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Otsuka Presents Landmark Final Phase 3 VISIONARY Results at ASN Demonstrating VOYXACT® (sibeprenlimab-szsi) Stabilized Kidney Function and Reduced Risk of Disease Progression and Kidney Failure, Redefining Treatment Paradigm in IgA Nephropathy

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  • Results from the Phase 3 VISIONARY trial showed a 97.1% reduction in the risk of a composite kidney outcome event of kidney function decline or kidney failure in patients treated with VOYXACT compared with placebo over two years.

  • VISIONARY demonstrated sustained preservation of kidney function across all prespecified subgroups over two years, supporting the findings previously reported in the entire study population and confirming the role of selective APRIL inhibition as a disease-modifying treatment in IgAN.

  • Overall VOYXACT was safe and well tolerated over two years as compared to placebo, suggesting that it has a favorable clinical profile for therapeutic use.

  • Final results were published today in The New England Journal of Medicine.

  • Otsuka successfully completed rolling submission of a supplemental Biologics License Application (sBLA) to the U.S. FDA for traditional approval of VOYXACT.

PRINCETON, N.J. & TOKYO, October 22, 2026--Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced the final two-year results from the Phase 3 VISIONARY study demonstrating sustained preservation of kidney function with VOYXACT® (sibeprenlimab-szsi) in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. Treatment with VOYXACT stabilized kidney function and reduced the risk of a composite kidney outcome event of kidney function decline or kidney failure compared with placebo by 97.1%, translating to meaningful clinical outcomes in adults with primary IgAN at risk for disease progression. With the largest patient population evaluated through two years in a placebo-controlled trial, VISIONARY provides a substantial and robust body of evidence and is the first Phase 3 IgAN study to achieve the 2025 KDIGO treatment goal of slowing kidney function decline to near-physiologic rates (<1 mL/min/1.73 m²/year for most adults), effectively halting disease progression1. These findings further support selective APRIL inhibition as a disease-modifying therapeutic approach targeting a key driver of IgAN pathogenesis without broader immune suppression2,3,4. At two years, overall safety remained favorable for VOYXACT compared to placebo, with similar rates of adverse events, including infections and injection site reactions between the treatment groups. These data were presented today at American Society of Nephrology (ASN) Kidney Week 2026 in Denver, Colorado, as a featured oral presentation during the Opening Plenary Session, as a late-breaking poster presentation, and within the ASN press program. These findings were published simultaneously today in The New England Journal of Medicine.

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