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 |
Indications
FDA
EMA
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
511 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stroke | D020521 | EFO_0000712 | I63.9 | 21 | 62 | 61 | 18 | 97 | 239 |
| Ischemic stroke | D000083242 | — | — | 18 | 52 | 52 | 19 | 69 | 194 |
| Ischemia | D007511 | EFO_0000556 | — | 8 | 25 | 32 | 7 | 44 | 108 |
| Cerebral infarction | D002544 | — | I63 | 5 | 20 | 21 | 4 | 24 | 66 |
| Embolism | D004617 | — | — | 2 | 3 | 11 | 9 | 15 | 40 |
| Thrombosis | D013927 | — | — | 3 | 3 | 9 | 10 | 16 | 40 |
| Pulmonary embolism | D011655 | EFO_0003827 | I26 | 1 | 3 | 10 | 9 | 12 | 35 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 3 | 8 | 8 | 1 | 15 | 32 |
| Infarction | D007238 | EFO_0009463 | — | — | 3 | 13 | 9 | 6 | 31 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 1 | 12 | 4 | 5 | 22 |
Show 36 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 | — | 6 | 15 |
| Arterial occlusive diseases | D001157 | EFO_0009085 | — | — | 2 | 5 | — | 7 | 13 |
| Brain ischemia | D002545 | EFO_0003883 | I67.82 | 1 | 2 | 2 | — | 4 | 8 |
| Cerebral intraventricular hemorrhage | D000074042 | — | — | 1 | 2 | 1 | — | 3 | 7 |
| Covid-19 | D000086382 | — | U07.1 | — | 2 | 1 | — | 3 | 6 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | 1 | 3 | — | 1 | 6 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | 1 | — | 3 | — | 2 | 6 |
| Intracranial hemorrhages | D020300 | EFO_0000551 | I62 | 1 | — | 1 | — | 3 | 5 |
| Retinal artery occlusion | D015356 | EFO_1001154 | H34.1 | — | — | 2 | — | 2 | 4 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | 1 | 2 | — | 2 | 4 |
Show 40 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | MP_0001845 | — | — | 2 | — | — | 2 | 4 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | 1 | — | — | 3 | 4 |
| Adenocarcinoma | D000230 | — | — | 1 | 1 | — | — | 1 | 3 |
| Leukemia | D007938 | — | C95 | 2 | 2 | — | — | — | 3 |
| Neoplasms | D009369 | — | C80 | 2 | 2 | — | — | — | 3 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | — | — | 2 | 3 |
| Malignant pleural effusion | D016066 | — | J91.0 | 1 | 1 | — | — | — | 2 |
| Respiratory insufficiency | D012131 | — | J96.9 | — | 2 | — | — | — | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | 2 | 1 | — | — | — | 2 |
| Preleukemia | D011289 | — | — | 2 | 1 | — | — | — | 2 |
Show 39 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Retinal vein occlusion | D012170 | EFO_1001157 | H34.81 | 2 | — | — | — | — | 2 |
| Flushing | D005483 | — | R23.2 | 1 | — | — | — | 1 | 2 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | — | — | — | — | 1 |
| Rectal neoplasms | D012004 | — | — | 1 | — | — | — | — | 1 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | — | — | — | — | 1 |
| Thrombophlebitis | D013924 | — | — | 1 | — | — | — | — | 1 |
| Glaucoma | D005901 | EFO_0000516 | H40 | 1 | — | — | — | — | 1 |
| Open-angle glaucoma | D005902 | EFO_0004190 | H40.1 | 1 | — | — | — | — | 1 |
| Adjuvant chemotherapy | D017024 | — | — | 1 | — | — | — | — | 1 |
| Gallstones | D042882 | EFO_0004210 | — | 1 | — | — | — | — | 1 |
Show 16 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | — | — | 4 | 4 |
| Hemostatic disorders | D020141 | — | — | — | — | — | — | 4 | 4 |
| Thrombotic stroke | D000083244 | — | — | — | — | — | — | 4 | 4 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | — | — | 3 | 3 |
| Fibrinolysis | D005342 | — | — | — | — | — | — | 3 | 3 |
| Toxemia | D014115 | — | — | — | — | — | — | 3 | 3 |
| Thrombolytic therapy | D015912 | — | — | — | — | — | — | 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 78 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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19,972 adverse events reported
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