Otsuka Pharmaceutical and Otsuka Pharmaceutical Development & Commercialisation (OPDC) have announced positive topline results from the Phase 3  VISIONARY trial evaluating Voyxact (sibeprenlimab-szsi) in adults with IgA nephropathy (IgAN), demonstrating its potential to slow disease progression and improve long-term kidney outcomes.

The study met its key objectives, with Voyxact showing statistically significant stabilization of kidney function, alongside evidence of improvement compared with placebo over a two-year period. The therapy also demonstrated robust reductions in the risk of progression to kidney failure, reinforcing the therapeutic potential of selectively targeting the cytokine A Proliferation-Inducing Ligand (APRIL) pathway.

According to the company, Voyxact is the first APRIL inhibitor to demonstrate statistically significant improvements in estimated glomerular filtration rate (eGFR) compared with placebo over two years, highlighting its potential as a disease-modifying treatment for IgA nephropathy.

Kidney function was assessed using annualised eGFR slope and mean change from baseline, with the findings aligning with the 2025 KDIGO guidelines, which recommend slowing kidney function decline to near physiological levels in adults with primary IgA nephropathy at risk of disease progression.

Voyxact was also well tolerated throughout the study, with a favourable safety profile that remained consistent with earlier interim analyses and comparable to placebo.

The positive Phase 3 results complete the VISIONARY study dataset and support Otsuka's ongoing rolling submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking traditional approval for the therapy. The company also plans to submit the data to global regulatory authorities and present the complete analyses at an upcoming scientific congress.

Voyxact received accelerated approval from the US FDA in November 2025 for reducing proteinuria in adults with IgA nephropathy.

Commenting on the findings, John Kraus, Executive Vice President and Chief Medical Officer, OPDC, said the results demonstrate clinically meaningful stabilization and improvement in kidney function over two years, marking a significant therapeutic advancement for patients with IgA nephropathy. He added that the growing body of evidence supports selective APRIL inhibition as a disease-modifying approach that targets the underlying drivers of the disease without causing broad B-cell depletion, while improving long-term kidney outcomes.