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Denosumab - Amgen

Drug Profile

Denosumab - Amgen

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

Latest Information Update: 10 Jan 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; Monoclonal antibodies; Osteoporosis therapies
  • Mechanism of Action RANK ligand inhibitors
  • Orphan Drug Status

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

    Yes - Bone cancer; Malignant hypercalcaemia
  • 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

  • 01 Dec 2018 Efficacy data from a phase III trial in Multiple myeloma presented at the 60th Annual Meeting and Exposition of the American Society of Hematology (ASH-Hem-2018)
  • 01 Dec 2018 Safety data from a phase III trial in Multiple myeloma presented at the 60th Annual Meeting and Exposition of the American Society of Hematology (ASH-Hem-2018)
  • 13 Nov 2018 Efficacy and safety data from a phase II study in Non-small cell lung cancer presented at the 30th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR -2018)
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