Otsuka Pharmaceutical’s Voyxact (sibeprenlimab-szsi) has preserved kidney function for 12 months in patients with primary IgA nephropathy (IgAN) in a Phase III trial.
In the VISIONARY study (NCT05248646), patients treated with Voyxact saw a 0.7 mL/min/1.73 m2 increase in estimated glomerular filtration rate (eGFR) compared to a decline of 4.8 mL/min/1.73 m2 in the placebo-treated group.
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At 12 months, Voyxact showed a mean eGFR change from baseline that meets the KDIGO treatment goal to reduce the annual kidney function decline to the normal physiological rate of (<1 mL/min/1.73 m2/year).
The annualised slope of eGFR showed a 3-point decline after a year in the treated population compared to a 7.6-point decline in the placebo cohort.
The Tokyo-based pharmaceutical company said that these findings provide clinical evidence linking upstream selective A-PRoliferation-Inducing Ligand (APRIL) inhibition to downstream preservation of kidney function, reinforcing Voyxact’s ability to improve long-term patient outcomes.
The overall safety profile of Voyxact was comparable to placebo, with infections and injection site reactions the most common adverse events (AEs).
Dr Vlado Perkovic, Provost at the University of New South Wales, Australia, said: “For patients with IgA nephropathy, slowing the loss of kidney function is essential to improve long-term outcomes, including the likelihood of kidney failure and the need for dialysis or transplant. These data are very encouraging and suggest that selective inhibition of APRIL may slow eGFR decline, helping patients preserve kidney function and improve long-term outcomes.”
Voyxact blocks A-proliferation-inducing ligand (APRIL), a key factor in the four-hit process of IgAN pathogenesis, promoting production of pathogenic galactose-deficient IgA1 (Gd-IgA1). Blocking APRIL reduces serum Gd-IgA1 levels implicated in IgAN development.
The VISIONARY trial is ongoing and will evaluate the long-term safety and efficacy of Voyxact in preserving kidney function based on the annualised slope of eGFR and estimated glomerular filtration rate change from baseline over a 24-month treatment period. Additional longer-term assessments are planned in the Phase II/III open-label extension study (NCT05248659).
In November 2025, the US Food and Drug Administration (FDA) granted accelerated approval to Otsuka’s Voyxact based on interim data from the VISIONARY study, which showed a 51% placebo-adjusted reduction in proteinuria at nine months.
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.
The data were presented at the European Renal Association (ERA) Congress 2026 in Glasgow, Scotland, which took place from 3 to 6 June 2026. Full data from the VISIONARY study final analysis will be presented at a future medical conference.
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 (B cell activating factor) 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.
