Pegintron(peginterferon alfa-2b)
PegIntron, PegIntron/ Rebetol Combo Pack, Sylatron, ViraferonPeg (peginterferon alfa-2b) is a protein pharmaceutical. Peginterferon alfa-2b was first approved as Pegintron on 2000-05-24. It is used to treat brain neoplasms, chronic hepatitis c, colorectal neoplasms, cryoglobulinemia, and essential thrombocythemia amongst others in the USA. It has been approved in Europe to treat chronic hepatitis c. The pharmaceutical is active against interferon alpha/beta receptor 1.
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Commercial
Therapeutic Areas
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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)
Peginterferon alfa-2b
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Sylatron | peginterferon alfa-2b | Merck Sharp & Dohme | N-103949 DISCN | 2011-03-29 | 3 products |
| Pegintron | peginterferon alfa-2b | Merck Sharp & Dohme | N-103949 DISCN | 2001-01-19 | 8 products |
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Peginterferon alfa-2b
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Ribavirin
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| PegIntron/ Rebetol Combo Pack | peginterferon alfa-2b and ribavirin | Merck Sharp & Dohme | N-125196 DISCN | 2008-06-13 | 4 products |
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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 |
|---|---|---|---|---|---|---|---|---|---|
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 4 | 29 | 47 | 21 | 45 | 141 |
| Hepatitis c | D006526 | — | B19.2 | 5 | 15 | 21 | 11 | 24 | 70 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 1 | 3 | 11 | 12 | 7 | 33 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 4 | 9 | 5 | 3 | 3 | 22 |
| Hepacivirus | D016174 | — | — | — | 2 | 1 | 3 | 7 | 12 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | 8 | 1 | 2 | 11 |
| Hepatitis b | D006509 | — | — | — | — | 1 | 1 | 5 | 7 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | — | 2 | 4 | 1 | — | 6 |
| Hiv | D006678 | — | O98.7 | 1 | 1 | — | 2 | — | 4 |
| Fibrosis | D005355 | — | — | — | 1 | 1 | 1 | — | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Melanoma | D008545 | — | — | 10 | 12 | 3 | — | 1 | 22 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | 6 | 3 | — | — | 9 |
| Polycythemia vera | D011087 | — | D45 | 1 | 1 | 4 | — | — | 5 |
| Chronic hepatitis | D006521 | — | K73.9 | 2 | 2 | 1 | — | — | 4 |
| Essential thrombocythemia | D013920 | — | D47.3 | — | 2 | 1 | — | — | 3 |
| Primary myelofibrosis | D055728 | — | D47.4 | — | 2 | 1 | — | — | 3 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | 1 | — | 1 | 2 |
| Depression | D003863 | — | F33.9 | — | — | 1 | — | 1 | 2 |
| Coinfection | D060085 | — | — | — | — | 2 | — | — | 2 |
| Experimental liver cirrhosis | D008106 | — | — | — | 2 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 5 | 1 | — | — | — | 6 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | 3 | — | — | — | 4 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 4 | 3 | — | — | — | 4 |
| Myeloid leukemia chronic-phase | D015466 | — | — | 1 | 2 | — | — | — | 3 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 3 | 3 | — | — | — | 3 |
| Uveal neoplasms | D014604 | EFO_1001230 | — | — | 2 | — | — | 1 | 3 |
| Leukemia | D007938 | — | C95 | — | 2 | — | — | — | 2 |
| Fallopian tube neoplasms | D005185 | — | — | 2 | 1 | — | — | — | 2 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | 1 | — | — | 1 | 2 |
| Squamous cell carcinoma | D002294 | — | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | — | — | 2 | 2 |
| Intravenous substance abuse | D015819 | — | — | — | — | — | — | 1 | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | — | — | — | 1 | 1 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | — | 1 | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | — | 1 | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | — | — | — | 1 | 1 |
| Up-regulation | D015854 | — | — | — | — | — | — | 1 | 1 |
| Virus diseases | D014777 | — | B34 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Peginterferon alfa-2b |
| INN | peginterferon alfa-2b |
| Description | Interferon alpha-2 precursor (Interferon alpha-A) (LeIF A) |
| Classification | Protein |
| Drug class | PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201561 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00022 |
| UNII ID | G8RGG88B68 (ChemIDplus, GSRS) |
Target
Agency Approved
IFNAR1
IFNAR1
Organism
Homo sapiens
Gene name
IFNAR1
Gene synonyms
IFNAR
NCBI Gene ID
Protein name
interferon alpha/beta receptor 1
Protein synonyms
alpha-type antiviral protein, beta-type antiviral protein, CRF2-1, Cytokine receptor class-II member 1, Cytokine receptor family 2 member 1, IFN-alpha/beta receptor 1, IFN-R-1, IFNalpha/beta receptor 1, interferon (alpha, beta and omega) receptor 1, interferon receptor 1, interferon-alpha/beta receptor alpha chain, interferon-beta receptor 1, Type I interferon receptor 1
Uniprot ID
Mouse ortholog
Ifnar1 (15975)
interferon alpha/beta receptor 1 (Q80UJ3)
Alternate
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Variants
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Financial
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Trends
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Safety
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Adverse Events
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26,725 adverse events reported
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