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Drug ReportsSimoctocog alfa
Simoctocog alfa
Nuwiq, Vihuma (simoctocog alfa) is a protein pharmaceutical. Simoctocog alfa was first approved as Nuwiq on 2014-07-22. It is used to treat factor VII deficiency, hemophilia a, hemorrhage, and von willebrand diseases in the USA. It has been approved in Europe to treat hemophilia a.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
hereditary congenital and neonatal diseases and abnormalitiesD009358
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
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Drug Products
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New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Clinical
Clinical Trials
354 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hemophilia aD006467EFO_0007267D66423610549107316
Hemophilia bD002836—D67221111025
Blood coagulation disordersD001778EFO_0009314D68.95163620
Hemostatic disordersD020141——5163620
Von willebrand diseasesD014842EFO_0003910D68.012123219
HemorrhageD006470MP_0001914R58——3339
Hematologic diseasesD006402EFO_0005803D75.9111226
Inherited blood coagulation disordersD025861—————123
RecurrenceD012008—————123
Immune toleranceD007108—————1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Deficiency diseasesD003677EFO_1001067E63——1—12
Hemorrhagic disordersD006474—D69.9——1—12
Bone diseasesD001847—M89.9——1——1
MenorrhagiaD008595EFO_0003945N92.0——1——1
Indications Phases 2
Indication
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Ontology
ICD-10
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Healthy volunteers/patients———41———5
SclerosisD012598———1——34
Genetic therapyD015316——11——12
Systemic sclerodermaD012595EFO_0000717M34.0—1———1
Diffuse sclerodermaD045743EFO_0000404——1———1
GlioblastomaD005909EFO_0000515——1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
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Type 3 von willebrand diseaseD056729Orphanet_166096D68.031———12
Cardiovascular diseasesD002318HP_0001626—1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
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Multiple sclerosisD009103EFO_0003885G35————33
Coagulation protein disordersD020147——————22
Relapsing-remitting multiple sclerosisD020529EFO_0003929—————11
Replacement arthroplastyD019643——————11
Sickle cell anemiaD000755EFO_0000697D57————11
HemolysisD006461——————11
Hemolytic anemiaD000743—D55-D59————11
Inborn genetic diseasesD030342EFO_0000508—————11
X-linked genetic diseasesD040181——————11
Venous thromboembolismD054556EFO_0004286I74————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSimoctocog alfa
INNsimoctocog alfa
Description
Factor VIII is a medication used to treat and prevent bleeding in people with hemophilia A and other causes of low factor VIII. Certain preparations may also be used in those with von Willebrand's disease. It is given by slow injection into a vein.
Classification
Protein
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI1300486
ChEMBL IDCHEMBL2108319
ChEBI ID—
PubChem CID—
DrugBank—
UNII IDP89DR4NY54 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Additional graphs summarizing 146 documents
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Safety
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No Black-box warning
Adverse Events
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56 adverse events reported
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