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Drug ReportsNonacog beta pegol
Nonacog beta pegol
Refixia (nonacog beta pegol) is a protein pharmaceutical. Nonacog beta pegol was first approved as Refixia on 2017-06-02. It has been approved in Europe to treat hemophilia b.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
rebinynBiologic Licensing Application2022-08-11
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hemophilia b—D002836D67
Agency Specific
FDA
EMA
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Patent Expiration
No data
ATC Codes
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HCPCS
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Clinical
Clinical Trials
13 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
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Total
Hemophilia aD006467EFO_0007267D662—6—412
Hemophilia bD002836—D672—6—412
Blood coagulation disordersD001778EFO_0009314D68.92—5—18
Hemostatic disordersD020141——2—5—18
HemorrhageD006470MP_0001914R58——2—13
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ThrombosisD013927——————11
ThrombophiliaD019851—D68.59————11
Connective tissue diseasesD003240EFO_1001986M35————11
Hematologic diseasesD006402EFO_0005803D75.9————11
Sickle cell anemiaD000755EFO_0000697D57————11
Blood platelet disordersD001791——————11
Von willebrand diseasesD014842EFO_0003910D68.0————11
ThalassemiaD013789EFO_1001996D56————11
Hemorrhagic disordersD006474—D69.9————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNonacog beta pegol
INNnonacog beta pegol
Description
Factor IX (or Christmas factor) (EC 3.4.21.22) is one of the serine proteases of the coagulation system; it belongs to peptidase family S1. Deficiency of this protein causes haemophilia B. It was discovered in 1952 after a young boy named Stephen Christmas was found to be lacking this exact factor, leading to haemophilia.
Classification
Protein
Drug classPEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL2108348
ChEBI ID—
PubChem CID—
DrugBank—
UNII ID27Y83O992Q (ChemIDplus, GSRS)
Target
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Variants
No data
Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 169 documents
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Safety
Black-box Warning
No Black-box warning
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17 adverse events reported
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