IgA Nephropathy Pipeline 2025: FDA Updates, Therapy Innovations, and Clinical Trial Landscape Analysis by DelveInsight | Visterra, Chinook Therapeutics, Novartis, IgA proteases Selecta Biosciences

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, IgA Nephropathy pipeline constitutes 25+ key companies continuously working towards developing 30+ IgA Nephropathy treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"IgA Nephropathy Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the IgA Nephropathy Market.

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.

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

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Companies across the globe are diligently working toward developing novel IgA Nephropathy treatment therapies with a considerable amount of success over the years.

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IgA Nephropathy companies working in the treatment market are Chinook Therapeutics, Guangdong Hengrui Pharmaceutical Co., Ltd., Takeda, Visterra, Chinook Therapeutics, Novartis, IgA proteases Selecta Biosciences, Shanghai Alebund Pharmaceuticals, Rohto Pharmaceutical, Wuhan Createrna Science and Technology, Guangdong Hengrui Pharmaceutical, LRx Ionis Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Travere Therapeutics, and others, are developing therapies for the IgA Nephropathy treatment

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Emerging IgA Nephropathy therapies in the different phases of clinical trials are- Atrasentan, SHR-2010, TAK-079, Sibeprenlimab, Atrasentan, LNP023, Research programme, AP 305, ADR-001, MY 008, SHR-2010, IONIS FB, HR19042, Sparsentan, HR19042, and others are expected to have a significant impact on the IgA Nephropathy market in the coming years.

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In January 2026, Vera Therapeutics, Inc. (Nasdaq: VERA), a late-stage biotech company developing innovative therapies for serious immune-mediated diseases, announced that the U.S. FDA has accepted its Biologics License Application (BLA) for atacicept for the treatment of adults with immunoglobulin A nephropathy (IgAN) under Priority Review. Submitted through the Accelerated Approval pathway, the application has been assigned a PDUFA target action date of July 7, 2026. If approved, atacicept may provide patients with a convenient once-weekly, at-home subcutaneous treatment delivered via an autoinjector.

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In November 2025, The U.S. Food and Drug Administration granted accelerated approval to Otsuka Pharmaceutical's injectable therapy, marking the first treatment in a new class for a rare and potentially life-threatening kidney disorder. The newly approved drug, Voyxact, is indicated for reducing proteinuria in patients with immunoglobulin A nephropathy (IgAN), an autoimmune condition characterized by protein accumulation in the kidneys that can ultimately progress to kidney failure.

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In October 2025, With plans to seek full FDA approval next year for Fabhalta (iptacopan) in IgA nephropathy (IgAN), Novartis has released final results from the Phase III APPLAUSE-IgAN trial, showing sustained slowing of kidney function decline with the oral Factor B inhibitor targeting the alternative complement pathway. Fabhalta received accelerated FDA approval for IgAN in August of last year based on interim findings from the same study, which included 470 patients treated with RAS inhibitors, with or without SGLT2 inhibitors. At the nine-month assessment, Fabhalta reduced proteinuria by 44% compared with a 9% reduction in the placebo group, representing a clinically meaningful 38% relative improvement.

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In May 2025, Otsuka Pharmaceuticals has announced that the FDA has accepted the Biologics License Application (BLA) for sibeprenlimab, an APRIL (a proliferation-inducing ligand) inhibitor, intended for the treatment of immunoglobulin A nephropathy (IgAN). This comes after the drug received Breakthrough Therapy Designation from the FDA in 2024 for the same indication. The BLA is supported by results from the Phase III VISIONARY trial. As noted by GlobalData, the FDA's priority review highlights sibeprenlimab's potential to surpass existing treatments and its promise as a novel therapeutic option. If approved, it could become the first disease-modifying therapy to comprehensively address IgAN management.

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In March 2025, Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) has shared topline results from Part 2 of its Phase 1/2 clinical study of ARO-C3, an investigational RNA interference (RNAi) therapy. The treatment is designed to reduce the liver's production of complement component 3 (C3), with the goal of targeting various complement-mediated disorders.

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In November 2024, Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka Pharmaceutical Co., Ltd. have revealed their intention to file a Biologics License Application (BLA) in the U.S. for sibeprenlimab, an investigational treatment for adults with immunoglobulin A nephropathy (IgA nephropathy), during the first half of 2025. This decision follows a recent meeting with the U.S. FDA, where the positive interim results from the ongoing Phase 3 VISIONARY trial (NCT05248646) were discussed.

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In April 2024, Novartis, the Swiss pharmaceutical giant, has shared interim results from its Phase III APPLAUSE-IgAN trial, which is assessing Fabhalta (iptacopan) in adults with Immunoglobulin A nephropathy (IgAN). The placebo-controlled, randomized study enrolled 518 patients with primary IgAN, each receiving twice-daily oral doses of Fabhalta.

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In January 2024, Vera Therapeutics, Inc. (Nasdaq: VERA), a late-stage clinical biotechnology firm dedicated to developing novel therapies for serious immunologic diseases, has announced the appointment of two experienced industry leaders to drive the progression of its drug programs. This includes atacicept, the company's lead Phase 3 candidate for IgA nephropathy (IgAN). Effective immediately, Dr. Robert M. Brenner has been named Chief Medical Officer, succeeding Dr. Celia Lin, while William D. Turner has joined as Chief Development Officer.

IgA Nephropathy Overview

IgA Nephropathy, also known as Berger's disease, is a kidney disorder caused by the buildup of immunoglobulin A (IgA) in the kidneys. This buildup leads to inflammation and damage in the glomeruli the tiny filters in the kidneys that remove waste from the blood. Over time, it can cause progressive kidney dysfunction, leading to chronic kidney disease or kidney failure in some cases. Common symptoms include blood in the urine (hematuria), proteinuria, high blood pressure, and swelling in the hands and feet. The exact cause is unknown, and there is currently no cure, but treatments aim to slow disease progression and manage symptoms.

Explore the latest IgA Nephropathy pipeline insights 2025, including emerging therapies, clinical trials, and market opportunities. Stay ahead in IgA Nephropathy Clinical Trials [https://www.delveinsight.com/sample-request/iga-nephropathy-igan-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

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

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SHR-2010: Guangdong Hengrui Pharmaceutical Co., Ltd.

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TAK-079: Takeda

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Sibeprenlimab: Visterra

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Atrasentan: Chinook Therapeutics

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LNP023: Novartis Pharmaceuticals

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Research programme: IgA proteases Selecta Biosciences

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AP 305: Shanghai Alebund Pharmaceuticals

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ADR-001: Rohto Pharmaceutical

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MY 008: Wuhan Createrna Science and Technology

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SHR-2010: Guangdong Hengrui Pharmaceutical

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IONIS FB: LRx Ionis Pharmaceuticals

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HR19042: Jiangsu HengRui Medicine Co., Ltd.

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Sparsentan: Travere Therapeutics

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HR19042: Jiangsu HengRui Medicine Co., Ltd.

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

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Oral

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Parenteral

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Intravenous

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Subcutaneous

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Topical

IgA Nephropathy Molecule Type

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

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Monoclonal Antibody

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Peptides

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Polymer

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Small molecule

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Gene therapy

IgA Nephropathy Pipeline Therapeutics Assessment

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IgA Nephropathy Assessment by Product Type

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IgA Nephropathy By Stage and Product Type

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IgA Nephropathy Assessment by Route of Administration

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IgA Nephropathy By Stage and Route of Administration

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IgA Nephropathy Assessment by Molecule Type

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IgA Nephropathy by Stage and Molecule Type

DelveInsight's IgA Nephropathy Report covers around 30+ products under different phases of clinical development like

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Late-stage products (Phase III)

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Mid-stage products (Phase II)

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Early-stage product (Phase I)

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Pre-clinical and Discovery stage candidates

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Discontinued & Inactive candidates

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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 [https://www.delveinsight.com/sample-request/iga-nephropathy-igan-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

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

Key companies developing therapies for IgA Nephropathy are - Novartis, Omeros Corporation, Otsuka Pharmaceutical, Alnylam Pharmaceuticals, MorphoSys AG, Arrowhead Pharmaceuticals, Takeda, Chinook Therapeutics, Inc., RemeGen Co., Ltd., Novartis, Omeros Corporation, Otsuka Pharmaceutical, Alnylam Pharmaceuticals, MorphoSys AG, Rohto Pharmaceutical, Alexion Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Ionis Pharmaceuticals, Inc., Vera Therapeutics, Inc., Eledon Pharmaceuticals, Guangdong Hengrui Pharmaceutical Co., Ltd, Apellis Pharmaceuticals, Inc., and others.

IgA Nephropathy Pipeline Analysis:

The IgA Nephropathy pipeline report provides insights into

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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.

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It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for IgA Nephropathy Treatment.

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IgA Nephropathy key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

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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.

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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.

Download Sample PDF Report to know more about IgA Nephropathy drugs and therapies [https://www.delveinsight.com/sample-request/iga-nephropathy-igan-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

IgA Nephropathy Pipeline Market Drivers

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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

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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

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Coverage: Global

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Key IgA Nephropathy Companies: Chinook Therapeutics, Guangdong Hengrui Pharmaceutical Co., Ltd., Takeda, Visterra, Chinook Therapeutics, Novartis, IgA proteases Selecta Biosciences, Shanghai Alebund Pharmaceuticals, Rohto Pharmaceutical, Wuhan Createrna Science and Technology, Guangdong Hengrui Pharmaceutical, LRx Ionis Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., Travere Therapeutics, and others

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Key IgA Nephropathy Therapies: Atrasentan, SHR-2010, TAK-079, Sibeprenlimab, Atrasentan, LNP023, Research programme, AP 305, ADR-001, MY 008, SHR-2010, IONIS FB, HR19042, Sparsentan, HR19042, and others

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IgA Nephropathy Therapeutic Assessment: IgA Nephropathy current marketed and IgA Nephropathy emerging therapies

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IgA Nephropathy Market Dynamics: IgA Nephropathy market drivers and IgA Nephropathy market barriers

Request for Sample PDF Report for IgA Nephropathy Pipeline Assessment and clinical trials [https://www.delveinsight.com/sample-request/iga-nephropathy-igan-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

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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