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Sibeprenlimab - Visterra

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Drug Profile

Sibeprenlimab - Visterra

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

Latest Information Update: 27 Nov 2025

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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

  • 26 Nov 2025 Registered for IgA nephropathy in USA (SC) - First global approval
  • 26 Nov 2025 Updated efficacy, adverse event and pharmacodynamimcs data from the phase III VISIONARY trial in IgA nephropathy released by Otsuka Pharmaceutical
  • 24 Nov 2025 Preregistration for IgA nephropathy in China (SC) (Otsuka Pharmaceutical pipeline, November 2025)

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