Alteplase
Highest phase reached
Approved
Drug type
Enzyme
First approval year
1996
- First approval year
- 1996
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Enzyme
- Drug name
- Alteplase
- actilyse
- Actilyse
- actilyse cathflo
- Actilyse cathflo
- activase
- Activase
- cathflo activase
- Cathflo activase
- actilyse
- Actilyse
- Actilyse (Thrombolytic therapy)
- activase
- Activase
- alteplasa
- Alteplasa
- alteplase
- Alteplase
- Alteplase (Actilyse)
- Alteplase (from current manufacturing process)
- Alteplase (from modified manufacturing process)
- Alteplase (genetical recombination)
- ALTEPLASE (GENETICAL RECOMBINATION) [JAN]
- Alteplase (iv t-PA)
- alteplase (recombinant t-PA)
- alteplase [INN]
- ALTEPLASE [JAN]
- ALTEPLASE [MART.]
- ALTEPLASE [PURPLE BOOK CDER]
- ALTEPLASE [USAN]
- ALTEPLASE [USP MONOGRAPH]
- ALTEPLASE [VANDF]
- Alteplase [WHO-DD]
- alteplase for injection
And 54 more, listed on the interactive page.
- CAS registry numbers
- 105857-23-6
- ChEMBL ID
- CHEMBL1201593
- RxNorm IDs (RxCUI)
- 8410
- FDA ingredient codes (UNII)
- 1RXS4UE564
- B01AD02
- S01XA13
Sources for recorded values
- Applicant
- GENENTECH
- Approval date
- 13 Nov 1987
- Application number
- BLA103172
- Patents
- 0
- Designations
- 2
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Drug name stem
- -ase
Administration routes
- Parenteral
Mechanisms of action
- Mechanism
- Tissue-type plasminogen activator exogenous protein
- Action type
- EXOGENOUS_PROTEIN
- Target
- Tissue-type plasminogen activator
- Protein identifier
- P00750
Open Targets mechanisms
- Mechanism
- Tissue-type plasminogen activator exogenous protein
- Action type
- EXOGENOUS PROTEIN
- Target
- Tissue-type plasminogen activator
- Condition
- Cardiovascular Diseases
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000319
- Subject identifier
- D002318
- Condition
- Heart Failure
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000373
- Subject identifier
- D006333
- Condition
- Infections
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000544
- Subject identifier
- D007239
- Condition
- Myocardial Infarction
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000612
- Subject identifier
- D009203
- Condition
- Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Nervous System Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000618
- Subject identifier
- D009422
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000694
- Subject identifier
- D045169
- Condition
- Stroke
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000712
- Subject identifier
- D020521
- Condition
- Subarachnoid Hemorrhage
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000713
- Subject identifier
- D013345
- Condition
- Macular Degeneration
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001365
- Subject identifier
- D008268
- Condition
- Coronary Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001645
- Subject identifier
- D003327
- Condition
- Abscess
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003030
- Subject identifier
- D000038
- Condition
- Empyema
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003097
- Subject identifier
- D004653
- Condition
- Heart Failure
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003144
- Subject identifier
- D006333
- Condition
- Pulmonary Embolism
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003827
- Subject identifier
- D011655
- Condition
- Venous Thrombosis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003907
- Subject identifier
- D020246
- Condition
- Angina, Stable
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003913
- Subject identifier
- D060050
- Condition
- Eye Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003966
- Subject identifier
- D005128
- Condition
- Cerebral Hemorrhage
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005669
- Subject identifier
- D002543
- Condition
- Bronchitis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0009661
- Subject identifier
- D001991
- Condition
- Empyema, Pleural
- Highest recorded phase
- 3
- Condition identifier
- EFO:0009680
- Subject identifier
- D016724
- Condition
- Respiratory Insufficiency
- Highest recorded phase
- 2
- Condition identifier
- EFO:0009686
- Subject identifier
- D012131
- Condition
- Respiratory Distress Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:1000637
- Subject identifier
- D012128
- Condition
- Retinal Artery Occlusion
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001154
- Subject identifier
- D015356
- Condition
- Retinal Vein Occlusion
- Highest recorded phase
- 1
- Condition identifier
- EFO:1001157
- Subject identifier
- D012170
And 15 more, listed on the interactive page.
- Condition identifier
- EFO_0000373
- Condition identifier
- EFO_0000544
- Condition identifier
- EFO_0000544
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000612
- Condition identifier
- EFO_0000616
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000618
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000712
- Condition identifier
- EFO_0000713
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003030
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003086
- Condition identifier
- EFO_0003097
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003144
- Condition identifier
- EFO_0003827
- Condition identifier
- EFO_0003884
- Condition identifier
- EFO_0003907
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003966
- Condition identifier
- EFO_0005669
- Highest recorded phase
- 3
- Condition identifier
- EFO_0009680
- Highest recorded phase
- 3
- Condition identifier
- EFO_0020925
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000637
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001154
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001157
- Highest recorded phase
- 1
- Condition identifier
- GO_0007596
- Condition identifier
- HP_0000016
- Highest recorded phase
- 2
- Condition identifier
- HP_0000238
- Highest recorded phase
- 1
And 48 more, listed on the interactive page.
- Event
- angioedema
- Reports
- 486
- Reporting signal score
- 1,024.52
- Event
- aphasia
- Reports
- 78
- Reporting signal score
- 90.9108
- Event
- arthralgia
- Reports
- 12
- Reporting signal score
- 69.1822
- Event
- blood fibrinogen decreased
- Reports
- 48
- Reporting signal score
- 182.714
- Event
- brain herniation
- Reports
- 19
- Reporting signal score
- 58.7564
- Event
- brain oedema
- Reports
- 53
- Reporting signal score
- 102.124
- Event
- cerebral artery occlusion
- Reports
- 26
- Reporting signal score
- 77.9917
- Event
- cerebral haematoma
- Reports
- 81
- Reporting signal score
- 263.846
- Event
- cerebral haemorrhage
- Reports
- 355
- Reporting signal score
- 987.731
- Event
- cerebral hyperperfusion syndrome
- Reports
- 16
- Reporting signal score
- 73.3501
- Event
- cerebral infarction
- Reports
- 125
- Reporting signal score
- 194.496
- Event
- cerebral ischaemia
- Reports
- 38
- Reporting signal score
- 71.4445
- Event
- chest pain
- Reports
- 222
- Reporting signal score
- 138.849
- Event
- coma scale abnormal
- Reports
- 38
- Reporting signal score
- 81.548
- Event
- diarrhoea
- Reports
- 7
- Reporting signal score
- 160.145
- Event
- electrocardiogram st segment elevation
- Reports
- 33
- Reporting signal score
- 63.9432
- Event
- extrasystoles
- Reports
- 33
- Reporting signal score
- 56.0951
- Event
- fatigue
- Reports
- 19
- Reporting signal score
- 139.314
- Event
- gingival bleeding
- Reports
- 62
- Reporting signal score
- 105.421
- Event
- haematoma
- Reports
- 124
- Reporting signal score
- 187.181
- Event
- haemorrhage
- Reports
- 269
- Reporting signal score
- 366.766
- Event
- haemorrhage intracranial
- Reports
- 345
- Reporting signal score
- 1,106.25
- Event
- haemorrhagic cerebral infarction
- Reports
- 28
- Reporting signal score
- 101.526
- Event
- haemorrhagic infarction
- Reports
- 38
- Reporting signal score
- 159.333
- Event
- haemorrhagic stroke
- Reports
- 34
- Reporting signal score
- 67.8896
And 27 more, listed on the interactive page.
- NCT00000468
- NCT00000472
- NCT00000505
- NCT00148460
- NCT01930682
- NCT02182011
- NCT02257294
- NCT02894138
- NCT03335839
- NCT00001713
- NCT00029315
- NCT00650858
- NCT00784134
- NCT00044057
- NCT01098981
- NCT01150266
- NCT01183533
- NCT01464788
- NCT01949948
- NCT02180204
- NCT02388061
- NCT02572336
- NCT02814409
- NCT03151993
- NCT03357133
And 92 more, listed on the interactive page.
- Dose
- 0.9 mg/kg (not to exceed 90 mg) for stroke; not to exceed 100 mg for myocardial infarction; 100 mg for massive pulmonary embolism
- Route
- Intravenous
- How often
- As needed or specific timeframes for different conditions (e.g., over 60 minutes, over 2 hours, etc.)
- Administer as soon as possible within 3 hours of symptom onset
- Do not add other medications to infusions containing Activase
- Use within 8 hours of reconstitution
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 50242-041
Related records
Trials (232)
- 'Thrombectomy in High-Risk Pulmonary Embolism - Device Versus Thrombolysis Netherlands': TORPEDO-NL
- 1-year Clinical Outcomes in Recombinant Tissue Plasminogen Activator (Rt-PA) Treated Chinese Acute Ischaemic Stroke (AIS) Patients
- 24 Hours Treatment with Alteplase in Patients with Ischemic Stroke
- A Comparison of Two Protocol for Maxillary Molar Intrusion Buccal Miniscrew and TPA Versus Vertical Holding Appliance
- A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety of IV THrombolysis (Alteplase) in Patients With acutE Central retInal Artery Occlusion
- A PhaseⅡ of Injection for Recombinant Human Tissue Plasminogen Kinase Derivative in Treatment of Acute Ischemic Stroke.
- A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity
- A Study in Healthy Men to Compare 2 Different Formulations of Alteplase
- A Study of Intra-thrombus Plasmin (Human) In Acute Peripheral Arterial Occlusion
- A Study of Intravenous Thrombolysis With Alteplase in MRI-Selected Patients
- A Study of Pre-hospital Treatment of Acute Myocardial Infarction Based on Diagnosis by Interpretation of Remotely Acquired ECG and Thrombolysis With Accelerated Alteplase ( Actilyse®)
- A Study of the Efficacy and Safety of Alteplase in Participants With Mild Stroke
- A Study of the Safety, Imaging and Clinical Outcomes of THR-18 in Acute Stroke Subjects Treated With tPA
- A Study to Evaluate the Effects of YM872 on Brain Function and Disability When Administered in Combination With Alteplase (Tissue Plasminogen Activator)
- A Study to Investigate the Procoagulant Effect of Tenecteplase (TNK-tPA), Alteplase (Rt-PA) and Streptokinase (SK) Administered to Patients With Acute Myocardial Infarction (AMI)
- A Study to Test Whether Different Doses of Alteplase Help People With Severe Breathing Problems Because of COVID-19
- A Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism
- A Trial of Low-dose Adjunctive alTeplase During prIMary PCI
- ACT-GLOBAL Adaptive Platform Trial for Stroke
- Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis
Approved for (7)
- Congestive heart failure
- Eye disorder
- Heart failure
- Myocardial infarction
- Pulmonary embolism
- Stroke disorder
- Thrombotic disease
In development for (25)
- Abscess Phase 3
- Acute respiratory distress syndrome Phase 3
- Age-related macular degeneration Phase 2
- Arterial occlusion Phase 2
- Brain ischemia Phase 3
- Bronchitis Phase 2
- Cancer Phase 2
- Cardiovascular disorder Phase 3
- Cerebral infarction Phase 3
- Coronary artery disorder Phase 3
- COVID-19 Phase 2
- Empyema Phase 3
- Hematopoietic and lymphoid cell neoplasm Early phase 1
- Intracerebral hemorrhage Phase 3
- Ischemic stroke Phase 3
- Myocardial ischemia Phase 3
- Neoplasm Phase 2
- Nervous system disorder Phase 2
- Pleural empyema Phase 3
- Respiratory failure Phase 2
Other linked conditions (2)
Targets (1)
- PLAT Tissue-type plasminogen activator exogenous protein