Prolia(denosumab)
Prolia, 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
Prolia, 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)
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| osteoporotic fractures | — | D058866 | — |
| 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
305 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 | HP_0000939 | M81.0 | 5 | 15 | 21 | 22 | 14 | 75 |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | 4 | 4 | 18 | 13 | 11 | 50 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 6 | 11 | 8 | 2 | — | 27 |
| Metabolic bone diseases | D001851 | HP_0000938 | — | 1 | 4 | 9 | 1 | 3 | 18 |
| Neoplasms | D009369 | — | C80 | 2 | 4 | 5 | 1 | 2 | 13 |
| Giant cell tumor of bone | D018212 | — | — | — | 3 | 2 | 2 | 3 | 10 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | 1 | 4 | 1 | — | 8 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | — | 2 | 4 | 1 | — | 7 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | 2 | — | 1 | 1 | 5 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | 1 | — | 1 | 1 | 4 |
Show 16 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | — | 5 | 2 | — | — | 7 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 3 | 1 | — | 1 | 5 |
| Osteogenesis imperfecta | D010013 | — | Q78.0 | — | 1 | 2 | — | — | 3 |
| Parathyroid neoplasms | D010282 | — | — | — | 1 | 1 | — | — | 2 |
| Carcinoma | D002277 | — | C80.0 | — | 1 | 1 | — | — | 2 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | — | 1 | 1 | — | — | 2 |
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | — | — | 2 | — | — | 2 |
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | — | 1 | 1 | — | — | 2 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | 1 | — | 1 | 2 |
| Systemic mastocytosis | D034721 | — | C96.21 | — | — | 1 | — | — | 1 |
Show 7 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 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 2 | — | — | — | 2 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | 2 | — | — | — | 2 |
| Melanoma | D008545 | — | — | 1 | 2 | — | — | — | 2 |
| Aneurysmal bone cysts | D017824 | EFO_1001760 | M85.5 | 1 | 2 | — | — | — | 2 |
| Male infertility | D007248 | EFO_0004248 | N46 | — | 2 | — | — | — | 2 |
| Critical illness | D016638 | — | — | — | 1 | — | — | — | 1 |
| Nasopharyngeal carcinoma | D000077274 | — | — | — | 1 | — | — | — | 1 |
| Nasopharyngeal neoplasms | D009303 | — | — | — | 1 | — | — | — | 1 |
| Smoldering multiple myeloma | D000075122 | — | — | — | 1 | — | — | — | 1 |
Show 34 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 10 | — | — | — | — | 10 |
| Male breast neoplasms | D018567 | — | — | 1 | — | — | — | — | 1 |
| Breast density | D000071060 | — | — | 1 | — | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | — | — | — | 1 |
| Aging | D000375 | GO_0007568 | R41.81 | 1 | — | — | — | — | 1 |
| Replacement arthroplasty hip | D019644 | — | — | 1 | — | — | — | — | 1 |
| Bone neoplasms | D001859 | EFO_0003820 | D16 | 1 | — | — | — | — | 1 |
| Secondary hyperparathyroidism | D006962 | EFO_1001173 | — | 1 | — | — | — | — | 1 |
| Hypocalcemia | D006996 | HP_0002901 | E83.51 | 1 | — | — | — | — | 1 |
| Immunosuppression therapy | D007165 | — | — | 1 | — | — | — | — | 1 |
Show 3 more
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 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 1 | 1 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | — | — | — | — | 1 | 1 |
| Bisphosphonate-associated osteonecrosis of the jaw | D059266 | — | — | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | — | 1 | 1 |
| Menopause | D008593 | EFO_0003922 | N95 | — | — | — | — | 1 | 1 |
| Mortality | D009026 | EFO_0004352 | — | — | — | — | — | 1 | 1 |
| Drug therapy | D004358 | — | — | — | — | — | — | 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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,815 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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143,858 adverse events reported
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