Denosumab

Drug Profile

Denosumab

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

Latest Information Update: 13 Oct 2017

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At a glance

  • Originator Amgen
  • Developer Amgen; Daiichi Sankyo Company; European Thoracic Oncology Platform; GlaxoSmithKline; Jules Bordet Institute; Melbourne Health
  • Class Antineoplastics; Antirheumatics; 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; Male osteoporosis; Malignant hypercalcaemia; Osteoporosis; Postmenopausal osteoporosis; Rheumatoid arthritis
  • Registered Corticosteroid-induced osteoporosis
  • Phase III Breast cancer; Non-small cell lung cancer; Osteogenesis imperfecta
  • No development reported Multiple myeloma

Most Recent Events

  • 09 Oct 2017 Registered for Corticosteroid-induced osteoporosis in USA (SC)
  • 09 Oct 2017 FDA assigns PDUFA action date of 28/05/2018 for denosumab for Glucocorticoid-induced osteoporosis
  • 01 Sep 2017 Jules Bordet Institute and Amgen terminates the D-Beyond phase II trial in Breast cancer (Early-stage disease, Newly diagnosed) in Belgium, Australia, due to poor recruitment (SC) (EudraCT2011-006224-21) (NCT01864798)
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