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 |
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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 |