IgA nephropathy Clinical Trials Analysis 2024: FDA Approvals, Pipeline, Therapies, Treatment Market and Key Companies by DelveInsight

IgA nephropathy Clinical Trials

(Albany, USA) IgA nephropathy pipeline report showcase a robust space with 30+ key companies working to develop 30+ pipeline therapies for IgA nephropathy treatment. 

DelveInsight’s ‘IgA Nephropathy Pipeline Insight 2024’ report provides comprehensive global coverage of available, marketed, and pipeline IgA nephropathy therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the IgA nephropathy pipeline domain.

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Key Takeaways from the IgA Nephropathy Pipeline Report

• DelveInsight’s IgA nephropathy pipeline report depicts a robust space with 30+ active players working to develop 30+ pipeline therapies for IgA nephropathy treatment. 
• Leading IgA nephropathy companies working in the treatment market are Chinook Therapeutics, Inc., RemeGen Co., Ltd., Novartis, Jiangsu HengRui Medicine Co., Ltd., Ionis Pharmaceuticals, Inc., 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, Takeda, Travere Therapeutics, BioCryst Pharmaceuticals, Transcenta Holding, Shanghai Alebund Pharmaceuticals, DiaMedica Therapeutics, SELECTA BIOSCIENCES, Kira Pharmaceuticals, Alpine Immune Sciences, and others.
• Some of the IgA nephropathy drugs in various phases of development are BION-1301, Telitacicept, LNP023, HR19042, IONIS-FB-LRx, Atacicept, Atrasentan, AT-1501, SHR-2010, OMS721, Sibeprenlimab, Cemdisiran, Felzartamab, ADR-001, Ravulizumab, ALXN2050, APL-2, ARO-C3, Mezagitamab, Sparsentan, BCX9930, TST 004, AP 305, AP 308, DM199, KP104, ALPN-303,  and others.
• In October 2023, Novartis announced positive top-line results from the pre-specified interim analysis of the Phase III APPLAUSEIgAN study (NCT04578834) at 9 months. Submission for possible accelerated approval to the FDA was accepted and has received priority review. The study is to evaluate iptacopan’s ability to slow IgAN progression by measuring estimated glomerular filtration rate (eGFR) slope over 24 months with topline results expected in 2025.
• In June 2023, Chinook Therapeutics, Inc. announced that it has entered into an agreement and plan of merger withNovartis AG pursuant to which Novartis will acquire Chinook for $40 per share in cash, or a total of $3.2 billion.
• 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, 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).

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IgA Nephropathy Overview

IgA nephropathy, also known as Berger’s disease, is a chronic kidney disorder characterized by the deposition of immunoglobulin A (IgA) in the glomeruli, the filtering units of the kidneys. This deposition triggers inflammation, leading to progressive kidney damage. The exact cause of IgA nephropathy remains unclear, but it is thought to involve a combination of genetic predisposition, abnormal immune response, and environmental factors.

Patients with IgA nephropathy often present with recurrent episodes of hematuria (blood in the urine), which may be visible or detected microscopically. Other symptoms can include proteinuria (protein in the urine), hypertension, and, in advanced cases, swelling in the legs and feet due to fluid retention. Diagnosis is confirmed through kidney biopsy, which reveals the characteristic IgA deposits.

The progression of IgA nephropathy varies widely among individuals. Some may experience only mild disease with stable kidney function, while others may progress to end-stage renal disease requiring dialysis or transplantation. Management focuses on controlling blood pressure, reducing proteinuria, and slowing disease progression through medications such as angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). Emerging treatments, including targeted immunotherapies, are currently under investigation to provide better outcomes for patients with this challenging condition.

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IgA Nephropathy Pipeline Drugs mentioned in the report:

• Sparsentan: Travere Therapeutics
• Atrasentan: Chinook Therapeutics
• LNP023: Novartis Pharmaceuticals
• HR19042: Jiangsu HengRui Medicine Co., Ltd.
• ADR-001: Rohto Pharmaceutical Co., Ltd.
• And Many Others

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IgA Nephropathy Therapeutics Assessment

The IgA nephropathy pipeline report proffers an integral view of IgA nephropathy emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration.

Scope of the IgA Nephropathy Pipeline Report 

• Coverage: Global 
• IgA Nephropathy Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
• IgA Nephropathy Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
• IgA Nephropathy Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical
• IgA Nephropathy Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy
• IgA Nephropathy Therapeutics Assessment By Mechanism of Action: Endothelin A receptor antagonists, Angiotensin type 1 receptor antagonists, Bacteria replacements, Gastrointestinal microbiome modulators, Opioid kappa receptor antagonists, Opioid mu receptor agonists, Serotonin 3 receptor antagonists
• Key IgA Nephropathy Companies: Chinook Therapeutics, Inc., RemeGen Co., Ltd., Novartis, Jiangsu HengRui Medicine Co., Ltd., Ionis Pharmaceuticals, Inc., 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, Takeda, Travere Therapeutics, BioCryst Pharmaceuticals, Transcenta Holding, Shanghai Alebund Pharmaceuticals, DiaMedica Therapeutics, SELECTA BIOSCIENCES, Kira Pharmaceuticals, Alpine Immune Sciences, and others.
• Key IgA Nephropathy Pipeline Therapies: BION-1301, Telitacicept, LNP023, HR19042, IONIS-FB-LRx, Atacicept, Atrasentan, AT-1501, SHR-2010, OMS721, Sibeprenlimab, Cemdisiran, Felzartamab, ADR-001, Ravulizumab, ALXN2050, APL-2, ARO-C3, Mezagitamab, Sparsentan, BCX9930, TST 004, AP 305, AP 308, DM199, KP104, ALPN-303, and others.

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Table of Contents

1. IgA Nephropathy Pipeline Report Introduction

2. IgA Nephropathy Pipeline Report Executive Summary

3. IgA Nephropathy Pipeline: Overview

4. Analytical Perspective In-depth Commercial Assessment

5. IgA Nephropathy Clinical Trial Therapeutics

6. IgA Nephropathy Pipeline: Late Stage Products (Pre-registration)

7. IgA Nephropathy Pipeline: Late Stage Products (Phase III)

8. IgA Nephropathy Pipeline: Mid Stage Products (Phase II)

9. IgA Nephropathy Pipeline: Early Stage Products (Phase I)

10. IgA Nephropathy Pipeline Therapeutics Assessment

11. Inactive Products in the IgA Nephropathy Pipeline

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

13. Key IgA Nephropathy Companies

14. Key Products in the IgA Nephropathy Pipeline

15. IgA Nephropathy Unmet Needs

16. IgA Nephropathy Market Drivers and Barriers

17. Future Perspectives and Conclusion

18. Analyst Views

19. Appendix

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