Alteplase
Activase (alteplase) is an enzyme pharmaceutical. Alteplase was first approved as Activase on 1987-11-13. It is used to treat arterial occlusive diseases, intracranial embolism and thrombosis, myocardial infarction, pulmonary embolism, and stroke in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Cathflo activase
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 |
|---|---|---|
| activase | Biologic Licensing Application | 2024-11-19 |
| cathflo activase | Biologic Licensing Application | 2024-11-19 |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
Code | Description |
|---|---|
| J2997 | Injection, alteplase recombinant, 1 mg |
Clinical
Clinical Trials
509 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pleural effusion | D010996 | — | J90 | — | — | — | 1 | 2 | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 4 | 1 | — | 3 | 8 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 2 | 2 | — | — | 4 |
| Cerebral hemorrhage | D002543 | — | — | — | 2 | 2 | — | — | 4 |
| Thrombosis | D013927 | — | — | 1 | — | 2 | — | — | 3 |
| Venous thrombosis | D020246 | — | I82.40 | — | — | 2 | — | — | 2 |
| Syndrome | D013577 | — | — | — | 1 | 1 | — | — | 2 |
| Postphlebitic syndrome | D011186 | — | I87.0 | — | — | 2 | — | — | 2 |
| Postthrombotic syndrome | D054070 | EFO_0007452 | I87.0 | — | — | 2 | — | — | 2 |
| Cerebral intraventricular hemorrhage | D000074042 | — | — | — | 1 | 1 | — | — | 2 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemic stroke | D000083242 | — | — | — | 1 | — | — | 2 | 3 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | — | — | — | 1 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 1 | — | — | — | 1 |
| Respiratory insufficiency | D012131 | — | J96.9 | — | 1 | — | — | — | 1 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | — | 1 | — | — | — | 1 |
| Acute lung injury | D055371 | EFO_0004610 | — | — | 1 | — | — | — | 1 |
| Newborn respiratory distress syndrome | D012127 | — | P22 | — | 1 | — | — | — | 1 |
| Protein-losing enteropathies | D011504 | — | — | — | 1 | — | — | — | 1 |
| Bronchitis | D001991 | — | J40 | — | 1 | — | — | — | 1 |
| Acute disease | D000208 | — | — | — | 1 | — | — | — | 1 |
Show 3 more
Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemia | D007511 | EFO_0000556 | — | — | — | — | — | 2 | 2 |
| Cerebral infarction | D002544 | — | I63 | — | — | — | — | 2 | 2 |
| Empyema | D004653 | EFO_0003097 | — | — | — | — | — | 2 | 2 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Alteplase |
| INN | alteplase |
| Description | Alteplase (t-PA) is a thrombolytic medication, used to treat acute ischemic stroke, acute ST-elevation myocardial infarction (a type of heart attack), pulmonary embolism associated with low blood pressure, and blocked central venous catheter. It is given by injection into a vein or artery. Alteplase is the same as the normal human plasminogen activator produced in vascular endothelial cells and is synthesized via recombinant DNA technology in Chinese hamster ovary cells (CHO). Alteplase causes the breakdown of a clot by inducing fibrinolysis.
|
| Classification | Enzyme |
| Drug class | enzymes: tissue-type plasminogen activators |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
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Trends
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Safety
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19,972 adverse events reported
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