Hyperoxaluria - Pipeline Insight, 2024

This “Hyperoxaluria - Pipeline Insight, 2024” report provides comprehensive insights about 9+ companies and 10+ pipeline drugs in Hyperoxaluria 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

Hyperoxaluria: Understanding

Hyperoxaluria: Overview

Hyperoxaluria Kidney stones, or renal calculi, are a common medical issue affecting around 10% of people, with calcium stones being the most prevalent type. Calcium oxalate stones, the most common variety, typically form due to an imbalance between calcium and oxalate levels or a lack of sufficient crystallization inhibitors in the body. Hyperoxaluria, an excess of urinary oxalate, can be primary or secondary and leads to kidney stone formation, with varying degrees of severity and rapidity of onset. While the acute management of renal calculi is well-established, it is crucial to investigate the underlying cause in each patient to improve their quality of life and prevent or delay recurrences and complications. Clinicians should offer 24-hour urine testing and preventive therapy to every nephrolithiasis patient, but often recommend it only to those highly motivated to adhere to long-term preventive treatments.

Hyperoxaluria can be categorized into primary and secondary forms based on its etiology. Primary hyperoxaluria results from a genetic defect or absence of specific enzymatic activity, leading to significantly elevated oxalate levels in the body, while secondary hyperoxaluria is more common and can be caused by various factors such as dietary intake or underlying medical conditions.

The most common symptoms of Hyperoxaluria include recurrent kidney stones, blood in the urine, urinary tract infections, and pain when urinating. In severe cases, Hyperoxaluria can lead to kidney failure and the accumulation of oxalate crystals in other organs, causing complications like bone pain, anemia, and nerve damage.

The management of Hyperoxaluria involves a combination of conservative, medical, and surgical measures, along with the treatment of nephrolithiasis. Increasing fluid intake is crucial, with a goal of at least 2 liters of urine output per day to reduce calcium oxalate super saturation. Potassium citrate supplements are used to maintain urinary citrate levels and pH between 6.2 and 6.8, which helps prevent calcium oxalate crystal aggregation. Dietary modifications, such as limiting oxalate-rich foods and maintaining a reasonable calcium intake with supplementation during high-oxalate meals, can be beneficial in secondary Hyperoxaluria. Pyridoxine (vitamin B6) supplementation, up to 500 mg daily in divided doses, has been shown to reduce Hyperoxaluria in about 50% of patients with secondary Hyperoxaluria, with women responding better than men for unknown reasons.

"Hyperoxaluria - Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Hyperoxaluria pipeline landscape is provided which includes the disease overview and Hyperoxaluria treatment guidelines. The assessment part of the report embraces, in depth Hyperoxaluria 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, Hyperoxaluria 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 Hyperoxaluria R&D. The therapies under development are focused on novel approaches to treat/improve Hyperoxaluria.

Hyperoxaluria Emerging Drugs Chapters

This segment of the Hyperoxaluria report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II/III, 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.

Hyperoxaluria Emerging Drugs

Oxabact: OxThera

Oxalobacter formigenes is an anaerobe, non-pathogenic bacterium which exclusively uses oxalate as the energy source. OxThera has taken this bacterial strain isolated from the human gut and developed a live biotherapeutic product candidate. The drug is currently being evaluated under Phase III clinical trial for the treatment of patients with Hyperoxaluria.

SYNB8802: Synlogic

SYNB8802 is designed to consume dietary oxalate throughout the GI tract. SYNB8802 has demonstrated proof of concept through positive and clinically significant lowering of urinary oxalate in a Phase Ib study in patients with a history of gastric bypass surgery. The drug is currently being evaluated under Phase I clinical trial for the treatment of Hyperoxaluria.

Hyperoxaluria: Therapeutic Assessment

This segment of the report provides insights about the different Hyperoxaluria drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Hyperoxaluria

There are approx. 9+ key companies which are developing the therapies for Hyperoxaluria. The companies which have their Hyperoxaluria drug candidates in the most advanced stage, i.e. Phase III include, OxThera.

Phases

This report covers around 10+ 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

Hyperoxaluria pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intravenous
• Subcutaneous
• Oral
• Intramuscular
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Hyperoxaluria: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Hyperoxaluria 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 Hyperoxaluria drugs.

Hyperoxaluria Report Insights

• Hyperoxaluria Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Hyperoxaluria 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 Hyperoxaluria drugs?
• How many Hyperoxaluria drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Hyperoxaluria?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Hyperoxaluria 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 Hyperoxaluria and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• OxThera
• Synlogic
• Federation Bio
• Biocodex
• Allena Pharmaceuticals

Key Products

• Oxabact
• SYNB8802
• FB-001
• Stiripentol
• ALLN-177

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