Mircera(methoxy polyethylene glycol-epoetin beta)
Mircera (methoxy polyethylene glycol-epoetin beta) is a protein pharmaceutical. Methoxy polyethylene glycol-epoetin beta was first approved as Mircera on 2007-07-20. It is used to treat anemia in the USA. It has been approved in Europe to treat anemia and chronic kidney failure.
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Commercial
Therapeutic Areas
Trade Name
FDA
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Mircera (discontinued: Mircera)
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 |
|---|---|---|
| mircera | Biologic Licensing Application | 2024-06-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| anemia | HP_0001903 | D000740 | D64.9 |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
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Clinical
Clinical Trials
117 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anemia | D000740 | HP_0001903 | D64.9 | 1 | 7 | 41 | 12 | 16 | 76 |
| Chronic renal insufficiency | D051436 | — | N18 | — | 3 | 10 | 5 | 13 | 31 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 3 | 9 | 4 | 14 | 30 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | 1 | — | 1 | 1 | 3 |
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | — | — | — | 1 | — | 1 |
| Kidney transplantation | D016030 | — | — | — | — | — | 1 | — | 1 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acidosis | D000138 | EFO_1000014 | E87.2 | — | — | — | — | 1 | 1 |
| Hemolytic anemia | D000743 | — | D55-D59 | — | — | — | — | 1 | 1 |
| Renal tubular acidosis | D000141 | — | N25.89 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Methoxy polyethylene glycol-epoetin beta |
| INN | — |
| Description | Methoxy polyethylene glycol-epoetin beta, sold under the brand name Mircera, is a long-acting erythropoietin receptor activator (CERA) used for the treatment of anaemia associated with chronic kidney disease. It is the first approved, chemically modified erythropoiesis-stimulating agent (ESA).
|
| Classification | Protein |
| Drug class | erythropoietins |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3707314 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB09107 |
| UNII ID | — |
Target
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Variants
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Financial
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Mircera – Roche
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PubMed Central
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Additional graphs summarizing 345 documents
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Safety
Black-box Warning
Black-box warning for: Mircera
Adverse Events
Top Adverse Reactions
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9,927 adverse events reported
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