PRINCETON, N.J. & TOKYO — Otsuka Pharmaceutical has announced promising interim results from its Phase 3 VISIONARY trial, showing that its investigational drug sibeprenlimab significantly reduces proteinuria in patients with immunoglobulin A nephropathy (IgAN), a chronic kidney disease that can lead to end-stage renal failure.
In data presented at the European Renal Association (ERA) Congress in Vienna, sibeprenlimab demonstrated a 51.2% reduction in proteinuria (P<0.0001) after nine months of treatment compared to placebo. Proteinuria, or excess protein in the urine, is a key marker for disease progression in IgAN. The findings come from the largest Phase 3 trial conducted to date for this condition.
Sibeprenlimab is a monoclonal antibody that targets APRIL (A Proliferation-Inducing Ligand), a protein implicated in the formation of pathogenic immune complexes involved in IgAN. By inhibiting APRIL, sibeprenlimab reduces levels of immunoglobulin A, potentially slowing disease progression.
“The robust proteinuria reduction observed in the VISIONARY trial reinforces our belief in sibeprenlimab’s potential to become an effective treatment for IgAN,” said Dr. John Kraus, Chief Medical Officer at Otsuka Pharmaceutical Development & Commercialization, Inc. “Controlling proteinuria is key to improving long-term kidney outcomes in these patients.”
The trial also reported a favorable safety profile, with 76.3% of sibeprenlimab-treated patients experiencing treatment-emergent adverse events (TEAEs), compared to 84.5% in the placebo group. Serious TEAEs occurred in 3.9% of patients in the sibeprenlimab group, versus 5.4% for placebo.
Sibeprenlimab has already been granted Priority Review by the U.S. Food and Drug Administration following its Biologics License Application (BLA) submission in March. A decision is expected by November 28, 2025.
Administered via a monthly subcutaneous injection, sibeprenlimab is designed for self-injection or caregiver administration, offering convenience for patients.
The VISIONARY trial remains ongoing in a blinded format and will continue to monitor changes in kidney function, particularly estimated glomerular filtration rate (eGFR), over 24 months. Final results are expected in early 2026.
“These results offer new hope for patients living with IgAN,” said Dr. Dana Rizk, Professor of Medicine at the University of Alabama at Birmingham and a lead investigator in the study. “The strong efficacy and safety data suggest sibeprenlimab may offer a novel, targeted approach to treating this complex disease.”
