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Belimumab - AstraZeneca/GSK

Drug Profile

Belimumab - AstraZeneca/GSK

Alternative Names: Anti-BLyS monoclonal antibody; Benlysta; BmAb; GSK1550188; HGS-1006; LSB; LymphoStat-B; monoclonal anti-BLyS

Latest Information Update: 30 Jun 2025

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At a glance

  • Originator Cambridge Antibody Technology; Human Genome Sciences
  • Developer Assistance Publique Hopitaux de Paris; Cancer Trials Australia; GlaxoSmithKline; GSK; Hospital for Special Surgery; Human Genome Sciences; National Institute of Allergy and Infectious Diseases; North Shore-Long Island Jewish Health System; University of Pennsylvania; University of Wisconsin-Madison; Washington University School of Medicine
  • Class Anti-inflammatories; Antineoplastics; Antirheumatics; Immunotherapies; Monoclonal antibodies; Skin disorder therapies; Urologics
  • Mechanism of Action B cell activating factor inhibitors
  • Orphan Drug Status

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

    Yes - Systemic lupus erythematosus
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Lupus nephritis; Systemic lupus erythematosus
  • Phase III Anti-neutrophil cytoplasmic antibody-associated vasculitis; Interstitial lung diseases
  • Phase II/III Myositis; Systemic scleroderma
  • Phase II Membranous glomerulonephritis; Multiple sclerosis; Myasthenia gravis; Renal transplant rejection
  • No development reported Graft-versus-host disease; Waldenstrom's macroglobulinaemia
  • Discontinued Rheumatoid arthritis; Sjogren's syndrome

Most Recent Events

  • 25 Jun 2025 Registered for Lupus nephritis (In children, In adolescents) in USA (SC)
  • 12 Dec 2024 Phase-III clinical trials in Interstitial lung diseases in Argentina, South Korea (SC) (NCT06716606) (EudraCT2023-509370-39)
  • 04 Dec 2024 GlaxoSmithKline plans a phase III trial for Interstitial lung diseases (systemic sclerosis associated interstitial lung disease) in Argentina, Belgium, Brazil, China, Denmark, Finland, France, Germany, Greece, Israel, Italy, Mexico, South Korea, Spain (SC, Injection) (NCT06716606)

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