Denosumab

Drug Profile

Denosumab

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

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Amgen
  • Developer Amgen; Daiichi Sankyo Company; European Thoracic Oncology Platform; GlaxoSmithKline
  • Class Antineoplastics; 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 03 Mar 2017 Efficacy and adverse events data from a phase III trial in Multiple myeloma released by Amgen
  • 14 Feb 2017 Amgen has patent protection for Denosumab in USA and European Union (Amgen 10-K, February 2017)
  • 13 Feb 2017 Phase-II clinical trials in Breast cancer (Adjuvant therapy) in Germany (SC) (NCT02682693)
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