Denosumab

Drug Profile

Denosumab

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

Latest Information Update: 02 Jan 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

  • 28 Nov 2016 Updated efficacy data from a phase III trial in Bone metastasis presented at the 41st European Society for Medical Oncology Congress (ESMO-2016)
  • 20 Oct 2016 Top-line efficacy and adverse events data from a phase III trial in bone disorders released by Amgen
  • 23 Sep 2016 Preregistration for Rheumatoid arthritis in Japan (SC)
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top