sibeprenlimab

Sibeprenlimab is an investigational **humanized IgG2 monoclonal antibody** developed by Visterra and Otsuka for **immunoglobulin A nephropathy**. It selectively binds to and neutralizes **APRIL** (A Proliferation-Inducing Ligand, TNFSF13), a cytokine implicated in the pathogenesis of IgA nephropathy by promoting production of pathogenic **galactose-deficient IgA1** and downstream immune-complex formation. By inhibiting APRIL, sibeprenlimab lowers IgA and Gd-IgA1 levels and is intended to reduce proteinuria and slow kidney function decline. The program advanced from phase 1 healthy-volunteer studies and a positive phase 2 ENVISION trial to the phase 3 VISIONARY study in adults with IgA nephropathy, where 400 mg subcutaneous dosing every 4 weeks showed a statistically significant 51.2% reduction in proteinuria at 9 months versus placebo. The drug was originally designed and engineered by Visterra, now within Otsuka.

Brand names

VOYXACT

Other names

sibeprenlimab-szsisibeprenlimab