Denosumab - Amgen

Drug Profile

Denosumab - Amgen

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

Latest Information Update: 28 Sep 2018

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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 - 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

  • 04 Sep 2018 Phase-II clinical trials in Bone metastases (Combination therapy, Metastatic disease) in Canada (SC) (NCT03520231)
  • 01 Sep 2018 Phase-II clinical trials in Malignant melanoma (Inoperable/Unresectable, Combination therapy, Metastatic disease) in USA (SC) (NCT03620019)
  • 10 Aug 2018 Amgen completes a phase III access study for Bone metastases who have completed previous phase III trial in Argentina, Austria, Belgium, Brazil, Czech Republic, France, Hungary, India, Israel, Italy, Japan, Latvia, Lithuania, Panama, Peru, Poland, Russia, South Africa, Spain, and Ukraine (NCT01419717)
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