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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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| neoplasms | D009369 |
| digestive system diseases | D004066 |
| nervous system diseases | D009422 |
| eye diseases | D005128 |
| urogenital diseases | D000091642 |
| cardiovascular diseases | D002318 |
| hemic and lymphatic diseases | D006425 |
| skin and connective tissue diseases | D017437 |
| immune system diseases | D007154 |
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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
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Pegasys | peginterferon alfa-2a | Pharma& | N-103964 RX | 2002-10-16 | 2 products |
Show 1 discontinued
Peginterferon alfa-2a
+
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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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| pegasys | Biologic Licensing Application | 2019-11-08 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| brain neoplasms | EFO_0003833 | D001932 | C71 |
| chronic hepatitis b | EFO_0004239 | D019694 | B18.1 |
| chronic hepatitis c | EFO_0004220 | D019698 | B18.2 |
| colorectal neoplasms | — | D015179 | — |
| cryoglobulinemia | EFO_0005846 | D003449 | D89.1 |
| essential thrombocythemia | — | D013920 | D47.3 |
| hairy cell leukemia | — | D007943 | C91.4 |
| hemangioma | — | D006391 | D18.0 |
| hepatitis d | EFO_0007304 | D003699 | — |
| hepatocellular carcinoma | — | D006528 | C22.0 |
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Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
715 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 | 72 | 87 | 67 | 54 | 278 |
| Hepatitis c | D006526 | B19.2 | 6 | 36 | 42 | 23 | 25 | 125 | |
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | 12 | 29 | 20 | 49 | 17 | 120 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 10 | 25 | 11 | 7 | 3 | 50 |
| Hepatitis b | D006509 | — | 5 | 5 | 3 | 8 | 20 | ||
| Hepacivirus | D016174 | — | 8 | 5 | 2 | 6 | 19 | ||
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 2 | 11 | 1 | 6 | 18 |
| Neoplasms | D009369 | C80 | 5 | 4 | — | 1 | — | 10 | |
| Chronic hepatitis | D006521 | K73.9 | 2 | 4 | 3 | 1 | — | 8 | |
| Chronic hepatitis d | D019701 | — | 3 | 3 | 1 | — | 7 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Melanoma | D008545 | 5 | 10 | 4 | — | 1 | 18 | ||
| Renal cell carcinoma | D002292 | 2 | 8 | 3 | — | 1 | 11 | ||
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 1 | 4 | 5 | — | — | 8 | |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 2 | 5 | 1 | — | — | 7 |
| Polycythemia vera | D011087 | D45 | 1 | 1 | 4 | — | — | 6 | |
| Infections | D007239 | EFO_0000544 | — | 1 | 2 | — | 1 | 4 | |
| Fibrosis | D005355 | — | 1 | 1 | — | 2 | 4 | ||
| Primary myelofibrosis | D055728 | D47.4 | 1 | 1 | 1 | — | — | 3 | |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis d | D003699 | EFO_0007304 | — | 3 | — | — | — | 3 | |
| Kaposi sarcoma | D012514 | C46 | 2 | 1 | — | — | — | 3 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 2 |
| Leukemia | D007938 | C95 | — | 2 | — | — | — | 2 | |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | 2 | — | — | — | 2 |
| Fallopian tube neoplasms | D005185 | 1 | 2 | — | — | — | 2 | ||
| Uveal neoplasms | D014604 | EFO_1001230 | — | 2 | — | — | — | 2 | |
| Adenocarcinoma | D000230 | — | 1 | — | — | — | 1 | ||
| Squamous cell carcinoma | D002294 | — | 1 | — | — | — | 1 | ||
| Squamous cell neoplasms | D018307 | — | 1 | — | — | — | 1 |
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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 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Intravenous substance abuse | D015819 | — | — | — | — | 1 | 1 | ||
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | 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 | 198153-51-4 |
| RxCUI | 120608 |
| ChEMBL ID | CHEMBL1201560 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00008 |
| UNII ID | Q46947FE7K (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
Identifier | Target mutation | Effect | Evaluation | Status |
|---|---|---|---|---|
| VCV000225949 | IFNL4, 151-152G>A | drug response | 2021-03-24 | 1A |
| VCV000226027 | IFNL3 | drug response | 2021-03-29 | 1B |
| VCV000375658 | IFNL3, 259-126T>C | drug response | 2021-03-24 | 2A |
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,231 documents
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Safety
Black-box Warning
Black-box warning for: Pegasys
Adverse Events
Top Adverse Reactions
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66,789 adverse events reported
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