Otsuka Pharmaceutical’s Voyxact (sibeprenlimab-szsi) stabilised kidney function for over two years in patients with primary IgA nephropathy (IgAN) at risk for disease progression.
In the Phase III VISIONARY trial (NCT05248646), estimated glomerular filtration rate (eGFR) was stabilised with an annualised estimated eGFR slope of 0.3mL/min/1.73 m²/year with Voyxact compared to a 4.2mL/min/1.73 m²/year reduction with placebo, meeting the study’s key secondary endpoint.
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This is equivalent to a statistically significant treatment effect of 4.5mL/min/1.73 m²/year after two years.
Results were presented during a late-breaking oral presentation at the GlomCon Hawaii 2026 conference.
Voyxact is the first IgAN treatment to achieve the KDIGO therapeutic goal of effectively halting progressive kidney function decline to physiologic rate (<1 mL/min/1.73 m²/year for most adults).
The primary efficacy endpoint assessed proteinuria reduction, as measured by the change in 24-hour urine protein-to-creatinine ratio (uPCR-24h) from baseline compared with placebo, after nine months of treatment.
The overall safety profile of Voyxact remained consistent through two years and was comparable to placebo, with similar rates of overall adverse events, infections and infestations.
Dr Dana Rizk, professor of medicine in the division of nephrology at the University of Alabama at Birmingham, said: “The VISIONARY two-year eGFR results achieved the KDIGO treatment goal of reducing kidney function decline to near physiological level, fundamentally altering the disease progression.”
Voyxact was the first US Food and Drug Administration (FDA)-approved selective A-PRoliferation-Inducing-Ligand (APRIL) inhibitor. It was granted accelerated approval by the FDA in November 2025 after the drug showed a 51% placebo-adjusted reduction in proteinuria at nine months. Vera Therapeutics’ Trutakna (atacicept-vymj), an APRIL and B-cell activating factor (BAFF) blocker, gained accelerated approval in July 2026.
Proteinuria is a widely accepted indicator of kidney health in IgAN. Lowering proteinuria is associated with slowing damage to the kidneys, which is why it is used as a surrogate marker for accelerated approval.
This latest data comes shortly after Otsuka confirmed the trial showed benefit in eGFR after 12 months of treatment.
IgAN market heating up
Otsuka is not the only company to show success in IgAN in recent months. In February 2026, Novartis presented the final data from its Phase III ALIGN trial of Vanrafia (atrasentan) in IgAN. The randomised, global, double-blind, placebo-controlled, multi-centre trial showed a 2.39ml / min / 1.73m² difference in eGFR change from baseline as compared to placebo at week 136, four weeks after ending treatment.
In March 2026, Vertex announced it would be seeking approval of povetacicept, an engineered fusion protein and dual inhibitor of the BAFF and APRIL cytokines, after the Phase III RAINER trial (NCT06564142) met its primary endpoint.
More established therapies include Calliditas Therapeutics’ Tarpeyo (budesonide), which gained accelerated approval from the FDA in 2021, and Travere Therapeutics’ Filspari (sparsentan), which gained accelerated approval in 2023.
