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AboutPricing
Drug ReportsDenosumab
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
Clinical
Drug
Target
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Financial
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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
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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
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)
Denosumab
Tradename
Proper name
Company
Number
Date
Products
ProliadenosumabAmgenN-125320 RX2010-06-01
1 products
XgevadenosumabAmgenN-125320 RX2010-11-18
1 products
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
proliaBiologic Licensing Application2024-03-08
xgevaBiologic Licensing Application2024-01-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
postmenopausal osteoporosisEFO_0003854D015663—
osteoporotic fractures—D058866—
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
318 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
OsteoporosisD010024HP_0000939M81.0——1——1
Postmenopausal osteoporosisD015663EFO_0003854———1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
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)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
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
No data
Financial
Revenue by drug
$
€
£
â‚£
Prolia – Amgen
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Xgeva – Amgen
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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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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 14,194 documents
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Safety
Black-box Warning
Black-box warning for: Prolia
Adverse Events
Top Adverse Reactions
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164,926 adverse events reported
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