Betaseron, Betaferon(interferon beta-1b)
Betaferon, Betaseron, Extavia (interferon beta-1b) is a protein pharmaceutical. Interferon beta-1b was first approved as Betaseron on 1993-07-23. It is used to treat multiple sclerosis in the USA. It has been approved in Europe to treat multiple sclerosis.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Betaseron (discontinued: Extavia)
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| betaseron | Biologic Licensing Application | 2023-07-28 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| multiple sclerosis | EFO_0003885 | D009103 | G35 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1830 | Injection, interferon beta-1b, 0.25 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered) |
Clinical
Clinical Trials
99 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 2 | 17 | 9 | 17 | 44 | 87 |
| Sclerosis | D012598 | — | — | 1 | 14 | 8 | 16 | 39 | 77 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 8 | 4 | 12 | 12 | 36 |
| Neurobehavioral manifestations | D019954 | EFO_0004364 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | 3 | 2 | — | — | 3 |
| Chronic progressive multiple sclerosis | D020528 | EFO_0003840 | — | — | — | 1 | — | 2 | 3 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | 1 | — | 1 | 3 |
| Severe acute respiratory syndrome-related coronavirus | D045473 | NCBITaxon_227859 | — | — | 1 | 1 | — | — | 1 |
| Neuritis | D009443 | — | — | — | 1 | 1 | — | — | 1 |
| Optic neuritis | D009902 | EFO_0007405 | H46 | — | 1 | 1 | — | — | 1 |
| Middle east respiratory syndrome coronavirus | D065207 | — | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | — | — | 6 | — | — | — | 6 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | — | — | 1 | 2 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | — | — | — | 1 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcoma | D012509 | — | — | 1 | — | — | — | — | 1 |
| Kaposi sarcoma | D012514 | — | C46 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Injection site reaction | D000075662 | — | — | — | — | — | — | 1 | 1 |
| Metabolic bone diseases | D001851 | HP_0000938 | — | — | — | — | — | 1 | 1 |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | — | 1 | 1 |
| Depression | D003863 | — | F33.9 | — | — | — | — | 1 | 1 |
| Atrophy | D001284 | — | — | — | — | — | — | 1 | 1 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | — | — | — | 1 | 1 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | — | — | 1 | 1 |
| Cytomegalovirus retinitis | D017726 | EFO_1001302 | — | — | — | — | — | 1 | 1 |
| Retinitis | D012173 | — | H30.9 | — | — | — | — | 1 | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Interferon beta-1b |
| INN | — |
| Description | Interferon beta precursor (IFN-beta) (Fibroblast interferon) |
| Classification | Protein |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201563 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00068 |
| UNII ID | — |
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,080 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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31,787 adverse events reported
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