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Denosumab (Prolia)
Denosumab (Prolia) is a RANKL inhibitor (monoclonal antibody) Small molecule drug developed by Prince of Wales Hospital, Shatin, Hong Kong. It is currently FDA-approved for Postmenopausal osteoporosis, Bone metastases from solid tumors, Giant cell tumor of bone. Also known as: Prolia, Xgeva.
Denosumab is a monoclonal antibody that binds to RANKL, preventing bone resorption by inhibiting osteoclast formation and activation.
Denosumab is a monoclonal antibody that binds to RANKL, preventing bone resorption by inhibiting osteoclast formation and activation. Used for Postmenopausal osteoporosis, Bone metastases from solid tumors, Giant cell tumor of bone.
At a glance
| Generic name | Denosumab (Prolia) |
|---|---|
| Also known as | Prolia, Xgeva |
| Sponsor | Prince of Wales Hospital, Shatin, Hong Kong |
| 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 | FDA-approved |
Mechanism of action
Denosumab targets RANKL (receptor activator of nuclear factor kappa-B ligand), a key mediator of osteoclast differentiation and survival. By blocking RANKL signaling, it reduces bone turnover and increases bone mineral density. This mechanism makes it effective for treating conditions characterized by excessive bone loss, such as osteoporosis and bone metastases.
Approved indications
- Postmenopausal osteoporosis
- Bone metastases from solid tumors
- Giant cell tumor of bone
- Hypercalcemia of malignancy
Common side effects
- Hypocalcemia
- Osteonecrosis of the jaw
- Atypical femoral fractures
- Back pain
- Arthralgia
- Infection
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 (Prolia) CI brief — competitive landscape report
- Denosumab (Prolia) updates RSS · CI watch RSS
- Prince of Wales Hospital, Shatin, Hong Kong portfolio CI
Frequently asked questions about Denosumab (Prolia)
What is Denosumab (Prolia)?
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Is Denosumab (Prolia) also known as anything else?
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What does Denosumab (Prolia) target?
Related
- Drug class: All RANKL inhibitor (monoclonal antibody) drugs
- Target: All drugs targeting RANKL (receptor activator of nuclear factor kappa-B ligand)
- Manufacturer: Prince of Wales Hospital, Shatin, Hong Kong — full pipeline
- Therapeutic area: All drugs in Bone metabolism / Oncology
- Indication: Drugs for Postmenopausal osteoporosis
- Indication: Drugs for Bone metastases from solid tumors
- Indication: Drugs for Giant cell tumor of bone
- Also known as: Prolia, Xgeva
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing