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. Author manuscript; available in PMC: 2016 Mar 1.
Published in final edited form as: Expert Opin Drug Metab Toxicol. 2015 Jan 22;11(3):461–470. doi: 10.1517/17425255.2015.1000860
Drug Name Denosumab
Phase Post-marketing
Approved Indications Treatment of postmenopausal women with osteoporosis at high risk for fracture;
Treatment to increase bone mass in men with osteoporosis at high risk of fracture;
Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer;
Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
Mechanism of action Suppression of bone resorption by binding to RANK ligand, preventing its binding to RANK and decreasing osteoclast formation, activity, and survival
Route of administrationChemical structure Subcutaneous every 6 months(C6404 H9912 N1724 O2004 S50) consists of 2 heavy and 2 light chains; each light chain consists of 215 amino acids and each heavy chain consists of 448 amino acids with 4 intramolecular disulfides. Fully human monoclonal IgG2 antibody to RANK ligand
Pivotal trials FREEDOM, ADAMO