Novartis' VANRAFIA Approval Disrupts IgA Nephropathy Market, Paving Way for New Therapeutic Paradigm | DelveInsight
VANRAFIA (atrasentan), FDA-approved in April 2025, showed strong proteinuria reduction without REMS but carries similar safety warnings, requiring ongoing liver and pregnancy monitoring. However, its approval has sparked the competition between other pharma companies such as Vertex Pharmaceuticals, Vera Therapeutics, and AstraZeneca, among others, to bring their candidates to the IgAN market.
LAS VEGAS, April 28, 2025 /PRNewswire/ -- IgA nephropathy (IgAN) is an autoimmune disorder that affects the kidneys by impairing the filtration function of the small blood vessels. It is caused by an abnormal protein that damages the glomeruli, the kidneys' filtering structures. Other IgA nephropathy symptoms may include protein in the urine (proteinuria), swelling in the hands and feet, and high blood pressure. Over time, it can lead to chronic kidney disease if not managed properly. According to DelveInsight, there were 415K prevalent IgAN cases across the 7MM in 2024, with this number expected to grow at a CAGR of 0.6% through 2034.
The IgA nephropathy treatment approach aims to reduce proteinuria, manage blood pressure, and slow the progression of the disease. First-line IgA nephropathy treatment typically involves angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), with sodium-glucose co-transporter 2 (SGLT2) inhibitors providing added kidney protection. Emerging targeted therapies like sparsentan—a dual endothelin receptor antagonist and angiotensin receptor blocker—and targeted-release budesonide have shown encouraging results. FDA-approved drugs for IgA nephropathy treatment include VANRAFIA (atrasentan), FABHALTA (iptacopan), FILSPARI (sparsentan), and TARPEYO/KINPEYGO (budesonide).
Learn more about the IgA nephropathy Berger's disease treatment @ IgA Nephropathy Disease Treatment Market
FILSPARI is the first and only once-daily oral therapy for IgA nephropathy that does not suppress the immune system and is approved in both the US and Europe. By blocking endothelin-1 and angiotensin II, it addresses glomerular damage and offers a long-term approach to preserving kidney function. Due to potential safety concerns, access to FILSPARI in the US is regulated through the Risk Evaluation and Mitigation Strategies (REMS) program. In Europe, it is marketed by CSL Vifor, and in Japan by Renalys Pharma. Results from a registration-enabling study are anticipated in the second half of 2025.
In February 2023, the FDA granted accelerated approval for FILSPARI to lower proteinuria in adults with primary IgAN at risk of rapid disease progression, along with a priority review designation. In April 2024, Conditional Marketing Authorization (CMA) was issued by the European Commission for use in adults with IgAN and significant proteinuria. By September 2024, FILSPARI received full FDA approval to slow kidney function decline, supported by positive long-term data from the PROTECT Study. Later, in November 2024, it was also approved by the MHRA in the UK and in Germany for the treatment of primary IgAN.
Budesonide delayed-release capsules, sold under the name TARPEYO in the U.S., are approved for reducing proteinuria in adults with primary IgA nephropathy who are at risk of rapid disease progression. Designed for targeted release in the ileum, the drug helps modulate immune mechanisms associated with IgA pathogenesis, leading to a significant drop in proteinuria and stabilization of kidney function. In Europe, it is marketed as KINPEYGO through a collaboration with STADA Arzneimittel, holding orphan drug designation and market exclusivity through 2032. In Japan, Viatris is developing the drug under the name NEFECON (VR-205), with Phase III data anticipated in 2026.
In July 2024, STADA, a partner of Calliditas Therapeutics, received full marketing authorization from the European Commission for KINPEYGO to treat IgAN, maintaining orphan status and exclusivity until 2032. In the U.S., TARPEYO gained full FDA approval in December 2023 to slow kidney function decline in adults with IgAN at risk of progression, following its initial accelerated approval in December 2021 for primary IgAN. Additionally, the UK's MHRA granted conditional marketing authorization (CMA) for KINPEYGO for IgAN in February 2023
Atrasentan, an oral and selective Endothelin A Receptor (ETAR) antagonist, is under development for IgAN and other rare kidney diseases. Following its acquisition of Chinook Therapeutics, Novartis is advancing atrasentan as part of its precision nephrology strategy, aiming to lower proteinuria and slow kidney function decline. In April 2025, the FDA granted accelerated approval to VANRAFIA—marking it as the first selective ETAR antagonist approved for reducing proteinuria in patients with primary IgAN at high risk of rapid progression.
This approval was based on early clinical data, while confirmation of its impact on kidney function is still pending. Continued approval hinges on results from the ongoing Phase III ALIGN study, which is evaluating changes in eGFR, with final results expected in Q1 2026. Furthermore, atrasentan received Orphan Drug Designation from the European Medicines Agency in December 2021 for primary IgAN. In May 2024, Novartis also announced positive Phase III results, demonstrating a clinically significant reduction in proteinuria among IgAN patients treated with atrasentan.
To know more about the new treatment for IgA nephropathy, visit @ FDA-approved Drugs for IgA Nephropathy
Safety concerns continue to be a significant challenge in IgAN treatment, despite recent progress. Approved therapies often have severe side effects, such as corticosteroids causing hypertension and infections, or complement inhibitors raising infection risks. These issues hinder long-term adherence, particularly in vulnerable groups like children and older adults. As treatment increasingly focuses on chronic management, the need for safer, more targeted therapies is critical to maintaining efficacy while minimizing side effects.
Vertex Pharmaceuticals, Vera Therapeutics, Novartis, and AstraZeneca (Alexion Pharmaceuticals), among others, are progressing their assets through various clinical trial phases, driving innovation in the IgAN market and creating significant growth opportunities.
The IgA nephropathy pipeline possesses some drugs in early, mid, and late-stage developments to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including APRIL inhibitor (Sibeprenlimab, Zigakibart), Complement inhibitor (IONIS-FB-LRx/RG6299), BAFF and APRIL antagonist (Povetacicept), C5 complement inhibitor (ULTOMIRIS), BLyS inhibitor and APRIL inhibitor (Atacicept), Anti CD38 (Felzartamab, Mezagitamab), Complement factor D inhibitor (Vemircopan), Targets complement protein Bb (Ruxoprubart), Binding to and blocking both C3d and factor H (ADX-097), Blocks both the alternative (Factor H) and terminal (C5) complement pathways (KP104), Soluble urokinase plasminogen activator receptor (suPAR) inhibitors (WAL0921), C3 inhibitor (ARO-C3), and others in different lines of treatment. The expected launch of these therapies shall further create a positive impact on the market.
Discover which therapies are expected to grab major IgA nephropathy drug market share @ New Medicine for IgA Nephropathy
Povetacicept (ALPN-303) is a dual inhibitor targeting B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL)—two critical cytokines involved in the function of B cells, T cells, and innate immune cells. Designed using a transmembrane activator and CAML interactor (TACI) domain, it has shown improved potency and stronger binding in preclinical models compared to other BAFF/APRIL inhibitors. Clinical results in IgA nephropathy (IgAN) suggest it may offer best-in-class efficacy, highlighting its promise as a potential disease-modifying treatment.
Vertex Pharmaceuticals is currently conducting the global Phase III RAINIER trial for povetacicept in IgAN patients across the US, Europe, and Asia. Enrollment for the interim analysis group is projected to finish in 2025, with the company aiming for accelerated FDA approval based on 36-week treatment data. This initiative follows Vertex's USD 5 billion acquisition of Alpine Immune Sciences in May 2024, bringing povetacicept into its immunology portfolio as a key pipeline asset.
Atacicept is an experimental recombinant fusion protein engineered to block BAFF and APRIL—two cytokines essential for B-cell survival and the production of autoantibodies. By targeting these pathways, atacicept aims to counter a core disease mechanism in IgA nephropathy (IgAN), which is driven by dysregulated B-cell activity. In May 2024, the U.S. FDA granted Breakthrough Therapy Designation to atacicept for IgAN, acknowledging its potential to deliver meaningful clinical improvements.
Vera Therapeutics is progressing atacicept in the pivotal Phase III ORIGIN trial. Full trial enrollment was achieved in April 2025, with the primary endpoint cohort of 200 patients enrolled earlier in September 2024. This group will generate 36-week data on urine protein-to-creatinine ratio (UPCR), which is expected to support a Biologics License Application (BLA) submission to the FDA following top-line results anticipated in Q2 2025. Looking ahead, the PIONEER study is planned for launch in 2025 to assess atacicept in a wider IgAN patient population, including those with advanced kidney impairment, atypical proteinuria, and recurrent disease after kidney transplantation.
Zigakibart (FUB523; previously known as BION-1301) is a subcutaneous monoclonal antibody that targets APRIL and is currently in Phase III development for IgA nephropathy, with a regulatory submission expected in 2027. The treatment strategy involves modulating immune responses driven by APRIL, which plays a key role in the progression of the disease. Earlier, Zigakibart underwent a Phase I/II trial: Parts 1 and 2 demonstrated safety in healthy participants, while Part 3 evaluated its effectiveness in patients with IgAN. Interim results from Cohorts 1 and 2, shared during ASN Kidney Week in November 2022, supported advancing a 600 mg biweekly subcutaneous dose into Phase III trials.
In July 2022, the European Commission granted orphan drug designation (ODD) to BION-1301 for primary IgAN, offering regulatory incentives for its development in the EU. Strengthening its IgAN pipeline further, Novartis acquired Chinook Therapeutics in August 2023 for up to USD 3.5 billion, adding Zigakibart and other kidney-related assets to its late-stage portfolio.
Discover more about drugs for IgA nephropathy in development @ IgA Nephropathy Clinical Trials Market
The anticipated launch of these emerging IgA nephropathy treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the IgA nephropathy market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
DelveInsight estimates that the market size for IgA nephropathy in the 7MM is expected to grow fromUSD 730 million in 2024 with a significant CAGR of 30.5% by 2034. This expansion across the 7MM will be driven by the introduction of innovative therapies, povetacicept, atacicept, zigakibart, and ULTOMIRIS, among others. Furthermore, the rising prevalence of IgAN will be fueled by factors such as improved diagnostic practices, greater disease awareness, and wider use of kidney biopsies.
DelveInsight's latest published market report titled as IgA Nephropathy Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the IgA nephropathy country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The IgA nephropathy market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:
- Total Diagnosed Prevalent Cases of IgAN
- Gender-specific Diagnosed Prevalent Cases of IgAN
- Age-specific Diagnosed Prevalent Cases of IgAN
The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM IgA nephropathy market. Highlights include:
- 10-year Forecast
- 7MM Analysis
- Epidemiology-based Market Forecasting
- Historical and Forecasted Market Analysis upto 2034
- Emerging Drug Market Uptake
- Peak Sales Analysis
- Key Cross Competition Analysis
- Industry Expert's Opinion
- Access and Reimbursement
Download this IgA nephropathy market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the IgA nephropathy market. Also, stay abreast of the mitigating factors to improve your market position in the IgA nephropathy therapeutic space.
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