denosumab   Click here for help

GtoPdb Ligand ID: 6886

Synonyms: AMG-162 | M05BX04 | Prolia® | Xgeva®
Approved drug
denosumab is an approved drug (FDA and EMA (2010))
Compound class: Antibody
Comment: Denosumab suppresses the activity of RANK ligand (RANKL), which normally promotes bone removal and resorption, but which becomes over active in many bone loss diseases.
Denosumab is produced from CHO cells stably expressing recombinant antibody component proteins [1]. It was the first RANKL inhibitor to be approved by the FDA.

Biosimilars: The FDA approved denosumab-bbdz (Jubbonti®, February 2024) and denosumab-bbdz (Wyost®, March 2024) as interchangeable biosimilars to the reference agent Prolia®.
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References
1. Boyle WJ, Martin FH, Corvalan JR, Davis CG. (2008)
Immmunoglobulin which prevents binding of osteoprotegerin ligand (OPGL) to osteoclast differentiation and activation receptor (ODAR) for treatment and prevention of bone, inflammatory, arthritic and autoimmune disorders.
Patent number: US7364736. Assignee: Amgen Inc.. Priority date: 26/06/2001. Publication date: 29/04/2008.
2. Coleman RE. (2006)
Clinical features of metastatic bone disease and risk of skeletal morbidity.
Clin Cancer Res, 12 (20 Pt 2): 6243s-6249s. [PMID:17062708]
3. McClung MR, Lewiecki EM, Cohen SB, Bolognese MA, Woodson GC, Moffett AH, Peacock M, Miller PD, Lederman SN, Chesnut CH et al.. (2006)
Denosumab in postmenopausal women with low bone mineral density.
N Engl J Med, 354 (8): 821-31. [PMID:16495394]
4. Stewart AF. (2005)
Clinical practice. Hypercalcemia associated with cancer.
N Engl J Med, 352 (4): 373-9. [PMID:15673803]