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Sibeprenlimab - Visterra

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Drug Profile

Sibeprenlimab - Visterra

Alternative Names: Sibeprenlimab-szsi; VIS-649; VOYXACT

Latest Information Update: 11 Aug 2026

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At a glance

  • Originator Visterra
  • Class Antirheumatics; Monoclonal antibodies; Urologics
  • Mechanism of Action Tumour necrosis factor ligand superfamily member 13 inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - IgA nephropathy
  • New Molecular Entity Yes

Highest Development Phases

  • Registered IgA nephropathy
  • Phase II Sjogren's syndrome

Most Recent Events

  • 03 Aug 2026 Updated efficacy and adverse events data from a phase-III VISIONARY trial in IgA nephropathy released by Otsuka
  • 02 Jul 2026 Otsuka Pharmaceutical plans global regulatory submissions for IgA nephropathy
  • 04 Jun 2026 Otsuka Pharmaceutical initiates a rolling submission of a supplemental Biologics License Application (sBLA) to the US FDA for VOYXACT in IgA Nephropathy

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