Otsuka has reported positive full results from its Phase 3 VISIONARY trial, showing its drug Voyxact stabilised kidney function in adults with IgA nephropathy over two years.
Voyxact, known clinically as sibeprenlimab-szsi, demonstrated statistically significant stabilisation of kidney function with evidence of improvement, assessed by annualised slope and mean change from baseline in estimated glomerular filtration rate, or eGFR.
The results align with the KDIGO 2025 IgAN Guidelines, which set a target of reducing kidney function decline to near physiological levels of less than 1 mL/min/1.73 m² per year.
Otsuka says Voyxact is the first APRIL inhibitor to demonstrate statistically significant eGFR stabilisation with evidence of improvement versus placebo across a two-year study period.
The drug also showed robust reductions in risk of progression to kidney failure, reinforcing what Otsuka describes as the therapeutic potential of selectively blocking APRIL.
At the 12-month interim mark, Voyxact-treated patients showed a mean change in eGFR from baseline of positive 0.7 mL/min/1.73 m², compared to a decline of negative 4.8 mL/min/1.73 m² in the placebo group.
The annualised slope of eGFR showed a three-point decline after one year in the treated population, compared to a 7.6-point decline among those receiving placebo.
John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka, commented directly on the significance of the findings for patients living with the progressive kidney disease.
“These positive Phase 3 VISIONARY eGFR results demonstrate statistically significant and clinically meaningful kidney function stabilization that reinforce VOYXACT’s potential to fundamentally halt disease progression beyond symptom management,” said Kraus.
Voyxact works by blocking A-PRoliferation-Inducing-Ligand, known as APRIL, which results in reduced levels of serum galactose-deficient IgA1, a protein implicated in the development and progression of IgAN.
The drug was granted accelerated approval by the US FDA in November 2025 after meeting the VISIONARY study’s primary endpoint of statistically significant proteinuria reduction compared to placebo at nine months.
The newly released full-study findings complete the Phase 3 VISIONARY dataset, marking a further milestone in Otsuka’s rolling submission of a supplemental Biologics License Application to the FDA for traditional approval.
Voyxact was reported to be well tolerated throughout the trial, with a favourable safety profile consistent with prior interim results and described as comparable to placebo.
IgA nephropathy is a progressive kidney disease caused by the accumulation of abnormal antibodies in the kidneys, and remains one of the most common causes of kidney failure in younger adults globally.