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VOYXACT® (sibeprenlimab)

Learn how VOYXACT is changing the immunoglobulin A nephropathy (IgAN) landscape.

Latest news

Sibeprenlimab approved in Mainland China under the brand name Izaike® Sibeprenlimab approved in Mainland China under the brand name Izaike®
June 8, 2026
Sibeprenlimab approved in Mainland China under the brand name Izaike®
The National Medical Products Administration (NMPA) approved Izaike to reduce proteinuria in adults with primary IgAN at risk of disease progression. The approval was based on results from the phase 3 VISIONARY study, which included 102 participants from Mainland China. In the Chinese subgroup, sibeprenlimab treatment resulted in a 61.9% decrease in the 24-hour urine protein-to-creatinine ratio (UPCR) at 9 months compared with placebo. A 51.2% reduction in 24-hour UPCR vs placebo at 9 months was reported for the overall study population.
Positive interim data reported from the phase 3 VISIONARY trial Positive interim data reported from the phase 3 VISIONARY trial
June 4, 2026
Positive interim data reported from the phase 3 VISIONARY trial
Presented at the at the European Renal Association (ERA) Congress 2026, the results showed preserved kidney function over 12 months compared with placebo in adults with primary IgA nephropathy (IgAN) at risk for disease progression: mean change in eGFR from baseline of +0.7 mL/min/1.73 m² with VOYXACT vs -4.8 mL/min/1.73 m² with placebo, for a treatment effect of 5.5 mL/min/1.73 m². VOYXACT’s overall safety profile was comparable to that of placebo, with infections and injection site reactions as the most commonly reported adverse events. Full data are expected at a future conference.
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What is sibeprenlimab (VOYXACT) and what sets it apart

VOYXACT, a first-in-class selective APRIL (A PRoliferation-Inducing Ligand) inhibitor, is positioned to be a high-impact, disease-modifying entrant in IgAN. It has demonstrated one of the most robust efficacy profiles in proteinuria reduction for IgAN thus far, as well as a well-established safety profile across dose ranges.

It targets a key IgAN pathogenic pathway to reduce galactose-deficient IgA1 (Gd-IgA1) production and subsequent immune complex formation, addressing the cause of disease progression. It represents a major commercial milestone for the company after it initiated the largest IgAN trial to date.

About VOYXACT

  • Company: Otsuka Pharmaceutical Co Ltd
  • Type: Monoclonal antibody targeting APRIL
  • Usage: Subcutaneous administration every 4 weeks to treat IgAN
    Also being evaluated to treat Sjögren’s syndrome
  • When will sibeprenlimab be available?
    Expected launch 2026: United States
    Expected launch 2028: Japan
    Expected launch 2029: European Union

VOYXACT sales and success forecasts

$955m
expected sales in the G7 markets in 2031
95%
probability of success for VOYXACT in the United States

There is very strong genetic support for this pathway. I think it is probably the most exciting pathway that is being targeted to address the primary disease mechanism. I'm very enthusiastic about it.

Nephrologist United States

Drugs in the 2026 list