Otsuka Reports Positive Phase 3 VISIONARY Two-Year eGFR Results Demonstrating VOYXACT® (sibeprenlimab-szsi) Prevented Progression to Kidney Failure and Improved Kidney Function in IgA Nephropathy (IgAN)
First ever APRIL inhibitor to demonstrate statistically significant eGFR stabilization with evidence of improvement versus placebo over two years, highlighting VOYXACT’s promising ability to provide long-term kidney protection and enhance clinical outcomes in IgAN
VOYXACT showed robust reductions in risk of progression to kidney failure, reinforcing the therapeutic potential of selectively blocking APRIL
VOYXACT received U.S. FDA accelerated approval for reduction in proteinuria in adults with IgAN in November 2025. These new findings complete the Phase 3 VISIONARY study dataset, marking another milestone in Otsuka’s rolling submission of a supplemental Biologics License Application (sBLA) to the U.S. FDA for VOYXACT traditional approval
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced positive topline full study results from the Phase 3 VISIONARY trial. VOYXACT® (sibeprenlimab-szsi) demonstrated statistically significant stabilization of kidney function, with evidence of improvement over two years, as assessed by annualized slope and mean change from baseline in estimated glomerular filtration rate (eGFR). These results align with the KDIGO 2025 IgAN Guidelines of reducing kidney function decline to near physiological levels (<1 mL/min/1.73 m² per year) in adults with primary IgA nephropathy (IgAN) at risk of disease progression1. VOYXACT was well tolerated, with a favorable safety profile consistent with prior interim results and comparable to placebo. These data from the VISIONARY study will be submitted to support marketing applications with global health authorities, including in an sBLA, which will be submitted to the U.S. Food and Drug Administration (FDA) for the traditional approval of VOYXACT. These analyses will also be submitted for presentation at an upcoming scientific congress.
