Drug Profile

Denosumab - Amgen

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

Latest Information Update: 14 Jun 2025

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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 - Bone cancer; Malignant hypercalcaemia; Osteogenesis imperfecta
New Molecular Entity Yes

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

10 Dec 2024 Efficacy and adverse events data from phase II trial in Breast cancer presented at the 47th Annual San Antonio Breast Cancer Symposium (SABCS-2024)
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)

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