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
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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 | 2025-05-08 |
| 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
562 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 | 1 | 1 | 2 | 4 |
| Covid-19 | D000086382 | — | U07.1 | — | 2 | — | 1 | — | 3 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 1 | — | 1 | — | 2 |
| Infarction | D007238 | EFO_0009463 | — | — | 1 | — | 1 | — | 2 |
| Pulmonary embolism | D011655 | EFO_0003827 | I26 | — | — | — | 1 | — | 1 |
| Embolism | D004617 | — | — | — | — | — | 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 | 1 | 3 | 1 | — | 2 | 7 |
| Thrombosis | D013927 | — | — | 1 | — | 3 | — | — | 4 |
| Venous thrombosis | D020246 | — | I82.40 | — | — | 2 | — | — | 2 |
| Postthrombotic syndrome | D054070 | EFO_0007452 | I87.0 | — | — | 2 | — | — | 2 |
| Cerebral hemorrhage | D002543 | — | — | — | 1 | 1 | — | — | 2 |
| Cerebral intraventricular hemorrhage | D000074042 | — | — | — | 1 | 1 | — | — | 2 |
| Central venous catheters | D062905 | — | — | — | — | 2 | — | — | 2 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | — | 1 | — | — | 1 |
| Postphlebitic syndrome | D011186 | — | I87.0 | — | — | 1 | — | — | 1 |
| Intracranial hemorrhages | D020300 | EFO_0000551 | I62 | — | — | 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 | 1 | — | — | 2 | 4 |
| Respiratory insufficiency | D012131 | — | J96.9 | — | 2 | — | — | — | 2 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | 1 | 1 | — | — | — | 2 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | — | 1 | — | — | — | 1 |
| Congenital heart defects | D006330 | — | Q24.9 | — | 1 | — | — | — | 1 |
| Protein-losing enteropathies | D011504 | — | — | — | 1 | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | — | 1 | — | — | — | 1 |
| Abscess | D000038 | EFO_0003030 | — | — | 1 | — | — | — | 1 |
| Abdominal abscess | D018784 | EFO_1001753 | — | — | 1 | — | — | — | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 1 | — | — | — | 1 |
Show 2 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemia | D007511 | EFO_0000556 | — | 1 | — | — | — | 2 | 3 |
| Cerebral infarction | D002544 | — | I63 | 1 | — | — | — | 1 | 2 |
| Acute lung injury | D055371 | EFO_0004610 | — | 1 | — | — | — | — | 1 |
| Newborn respiratory distress syndrome | D012127 | — | P22 | 1 | — | — | — | — | 1 |
| Syndrome | D013577 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Empyema | D004653 | EFO_0003097 | — | — | — | — | — | 2 | 2 |
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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20,207 adverse events reported
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