Retavase, Ecokinase(reteplase)
Rapilysin, Retavase (reteplase) is an enzyme pharmaceutical. Reteplase was first approved as Rapilysin on 1996-08-29. It is used to treat myocardial infarction and ventricular dysfunction in the USA. It has been approved in Europe to treat myocardial infarction.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Retavase
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)
Reteplase
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Retavase | reteplase | Chiesi Farmaceutici | N-103786 RX | 1996-10-30 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| retavase | Biologic Licensing Application | 2024-09-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myocardial infarction | EFO_0000612 | D009203 | I21 |
| ventricular dysfunction | — | D018754 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J2993 | Injection, reteplase, 18.1 mg |
Clinical
Clinical Trials
12 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 3 | 2 | — | 5 |
| Infarction | D007238 | EFO_0009463 | — | — | — | 3 | 2 | — | 5 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | — | — | 2 | — | 2 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 3 | 1 | — | — | 4 |
| Ischemic stroke | D000083242 | — | — | — | 1 | 1 | — | — | 2 |
| St elevation myocardial infarction | D000072657 | — | — | — | — | 1 | — | — | 1 |
| Thrombosis | D013927 | — | — | — | — | 1 | — | — | 1 |
| Catheter obstruction | D061807 | — | — | — | — | 1 | — | — | 1 |
| Ischemia | D007511 | EFO_0000556 | — | — | — | 1 | — | — | 1 |
| Cerebral infarction | D002544 | — | I63 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary embolism | D011655 | HP_0002204 | I26 | — | 1 | — | — | — | 1 |
| Embolism | D004617 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Reteplase |
| INN | reteplase |
| Description | Reteplase, trade names include Retavase, is a thrombolytic drug, used to treat heart attacks by breaking up the clots that cause them.
|
| Classification | Enzyme |
| Drug class | enzymes: tissue-type plasminogen activators |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2107885 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00015 |
| UNII ID | DQA630RIE9 (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,029 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,217 adverse events reported
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