Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that VOYXACT® (sibeprenlimab-szsi) preserved kidney function compared to placebo over 12 months in adults with primary IgA nephropathy (IgAN) at risk for disease progression. VOYXACT demonstrated an increase in mean change for the estimated glomerular filtration rate (eGFR) from baseline of +0.7 mL/min/1.73 m2 compared to a decline of -4.8 mL/min/1.73 m2 in the placebo-treated group, providing early evidence that sibeprenlimab may stabilize eGFR decline in patients with IgA nephropathy, which will be further validated in the ongoing Phase 3 VISIONARY trial. These results were presented at the European Renal Association (ERA) Congress 2026 in Glasgow as part of a pre-specified interim analysis of the VISIONARY Phase 3 trial. In the VISIONARY study, VOYXACT was well tolerated with a favorable safety profile in line with previously reported data1. Full data from the VISIONARY study final analysis will be presented at a future medical conference. These findings provide clinical evidence linking upstream selective A-PRoliferation-Inducing Ligand (APRIL) inhibition to downstream preservation of kidney function, reinforcing VOYXACT’s ability to improve long-term outcomes.
