PRINCETON, N.J. and TOKYO, Japan, July 1, 2026
Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. announced positive topline results from the Phase 3 VISIONARY trial, demonstrating that VOYXACT® (sibeprenlimab-szsi) achieved statistically significant stabilization of kidney function with evidence of improved estimated glomerular filtration rate (eGFR) compared with placebo over two years in adults with IgA nephropathy (IgAN). The findings make VOYXACT the first APRIL inhibitor to demonstrate meaningful long-term preservation of kidney function while significantly reducing the risk of progression toward kidney failure. The therapy, which previously received U.S. FDA accelerated approval in November 2025 based on proteinuria reduction, has now completed the confirmatory Phase 3 dataset required to support Otsuka’s ongoing supplemental Biologics License Application (sBLA) seeking traditional approval. The company reported that the treatment maintained a favorable safety profile comparable to placebo throughout the two-year study period, reinforcing its potential as a disease-modifying therapy for patients with progressive IgAN.
Phase 3 VISIONARY Trial Meets Key Clinical Endpoints
The global VISIONARY study enrolled adults with primary IgA nephropathy, a chronic immune-mediated kidney disease that frequently progresses to kidney failure despite standard supportive care. The randomized, double-blind, placebo-controlled trial evaluated both proteinuria reduction at nine months and long-term kidney function measured by annualized eGFR slope over 24 months. According to Otsuka, VOYXACT successfully met both endpoints, showing statistically significant stabilization of kidney function while demonstrating evidence of improvement compared with placebo. Investigators noted that treatment reduced kidney function decline to levels approaching the goals outlined in the KDIGO 2025 IgAN Guidelines, highlighting the therapy’s ability to slow disease progression beyond symptom management. Otsuka also confirmed that the complete two-year dataset will be submitted to global regulatory authorities, including the U.S. FDA, as part of its rolling sBLA submission for traditional approval, while full analyses will be presented at an upcoming scientific congress.
Selective APRIL Inhibition Targets the Root Cause of IgAN
Unlike conventional therapies that broadly suppress the immune system, VOYXACT selectively inhibits APRIL (A Proliferation-Inducing Ligand), a key driver of IgA nephropathy pathogenesis. By blocking APRIL, the therapy reduces production of galactose-deficient IgA1 (Gd-IgA1), the abnormal antibody responsible for immune complex formation and kidney damage in IgAN. Previous analyses from the VISIONARY program demonstrated significant reductions in proteinuria, hematuria, and pathogenic Gd-IgA1, while the newly reported two-year data confirm sustained preservation of kidney function. Otsuka emphasized that this targeted mechanism enables disease modification without broad B-cell depletion, potentially offering a safer long-term treatment strategy. Throughout the trial, VOYXACT remained well tolerated, with infections and mild injection-site reactions representing the most frequently reported adverse events, occurring at rates similar to placebo.
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Otsuka Expands Leadership in IgA Nephropathy Treatment
The successful completion of the VISIONARY Phase 3 study represents a major milestone for Otsuka’s nephrology portfolio and strengthens the clinical evidence supporting VOYXACT as a potential long-term treatment for IgA nephropathy. Company executives noted that the two-year findings provide compelling confirmation that selective APRIL inhibition can significantly alter disease progression by preserving kidney function and reducing the likelihood of kidney failure. Otsuka plans to continue discussions with regulatory authorities while advancing traditional approval submissions worldwide. The company also continues long-term follow-up through an open-label extension study designed to further evaluate the durability of clinical benefit and long-term safety. If approved for its expanded indication, VOYXACT could become one of the most significant disease-modifying therapies available for patients with IgAN, addressing a major unmet need in chronic kidney disease management through precision immunology and targeted biologic therapy.
Source: Otsuka, press release
