Nonacog alfa
BeneFIX (nonacog alfa) is a protein pharmaceutical. Nonacog alfa was first approved as Benefix on 1997-08-27. It is used to treat factor VII deficiency, hemophilia a, hemophilia b, and hypoprothrombinemias in the USA. It has been approved in Europe to treat hemophilia b.
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EMA
Brand Name | Status | Last Update |
|---|---|---|
| benefix | Biologic Licensing Application | 2010-12-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hemophilia a | EFO_0007267 | D006467 | D66 |
| hemophilia b | — | D002836 | D67 |
| hypoprothrombinemias | — | D007020 | — |
| factor vii deficiency | HP_0008169 | D005168 | D68.2 |
Agency Specific
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Clinical
Clinical Trials
162 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 a | D006467 | EFO_0007267 | D66 | 32 | 25 | 45 | 14 | 46 | 145 |
| Hemophilia b | D002836 | — | D67 | 29 | 26 | 42 | 11 | 40 | 130 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | 1 | — | 3 | 2 | 1 | 7 |
| Hemostatic disorders | D020141 | — | — | 1 | — | 3 | 2 | 1 | 7 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | 2 | 3 | — | 5 |
| Cardiac surgical procedures | D006348 | — | — | — | — | — | 2 | — | 2 |
| Joint diseases | D007592 | HP_0003040 | M12.9 | — | — | — | 1 | 1 | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | 1 | — | 1 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | — | 1 | — | 1 |
| Hemarthrosis | D006395 | EFO_1001344 | M25.0 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | — | 1 | — | — | 1 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | — | 1 | — | — | 1 |
| Hemorrhagic disorders | D006474 | — | D69.9 | — | — | 1 | — | — | 1 |
| Hemorrhagic shock | D012771 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Thrombosis | D013927 | — | — | 1 | 1 | — | — | — | 2 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | 1 | — | — | — | 1 |
| Embolism | D004617 | — | — | — | 1 | — | — | — | 1 |
| Thromboembolism | D013923 | HP_0001907 | — | — | 1 | — | — | — | 1 |
| Embolism and thrombosis | D016769 | — | — | — | 1 | — | — | — | 1 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | 1 | — | — | — | 1 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | 1 | — | — | — | 1 |
| Transsexualism | D014189 | — | F64.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Menorrhagia | D008595 | EFO_0003945 | N92.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | — | — | — | 2 | 2 |
| Mucopolysaccharidoses | D009083 | — | E76.3 | — | — | — | — | 1 | 1 |
| Mucopolysaccharidosis i | D008059 | — | E76.0 | — | — | — | — | 1 | 1 |
| Mucopolysaccharidosis ii | D016532 | — | E76.1 | — | — | — | — | 1 | 1 |
| Liver transplantation | D016031 | EFO_0010682 | — | — | — | — | — | 1 | 1 |
| Von willebrand diseases | D014842 | EFO_0003910 | D68.0 | — | — | — | — | 1 | 1 |
| Hemostasis | D006487 | — | — | — | — | — | — | 1 | 1 |
| Genetic therapy | D015316 | — | — | — | — | — | — | 1 | 1 |
| Osteoporosis | D010024 | HP_0000939 | M81.0 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Nonacog alfa |
| INN | nonacog alfa |
| Description | BeneFIX (nonacog alfa) is a protein pharmaceutical. Nonacog alfa was first approved as Benefix on 1997-08-27. It is used to treat factor vii deficiency, hemophilia a, hemophilia b, and hypoprothrombinemias in the USA. It has been approved in Europe to treat hemophilia b. |
| Classification | Protein |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2109205 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | 382L14738L (ChemIDplus, GSRS) |
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Benefix – Pfizer
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Additional graphs summarizing 282 documents
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Safety
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3,767 adverse events reported
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