VOYXACT, Otsuka Holdings' IgA nephropathy drug, has produced the two-year phase 3 result at the center of its next regulatory step. The company said the 24-month VISIONARY trial showed statistically significant stabilization and improvement in eGFR, a measure of kidney function, versus placebo in adults with primary IgA nephropathy at risk of disease progression.
For readers outside Japan, the significance is that Otsuka is trying to move the drug beyond a narrower US approval. VOYXACT won accelerated FDA approval in November 2025 for reducing proteinuria in adults with IgA nephropathy. Otsuka said the completed phase 3 dataset is an important milestone in the staged review of its supplemental biologics license application for traditional approval, and that the same data will be used for filings with regulators in other countries.
Otsuka also described sibeprenlimab as the first APRIL inhibitor to show a two-year eGFR benefit against placebo. In the release, the company said the trial met kidney-function measures including annualized eGFR slope and mean change from baseline over the full two years. It added that the result matched KDIGO treatment goals for keeping annual kidney-function decline below 1 mL/min/1.73 m², and that safety was consistent with earlier interim analyses and similar to placebo. The release also says the drug substantially reduced the risk of progression to kidney failure, but it does not publish the underlying figures in the text provided.
The immediate business message is more subdued than the science. Otsuka said there is no change to its earnings forecast for the year ending December 2026, even as it called VOYXACT one of the products expected to drive future growth. So the near-term consequence is a stronger regulatory package, not a fresh earnings upgrade. Two caveats remain: the disclosure does not include the detailed efficacy tables behind the top-line claim, and it gives no timetable for an FDA decision. Otsuka said fuller analyses will be presented at a future international medical meeting.