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Denosumab - Amgen

Drug Profile

Denosumab - Amgen

Alternative Names: AMG-162; PRALIA; Prolia; Ranmark; Xgeva

Latest Information Update: 10 Nov 2019

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At a glance

  • Originator Amgen
  • Developer Amgen; Daiichi Sankyo Company; European Thoracic Oncology Platform; GlaxoSmithKline; Jules Bordet Institute; Melbourne Health; University Health Network
  • Class Antihypercalcaemics; Antineoplastics; Antirheumatics; Calcium regulators; Immunotherapies; Monoclonal antibodies; Osteoporosis therapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; RANK ligand inhibitors
  • Orphan Drug Status

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

    Yes - Malignant hypercalcaemia; Bone cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Bone cancer; Bone disorders; Bone metastases; Corticosteroid-induced osteoporosis; Male osteoporosis; Malignant hypercalcaemia; Osteoporosis; Postmenopausal osteoporosis; Rheumatoid arthritis
  • Phase III Breast cancer; Non-small cell lung cancer; Osteogenesis imperfecta
  • Phase II Malignant melanoma
  • No development reported Multiple myeloma

Most Recent Events

  • 31 Oct 2019 Denosumab licensed to BeiGene in China
  • 12 Jun 2019 Efficacy data from a phase II trial in Rheumatoid arthritis presented at the 20th Annual Congress of the European League Against Rheumatism (EULAR-2019)
  • 12 Jun 2019 Efficacy data from subset of patients from the GIOP phase III trial in Corticosteroid-induced osteoporosis presented at the 20th Annual Congress of the European League Against Rheumatism (EULAR- 2019)
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