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Inebilizumab - Horizon Therapeutics plc

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Drug Profile

Inebilizumab - Horizon Therapeutics plc

Alternative Names: 16C4-aFuc; A-fucosylated anti-CD19 antibody; Anti-CD19 MAb-Horizon Therapeutics plc; Inebilizumab-cdon; MEDI 551; MT-0551; UPLIZNA; VIB-0551

Latest Information Update: 22 Oct 2025

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At a glance

  • Originator Duke University
  • Developer Horizon Therapeutics plc; Jiangsu Hansoh Pharmaceutical; MedImmune; Mitsubishi Tanabe Pharma Corporation
  • Class Antineoplastics; Eye disorder therapies; Immunotherapies; Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; T lymphocyte stimulants
  • Orphan Drug Status

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

    Yes - Neuromyelitis optica; Scleroderma; Myasthenia gravis
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Neuromyelitis optica
  • Registered Immunoglobulin G4-related disease
  • Preregistration Myasthenia gravis
  • Phase III Systemic scleroderma
  • Phase II Systemic lupus erythematosus
  • No development reported Renal transplant rejection
  • Discontinued B-cell lymphoma; Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Multiple myeloma; Multiple sclerosis

Most Recent Events

  • 14 Oct 2025 Preregistration for Myasthenia gravis in Japan (IV)
  • 29 Sep 2025 CHMP recommends extension of indication for Inebilizumab to include Immunoglobulin G4-related disease
  • 11 Jun 2025 Updated efficacy data from a phase III clinical trial in Immunoglobulin G4 related disease presented at 26th Annual Congress of the European League Against Rheumatism (EULAR-2025)

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