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Xgeva®
Xgeva (denosumab) is a monoclonal antibody that inhibits RANKL, preventing osteoclast formation and bone resorption.
Xgeva (denosumab) is a monoclonal antibody that inhibits RANKL, preventing osteoclast formation and bone resorption. Used for Prevention of skeletal-related events in patients with bone metastases from solid tumors, Treatment of giant cell tumor of bone, Prevention of bone loss in patients with hormone-responsive breast cancer receiving aromatase inhibitors.
At a glance
| Generic name | Xgeva® |
|---|---|
| Also known as | Denosumab, Denosumab Injection |
| Sponsor | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
| Drug class | RANKL inhibitor (monoclonal antibody) |
| Target | RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand) |
| Modality | Small molecule |
| Therapeutic area | Oncology, Bone Health |
| Phase | FDA-approved |
Mechanism of action
Denosumab binds to receptor activator of nuclear factor kappa-B ligand (RANKL), a key mediator of osteoclast differentiation and activation. By blocking RANKL signaling, the drug suppresses bone resorption, increases bone mineral density, and reduces skeletal-related events in patients with bone metastases or osteoporosis.
Approved indications
- Prevention of skeletal-related events in patients with bone metastases from solid tumors
- Treatment of giant cell tumor of bone
- Prevention of bone loss in patients with hormone-responsive breast cancer receiving aromatase inhibitors
Common side effects
- Hypocalcemia
- Osteonecrosis of the jaw
- Fatigue
- Nausea
- Back pain
Key clinical trials
- A Study for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China (PHASE4)
- A Phase 3 Study to Compare Biosimilar Denosumab With Prolia® (PHASE3)
- Prevention of Symptomatic Skeletal Events With Denosumab Administered Every 4 Weeks Versus Every 12 Weeks (PHASE3)
- Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers (PHASE1)
- Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone (PHASE4)
- Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis (PHASE3)
- Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women (PHASE4)
- Single Dose, Three-arm Study to Compare the Pharmacokinetic Similarity of MAB-22 Versus Prolia® (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xgeva® CI brief — competitive landscape report
- Xgeva® updates RSS · CI watch RSS
- Jiangsu Hansoh Pharmaceutical Co., Ltd. portfolio CI