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Drug ReportsMoroctocog alfa
Moroctocog alfa
ReFacto (moroctocog alfa) is a protein pharmaceutical. Moroctocog alfa was first approved as Refacto af on 1999-04-13. 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
Trade Name
FDA
EMA
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Drug Products
FDA
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New Drug Application (NDA)
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Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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xynthaBiologic Licensing Application2011-01-13
Indications
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Clinical
Clinical Trials
400 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_0007267D66463811452121347
Blood coagulation disordersD001778EFO_0009314D68.9511231131
Hemophilia bD002836D67221221128
Hemostatic disordersD0201414283824
Von willebrand diseasesD014842EFO_0003910D68.012143322
HemorrhageD006470MP_0001914R5843714
Hematologic diseasesD006402EFO_0005803D75.91132511
Coagulation protein disordersD020147141410
Inherited blood coagulation disordersD0258612158
RecurrenceD012008123
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hemorrhagic disordersD006474D69.9336
Inborn genetic diseasesD030342EFO_0000508235
Type 3 von willebrand diseaseD056729Orphanet_166096D68.031124
X-linked genetic diseasesD040181112
Bone diseasesD001847M89.911
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients415
Genetic therapyD0153161112
Systemic sclerodermaD012595EFO_0000717M3411
Raynaud diseaseD011928EFO_1001145I73.011
Brain neoplasmsD001932EFO_0003833C7111
GlioblastomaD005909EFO_000051511
HemostasisD00648711
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
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Total
MenorrhagiaD008595EFO_0003945N92.0112
Cardiovascular diseasesD002318EFO_0000319I9811
Factor vii deficiencyD005168D68.211
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple sclerosisD009103EFO_0003885G3533
SclerosisD01259833
ThrombosisD01392733
Motor activityD009043EFO_000394022
Postpartum hemorrhageD006473O7222
InfertilityD007246EFO_000054522
Pregnancy complicationsD01124822
Breast neoplasmsD001943EFO_0003869C5011
SeromaD04929111
Relapsing-remitting multiple sclerosisD020529EFO_000392911
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMoroctocog alfa
INNmoroctocog alfa
Description
Moroctocog alfa (trade name ReFacto in the EU) is a recombinant antihemophilic factor genetically engineered from Chinese hamster ovary (CHO) cell line. Chemically it is a glycoprotein. It is manufactured by Genetics Institute, Inc. and used to control and prevent hemorrhagic bleeding and prophylaxis associated with surgery or to reduce the number of spontaneous bleeding episodes in patients with hemophilia A. It is partially a recombinant coagulation factor VIII since it has an amino acid sequence which compares to the 90 + 80 kDa form of factor VIII (BDDrFVIII). It also has posttranslational modifications which are similar to those of the plasma-derived molecule. It can not prevent hemorrhagic bleeding associated with von Willebrand's disease since it is not a von Willebrand factor.
Classification
Protein
Drug class
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID
RxCUI
ChEMBL IDCHEMBL2109137
ChEBI ID
PubChem CID
DrugBankDB13999
UNII ID113E3Z3CJJ (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Refacto Pfizer
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PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 454 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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3,295 adverse events reported
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