Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 18 |
| INN | Denosumab |
| Status | Approved |
| Drug code(s) | AMG 162 |
| Brand name | Prolia, XGEVA |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse |
| Target(s) | RANK-L |
| Indications of clinical studies | Osteoporosis, Breast Cancer With Bone Metastasis |
| Primary therapeutic area | Skeletal disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 01, 2001 |
| Start of Phase 2 | July 02, 2003 |
| Start of Phase 3 | August 10, 2004 |
| Date BLA/NDA submitted to FDA | December 19, 2008 |
| Year of first approval (global) | 2010 |
| Date of first US approval | June 01, 2010 |
| INN, US product name | Denosumab |
| US or EU approved indications | Bone-related diseases. As Xgeva: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors; Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy; treatment for adult multiple myeloma patients to prevent skeletal-related events (EU). As Prolia: Treatment of postmenopausal women with osteoporosis at high risk for fracture, Treatment to increase bone mass in men with osteoporosis at high risk for fracture, Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer); treatment for glucocorticoid-induced osteoporosis in men and women with high fracture risk |
| Company | Amgen |
| Licensee/Partner | None |
| Comments about company or candidate | First approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture (brand name Prolia). Under the brand name XGEVA, denosumab is also approved for prevention of skeletal-related events in patients with bone metastases from solid tumors; treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity; and hypercalcemia of malignancy |
| Full address of company | Thousand Oaks, California, United States North America United States of America https://www.amgen.com/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |