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Ofatumumab - Genmab/Novartis

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Drug Profile

Ofatumumab - Genmab/Novartis

Alternative Names: Anti-CD20 monoclonal antibody - Genmab; Arzerra; GSK-1841157; HuMax CD20; Kesimpta; OMB-157

Latest Information Update: 26 Sep 2025

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At a glance

  • Originator Genmab
  • Developer Genmab; GlaxoSmithKline; Mundipharma International; National Cancer Centre (Singapore); Novartis; Roswell Park Cancer Institute; University Health Network
  • Class Antineoplastics; Antirheumatics; Eye disorder therapies; Immunotherapies; Monoclonal antibodies; Neuroprotectants; Skin disorder therapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; CD20 antigen inhibitors; T lymphocyte stimulants
  • Orphan Drug Status

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

    Yes - Chronic lymphocytic leukaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Chronic lymphocytic leukaemia; Multiple sclerosis
  • Phase III B-cell lymphoma; Diffuse large B cell lymphoma; Follicular lymphoma
  • Phase II Mantle-cell lymphoma; Marginal zone B-cell lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma
  • Suspended Neuromyelitis optica
  • Discontinued Pemphigus vulgaris; Rheumatoid arthritis; Waldenstrom's macroglobulinaemia

Most Recent Events

  • 24 Sep 2025 Adverse events and efficacy data from the phase-III ALITHIOS trial in Multiple sclerosis released by Novartis
  • 24 Sep 2025 Adverse events and efficacy data from the phase-IIIb ARTIOS trial in Multiple sclerosis released by Novartis
  • 12 Mar 2025 Novartis Pharmaceuticals plans a phase III FILIOS trial for Multiple Sclerosis in March 2025 (Parenteral) (NCT06869785)

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