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 (discontinued: 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
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Ribavirin
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| pegasys | Biologic Licensing Application | 2024-12-23 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
778 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis | D006505 | — | K75.9 | 34 | 193 | 148 | 153 | 98 | 593 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 28 | 162 | 130 | 147 | 89 | 529 |
| Hepatitis c | D006526 | — | B19.2 | 22 | 157 | 130 | 114 | 65 | 463 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 14 | 100 | 95 | 86 | 54 | 333 |
| Chronic hepatitis | D006521 | — | K73.9 | 14 | 58 | 45 | 58 | 28 | 190 |
| Hepatitis b | D006509 | — | — | 14 | 37 | 27 | 51 | 36 | 156 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 14 | 40 | 24 | 52 | 27 | 149 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 7 | 23 | 14 | 11 | 3 | 53 |
| Infections | D007239 | EFO_0000544 | — | 2 | 27 | 9 | 6 | 2 | 44 |
| Leukemia | D007938 | — | C95 | 2 | 14 | 8 | 1 | 1 | 22 |
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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 | — | 3 | 14 | 6 | — | 1 | 20 |
| Melanoma | D008545 | — | — | 2 | 10 | 5 | — | — | 15 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | — | 9 | 8 | — | — | 15 |
| Myeloid leukemia | D007951 | — | C92 | 1 | 9 | 5 | — | — | 12 |
| Polycythemia vera | D011087 | — | D45 | 1 | 2 | 6 | — | — | 9 |
| Polycythemia | D011086 | EFO_0005804 | D75.1 | 1 | 2 | 6 | — | — | 9 |
| Recurrence | D012008 | — | — | 3 | 4 | 3 | — | — | 7 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | 3 | 2 | — | 1 | 6 |
| Essential thrombocythemia | D013920 | — | D47.3 | 1 | 3 | 2 | — | — | 6 |
| Thrombocytosis | D013922 | — | D75.83 | 1 | 3 | 2 | — | — | 6 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 4 | 5 | — | — | — | 5 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 3 | 4 | — | — | — | 4 |
| Herpesviridae infections | D006566 | EFO_0007309 | B00.4 | — | 3 | — | — | — | 3 |
| Hepatitis b virus | D006515 | — | — | 1 | 2 | — | — | 1 | 3 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | 3 | — | — | — | 3 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 1 | — | — | 2 | 3 |
| Squamous cell carcinoma | D002294 | — | — | 1 | 1 | — | — | — | 2 |
| Squamous cell neoplasms | D018307 | — | — | 1 | 1 | — | — | — | 2 |
| Multiple myeloma | D009101 | — | C90.0 | — | 2 | — | — | — | 2 |
| Plasma cell neoplasms | D054219 | — | — | — | 2 | — | — | — | 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 | — | — | — | 8 | — | — | — | 1 | 9 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 2 | — | — | — | — | 2 |
| Sarcoma | D012509 | — | — | 2 | — | — | — | — | 2 |
| Kaposi sarcoma | D012514 | — | C46 | 2 | — | — | — | — | 2 |
| Liver failure | D017093 | — | K72.9 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Alcoholic liver cirrhosis | D008104 | EFO_1000802 | K70.3 | 1 | — | — | — | — | 1 |
| Plexiform neurofibroma | D018318 | EFO_0000658 | — | 1 | — | — | — | — | 1 |
| Neurofibroma | D009455 | EFO_0000622 | — | 1 | — | — | — | — | 1 |
| Hemangiosarcoma | D006394 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | — | — | — | 2 | 2 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | — | — | — | 2 | 2 |
| Intravenous substance abuse | D015819 | — | — | — | — | — | — | 1 | 1 |
| T-cell lymphoma peripheral | D016411 | — | — | — | — | — | — | 1 | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 1 | 1 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 1 | 1 |
| Chronic fatigue syndrome | D015673 | EFO_0004540 | G93.31 | — | — | — | — | 1 | 1 |
| Cognition disorders | D003072 | — | — | — | — | — | — | 1 | 1 |
| Personality disorders | D010554 | — | F60.6 | — | — | — | — | 1 | 1 |
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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) |
Target
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Variants
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Financial
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Trends
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Safety
Black-box Warning
Black-box warning for: Pegasys
Adverse Events
Top Adverse Reactions
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65,345 adverse events reported
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