Hyperoxaluria - Pipeline Insight, 2025
Description
DelveInsight’s, “Hyperoxaluria - Pipeline Insight, 2025” report provides comprehensive insights about 2+ companies and 3+ 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
Hyperoxaluria: Overview
Hyperoxaluria, characterized by elevated urinary oxalate levels, is a significant contributor to kidney stone formation, particularly calcium oxalate stones. It can be classified into primary and secondary forms based on its underlying cause. While both types are associated with kidney stones, they differ in severity, onset, and complications. Effective management requires early detection, often through 24-hour urine testing, and preventive therapies to reduce recurrence and mitigate kidney damage. Hyperoxaluria can also lead to kidney damage even in the absence of stones, causing tubular toxicity and fibrosis, highlighting the importance of timely diagnosis and management.
Nephrolithiasis affects approximately 10% to 15% of individuals in the developed world, with men having a higher incidence than women. In the United States, the prevalence is about 10% in men and 7% in women, and recurrence rates for kidney stones can reach 50% within 10 years. Calcium-based stones, particularly calcium oxalate, make up about 80% of all kidney stones, with recurrence rates around 60% over a decade if preventive measures are not implemented. Secondary hyperoxaluria, a key contributor to recurrent stones, affects 25% to 45% of stone formers and is more prevalent in certain populations, particularly in Asia. Obesity and genetics also play a role in elevated urinary oxalate levels. Primary hyperoxaluria (PH), a rare genetic disorder, primarily affects children and is diagnosed late, often after nephrocalcinosis or end-stage renal disease develops, with a prevalence of 1 to 3 per 1 million in the U.S. and higher rates in inbred and developing populations.
Oxalate is an organic acid primarily found in plant foods, particularly in green leafy vegetables like spinach. While it has no known nutritional value for humans, oxalate can be absorbed in the colon, metabolized in the liver, and excreted in the urine, where it binds with calcium to form crystals. This can lead to the formation of calcium oxalate kidney stones, the most common type of stone. Oxalate is a potent promoter of kidney stones, being 15 to 20 times more effective than urinary calcium in promoting stone formation. Stone formation occurs through a series of steps, including nucleation, supersaturation, crystal growth, and agglomeration, influenced by factors such as urine pH, supersaturation levels, and the presence of crystallization inhibitors. In cases of elevated oxalate levels, such as in hyperoxaluria, calcium oxalate can accumulate in the renal tissues, causing nephrocalcinosis, inflammation, and potential renal damage, leading to chronic kidney disease (CKD) and end-stage renal disease (ESRD). Additionally, oxalate crystals may contribute to kidney fibrosis and damage through inflammation and cellular toxicity.
Treatment of hyperoxaluria involves a combination of conservative medical measures, surgical interventions for nephrolithiasis, and specific therapies aimed at reducing oxalate levels. Conservative management focuses on increasing fluid intake to enhance urine volume and reduce calcium oxalate supersaturation, with a target of at least 3 liters of urine per day. Urinary citrate supplementation with potassium citrate helps prevent crystal aggregation by maintaining a favorable urine pH, and dietary modifications, such as limiting oxalate-rich foods, are recommended. Pyridoxine (vitamin B6) supplementation can significantly reduce hyperoxaluria in patients with type I primary hyperoxaluria (PH), as it enhances the activity of Alanine-Glyoxylate Aminotransferase (AGT). For patients with secondary hyperoxaluria, dietary changes, calcium supplementation, and limiting excessive vitamin C intake are beneficial. Novel treatments include oral Oxalobacter formigenes supplements, anti-inflammatory agents targeting NLRP3 inflammasome activation, and the use of orthophosphates and magnesium supplements to reduce oxalate absorption. Other therapies, such as cholestyramine for enteric hyperoxaluria and pentosan polysulfate for inhibiting crystal aggregation, are also being explored. In cases of larger stones or those that do not pass, surgical intervention may be necessary.
""Hyperoxaluria- Pipeline Insight, 2025"" report by DelveInsight 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
This segment of the Hyperoxaluria report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase 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
Further product details are provided in the report……..
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:
Hyperoxaluria: Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, 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
Current Treatment Scenario and Emerging Therapies:
Geography Covered
- Global coverage
Hyperoxaluria: Overview
Hyperoxaluria, characterized by elevated urinary oxalate levels, is a significant contributor to kidney stone formation, particularly calcium oxalate stones. It can be classified into primary and secondary forms based on its underlying cause. While both types are associated with kidney stones, they differ in severity, onset, and complications. Effective management requires early detection, often through 24-hour urine testing, and preventive therapies to reduce recurrence and mitigate kidney damage. Hyperoxaluria can also lead to kidney damage even in the absence of stones, causing tubular toxicity and fibrosis, highlighting the importance of timely diagnosis and management.
Nephrolithiasis affects approximately 10% to 15% of individuals in the developed world, with men having a higher incidence than women. In the United States, the prevalence is about 10% in men and 7% in women, and recurrence rates for kidney stones can reach 50% within 10 years. Calcium-based stones, particularly calcium oxalate, make up about 80% of all kidney stones, with recurrence rates around 60% over a decade if preventive measures are not implemented. Secondary hyperoxaluria, a key contributor to recurrent stones, affects 25% to 45% of stone formers and is more prevalent in certain populations, particularly in Asia. Obesity and genetics also play a role in elevated urinary oxalate levels. Primary hyperoxaluria (PH), a rare genetic disorder, primarily affects children and is diagnosed late, often after nephrocalcinosis or end-stage renal disease develops, with a prevalence of 1 to 3 per 1 million in the U.S. and higher rates in inbred and developing populations.
Oxalate is an organic acid primarily found in plant foods, particularly in green leafy vegetables like spinach. While it has no known nutritional value for humans, oxalate can be absorbed in the colon, metabolized in the liver, and excreted in the urine, where it binds with calcium to form crystals. This can lead to the formation of calcium oxalate kidney stones, the most common type of stone. Oxalate is a potent promoter of kidney stones, being 15 to 20 times more effective than urinary calcium in promoting stone formation. Stone formation occurs through a series of steps, including nucleation, supersaturation, crystal growth, and agglomeration, influenced by factors such as urine pH, supersaturation levels, and the presence of crystallization inhibitors. In cases of elevated oxalate levels, such as in hyperoxaluria, calcium oxalate can accumulate in the renal tissues, causing nephrocalcinosis, inflammation, and potential renal damage, leading to chronic kidney disease (CKD) and end-stage renal disease (ESRD). Additionally, oxalate crystals may contribute to kidney fibrosis and damage through inflammation and cellular toxicity.
Treatment of hyperoxaluria involves a combination of conservative medical measures, surgical interventions for nephrolithiasis, and specific therapies aimed at reducing oxalate levels. Conservative management focuses on increasing fluid intake to enhance urine volume and reduce calcium oxalate supersaturation, with a target of at least 3 liters of urine per day. Urinary citrate supplementation with potassium citrate helps prevent crystal aggregation by maintaining a favorable urine pH, and dietary modifications, such as limiting oxalate-rich foods, are recommended. Pyridoxine (vitamin B6) supplementation can significantly reduce hyperoxaluria in patients with type I primary hyperoxaluria (PH), as it enhances the activity of Alanine-Glyoxylate Aminotransferase (AGT). For patients with secondary hyperoxaluria, dietary changes, calcium supplementation, and limiting excessive vitamin C intake are beneficial. Novel treatments include oral Oxalobacter formigenes supplements, anti-inflammatory agents targeting NLRP3 inflammasome activation, and the use of orthophosphates and magnesium supplements to reduce oxalate absorption. Other therapies, such as cholestyramine for enteric hyperoxaluria and pentosan polysulfate for inhibiting crystal aggregation, are also being explored. In cases of larger stones or those that do not pass, surgical intervention may be necessary.
""Hyperoxaluria- Pipeline Insight, 2025"" report by DelveInsight 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.
This segment of the Hyperoxaluria report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase 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
- Stiripentol: Biocodex
- META 001 PH: META Pharmaceuticals
Further product details are provided in the report……..
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. 2+ 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 II include, Biocodex.
- 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
- Oral
- Intravenous
- Subcutaneous
- Parenteral
- Topical
- Molecule Type
- Recombinant fusion proteins
- Small molecule
- Monoclonal antibody
- Peptide
- Polymer
- Gene therapy
- Product Type
Hyperoxaluria: Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, 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
- Pipeline Product Profiles
- Therapeutic Assessment
- Pipeline Assessment
- Inactive drugs assessment
- Unmet Needs
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?
- Biocodex
- META Pharmaceuticals
- Arbor Biotechnologies
- Stiripentol
- META 001 PH
- ABO-101
Table of Contents
60 Pages
- Introduction
- Executive Summary
- Hyperoxaluria: Overview
- Introduction
- Causes
- Pathophysiology
- Signs and Symptoms
- Diagnosis
- Treatment
- 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
- Hyperoxaluria– DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- Comparative Analysis
- Stiripentol: Biocodex
- Product Description
- Research and Development
- Product Development Activities
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- Comparative Analysis
- Drug Name: Company Name
- Product Description
- Research and Development
- Product Development Activities
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- Comparative Analysis
- Drug Name: Company Name
- Product Description
- Research and Development
- Product Development Activities
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Comparative Analysis
- META 001 PH: META Pharmaceuticals
- Product Description
- Research and Development
- Product Development Activities
- Drug profiles in the detailed report…..
- Inactive Products
- Comparative Analysis
- Hyperoxaluria Key Companies
- Hyperoxaluria Key Products
- Hyperoxaluria- Unmet Needs
- Hyperoxaluria- Market Drivers and Barriers
- Hyperoxaluria- Future Perspectives and Conclusion
- Hyperoxaluria Analyst Views
- Hyperoxaluria Key Companies
- Appendix
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