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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Dec 2025

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At a glance

  • Drugs Sibeprenlimab (Primary)
  • Indications IgA nephropathy
  • Focus Registrational; Therapeutic Use
  • Acronyms VISIONARY
  • Sponsors Otsuka Pharmaceutical Development & Commercialization

Most Recent Events

  • 26 Nov 2025 According to an Otsuka Pharmaceutical Media Release, Dr. Dana Rizk is a study investigator.
  • 26 Nov 2025 According to an Otsuka Pharmaceutical Media Release, eGFR data are expected in early 2026 and are intended to support traditional FDA approval.
  • 26 Nov 2025 According to an Otsuka Pharmaceutical Media Release, the U.S. Food and Drug Administration (FDA) has granted accelerated approval of VOYXACT (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. VOYXACT was granted accelerated approval based on the VISIONARY Phase 3 interim analysis.

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