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Denosumab (AMG 162)
Denosumab is a monoclonal antibody that inhibits RANKL, a key signaling molecule that activates osteoclasts and promotes bone resorption.
Denosumab is a monoclonal antibody that inhibits RANKL, a key signaling molecule that activates osteoclasts and promotes bone resorption. Used for Prevention of skeletal-related events in patients with bone metastases from solid tumors, Treatment of osteoporosis in postmenopausal women and men at high risk of fracture, Giant cell tumor of bone.
At a glance
| Generic name | Denosumab (AMG 162) |
|---|---|
| Sponsor | Amgen |
| Drug class | RANKL inhibitor (monoclonal antibody) |
| Target | RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand) |
| Modality | Small molecule |
| Therapeutic area | Oncology, Bone Metabolism |
| Phase | Phase 3 |
Mechanism of action
By binding to and neutralizing RANKL (receptor activator of nuclear factor kappa-B ligand), denosumab prevents the formation, function, and survival of osteoclasts, the cells responsible for bone breakdown. This leads to increased bone mineral density and reduced bone turnover, making it effective in conditions characterized by excessive bone loss such as osteoporosis and bone metastases.
Approved indications
- Prevention of skeletal-related events in patients with bone metastases from solid tumors
- Treatment of osteoporosis in postmenopausal women and men at high risk of fracture
- Giant cell tumor of bone
Common side effects
- Hypocalcemia
- Osteonecrosis of the jaw
- Atypical femoral fractures
- Infections
- Back pain
Key clinical trials
- Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma (PHASE2)
- A Study for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China (PHASE4)
- Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults (PHASE2)
- Romosozumab/Denosumab Study for Premenopausal IOP (PHASE2)
- A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency (PHASE2)
- Contribution of Bone to Urine Citrate
- The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation (PHASE4)
- Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China (PHASE4)
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:
- Denosumab (AMG 162) CI brief — competitive landscape report
- Denosumab (AMG 162) updates RSS · CI watch RSS
- Amgen portfolio CI