> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/alteplase-89461f67-4f40-4a00-ae4c-727752018887
> Record changed: 2026-10-13

# Alteplase

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201593)

Drug type

Enzyme

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201593)

First approval year

1996

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201593)

## Development status

**First approval year**

1996

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201593)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201593)

## Names and chemistry

**Drug type**

Enzyme

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201593)

**Drug name**

Alteplase

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201593)

### Brand names (8)

- actilyse
- Actilyse
- actilyse cathflo
- Actilyse cathflo
- activase
- Activase
- cathflo activase
- Cathflo activase

### Other names (79)

- 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.

## Identifiers

**CAS registry numbers**

- 105857-23-6

**ChEMBL ID**

CHEMBL1201593

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201593)

**RxNorm IDs (RxCUI)**

- 8410

**FDA ingredient codes (UNII)**

- 1RXS4UE564

### ATC classification codes (2)

- B01AD02
- S01XA13

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201593)

## Regulatory information

### United States

**Applicant**

GENENTECH

**Approval date**

13 Nov 1987

**Application number**

BLA103172

### Other regulatory facts

**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

## Pharmacology

### Drug classification

**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

### Investigated indications (40)

- **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.

### Open Targets indications (73)

- **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.

### Reported adverse events (52)

- **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.

### Trial references (117)

- NCT00000468  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000468)
- NCT00000472  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000472)
- NCT00000505  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000505)
- NCT00148460  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00148460)
- NCT01930682  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01930682)
- NCT02182011  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02182011)
- NCT02257294  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02257294)
- NCT02894138  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02894138)
- NCT03335839  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03335839)
- NCT00001713  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00001713)
- NCT00029315  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00029315)
- NCT00650858  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00650858)
- NCT00784134  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00784134)
- NCT00044057  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00044057)
- NCT01098981  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01098981)
- NCT01150266  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01150266)
- NCT01183533  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01183533)
- NCT01464788  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01464788)
- NCT01949948  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01949948)
- NCT02180204  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02180204)
- NCT02388061  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02388061)
- NCT02572336  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02572336)
- NCT02814409  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02814409)
- NCT03151993  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03151993)
- NCT03357133  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03357133)

And 92 more, listed on the interactive page.

## Dosing

**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.)

### Conditions of use (3)

- 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

## Chemical properties

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Natural product**

No

## National Drug Codes

- 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](https://trialight.com/data/condition/heart-failure-e230b1c3-ce91-5f80-b80f-81fc353ce5cc.md)
- [Myocardial infarction](https://trialight.com/data/condition/myocardial-infarction-b4e97483-7435-5701-81dc-26d955e420ec.md)
- [Pulmonary embolism](https://trialight.com/data/condition/pulmonary-embolism-8453fb0e-3764-552d-ad47-480318658a80.md)
- [Stroke disorder](https://trialight.com/data/condition/stroke-disorder-f6ef16d6-34dc-5c87-b764-37f0b5b8d504.md)
- [Thrombotic disease](https://trialight.com/data/condition/thrombotic-disease-3f54ef10-d2ed-524f-a020-8ecb2eb62a52.md)

### In development for (25)

- Abscess Phase 3
- [Acute respiratory distress syndrome](https://trialight.com/data/condition/acute-respiratory-distress-syndrome-8dc4b74c-8356-5dfd-bfa3-258d9d1e44ab.md) Phase 3
- [Age-related macular degeneration](https://trialight.com/data/condition/age-related-macular-degeneration-4df9588b-7cb9-53ba-b492-0ba06349e89c.md) Phase 2
- Arterial occlusion Phase 2
- Brain ischemia Phase 3
- [Bronchitis](https://trialight.com/data/condition/bronchitis-521c8a00-6a48-5246-b908-ec54f125daf0.md) Phase 2
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 2
- [Cardiovascular disorder](https://trialight.com/data/condition/cardiovascular-disorder-362e433e-88a4-575f-90af-50fe7239dec0.md) Phase 3
- Cerebral infarction Phase 3
- [Coronary artery disorder](https://trialight.com/data/condition/coronary-artery-disorder-6f736849-d477-587a-b3fa-b0621d573407.md) Phase 3
- [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Phase 2
- Empyema Phase 3
- [Hematopoietic and lymphoid cell neoplasm](https://trialight.com/data/condition/hematopoietic-and-lymphoid-cell-neoplasm-ed3616fa-22fe-5984-94b4-745416e01ef9.md) Early phase 1
- Intracerebral hemorrhage Phase 3
- [Ischemic stroke](https://trialight.com/data/condition/ischemic-stroke-22957443-39c1-55ea-8c6d-d5be07d42dc0.md) 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)

- [Chronic kidney disease](https://trialight.com/data/condition/chronic-kidney-disease-dc1fecbb-338b-5bbc-8d68-08e49db49918.md)
- [Kidney disorder](https://trialight.com/data/condition/kidney-disorder-e50371fe-f1a7-53fe-9cfb-9d6da9130e3c.md)

### Targets (1)

- [PLAT](https://trialight.com/data/target/plat-a3299700-f07b-5538-a04f-a846cd46af72.md) Tissue-type plasminogen activator exogenous protein

---

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