Skip to content
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.
Download report
Favorite
Top 200 Pharmaceuticals by Retail Sales
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
musculoskeletal diseasesD009140
nutritional and metabolic diseasesD009750
signs and symptoms pathological conditionsD013568
wounds and injuriesD014947
musculoskeletal and neural physiological phenomenaD055687
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)
Denosumab
Tradename
Proper name
Company
Number
Date
Products
XgevadenosumabAmgenN-125320 RX2010-11-18
1 products
ProliadenosumabAmgenN-125320 RX2010-06-01
1 products
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
proliaBiologic Licensing Application2020-03-26
xgevaBiologic Licensing Application2020-06-09
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
osteoporotic fracturesD058866
postmenopausal osteoporosisEFO_0003854D015663
Agency Specific
FDA
EMA
Expiration
Code
denosumab, Xgeva, Amgen Inc.
2121-12-05Orphan excl.
Patent Expiration
No data
ATC Codes
M: Musculo-skeletal system drugs
M05: Drugs for treatment of bone diseases
M05B: Drugs affecting bone structure and mineralization
M05BX: Other drugs affecting bone structure and mineralization in atc
M05BX04: Denosumab
HCPCS
Code
Description
J0897
Injection, denosumab, 1 mg
Clinical
Clinical Trials
249 clinical trials
View more details
Mock data
Subscribe for the real data
Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
OsteoporosisD010024EFO_0003882M81.05122014554
Postmenopausal osteoporosisD015663EFO_0003854441811542
Breast neoplasmsD001943EFO_0003869C505118125
Metabolic bone diseasesD001851HP_00009381491217
NeoplasmsD009369C802451112
Giant cell tumor of boneD01821231228
Prostatic neoplasmsD011471C611416
Rheumatoid arthritisD001172EFO_0000685M06.912115
Spinal cord injuriesD013119EFO_100191944
Primary hyperparathyroidismD049950EFO_0008519E21.0123
Show 14 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101C90.0527
Castration-resistant prostatic neoplasmsD064129246
Non-small-cell lung carcinomaD0022893115
Osteogenesis imperfectaD010013Q78.0123
Parathyroid neoplasmsD010282112
Renal cell carcinomaD002292112
Anorexia nervosaD000856EFO_0004215F50.022
Beta-thalassemiaD017086Orphanet_848D56.1112
Bone fracturesD050723EFO_0003931T14.8112
Systemic mastocytosisD034721C96.2111
Show 7 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Kidney neoplasmsD007680EFO_0003865C6433
Thyroid neoplasmsD013964EFO_000384122
MelanomaD008545122
Aneurysmal bone cystsD017824EFO_1001760M85.5122
Male infertilityD007248EFO_0004248N4622
Pancreatic neoplasmsD010190EFO_0003860C25111
Critical illnessD01663811
CarcinomaD002277C80.011
Nasopharyngeal neoplasmsD00930311
Smoldering multiple myelomaD00007512211
Show 35 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients9110
Male breast neoplasmsD01856711
Breast densityD00007106011
Ovarian neoplasmsD010051EFO_0003893C5611
AgingD000375GO_0007568R41.8111
Replacement arthroplasty hipD01964411
Immunosuppression therapyD00716511
Delayed hypersensitivityD00696811
Ultraviolet raysD01446611
Renal insufficiencyD051437HP_0000083N1911
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic kidney failureD007676EFO_0003884N18.611
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
Drug common nameDENOSUMAB
INNdenosumab
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 classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID615258-40-7
RxCUI993449
ChEMBL IDCHEMBL1237023
ChEBI ID
PubChem CID
DrugBankDB06643
UNII ID4EQZ6YO2HI (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
Clinical Variant
No data
Financial
Xgeva - Amgen
$
£
Mock data
Subscribe for the real data
Mock data
Subscribe for the real data
Prolia - Amgen
$
£
Mock data
Subscribe for the real data
Mock data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Additional graphs summarizing 11,156 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
211 adverse events reported
View more details