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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Trade Name
FDA
EMA
Aukelso, Bomyntra, Osenvelt, Xbryk, Xgeva (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 |
|---|---|---|
| bildyos | Biologic Licensing Application | 2025-09-10 |
| bilprevda | Biologic Licensing Application | 2025-09-10 |
| bomyntra | Biologic Licensing Application | 2025-03-31 |
| conexxence | Biologic Licensing Application | 2025-03-31 |
| denosumab-bmwo | Biologic Licensing Application | 2025-09-18 |
| jubbonti | Biologic Licensing Application | 2024-10-24 |
| osenvelt | Biologic Licensing Application | 2025-09-17 |
| prolia | Biologic Licensing Application | 2025-09-16 |
| stoboclo | Biologic Licensing Application | 2025-09-17 |
| wyost | Biologic Licensing Application | 2024-03-01 |
Show 1 more
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
328 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | 7 | 20 | 29 | 35 | 25 | 114 |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | 4 | 4 | 25 | 15 | 12 | 60 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 7 | 14 | 9 | 3 | 3 | 35 |
| Metabolic bone diseases | D001851 | — | — | 2 | 5 | 15 | 4 | 5 | 30 |
| Neoplasms | D009369 | — | C80 | 2 | 7 | 7 | 1 | 2 | 18 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 3 | 8 | 1 | 1 | 2 | 15 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | 5 | 2 | 6 | 13 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | 2 | 6 | 1 | — | 11 |
| Giant cell tumor of bone | D018212 | — | — | — | 3 | 2 | 2 | 3 | 10 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | — | 2 | 4 | 1 | — | 7 |
Show 25 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 | 4 | — | — | 9 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 3 | 1 | — | 1 | 5 |
| Bone neoplasms | D001859 | EFO_0003820 | D16 | 1 | 3 | 1 | — | — | 5 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | 1 | — | 1 | 3 |
| Bone marrow diseases | D001855 | — | — | — | 2 | 1 | — | — | 3 |
| Osteogenesis imperfecta | D010013 | — | Q78.0 | — | 1 | 2 | — | — | 3 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | — | 2 | 1 | — | — | 3 |
| Parathyroid neoplasms | D010282 | — | — | — | 1 | 1 | — | — | 2 |
| Carcinoma | D002277 | — | C80.0 | — | 1 | 1 | — | — | 2 |
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | — | — | 2 | — | — | 2 |
Show 25 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Male infertility | D007248 | EFO_0004248 | N46 | 2 | 4 | — | — | — | 4 |
| Osteosarcoma | D012516 | — | — | 1 | 1 | — | — | 1 | 3 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | — | 3 | — | — | — | 3 |
| Recurrence | D012008 | — | — | 2 | 2 | — | — | — | 3 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | 1 | — | — | — | 3 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 2 | 2 | — | — | — | 3 |
| Smoldering multiple myeloma | D000075122 | — | — | — | 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 |
Show 47 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 16 | — | — | — | — | 16 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | 1 | — | — | — | 1 | 2 |
| Male breast neoplasms | D018567 | — | — | 1 | — | — | — | — | 1 |
| Breast density | D000071060 | — | — | 1 | — | — | — | — | 1 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 1 | — | — | — | — | 1 |
| Aging | D000375 | GO_0007568 | R41.81 | 1 | — | — | — | — | 1 |
| Hyperparathyroidism | D006961 | EFO_0008506 | E21.3 | 1 | — | — | — | — | 1 |
| Secondary hyperparathyroidism | D006962 | EFO_1001173 | — | 1 | — | — | — | — | 1 |
| Hypocalcemia | D006996 | HP_0002901 | E83.51 | 1 | — | — | — | — | 1 |
| Allergic contact dermatitis | D017449 | — | L23 | 1 | — | — | — | — | 1 |
Show 4 more
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 14 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 15,944 documents
View more details
Safety
Black-box Warning
Black-box warning for: Bildyos, Conexxence, Denosumab-bmwo, Jubbonti, Prolia, Stoboclo
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
169,395 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use