Prolia(denosumab)
Jubbonti, Prolia, Wyost, Xgeva (denosumab) is an antibody pharmaceutical. Denosumab was first approved as Prolia on 2010-05-26. It is used to treat osteoporotic fractures and postmenopausal osteoporosis in the USA. It has been approved in Europe to treat bone fractures, bone resorption, neoplasm metastasis, and postmenopausal osteoporosis. The pharmaceutical is active against tumor necrosis factor ligand superfamily member 11.
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Commercial
Trade Name
FDA
EMA
Aukelso, Bomyntra, Boncresa, Jubereq, Osenvelt, Oziltus, Xbryk, Xgeva, Xtrenbo (discontinued: Wyost, Xgeva)
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| aukelso | Biologic Licensing Application | 2025-09-16 |
| bildyos | Biologic Licensing Application | 2025-09-10 |
| bilprevda | Biologic Licensing Application | 2025-09-10 |
| bomyntra | Biologic Licensing Application | 2025-03-31 |
| boncresa | Biologic Licensing Application | 2025-12-22 |
| bosaya | Biologic Licensing Application | 2025-09-16 |
| conexxence | Biologic Licensing Application | 2025-12-15 |
| denosumab-bmwo | Biologic Licensing Application | 2026-01-20 |
| enoby | Biologic Licensing Application | 2026-01-16 |
| jubbonti | Biologic Licensing Application | 2025-10-30 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| postmenopausal osteoporosis | EFO_0003854 | D015663 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
denosumab, Xgeva, Amgen Inc. | |||
| 2121-12-05 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0897 | Injection, denosumab, 1 mg |
Clinical
Clinical Trials
333 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | 3 | 9 | 15 | 4 | 6 | 37 |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | 1 | 3 | 9 | 1 | 4 | 18 |
| Metabolic bone diseases | D001851 | — | — | 1 | 4 | 11 | 1 | — | 17 |
| Neoplasms | D009369 | — | C80 | — | 4 | 5 | 1 | 1 | 11 |
| Giant cell tumor of bone | D018212 | — | — | — | 3 | — | 2 | — | 5 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 2 | — | 1 | — | 3 |
| Bone diseases | D001847 | — | M89.9 | — | — | 2 | 1 | — | 3 |
| Hip osteoarthritis | D015207 | EFO_1000786 | M16 | — | — | — | 1 | — | 1 |
| Primary hyperparathyroidism | D049950 | EFO_0008519 | E21.0 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 9 | 6 | — | — | 16 |
| Multiple myeloma | D009101 | — | C90.0 | — | 5 | 3 | — | — | 8 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | 5 | — | 1 | 6 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | — | 1 | 4 | — | — | 5 |
| Prostatic neoplasms | D011471 | — | C61 | — | — | 5 | — | — | 5 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 2 | 1 | — | 1 | 4 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 2 | 1 | — | — | 3 |
| Osteogenesis imperfecta | D010013 | — | Q78.0 | — | — | 2 | — | — | 2 |
| Spinal cord compression | D013117 | EFO_1001845 | G95.20 | — | — | 2 | — | — | 2 |
| Lymphoma | D008223 | — | C85.9 | — | 1 | 1 | — | — | 2 |
Show 19 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | — | 3 | — | — | — | 3 |
| Smoldering multiple myeloma | D000075122 | — | — | — | 2 | — | — | — | 2 |
| Melanoma | D008545 | — | — | 1 | 2 | — | — | — | 2 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | 1 | — | — | — | 2 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 1 | 1 | — | — | — | 2 |
| Hematopoietic stem cell transplantation | D018380 | — | — | — | 1 | — | — | — | 1 |
| Cutaneous malignant melanoma | D000096142 | — | — | — | 1 | — | — | — | 1 |
| Chondrosarcoma | D002813 | — | — | — | 1 | — | — | — | 1 |
| Aneurysmal bone cysts | D017824 | EFO_1001760 | M85.5 | — | 1 | — | — | — | 1 |
| Giant cell granuloma | D006101 | — | K06.8 | — | 1 | — | — | — | 1 |
Show 24 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Male breast neoplasms | D018567 | — | — | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
| Postmenopause | D017698 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteonecrosis | D010020 | EFO_0004259 | M87 | — | — | — | — | 2 | 2 |
| Prostheses and implants | D019736 | — | — | — | — | — | — | 1 | 1 |
| Tooth loss | D016388 | — | — | — | — | — | — | 1 | 1 |
| Anodontia | D000848 | — | K00.0 | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Denosumab |
| INN | denosumab |
| Description | Immunoglobulin G2, anti-(human tumor necrosis factor ligand superfamily member 11 (human osteoclast differentiation factor))(human monoclonal AMG162 heavy chain), disulfide with human monoclonal AMG162 light chain, dimer |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1237023 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB06643 |
| UNII ID | 4EQZ6YO2HI (ChemIDplus, GSRS) |
Target
Agency Approved
TNFSF11
TNFSF11
Organism
Homo sapiens
Gene name
TNFSF11
Gene synonyms
OPGL, RANKL, TRANCE
NCBI Gene ID
Protein name
tumor necrosis factor ligand superfamily member 11
Protein synonyms
CD254, ODF, OPGL, Osteoclast differentiation factor, Osteoprotegerin ligand, RANKL, receptor activator of nuclear factor kappa B ligand, Receptor activator of nuclear factor kappa-B ligand, TNF-related activation-induced cytokine, TRANCE, tumor necrosis factor (ligand) superfamily, member 11, tumor necrosis factor ligand 6B, tumor necrosis factor superfamily member 11
Uniprot ID
Mouse ortholog
Tnfsf11 (21943)
tumor necrosis factor ligand superfamily member 11 (Q9R1Y0)
Alternate
No data
Variants
No data
Financial
Estimated US medical usage
Denosumab
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,999 documents
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Safety
Black-box Warning
Black-box warning for: Bildyos, Boncresa, Bosaya, Conexxence, Enoby, Jubbonti, Ospomyv, Prolia, Stoboclo
Adverse Events
Top Adverse Reactions
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168,257 adverse events reported
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