Alteplase

Summary

Alteplase (CHEMBL1201593) is an approved enzyme (ATC B01AD02); indicated across 40 conditions including pulmonary embolism and stroke disorder.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Enzyme
• ATC class: B01AD02 (+1 more)
• Indications: 40 conditions
• Clinical trials: 108

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1201593
Name	Alteplase
Type	Enzyme
Max phase	4
ATC	B01AD02, S01XA13

Also known as: Actilyse, Actilyse cathflo, Activase, Alteplasa, Alteplase, Alteplase (genetical recombination), Alteplase for injection, recombinant, Cathflo activase, Ec 3.4.21.68, RT-PA, Tissue plasminogen activator alteplase

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

40 indications (8 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
pulmonary embolism	4	MONDO:0005279	EFO:0003827
stroke disorder	4	MONDO:0005098	EFO:0000712
myocardial infarction	4	MONDO:0005068	EFO:0000612
congestive heart failure	4	MONDO:0005009	EFO:0000373
thrombotic disease	4	MONDO:0000831	HP:0004419
eye disorder	4	MONDO:0005328	EFO:0003966
heart failure	4	MONDO:0005252	EFO:0003144
abscess	3	MONDO:0005227	EFO:0003030
empyema	3	MONDO:0005242	EFO:0003097
intracerebral hemorrhage	3	MONDO:0013792	EFO:0005669
subarachnoid hemorrhage	3	MONDO:0005099	EFO:0000713
retinal artery occlusion	3	MONDO:0006948	EFO:1001154
pleural empyema	3	MONDO:0018667	EFO:0009680
myocardial ischemia	3	MONDO:0024644	EFO:1001375
acute respiratory distress syndrome	3	MONDO:0006502	EFO:1000637
cerebral infarction	3	MONDO:0002679	MONDO:0002679
brain ischemia	3	MONDO:0005299	MONDO:0005299
cardiovascular disorder	3	MONDO:0004995	EFO:0000319
coronary artery disorder	3	MONDO:0005010	EFO:0001645
nervous system disorder	2	MONDO:0005071	EFO:0000618
neoplasm	2	MONDO:0005070	EFO:0000616
bronchitis	2	MONDO:0003781	EFO:0009661
severe acute respiratory syndrome	2	MONDO:0005091	EFO:0000694
age-related macular degeneration	2	MONDO:0005150	EFO:0001365
respiratory failure	2	MONDO:0021113	EFO:0009686
retinal vein occlusion	1	MONDO:0006951	EFO:1001157
thrombophlebitis	1	MONDO:0002800	HP:0004418
hematopoietic and lymphoid system neoplasm	0	MONDO:0002334	MONDO:0044881

12 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 108.

Phase distribution

Phase	Trials
Not specified	34
PHASE3	31
PHASE4	19
PHASE2	15
PHASE2/PHASE3	4
PHASE1	3
PHASE1/PHASE2	1
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03581877	PHASE4	ACTIVE_NOT_RECRUITING	Peripheral Systemic Thrombolysis Versus Catheter Directed Thrombolysis for Submassive PE
NCT05910125	PHASE4	NOT_YET_RECRUITING	Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke
NCT06653946	PHASE4	RECRUITING	the Predictors of Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients
NCT07111559	PHASE4	RECRUITING	Lacunar Stroke hyperAcute Clinical Utilization of Novel Approach Regimens: Rt-PA vs. DAPT Randomised Clinical Trial
NCT00412867	PHASE4	COMPLETED	Post-marketing Clinical Study of Alteplase for Acute Ischemic Stroke （Japan Alteplase Clinical Trial Ⅱ：J-ACT Ⅱ）
NCT00781378	PHASE4	COMPLETED	Low Dosage of rt-PA in the Treatment of Pulmonary Thromboembolism in China
NCT01670474	PHASE4	UNKNOWN	Prolonged Hemodialysis Catheter Survival With Copolymer Coating and Rt-PA
NCT01930682	PHASE4	COMPLETED	EARLY Routine Catheterization After Alteplase Fibrinolysis vs. PPCI in ST-Segment-Elevation MYOcardial Infarction
NCT01956955	PHASE4	UNKNOWN	Comparison of Low-Molecular-Weight Heparin (LMWH) and Unfractionated Heparin (UFH) in Combination With Thrombolytic Treatment of Acute Massive Pulmonary Thromboembolism
NCT02016547	PHASE4	TERMINATED	Thrombectomy Under Reopro Versus Alteplase to Treat Stoke
NCT02159521	PHASE4	COMPLETED	Treatment of Chronic Deep Vein Thrombosis (DVT) and Post-Thrombotic Syndrome (PTS) With the EkoSonic® Endovascular System
NCT02835534	PHASE4	COMPLETED	The Efficacy and Safety of rhTNK-tPA in Comparison With Alteplase(Rt-PA) as Fibrinolytic Therapy of Acute STEMI
NCT03506009	PHASE4	TERMINATED	Argatroban Plus r-tPA for Posterior Circulation Infarction（AR-PCI）
NCT03661411	PHASE4	COMPLETED	Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke
NCT03740958	PHASE4	COMPLETED	Argatroban Plus R-tPA for Acute Ischemic Stroke
NCT03988842	PHASE4	TERMINATED	Standard-dose Apixaban AFtEr Very Low-dose ThromboLYSis for Acute Intermediate-high Risk Acute Pulmonary Embolism
NCT04806373	PHASE4	COMPLETED	Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis
NCT06058884	PHASE4	COMPLETED	Predictors of AIS Unfavorable Outcomes
NCT06337175	PHASE4	COMPLETED	Predictors of Post-alteplase Hemorrhagic Transformation of Brain Infarction
NCT04430569	PHASE3	RECRUITING	Pulmonary Embolism International THrOmbolysis Study-3
NCT05728333	PHASE2/PHASE3	RECRUITING	Intravenous Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Stroke
NCT05797792	PHASE3	ACTIVE_NOT_RECRUITING	CHemical OptImization of Cerebral Embolectomy 2 (CHOICE 2).
NCT05856851	PHASE3	RECRUITING	Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy
NCT06658197	PHASE3	RECRUITING	Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke
NCT00147316	PHASE3	COMPLETED	Japan Alteplase Clinical Trial (J-ACT): Efficacy and Safety Study of Tissue Plasminogen Activator (Alteplase) for Ischemic Stroke
NCT00148460	PHASE3	COMPLETED	Trial to Compare the Efficacy and Safety of a Single Bolus of TNK-tPA (Tenecteplase, Metalyse®) With Accelerated Infusion of Rt-PA (Alteplase, Actilyse®) in Asian Patients With Acute Myocardial Infarction
NCT00153036	PHASE3	COMPLETED	Rt-PA in the Treatment of Acute Ischemic Stroke
NCT00540527	PHASE3	COMPLETED	Local Versus Systemic Thrombolysis for Acute Ischemic Stroke (SYNTHESIS)
NCT00784134	PHASE3	COMPLETED	Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
NCT00975962	PHASE3	COMPLETED	New Acute Treatment for Stroke - The Effect of Remote PERconditioning
NCT01525290	PHASE3	COMPLETED	Efficacy and Safety of MRI-based Thrombolysis in Wake-up Stroke
NCT01827046	PHASE3	COMPLETED	Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III
NCT01949948	PHASE3	COMPLETED	Study of Tenecteplase Versus Alteplase for Thrombolysis (Clot Dissolving) in Acute Ischemic Stroke
NCT01958164	PHASE3	COMPLETED	Efficacy and Safety of Actilyse 2 mg/ 2 ml in Comparison to Saline Solution in Patients With Central Venous Access Device Occlusion
NCT02072226	PHASE3	TERMINATED	A Study of the Efficacy and Safety of Alteplase in Participants With Mild Stroke
NCT02180204	PHASE2/PHASE3	WITHDRAWN	Tenecteplase Versus Alteplase in Ischemic Stroke Management (TALISMAN)
NCT02182011	PHASE3	COMPLETED	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)
NCT02604238	PHASE3	WITHDRAWN	Efficacy and Safety of Half Dose Alteplase Added to Heparine, in Patients With Moderate Pulmonary Embolism
NCT02894138	PHASE3	UNKNOWN	Optimal Coronary Flow After PCI for Myocardial Infarction - a Pilot Study
NCT02930837	PHASE3	COMPLETED	Safety and Efficacy of Alteplase When Administered in Chinese Patients With Acute Ischemic Hemispheric Stroke Where Thrombolysis is Initiated Between 3 and 4.5 Hours After Stroke Onset

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).