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Denosumab - Amgen

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Drug Profile

Denosumab - Amgen

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

Latest Information Update: 06 Mar 2024

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At a glance

  • Originator Amgen
  • Developer Amgen; Celgene Corporation; Daiichi Sankyo Company; European Thoracic Oncology Platform; GlaxoSmithKline; GSK; Jules Bordet Institute; Melbourne Health; University Health Network; University Hospital Ghent
  • 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; Osteogenesis imperfecta
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 01 Jan 2024 China includes Skeletal-Related Events into the latest National Reimbursement Drug List 2024 (NRDL)
  • 20 Dec 2023 Amgen completes a phase III trial in Corticosteroid-induced osteoporosis (In adolescents, In children) in USA, Australia, Belgium, Bulgaria, Canada, India, Italy, Mexico, Peru, Russia, Turkey, Colombia and Ukraine (SC) (NCT03164928)
  • 05 Dec 2023 Efficacy data from phase II GeparX trial in Breast cancer presented at the 46th Annual San Antonio Breast Cancer Symposium (SABCS-2023)
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