Two-year VISIONARY results showed a 97.1% lower risk of composite kidney outcome events and sustained kidney function preservation in adults with primary IgA nephropathy.
Company: Otsuka Pharmaceutical
Drug: Voyxact (sibeprenlimab-szsi)
Therapeutic Area: Nephrology / Chronic Kidney Disease
Clinical Trial: Phase 3 VISIONARY
Key Highlights
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Reduced Kidney Outcome Risk: Only 0.4% of patients receiving Voyxact experienced a composite kidney outcome event, compared with 11.2% receiving placebo, representing a 97.1% lower hazard.
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Preserved Kidney Function: At two years, the annualized estimated glomerular filtration rate (eGFR) slope was +0.3 mL/min/1.73 m²/year with Voyxact, compared with −4.2 mL/min/1.73 m²/year with placebo.
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Reduced Proteinuria: Voyxact achieved a 61.3% reduction in the 24-hour urine protein-to-creatinine ratio at Month 24.
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Improved Haematuria Outcomes: Among patients with haematuria at baseline, 78.6% receiving Voyxact achieved a negative urine dipstick result, compared with 20.2% receiving placebo.
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Favourable Safety Profile: Overall adverse event rates were comparable between treatment groups, with no new safety signals identified over two years.
Clinical Trial Results
The Phase 3 VISIONARY study evaluated Voyxact in 510 adults with primary immunoglobulin A nephropathy (IgAN) who were at risk of disease progression.
After two years, the composite kidney outcome occurred in 1 of 259 patients receiving Voyxact, compared with 28 of 251 patients receiving placebo.
The annualized eGFR slope showed a treatment difference of +4.5 mL/min/1.73 m²/year in favour of Voyxact, indicating sustained preservation of kidney function compared with placebo.
The findings were presented at the American Society of Nephrology’s Kidney Week 2026 and published simultaneously in The New England Journal of Medicine.
How Does Voyxact Work?
Voyxact is a humanized monoclonal antibody that selectively blocks APRIL (a proliferation-inducing ligand), a protein involved in the production of galactose-deficient IgA1, which contributes to IgAN disease development.
By inhibiting APRIL, Voyxact is designed to target an underlying mechanism of IgAN rather than focusing solely on the symptoms of kidney damage.
About IgA Nephropathy
IgA nephropathy is a chronic, immune-mediated kidney disease characterized by the accumulation of abnormal IgA-containing immune complexes in the kidneys. Over time, the disease can cause progressive loss of kidney function and potentially lead to kidney failure.
Regulatory Status
Voyxact received accelerated approval from the U.S. Food and Drug Administration in November 2025 to reduce proteinuria in adults with primary IgAN at risk of disease progression. Otsuka has submitted a supplemental biologics license application seeking traditional approval, incorporating the two-year kidney function findings.
The long-term clinical benefit of slowing kidney function decline remains subject to confirmation under the accelerated approval pathway.
Source: Otsuka Pharmaceutical — VISIONARY Phase 3 two-year results.
