Otsuka Reports Two-Year VISIONARY EGFR Results in IgA Nephropathy

Key Takeaways

• The topline readout centered on eGFR and was described as showing statistically significant kidney-function stabilization versus placebo over two years, with evidence of improvement.
• VOYXACT was characterized as well tolerated, with a favorable safety profile that was consistent with prior interim results and comparable to placebo.
• The company said the complete Phase 3 dataset will be presented at a scientific congress and used for global filings, including an sBLA to the U.S. FDA for traditional approval.

In adults with IgA nephropathy, the two-year Phase 3 VISIONARY readout for VOYXACT (sibeprenlimab-szsi) centered on kidney-function outcomes assessed by annualized eGFR slope over 24 months and mean change from baseline in eGFR at month 24. Otsuka announced positive topline full-study Phase 3 results on July 2, 2026, in this adult population. The company described statistically significant stabilization of kidney function versus placebo over two years, with evidence of improvement. The update focused on eGFR, distinguishing the full-study readout from earlier proteinuria reporting. The topline message was preservation of kidney function across 24 months.

VISIONARY is a global, randomized, double-blind, placebo-controlled Phase 3 study evaluating VOYXACT in adults with IgAN. According to Otsuka, this two-year update completes the Phase 3 dataset and provides the planned long-term efficacy view from the registration study. The primary efficacy endpoint was proteinuria reduction, measured as change in 24-hour urine protein-to-creatinine ratio from baseline versus placebo after nine months of treatment. Annualized eGFR slope over 24 months was designated as the key secondary endpoint. Mean change from baseline in eGFR at month 24 was also evaluated as a secondary endpoint, placing the two-year kidney-function analysis within the trial's broader endpoint hierarchy.

In the two-year efficacy update, the company described statistically significant kidney-function stabilization, with evidence of improvement over two years, as assessed by annualized eGFR slope and mean change from baseline in eGFR at month 24. As summarized in the release, the completed efficacy dataset pointed to two-year kidney-function stabilization versus placebo with evidence of improvement.

VOYXACT was described as well tolerated, with a favorable safety profile consistent with prior interim results and comparable to placebo. Otsuka said the analyses will support global marketing applications, including a rolling sBLA to the U.S. FDA for traditional approval, and will be presented at a scientific congress. The release also notes accelerated approval in November 2025 for reduction in proteinuria in adults with IgAN.