Primary Hyperoxyaluria Clinical Trials 2024: FDA Approvals, Medication, Treatment Market, Therapies, MOA, ROA, Companies by DelveInsight | Dicerna Pharma, Allena Pharma, Genentech, Biocode, Alnylum

Primary Hyperoxyaluria Clinical Trials 2024: FDA Approvals, Medication, Treatment Market, Therapies, MOA, ROA, Companies by DelveInsight | Dicerna Pharma, Allena Pharma, Genentech, Biocode, Alnylum
Primary Hyperoxyaluria Clinical Trials
Primary Hyperoxaluria pipeline constitutes 6+ key companies continuously working towards developing 6+ Primary Hyperoxaluria treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

(Albany, United States) Primary Hyperoxaluria Pipeline Insight, 2024 report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Primary Hyperoxaluria Market.

The Primary Hyperoxaluria Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

 

Some of the key takeaways from the Primary Hyperoxaluria Pipeline Report:

  • Primary Hyperoxaluria Companies across the globe are diligently working toward developing novel Primary Hyperoxaluria treatment therapies with a considerable amount of success over the years. 
  • Primary Hyperoxaluria companies working in the treatment market are Alnylam Pharmaceuticals, Dicerna Pharmaceuticals, Biocodex, and others, are developing therapies for the Primary Hyperoxaluria treatment 
  • Emerging Primary Hyperoxaluria therapies in the different phases of clinical trials are- Lumasiran, nedosiran, Stiripentol, DCR-PHXC, and others are expected to have a significant impact on the Primary Hyperoxaluria market in the coming years.   
  • In October 2023, Novo Nordisk has obtained approval from the US Food and Drug Administration (FDA) for Rivfloza (nedosiran) injection, aimed at lowering urinary oxalate levels in children aged nine and above, and adults with primary hyperoxaluria type 1 (PH1) who have relatively preserved kidney function. PH1 is a rare genetic disorder that leads to oxalate overproduction by the liver, affecting approximately one in 38,600 individuals worldwide. The approved doses of Rivfloza are 80mg, 128mg, or 160mg, administered monthly as a subcutaneous ribonucleic acid interference therapy. This approval is based on data from the pivotal Phase II PHYOX2 clinical study and interim results from the ongoing Phase III PHYOX3 extension study.
  • In October 2023, The Food and Drug Administration (FDA) has approved Rivfloza™ (nedosiran) to reduce urinary oxalate levels in children aged nine and older, as well as adults with primary hyperoxaluria type 1 (PH1) who have relatively preserved kidney function (e.g., estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m²).

 

Primary Hyperoxaluria Overview

Primary hyperoxaluria is a rare genetic disorder characterized by excessive production of oxalate, a compound that can form kidney stones and lead to kidney damage. It results from mutations in one of three genes: AGXT, GRHPR, or HOGA1, corresponding to different types of the condition.

The excess oxalate can precipitate in the kidneys, leading to calcium oxalate stone formation, which can cause severe pain, hematuria, and potentially chronic kidney disease. Symptoms often begin in childhood or early adulthood, though they can vary widely in onset and severity.

Diagnosis typically involves urine tests that show high levels of oxalate, along with genetic testing to confirm the specific mutation. Treatment options are limited and may include dietary modifications to reduce oxalate intake, increased fluid intake to dilute urine, and medications such as pyridoxine (vitamin B6) for certain types. In severe cases, interventions like dialysis or kidney transplantation may be necessary.

Early detection and management are crucial to prevent complications and preserve kidney function. Ongoing research aims to improve understanding of the disease and develop more effective treatments.

 

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Emerging Primary Hyperoxaluria Drugs Under Different Phases of Clinical Development Include:

  • Lumasiran: Alnylam Pharmaceuticals
  • nedosiran: Dicerna Pharmaceuticals
  • Stiripentol: Biocodex
  • DCR-PHXC: Dicerna Pharmaceuticals

 

Primary Hyperoxaluria Route of Administration

Primary 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 

  • Oral
  • Parenteral
  • Intravenous
  • Subcutaneous
  • Topical

 

Primary Hyperoxaluria Molecule Type

Primary Hyperoxaluria Products have been categorized under various Molecule types, such as

  • Recombinant fusion proteins
  • Small molecule
  • Monoclonal antibody
  • Peptide
  • Polymer
  • Gene therapy

 

Primary Hyperoxaluria Pipeline Therapeutics Assessment

  • Primary Hyperoxaluria Assessment by Product Type
  • Primary Hyperoxaluria By Stage and Product Type
  • Primary Hyperoxaluria Assessment by Route of Administration
  • Primary Hyperoxaluria By Stage and Route of Administration
  • Primary Hyperoxaluria Assessment by Molecule Type
  • Primary Hyperoxaluria by Stage and Molecule Type

 

DelveInsight’s Primary Hyperoxaluria Report covers around 6+ products under different phases of clinical development like

  • Late-stage products (Phase III)
  • Mid-stage products (Phase II)
  • Early-stage product (Phase I)
  • Pre-clinical and Discovery stage candidates
  • Discontinued & Inactive candidates
  • Route of Administration

 

Further Primary Hyperoxaluria product details are provided in the report. Download the Primary Hyperoxaluria pipeline report to learn more about the emerging Primary Hyperoxaluria therapies

 

Some of the key companies in the Primary Hyperoxaluria Therapeutics Market include:

Key companies developing therapies for Primary Hyperoxaluria are – Dicerna Pharmaceuticals, Allena Pharmaceuticals, Genentech, Biocode, Alnylum Pharm, OxThera, Tecoland Corporation, Zhejiang Tianxin Pharmaceutical Co., Takeda Pharmaceuticals, Wuxi Further Pharmaceutical Co Ltd, and others.

 

Primary Hyperoxaluria Pipeline Analysis:

The Primary Hyperoxaluria pipeline report provides insights into 

  • The report provides detailed insights about companies that are developing therapies for the treatment of Primary Hyperoxaluria with aggregate therapies developed by each company for the same.
  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Primary Hyperoxaluria Treatment.
  • Primary Hyperoxaluria key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Primary Hyperoxaluria Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. 
  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Primary Hyperoxaluria market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

 

Download Sample PDF Report to know more about Primary Hyperoxaluria drugs and therapies

 

Primary Hyperoxaluria Pipeline Market Drivers

  • Genetic Advancements, Innovative Treatments, Increased Diagnosis Rates, Orphan Drug Designation, Rising Awareness, are some of the important factors that are fueling the Primary Hyperoxaluria Market.

 

Primary Hyperoxaluria Pipeline Market Barriers

  • However, High Development Costs, Regulatory Challenges, Limited Patient Population, Clinical Trial Difficulties, Uncertain Long-term Efficacy, and other factors are creating obstacles in the Primary Hyperoxaluria Market growth.

 

Scope of Primary Hyperoxaluria Pipeline Drug Insight    

  • Coverage: Global
  • Key Primary Hyperoxaluria Companies: Alnylam Pharmaceuticals, Dicerna Pharmaceuticals, Biocodex, and others
  • Key Primary Hyperoxaluria Therapies: Lumasiran, nedosiran, Stiripentol, DCR-PHXC, and others
  • Primary Hyperoxaluria Therapeutic Assessment: Primary Hyperoxaluria current marketed and Primary Hyperoxaluria emerging therapies
  • Primary Hyperoxaluria Market Dynamics: Primary Hyperoxaluria market drivers and Primary Hyperoxaluria market barriers 

 

Request for Sample PDF Report for Primary Hyperoxaluria Pipeline Assessment and clinical trials

 

Table of Contents

1. Primary Hyperoxaluria Report Introduction

2. Primary Hyperoxaluria Executive Summary

3. Primary Hyperoxaluria Overview

4. Primary Hyperoxaluria- Analytical Perspective In-depth Commercial Assessment

5. Primary Hyperoxaluria Pipeline Therapeutics

6. Primary Hyperoxaluria Late Stage Products (Phase II/III)

7. Primary Hyperoxaluria Mid Stage Products (Phase II)

8. Primary Hyperoxaluria Early Stage Products (Phase I)

9. Primary Hyperoxaluria Preclinical Stage Products

10. Primary Hyperoxaluria Therapeutics Assessment

11. Primary Hyperoxaluria Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Primary Hyperoxaluria Key Companies

14. Primary Hyperoxaluria Key Products

15. Primary Hyperoxaluria Unmet Needs

16 . Primary Hyperoxaluria Market Drivers and Barriers

17. Primary Hyperoxaluria Future Perspectives and Conclusion

18. Primary Hyperoxaluria Analyst Views

19. Appendix

20. About DelveInsight

 

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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