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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
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 fractures—D058866—
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
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Mock data
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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_0003869C5051181—25
Metabolic bone diseasesD001851HP_00009381491217
NeoplasmsD009369C802451112
Giant cell tumor of boneD018212—31228
Prostatic neoplasmsD011471C61—141—6
Rheumatoid arthritisD001172EFO_0000685M06.912—115
Spinal cord injuriesD013119EFO_1001919———4—4
Primary hyperparathyroidismD049950EFO_0008519E21.0——12—3
Show 14 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101C90.0—52——7
Castration-resistant prostatic neoplasmsD064129—24——6
Non-small-cell lung carcinomaD002289—31—15
Osteogenesis imperfectaD010013Q78.0—12——3
Parathyroid neoplasmsD010282—11——2
Renal cell carcinomaD002292—11——2
Anorexia nervosaD000856EFO_0004215F50.0——2——2
Beta-thalassemiaD017086Orphanet_848D56.1—11——2
Bone fracturesD050723EFO_0003931T14.8——1—12
Systemic mastocytosisD034721C96.21——1——1
Show 7 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Kidney neoplasmsD007680EFO_0003865C64—3———3
Thyroid neoplasmsD013964EFO_0003841—2———2
MelanomaD00854512———2
Aneurysmal bone cystsD017824EFO_1001760M85.512———2
Male infertilityD007248EFO_0004248N46—2———2
Pancreatic neoplasmsD010190EFO_0003860C2511———1
Critical illnessD016638—1———1
CarcinomaD002277C80.0—1———1
Nasopharyngeal neoplasmsD009303—1———1
Smoldering multiple myelomaD000075122—1———1
Show 35 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—9———110
Male breast neoplasmsD0185671————1
Breast densityD0000710601————1
Ovarian neoplasmsD010051EFO_0003893C561————1
AgingD000375GO_0007568R41.811————1
Replacement arthroplasty hipD0196441————1
Immunosuppression therapyD0071651————1
Delayed hypersensitivityD0069681————1
Ultraviolet raysD0144661————1
Renal insufficiencyD051437HP_0000083N191————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic kidney failureD007676EFO_0003884N18.6————11
Epidemiology
Epidemiological information for investigational and approved indications
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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
8600
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
Q9P2Q3
Mouse ortholog
Tnfsf11 (21943)
tumor necrosis factor ligand superfamily member 11 (Q9R1Y0)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Xgeva - Amgen
$
€
£
₣
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Prolia - Amgen
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 11,156 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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211 adverse events reported
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