IgA Nephropathy Pipeline Drugs Analysis Report, 2023: FDA Approvals, Clinical Trials, Therapies, Mechanism of Action, Route of Administration by DelveInsight | IgA proteases Selecta Biosciences

The IgA Nephropathy 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.

“IgA Nephropathy Pipeline Insight, 2023“ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the IgA Nephropathy Market.

Some of the key takeaways from the IgA Nephropathy Pipeline Report:

• Companies across the globe are diligently working toward developing novel IgA Nephropathy treatment therapies with a considerable amount of success over the years. 
• IgA Nephropathy companies working in the treatment market are IgA proteases Selecta Biosciences, Shanghai Alebund Pharmaceutica, Rohto Pharmaceutical, Wuhan Createrna, Guangdong Hengrui Pharmaceutical, Ionis Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Visterra, Chinook Therapeutics, Novartis, Travere Therapeutics, and others, are developing therapies for the IgA Nephropathy treatment 

• Emerging IgA Nephropathy therapies in the different phases of clinical trials are- Research programme, AP 305, ADR-001, MY 008, SHR-2010, IONIS FB LRx, HR19042, Sibeprenlimab, Atrasentan, LNP023, Sparsentan, and others are expected to have a significant impact on the IgA Nephropathy market in the coming years.   
• In October 2023, In patients with IgA nephropathy (IgAN), Novartis reported good topline results from the interim analysis of the current pivotal Phase III ALIGN trial (NCT04573478) of the oral endothelin A receptor antagonist (ERA) atrasentan1. In patients with IgAN receiving supportive care (maximally tolerated and stable dose of a renin-angiotensin system [RAS] inhibitor), atrasentan showed superiority versus placebo with a clinically meaningful and highly statistically significant reduction in proteinuria (protein in urine)1. The study’s primary efficacy endpoint was met. Trasentan’s safety profile during the trial was in line with previously released information from the Phase II AFFINITY study’s IgAN cohort1,2-4.
• In June 2023, Chinook Therapeutics, Inc. declared that it has signed a merger agreement and plan with Novartis AG, wherein Novartis will purchase Chinook for a cash price of $40 per share, or a total of $3.2 billion.
• On November 7, 2022, Ionis Pharmaceuticals, Inc. presented positive results from a Phase 2 clinical study of IONIS-FB-LRx in patients with immunoglobulin A nephropathy (IgAN). Results from the study were presented in a poster session at the American Society of Nephrology’s (ASN) Kidney Week 2022.
• On November 05, 2022, Vera Therapeutics, Inc. announced new clinical data presented on the Company’s two product candidates, atacicept in immunoglobulin A nephropathy (IgAN) and MAU868 in kidney transplant. These data were presented in poster and oral presentations, respectively, at the American Society of Nephrology (ASN) Kidney Week 2022 Annual Meeting, held November 3-6, 2022, in Orlando, Florida.
• In October 2022, Transcenta Holding Limited announced that TST004, its best-in-class, humanized monoclonal antibody targeting MASP2, had received IND clearance from the U.S. Food and Drug Administration (FDA). MASP2, mannose-binding protein-associated serine protease 2, is a key enzyme in the lectin pathway initiation of complement activation. Studies have shown that lectin pathway activation contributes to multiple human diseases such as immunoglobulin A nephropathy (IgAN), hematopoietic stem-cell transplantation–associated thrombotic microangiopathy (HSCT-TMA). Therefore, inhibition of MASP2 might be a potential treatment approach for diseases related to lectin pathway activation.
• In September 2022, Eledon Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) had cleared the company’s Investigational New Drug (IND) application to evaluate tegoprubart for the treatment of IgA Nephropathy (IgAN).
• In August 2022, Alnylam Pharmaceuticals, Inc. announced positive results from a Phase 2 study of cemdisiran, an investigational RNAi therapeutic targeting the C5 component of the complement pathway, in development in collaboration with Regeneron Pharmaceuticals for the treatment of adult patients with immunoglobulin A nephropathy (IgAN). The results were presented at the 18th European Meeting on Complement in Human Disease (EMCHD), being held in Bern, Switzerland, on August 26-28.
• In August 2022, BioCryst Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) had lifted its partial clinical hold on the BCX9930 program. The company will resume enrollment in global clinical trials under revised protocols at a reduced dose of 400 mg twice daily of BCX9930. This includes the REDEEM-1 and REDEEM-2 pivotal trials in patients with paroxysmal nocturnal hemoglobinuria (PNH) and the RENEW proof-of-concept trial in patients with C3 glomerulopathy (C3G), immunoglobulin A nephropathy (IgAN) and primary membranous nephropathy (PMN).
• In July 2022, Chinook Therapeutics, Inc. announced the European Commission had granted orphan drug designation for BION-1301 for the treatment of primary IgA nephropathy (IgAN). The decision follows a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA).

IgA Nephropathy Overview

The most prevalent primary glomerular disease that can lead to end-stage renal failure (ESRD) is IgA nephropathy (IgAN), also known as Berger’s disease. IgA nephropathy can be classified as an autoimmune illness due to the vital relationship between circulating anti-glycan antibodies and an intrinsic antigen (galactose-deficient IgA1).

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Emerging IgA Nephropathy Drugs Under Different Phases of Clinical Development Include:

• Research programme: IgA proteases Selecta Biosciences
• AP 305: Shanghai Alebund Pharmaceutica
• ADR-001: Rohto Pharmaceutical
• MY 008: Wuhan Createrna Science and Technology
• SHR-2010: Guangdong Hengrui Pharmaceutical
• IONIS FB LRx: Ionis Pharmaceuticals
• HR19042: Jiangsu HengRui Medicine Co., Ltd.
• Sibeprenlimab: Visterra
• Atrasentan: Chinook Therapeutics
• LNP023: Novartis Pharmaceuticals
• Sparsentan: Travere Therapeutics

IgA Nephropathy Route of Administration

IgA Nephropathy 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

IgA Nephropathy Molecule Type

IgA Nephropathy Products have been categorized under various Molecule types, such as

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy 

IgA Nephropathy Pipeline Therapeutics Assessment

• IgA Nephropathy Assessment by Product Type
• IgA Nephropathy By Stage and Product Type
• IgA Nephropathy Assessment by Route of Administration
• IgA Nephropathy By Stage and Route of Administration
• IgA Nephropathy Assessment by Molecule Type
• IgA Nephropathy by Stage and Molecule Type

DelveInsight’s IgA Nephropathy Report covers around 30+ 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 IgA Nephropathy product details are provided in the report. Download the IgA Nephropathy pipeline report to learn more about the emerging IgA Nephropathy therapies

Some of the key companies in the IgA Nephropathy Therapeutics Market include:

Key companies developing therapies for IgA Nephropathy are – Chinook Therapeutics, Inc., RemeGen Co., Ltd., Novartis, Jiangsu HengRui Medicine Co., Ltd., Ionis Pharmaceuticals, Inc., Takeda, Travere Therapeutics, BioCryst Pharmaceuticals, Transcenta Holding, Shanghai Alebund Pharmaceuticals, Vera Therapeutics, Inc., Eledon Pharmaceuticals, Guangdong Hengrui Pharmaceutical Co., Ltd, Omeros Corporation, Otsuka Pharmaceutical, Alnylam Pharmaceuticals, MorphoSys AG, Rohto Pharmaceutical, Alexion Pharmaceuticals, Apellis Pharmaceuticals, Inc., Arrowhead Pharmaceuticals, DiaMedica Therapeutics, SELECTA BIOSCIENCES, Kira Pharmaceuticals, Alpine Immune Sciences, and others.

IgA Nephropathy Pipeline Analysis:

The IgA Nephropathy pipeline report provides insights into 

• The report provides detailed insights about companies that are developing therapies for the treatment of IgA Nephropathy 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 IgA Nephropathy Treatment.
• IgA Nephropathy key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• IgA Nephropathy 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 IgA Nephropathy 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.

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IgA Nephropathy Pipeline Market Drivers

• Increase in prevalence of IgA Nephropathy (IgAN), increment in the number of government initiatives to spread awareness are some of the important factors that are fueling the IgA Nephropathy Market.

IgA Nephropathy Pipeline Market Barriers

• However, lack of in-depth understanding of the disease pathogenesis, the unreported and undiagnosed IgA Nephropathy cases and other factors are creating obstacles in the IgA Nephropathy Market growth.

Scope of IgA Nephropathy Pipeline Drug Insight    

• Coverage: Global
• Key IgA Nephropathy Companies: IgA proteases Selecta Biosciences, Shanghai Alebund Pharmaceutica, Rohto Pharmaceutical, Wuhan Createrna, Guangdong Hengrui Pharmaceutical, Ionis Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Visterra, Chinook Therapeutics, Novartis, Travere Therapeutics, and others
• Key IgA Nephropathy Therapies: Research programme, AP 305, ADR-001, MY 008, SHR-2010, IONIS FB LRx, HR19042, Sibeprenlimab, Atrasentan, LNP023, Sparsentan, and others
• IgA Nephropathy Therapeutic Assessment: IgA Nephropathy current marketed and IgA Nephropathy emerging therapies
• IgA Nephropathy Market Dynamics: IgA Nephropathy market drivers and IgA Nephropathy market barriers 

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Table of Contents

1. IgA Nephropathy Report Introduction

2. IgA Nephropathy Executive Summary

3. IgA Nephropathy Overview

4. IgA Nephropathy- Analytical Perspective In-depth Commercial Assessment

5. IgA Nephropathy Pipeline Therapeutics

6. IgA Nephropathy Late Stage Products (Phase II/III)

7. IgA Nephropathy Mid Stage Products (Phase II)

8. IgA Nephropathy Early Stage Products (Phase I)

9. IgA Nephropathy Preclinical Stage Products

10. IgA Nephropathy Therapeutics Assessment

11. IgA Nephropathy Inactive Products

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

13. IgA Nephropathy Key Companies

14. IgA Nephropathy Key Products

15. IgA Nephropathy Unmet Needs

16 . IgA Nephropathy Market Drivers and Barriers

17. IgA Nephropathy Future Perspectives and Conclusion

18. IgA Nephropathy 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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