Pegasys(peginterferon alfa-2a)
Pegasys (peginterferon alfa-2a) is a protein pharmaceutical. Peginterferon alfa-2a was first approved as Pegasys on 2002-06-20. It is used to treat brain neoplasms, chronic hepatitis b, chronic hepatitis c, colorectal neoplasms, and cryoglobulinemia amongst others in the USA. It has been approved in Europe to treat chronic hepatitis b and chronic hepatitis c.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Pegasys
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-2a
Peginterferon alfa-2a
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Ribavirin
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Pegasys Copegus Combination Pack | peginterferon alfa-2a and ribavirin | Hoffmann-La Roche Inc. | N-125083 DISCN | 2004-06-04 | 3 products |
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Indications
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Agency Specific
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Clinical
Clinical Trials
784 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 | 8 | 82 | 78 | 76 | 47 | 281 |
| Hepatitis c | D006526 | — | B19.2 | 9 | 52 | 46 | 28 | 16 | 140 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 13 | 35 | 20 | 48 | 23 | 131 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 9 | 23 | 11 | 8 | 2 | 48 |
| Hepatitis b | D006509 | — | — | — | 6 | 7 | 4 | 8 | 24 |
| Hepacivirus | D016174 | — | — | 2 | 10 | 5 | 2 | 1 | 18 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 3 | 5 | 2 | 7 | 15 |
| Neoplasms | D009369 | — | C80 | 3 | 4 | — | 1 | — | 8 |
| Hiv | D006678 | — | O98.7 | 2 | 1 | — | 3 | 2 | 7 |
| Chronic hepatitis | D006521 | — | K73.9 | 1 | 3 | 2 | 1 | 1 | 7 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 2 | 12 | 6 | — | 2 | 19 |
| Melanoma | D008545 | — | — | 2 | 10 | 4 | — | — | 14 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | — | 7 | 8 | — | — | 13 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | 4 | 3 | — | — | 7 |
| Polycythemia vera | D011087 | — | D45 | 1 | 1 | 5 | — | — | 7 |
| Essential thrombocythemia | D013920 | — | D47.3 | 1 | 2 | 1 | — | — | 4 |
| Primary myelofibrosis | D055728 | — | D47.4 | 2 | 2 | 1 | — | — | 4 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 2 | — | 1 | 4 |
| Recurrence | D012008 | — | — | 1 | 1 | 2 | — | — | 3 |
| Polycythemia | D011086 | EFO_0005804 | D75.1 | — | 1 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | — | 4 | — | — | 1 | 5 |
| Hepatitis d | D003699 | EFO_0007304 | — | — | 3 | — | — | 1 | 4 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 4 | 4 | — | — | — | 4 |
| Hepatitis b virus | D006515 | — | — | 1 | 2 | — | — | 1 | 3 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 1 | — | — | 2 | 3 |
| Kaposi sarcoma | D012514 | — | C46 | 2 | 1 | — | — | — | 3 |
| Squamous cell carcinoma | D002294 | — | — | 1 | 1 | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 2 |
| Multiple myeloma | D009101 | — | C90.0 | — | 2 | — | — | — | 2 |
| T-cell lymphoma | D016399 | — | — | — | 1 | — | — | 1 | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 7 | — | — | — | 1 | 8 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Anus neoplasms | D001005 | EFO_0003835 | C21 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibrosis | D005355 | — | — | — | — | — | — | 2 | 2 |
| Intravenous substance abuse | D015819 | — | — | — | — | — | — | 1 | 1 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 1 | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | — | — | — | 1 | 1 |
| Chronic fatigue syndrome | D015673 | EFO_0004540 | G93.31 | — | — | — | — | 1 | 1 |
| Cognition disorders | D003072 | — | — | — | — | — | — | 1 | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | — | 1 | 1 |
| Ascites | D001201 | HP_0001541 | R18 | — | — | — | — | 1 | 1 |
| Esophageal and gastric varices | D004932 | EFO_0009545 | I85 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Peginterferon alfa-2a |
| INN | peginterferon alfa-2a |
| 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 | CHEMBL1201560 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00008 |
| UNII ID | Q46947FE7K (ChemIDplus, GSRS) |
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Safety
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Adverse Events
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62,323 adverse events reported
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