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AMG 162 / Denosumab
Denosumab is a monoclonal antibody that inhibits RANKL, a key regulator of osteoclast formation and bone resorption.
Denosumab is a monoclonal antibody that inhibits RANKL, a key regulator of osteoclast formation and bone resorption. Used for Postmenopausal osteoporosis, Bone loss in patients with cancer receiving aromatase inhibitors or androgen deprivation therapy, Prevention of skeletal-related events in patients with bone metastases from solid tumors.
At a glance
| Generic name | AMG 162 / Denosumab |
|---|---|
| Sponsor | Amgen |
| Drug class | RANKL inhibitor (monoclonal antibody) |
| Target | RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand) |
| Modality | Small molecule |
| Therapeutic area | Bone metabolism / Oncology |
| Phase | Phase 3 |
Mechanism of action
Denosumab binds to receptor activator of nuclear factor kappa-B ligand (RANKL), preventing its interaction with RANK on osteoclast precursor cells. This blocks osteoclast maturation and activation, leading to decreased bone resorption and increased bone mineral density. The drug is used to treat conditions characterized by excessive bone loss or osteoclast-mediated bone destruction.
Approved indications
- Postmenopausal osteoporosis
- Bone loss in patients with cancer receiving aromatase inhibitors or androgen deprivation therapy
- Prevention of skeletal-related events in patients with bone metastases from solid tumors
- Giant cell tumor of bone
Common side effects
- Hypocalcemia
- Osteonecrosis of the jaw
- Atypical femoral fractures
- Infections
- Back pain
- Arthralgia
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:
- AMG 162 / Denosumab CI brief — competitive landscape report
- AMG 162 / Denosumab updates RSS · CI watch RSS
- Amgen portfolio CI