-taniborbactam demonstrated a safety profile consistent withmeropenem.
Acute Pyelonephritis: Therapeutic Assessment
This segment of the report provides insights about the different Acute Pyelonephritis drugs segregated based on following parameters that define the scope of the report, such as:Major Players in Acute Pyelonephritis
There are approx. 5+ key companies which are developing the therapies for Acute Pyelonephritis. The companies which have their Acute Pyelonephritis drug candidates in the most advanced stage, i.e. phase III include, Spero Therapeutics.Phases
This report covers around 5+ products under different phases of clinical development like- 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
Acute Pyelonephritis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as- Intra-articular
- Intraocular
- Intrathecal
- Intravenous
- Ophthalmic
- Oral
- Parenteral
- Subcutaneous
- Topical
- Transdermal
Molecule Type
Products have been categorized under various Molecule types such as
- Oligonucleotide
- Peptide
- Small molecule
Product Type
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.Acute Pyelonephritis: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Acute Pyelonephritis 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 Acute Pyelonephritis drugs.Acute Pyelonephritis Report Insights
- Acute Pyelonephritis Pipeline Analysis
- Therapeutic Assessment
- Unmet Needs
- Impact of Drugs
Acute Pyelonephritis Report Assessment
- Pipeline Product Profiles
- Therapeutic Assessment
- Pipeline Assessment
- Inactive drugs assessment
- Unmet Needs
Key Questions
Current Treatment Scenario and Emerging Therapies:- How many companies are developing Acute Pyelonephritis drugs?
- How many Acute Pyelonephritis drugs are developed by each company?
- How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Acute Pyelonephritis?
- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Acute Pyelonephritis 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 Acute Pyelonephritis and their status?
- What are the key designations that have been granted to the emerging drugs?
Key Players
- Spero Therapeutics
- VenatoRx Pharmaceuticals
- Entasis Therapeutics
- Wockhardt
- Paratek Pharmaceuticals
Key Products
- Tebipenem pivoxil
- Cefepime-Taniborbactam
- Durlobactam
- WCK 4282
- Omadacyclin
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Table of Contents
IntroductionExecutive SummaryAcute Pyelonephritis- Analytical PerspectiveDrug profiles in the detailed report…..Drug profiles in the detailed report…..Drug profiles in the detailed report…..Drug profiles in the detailed report…..Acute Pyelonephritis Key CompaniesAcute Pyelonephritis Key ProductsAcute Pyelonephritis- Unmet NeedsAcute Pyelonephritis- Market Drivers and BarriersAcute Pyelonephritis- Future Perspectives and ConclusionAcute Pyelonephritis Analyst ViewsAcute Pyelonephritis Key CompaniesAppendix
Acute Pyelonephritis: Overview
Pipeline Therapeutics
Therapeutic Assessment
Late Stage Products (Phase III)
Tebipenem pivoxil: Spero Therapeutics
Mid Stage Products (Phase II)
Drug Name: Company Name
Early Stage Products (Phase I)
Drug Name: Company Name
Preclinical and Discovery Stage Products
Drug Name: Company Name
Inactive Products
List of Tables
List of Figures
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Spero Therapeutics
- VenatoRx Pharmaceuticals
- Entasis Therapeutics
- Wockhardt
- Paratek Pharmaceuticals