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 | 2022-09-13 |
| cathflo activase | Biologic Licensing Application | 2024-07-09 |
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
494 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 | 20 | 62 | 56 | 17 | 96 | 231 |
| Ischemic stroke | D000083242 | — | — | 17 | 52 | 46 | 18 | 69 | 186 |
| Ischemia | D007511 | EFO_0000556 | — | 7 | 25 | 28 | 6 | 44 | 102 |
| Cerebral infarction | D002544 | — | I63 | 4 | 20 | 18 | 3 | 24 | 61 |
| Thrombosis | D013927 | — | — | 3 | 3 | 8 | 10 | 16 | 39 |
| Embolism | D004617 | — | — | 2 | 3 | 11 | 9 | 13 | 38 |
| Pulmonary embolism | D011655 | HP_0002204 | I26 | 1 | 3 | 10 | 9 | 10 | 33 |
| Infarction | D007238 | EFO_0009463 | — | — | 3 | 13 | 8 | 6 | 30 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 2 | 8 | 6 | 1 | 15 | 29 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 1 | 12 | 3 | 5 | 21 |
Show 36 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arterial occlusive diseases | D001157 | EFO_0009085 | — | — | 2 | 5 | — | 7 | 13 |
| Cerebral hemorrhage | D002543 | — | — | 1 | 4 | 2 | — | 6 | 13 |
| Brain ischemia | D002545 | EFO_0003883 | I67.82 | 1 | 2 | 2 | — | 4 | 8 |
| Covid-19 | D000086382 | — | — | — | 2 | 1 | — | 3 | 6 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | 1 | 1 | 3 | — | 1 | 6 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | 1 | — | 3 | — | 2 | 6 |
| Cerebral intraventricular hemorrhage | D000074042 | — | — | — | 2 | 1 | — | 3 | 6 |
| Retinal artery occlusion | D015356 | EFO_1001154 | H34.1 | — | — | 2 | — | 2 | 4 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | 1 | 2 | — | 2 | 4 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 3 | 2 | — | — | 4 |
Show 38 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 | HP_0100806 | A41.9 | — | 1 | — | — | 3 | 4 |
| Leukemia | D007938 | — | C95 | 2 | 2 | — | — | — | 3 |
| Neoplasms | D009369 | — | C80 | 2 | 2 | — | — | — | 3 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | — | — | 2 | 3 |
| Adenocarcinoma | D000230 | — | — | 1 | 1 | — | — | — | 2 |
| Malignant pleural effusion | D016066 | — | J91.0 | 1 | 1 | — | — | — | 2 |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | 2 | — | — | — | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | 2 | 1 | — | — | — | 2 |
| Preleukemia | D011289 | — | — | 2 | 1 | — | — | — | 2 |
Show 34 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Intracranial hemorrhages | D020300 | EFO_0000551 | I62 | 1 | — | — | — | 3 | 4 |
| 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 | HP_0004418 | — | 1 | — | — | — | — | 1 |
| Glaucoma | D005901 | EFO_0000516 | H40 | 1 | — | — | — | — | 1 |
| Open-angle glaucoma | D005902 | EFO_0004190 | H40.1 | 1 | — | — | — | — | 1 |
| Adjuvant chemotherapy | D017024 | — | — | 1 | — | — | — | — | 1 |
Show 17 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 |
| Basal ganglia hemorrhage | D020145 | — | — | — | — | — | — | 3 | 3 |
| Transient ischemic attack | D002546 | EFO_0003764 | G45.9 | — | — | — | — | 3 | 3 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 3 | 3 |
| Malocclusion | D008310 | HP_0000689 | M26.4 | — | — | — | — | 3 | 3 |
Show 76 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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17,300 adverse events reported
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