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 | 2026-01-20 |
| cathflo activase | Biologic Licensing Application | 2026-01-20 |
Indications
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Agency Specific
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ATC Codes
B: Blood and blood forming organ drugs
— B01: Antithrombotic agents
— B01A: Antithrombotic agents
— B01AD: Enzymes, antithrombotic
— B01AD02: Alteplase
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01X: Other ophthalmologicals in atc
— S01XA: Other ophthalmologicals in atc
— S01XA13: Alteplase
HCPCS
Code | Description |
|---|---|
| J2997 | Injection, alteplase recombinant, 1 mg |
Clinical
Clinical Trials
582 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemic stroke | D000083242 | — | — | 16 | 60 | 73 | 22 | 66 | 216 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 19 | 54 | 57 | 16 | 89 | 216 |
| Ischemia | D007511 | EFO_0000556 | — | 9 | 16 | 17 | 6 | 36 | 78 |
| Cerebral infarction | D002544 | — | I63 | 5 | 13 | 13 | 4 | 16 | 45 |
| Thrombosis | D013927 | — | — | 3 | 4 | 12 | 8 | 18 | 44 |
| Pulmonary embolism | D011655 | EFO_0003827 | I26 | 1 | 4 | 12 | 10 | 14 | 41 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 3 | 13 | 5 | 7 | 27 |
| Embolism | D004617 | — | — | 2 | 1 | 6 | 3 | 12 | 24 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 2 | 2 | 4 | 1 | 14 | 22 |
| Infarction | D007238 | EFO_0009463 | — | — | 3 | 5 | 6 | 7 | 20 |
Show 33 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cerebral hemorrhage | D002543 | — | — | 2 | 4 | 3 | — | 8 | 16 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 3 | — | 7 | 10 |
| Intracranial hemorrhages | D020300 | EFO_0000551 | I62 | 1 | 1 | 2 | — | 4 | 8 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 3 | 4 | — | 1 | 7 |
| Arterial occlusive diseases | D001157 | EFO_0009085 | — | — | — | 1 | — | 6 | 7 |
| Cerebral intraventricular hemorrhage | D000074042 | — | — | 1 | 2 | 1 | — | 3 | 7 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | 2 | 1 | — | 4 | 6 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 4 | — | 2 | 6 |
| Retinal artery occlusion | D015356 | EFO_1001154 | H34.1 | — | — | 3 | — | 2 | 5 |
| Nervous system diseases | D009422 | — | G00-G99 | — | 3 | 1 | — | 2 | 5 |
Show 50 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 2 | 2 | — | — | — | 3 |
| Respiratory insufficiency | D012131 | — | J96.9 | — | 3 | — | — | — | 3 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | — | — | 2 | 3 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | — | — | 2 | 3 |
| Myelodysplastic syndromes | D009190 | — | D46 | 2 | 1 | — | — | — | 2 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 2 | 1 | — | — | — | 2 |
| Healthy volunteers/patients | — | — | — | 1 | 1 | — | — | — | 2 |
| Lung neoplasms | D008175 | — | C34.90 | — | 2 | — | — | — | 2 |
| Hypertensive intracranial hemorrhage | D020299 | — | — | — | 1 | — | — | 1 | 2 |
| Communicable diseases | D003141 | — | — | — | 1 | — | — | 1 | 2 |
Show 31 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronary artery disease | D003324 | — | I25.1 | 1 | — | — | — | 2 | 3 |
| Macular edema | D008269 | — | — | 1 | — | — | — | 1 | 2 |
| Retinal vein occlusion | D012170 | EFO_1001157 | H34.81 | 2 | — | — | — | — | 2 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | 1 | — | — | — | 1 | 2 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | — | — | — | — | 1 |
| Rectal neoplasms | D012004 | — | — | 1 | — | — | — | — | 1 |
| Malignant pleural effusion | D016066 | — | J91.0 | 1 | — | — | — | — | 1 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | — | — | — | — | 1 |
| Thrombophlebitis | D013924 | — | — | 1 | — | — | — | — | 1 |
| Glaucoma | D005901 | EFO_0000516 | H40 | 1 | — | — | — | — | 1 |
Show 49 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemostatic disorders | D020141 | — | — | — | — | — | — | 6 | 6 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | — | — | 4 | 4 |
| Thrombolytic therapy | D015912 | — | — | — | — | — | — | 4 | 4 |
| Thrombotic stroke | D000083244 | — | — | — | — | — | — | 4 | 4 |
| Fibrinolysis | D005342 | — | — | — | — | — | — | 3 | 3 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | — | — | 3 | 3 |
| Toxemia | D014115 | — | — | — | — | — | — | 3 | 3 |
| Basal ganglia hemorrhage | D020145 | — | — | — | — | — | — | 3 | 3 |
| Transient ischemic attack | D002546 | EFO_0003764 | G45.9 | — | — | — | — | 3 | 3 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 3 | 3 |
Show 81 more
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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Safety
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20,285 adverse events reported
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