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
Wyost, Xgeva (discontinued: 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 |
|---|---|---|---|
| postmenopausal osteoporosis | EFO_0003854 | D015663 | — |
| osteoporotic fractures | — | D058866 | — |
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
320 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 | 9 | 20 | 43 | 44 | 29 | 143 |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | 4 | 4 | 23 | 15 | 12 | 58 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 7 | 13 | 8 | 2 | 3 | 32 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 3 | 7 | 13 | 1 | 1 | 24 |
| Bone neoplasms | D001859 | EFO_0003820 | D16 | 2 | 6 | 10 | 2 | 3 | 23 |
| Metabolic bone diseases | D001851 | — | — | 1 | 6 | 11 | 2 | 4 | 23 |
| Neoplasms | D009369 | — | C80 | 3 | 7 | 5 | 1 | 2 | 17 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | 2 | 9 | 2 | — | 15 |
| Giant cell tumor of bone | D018212 | — | — | — | 3 | 2 | 2 | 3 | 10 |
| Giant cell tumors | D005870 | — | — | — | 3 | 2 | 2 | 3 | 10 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bone marrow diseases | D001855 | — | — | — | 3 | 8 | — | — | 11 |
| Multiple myeloma | D009101 | — | C90.0 | — | 6 | 4 | — | — | 10 |
| Plasma cell neoplasms | D054219 | — | — | — | 4 | 4 | — | — | 8 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 3 | 1 | — | 1 | 5 |
| Carcinoma | D002277 | — | C80.0 | — | 3 | 1 | — | — | 4 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | — | 3 | 1 | — | — | 4 |
| Lung neoplasms | D008175 | — | C34.90 | — | 3 | 1 | — | — | 4 |
| Second primary neoplasms | D016609 | — | — | — | 2 | 2 | — | — | 4 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | 2 | 1 | — | — | 3 |
| Osteogenesis imperfecta | D010013 | — | Q78.0 | — | 1 | 2 | — | — | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infertility | D007246 | EFO_0000545 | — | 2 | 5 | — | — | — | 5 |
| Male infertility | D007248 | EFO_0004248 | N46 | 2 | 4 | — | — | — | 4 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | 1 | — | — | — | 3 |
| Recurrence | D012008 | — | — | 1 | 2 | — | — | — | 3 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | 2 | — | — | — | 2 |
| Melanoma | D008545 | — | — | 1 | 2 | — | — | — | 2 |
| Aneurysmal bone cysts | D017824 | EFO_1001760 | M85.5 | 1 | 2 | — | — | — | 2 |
| Bone cysts | D001845 | — | M85.4 | 1 | 2 | — | — | — | 2 |
| Renal insufficiency | D051437 | — | N19 | 1 | 1 | — | — | — | 2 |
| Replacement arthroplasty hip | D019644 | — | — | 1 | 1 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 15 | — | — | — | — | 15 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | 1 | — | — | — | 1 | 2 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 2 | — | — | — | — | 2 |
| Male breast neoplasms | D018567 | — | — | 1 | — | — | — | — | 1 |
| Breast density | D000071060 | — | — | 1 | — | — | — | — | 1 |
| Aging | D000375 | GO_0007568 | R41.81 | 1 | — | — | — | — | 1 |
| Secondary hyperparathyroidism | D006962 | EFO_1001173 | — | 1 | — | — | — | — | 1 |
| Hypocalcemia | D006996 | HP_0002901 | E83.51 | 1 | — | — | — | — | 1 |
| Immunosuppression therapy | D007165 | — | — | 1 | — | — | — | — | 1 |
| Delayed hypersensitivity | D006968 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteonecrosis | D010020 | EFO_0004259 | M87 | — | — | — | — | 4 | 4 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 2 | 2 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 2 | 2 |
| Calcium metabolism disorders | D002128 | EFO_0005769 | E83.5 | — | — | — | — | 1 | 1 |
| Prostheses and implants | D019736 | — | — | — | — | — | — | 1 | 1 |
| Tooth loss | D016388 | — | — | — | — | — | — | 1 | 1 |
| Anodontia | D000848 | — | K00.0 | — | — | — | — | 1 | 1 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | — | — | — | — | 1 | 1 |
| Infectious arthritis | D001170 | EFO_1001351 | M00 | — | — | — | — | 1 | 1 |
| Bisphosphonate-associated osteonecrosis of the jaw | D059266 | — | — | — | — | — | — | 1 | 1 |
Show 13 more
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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 14,641 documents
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Safety
Black-box Warning
Black-box warning for: Prolia
Adverse Events
Top Adverse Reactions
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164,421 adverse events reported
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