Sibeprenlimab: First Approval

Drugs. 2026 May;86(5):765-768. doi: 10.1007/s40265-026-02298-x. Epub 2026 Mar 21.

Abstract

Sibeprenlimab (VOYXACT®; sibeprenlimab-szsi) is a fully humanized monoclonal antibody that binds to A PRoliferation Inducing Ligand (APRIL) being developed by Otsuka Pharmaceutical for the treatment of immunoglobulin A (IgA) nephropathy and Sjögren's disease. Signalling via APRIL is implicated in the inflammatory processes that ultimately result in damage to the glomeruli in patients with IgA nephropathy. Treatment with sibeprenlimab suppressed APRIL levels and reduced proteinuria in patients with IgA nephropathy, according to interim analyses from the ongoing VISIONARY phase III clinical trial. This article summarizes the milestones in the development of sibeprenlimab leading to this first approval to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression.

Publication types

  • Review

MeSH terms

  • Antibodies, Monoclonal, Humanized* / administration & dosage
  • Antibodies, Monoclonal, Humanized* / adverse effects
  • Antibodies, Monoclonal, Humanized* / pharmacology
  • Antibodies, Monoclonal, Humanized* / therapeutic use
  • Drug Approval
  • Glomerulonephritis, IGA* / drug therapy
  • Humans
  • Proteinuria / drug therapy
  • Sjogren's Syndrome* / drug therapy
  • Tumor Necrosis Factor Ligand Superfamily Member 13* / antagonists & inhibitors
  • Tumor Necrosis Factor Ligand Superfamily Member 13* / metabolism

Substances

  • Antibodies, Monoclonal, Humanized
  • Tumor Necrosis Factor Ligand Superfamily Member 13
  • TNFSF13 protein, human