Denosumab
- Generic Name
- Denosumab
- Brand Names
- Prolia, Xgeva, Wyost, Jubbonti
- Drug Type
- Biotech
- CAS Number
- 615258-40-7
- Unique Ingredient Identifier
- 4EQZ6YO2HI
- Background
Denosumab is a novel, fully human IgG2 monoclonal antibody specific to receptor activator of nuclear factor kappa-B ligand (RANKL), suppresses bone resorption markers in patients with a variety of metastatic tumors and is being investigated in multiple clinical trials for the prevention and treatment of bone metastases. Chemically, it consists of 2 heavy and 2 light chains. Each light chain consists of 215 amino acids. Each heavy chain consists of 448 amino acids with 4 intramolecular disulfides. FDA approved on June 1, 2010.
- Indication
Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. It reduces the incidence of vertebral, nonvertebral, and hip fractures. Prolia is also indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. It can also be used in men with osteoporosis at high risk for fracture or in men receiving androgen deprivation therapy for nonmetastatic prostate cancer to increase bone mass. Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors.
- Associated Conditions
- Bone Fractures, Bone Giant Cell Tumor, Bone Loss, Bone pain, Spinal Cord Compression, Bone destruction, High risk of fracture Osteoporosis, Refractory Hypercalcemia of malignancy
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
- First Posted Date
- 2006-05-12
- Last Posted Date
- 2017-08-01
- Lead Sponsor
- Amgen
- Target Recruit Count
- 200
- Registration Number
- NCT00325468
A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
- Conditions
- Postmenopausal Osteoporosis
- Interventions
- First Posted Date
- 2006-02-20
- Last Posted Date
- 2014-07-25
- Lead Sponsor
- Amgen
- Target Recruit Count
- 247
- Registration Number
- NCT00293813
Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
- First Posted Date
- 2005-12-01
- Last Posted Date
- 2017-03-15
- Lead Sponsor
- Amgen
- Target Recruit Count
- 96
- Registration Number
- NCT00259740
Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis
- First Posted Date
- 2004-11-08
- Last Posted Date
- 2021-10-25
- Lead Sponsor
- Amgen
- Target Recruit Count
- 227
- Registration Number
- NCT00095498
Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis
- First Posted Date
- 2004-09-21
- Last Posted Date
- 2010-12-31
- Lead Sponsor
- Amgen
- Target Recruit Count
- 332
- Registration Number
- NCT00091793
A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
- First Posted Date
- 2004-08-16
- Last Posted Date
- 2022-11-08
- Lead Sponsor
- Amgen
- Target Recruit Count
- 7808
- Registration Number
- NCT00089791
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
- First Posted Date
- 2004-08-11
- Last Posted Date
- 2018-10-17
- Lead Sponsor
- Amgen
- Target Recruit Count
- 1468
- Registration Number
- NCT00089674
Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density
- Conditions
- Low Bone Mineral Density
- Interventions
- First Posted Date
- 2002-08-07
- Last Posted Date
- 2013-09-18
- Lead Sponsor
- Amgen
- Target Recruit Count
- 412
- Registration Number
- NCT00043186
Drug Development Updates
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