BTIG analysts examined two-year data from the VISIONARY study of Voyxact (sibeprenlimab) in patients with IgA nephropathy and reported continued preservation of kidney function through 24 months.
The trial produced an annualized eGFR slope of +0.3 mL/min/1.73 m2 per year for patients treated with Voyxact, with a 95% confidence interval spanning -0.4 to +0.9. That outcome met the KDIGO therapeutic objective of limiting progressive kidney function decline to less than 1 mL/min/1.73 m2 per year.
When compared with placebo, Voyxact-treated participants showed an annualized eGFR slope improvement of +0.3 mL/min/1.73 m2/yr versus -4.2 mL/min/1.73 m2/yr for placebo, representing a treatment effect of +4.5 mL/min/1.73 m2/yr. The difference between arms reached statistical significance with p<0.0001.
Analysis of least squares mean changes from baseline in eGFR found that the Voyxact arm improved by +1.3 mL/min/1.73 m2 while the placebo group declined by -7.9 mL/min/1.73 m2, yielding a treatment effect of +9.2 mL/min/1.73 m2. This comparison was also statistically significant with p<0.0001.
On the regulatory and commercial fronts, the company initiated a rolling supplemental Biologics License Application after receiving accelerated approval from the U.S. Food and Drug Administration in November 2025. Otsuka reported second quarter 2026 Voyxact revenue of approximately $78 million, which the company said represents a run-rate of roughly $312 million. As of June 30, 2026, more than 2,000 new patients had started treatment since launch.
Otsuka projects fiscal year 2026 revenue of about $375 million for Voyxact, reflecting the drug’s first full year on the market. The VISIONARY two-year results were presented as a late-breaking oral at GlomCon in August. The patient population affected by IgA nephropathy is typically diagnosed between the ages of 16 and 35 and generally requires lifelong therapy.
Contextual notes - The 24-month eGFR results provide both slope-based and least squares mean comparisons favoring Voyxact over placebo, and the company has moved forward with regulatory filings while reporting early commercial uptake.