Denosumab
Cold Chain RequiredFDA Approved
Description
Denosumab is a fully human monoclonal antibody that inhibits RANK ligand, thereby reducing bone resorption and increasing bone density. It is used off-label for polyostotic fibrous dysplasia to reduce skeletal complications and bone pain. The drug has demonstrated efficacy in reducing bone turnover markers in fibrous dysplasia patients.
Indications & Therapeutic Use
Prevention of skeletal-related events in patients with bone metastases, giant cell tumor of bone, polyostotic fibrous dysplasia (off-label)
Global Availability (7 countries)
| Country | Access Route | Regulatory Pathway | Lead Time | Status |
|---|---|---|---|---|
| — | — | — | — | |
| — | — | — | — | |
| — | — | — | — | |
| — | — | — | — | |
| — | — | — | — | |
| — | — | — | — | |
| — | — | — | — |
Available Through
This drug is available for procurement through the following fulfilment partner.
Fulfilment Partner
Denosumab
| Generic Name | Denosumab |
| Brands | 1 brand available |
| Active Ingredient | Denosumab |
| Drug Class | Prevention of skeletal-related events in patients with bone metastases |
| Manufacturer | Amgen |
| Dosage Forms | Subcutaneous injection, 120mg/1.7mL solution |
| Medical Code | M05BX04 |
| Orphan Status | No |
| Cold Chain | Required |
| Lead Time | 14 days |
| Reg. Status | FDA Approved |
| Clinical Trial | NCT00896454 |
| Countries | 7 countries |
Authority Signals
Last Verified3/21/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations8 Validated Nodes