Activase

(Alteplase)

ApprovedProtein / enzyme

Alteplase is used to dissolve blood clots in patients who have had a heart attack or stroke, helping to restore blood flow and prevent permanent damage.[2] Activase is currently approved and in use across 34 indications[4].[1]

Activase is one of 686 small molecule programs targeting Thrombophlebitis. It is currently in Approved.

Indications

Total Trials

Active Trials

685

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

ThrombophlebitisActive, not recruiting

AbscessActive, not recruiting

Retinal Artery OcclusionActive, not recruiting

EmpyemaActive, not recruiting

Thrombotic DiseaseActive, not recruiting

Acute Respiratory FailureActive, not recruiting

StrokeUnknown

HemorrhageActive, not recruiting

Eye DiseaseUnknown

Acute Myocardial InfarctionActive, not recruiting

ThrombophlebitisPhase 1

Active, not recruiting

AbscessPhase 3

Active, not recruiting

Retinal Artery OcclusionPhase 3

Active, not recruiting

EmpyemaPhase 3

Active, not recruiting

Thrombotic DiseasePhase 3

Active, not recruiting

Acute Respiratory FailurePhase 2

Active, not recruiting

StrokePreclinical

Unknown

HemorrhagePhase 3

Active, not recruiting

Eye DiseasePreclinical

Unknown

Acute Myocardial InfarctionPreclinical

Active, not recruiting

Showing 10 of 34 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Activase

Roche

Approved

1 2

Spikevax

Moderna

Preclinical

21 3

Bnt162b2

BioNTech

Preclinical

29 4

COVID-19 Vaccine

Moderna

Preclinical

27 5

Biaxin

AbbVie

Preclinical

2 6

Stivarga

Bayer

Preclinical

1 7

Aimovig

Amgen

Preclinical

1 8

Aldactone

Pfizer

Preclinical

1 9

Nexavar

Bayer

Preclinical

1 10

Singulair

AstraZeneca

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2/3Recruiting

Stroke

NCT05728333

Q4 2026

Recruiting

Ischemic Stroke

NCT06194968

Phase 2Recruiting

Acute Respiratory Failure

NCT05540834

Q1 2027

Phase 1Recruiting

Pleural Effusion

NCT06184321

Q2 2027

Phase 3Recruiting

Stroke

NCT06658197

Clinical

Trials by Indication[1]

Stroke19 trials

Intravenous Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Stroke

Recruiting·XXinqiao Hospital of Chongqing·Phase 2/3·NCT05728333·800 enrolled

the Predictors of Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients

Recruiting·KKafrelsheikh University·Phase 4·NCT06653946·716 enrolled

Perfusion Computer Tomography: Imaging and Clinical Validation Following Reperfusion Therapy in Acute Ischaemic Stroke

Unknown status·RRabin Medical Center··NCT02309970·90 enrolled

Show 16 more trials

A Study of the Efficacy and Safety of Alteplase in Participants With Mild Stroke

Terminated· Roche logo

Roche·Phase 3·NCT02072226·313 enrolled

Wake up Symptomatic Stroke - Benefit of Intravenous Clot Busters or Endovascular Intervention

Unknown status·JJacobs Neurological Institute·Phase 2·NCT01455935·90 enrolled

An International Observational Study of the Safety and Efficacy of Thrombolysis in Stroke

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT02229890·593 enrolled

The Norwegian Tenecteplase Stroke Trial 2

Terminated·HHaukeland University Hospital·Phase 3·NCT03854500·201 enrolled

Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke

Not yet recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 4·NCT05910125·472 enrolled

Quality of Life After Stroke Using a Telemedicine-based Stroke Network

Unknown status·TThomas Jefferson University··NCT02447094·300 enrolled

Early Recanalization After Intravenous Thrombolysis With Tenecteplase Versus Alteplase in Distal Vessel Occlusion Strokes

Completed·—··NCT05635786·319 enrolled

Study for the Use of Alteplase in Patients Who Awaken With Stroke

Withdrawn·UUniversity of California, San Diego·Phase 1·NCT01150266

Safety of Intravenous Thrombolysis for Wake-up Stroke

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT01183533·40 enrolled

Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke

Recruiting·XXuanwu Hospital, Beijing·Phase 3·NCT06658197·850 enrolled

Dual IntraVenous Thrombolysis Approach (DIVA) in Patients With Medium-vessel-occlusion Strokes: a Retrospective Study

Completed·—··NCT05809921·294 enrolled

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

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02930837·120 enrolled

Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST)

Completed·TTasly Biopharmaceuticals Co., Ltd.·Phase 3·NCT03541668·674 enrolled

Safe Implementation of Thrombolysis in Stroke - Monitoring Study

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT02229812·6,475 enrolled

Efficacy and Safety of MRI-based Thrombolysis in Wake-up Stroke

Completed·UUniversitätsklinikum Hamburg-Eppendorf·Phase 3·NCT01525290·501 enrolled

Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis- (ATTEST)

Completed·NNHS Greater Glasgow and Clyde·Phase 2·NCT01472926·104 enrolled

Ischemic stroke16 trials

Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients （3T Stroke-II）

Unknown status·—·Phase 2·NCT05281549·225 enrolled

Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients （3T Stroke-Ⅲ）

Unknown status·—·Phase 3·NCT05745259·1,630 enrolled

Treatment of Acute Ischemic StroKe With Intravenous UroKinase Real-world Research: a Multicenter, Prospective Study

Recruiting·TThe First Affiliated Hospital of Zhengzhou University··NCT06194968·1,800 enrolled

Show 13 more trials

Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 3·NCT05856851·324 enrolled

Dual Thrombolytic Therapy With Mutant Pro-urokinase and Low Dose Alteplase for Ischemic Stroke

Completed·EErasmus Medical Center·Phase 2·NCT04256473·200 enrolled

Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke

Completed·UUniversity of Calgary·Phase 3·NCT03889249·1,600 enrolled

Study of Tenecteplase Versus Alteplase for Thrombolysis (Clot Dissolving) in Acute Ischemic Stroke

Completed·LLars Thomassen·Phase 3·NCT01949948·1,050 enrolled

24 Hours Treatment with Alteplase in Patients with Ischemic Stroke

Completed·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 3·NCT04879615·372 enrolled

Tenecteplase Versus Alteplase in Ischemic Stroke Management (TALISMAN)

Withdrawn·—·Phase 2/3·NCT02180204

Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China

Unknown status·HHuashan Hospital··NCT06078995·1,200 enrolled

Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke

Completed·GGeneral Hospital of Shenyang Military Region·Phase 4·NCT03661411·760 enrolled

Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China

Withdrawn·GGeneral Hospital of Shenyang Military Region··NCT03997292

Japan Alteplase Clinical Trial (J-ACT): Efficacy and Safety Study of Tissue Plasminogen Activator (Alteplase) for Ischemic Stroke

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 3·NCT00147316·103 enrolled

The Prevalence and Associated Factors of Early Deterioration After Successful Recanalization in Acute Ischemic Stroke

Unknown status·—··NCT04978181·30 enrolled

Thrombolysis Outcome in Ischemic Stroke

Completed·MMazandaran University of Medical Sciences··NCT04309357·214 enrolled

Post-marketing Clinical Study of Alteplase for Acute Ischemic Stroke （Japan Alteplase Clinical Trial Ⅱ：J-ACT Ⅱ）

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 4·NCT00412867·58 enrolled

Pulmonary Embolism7 trials

Efficacy and Safety of Half Dose Alteplase Added to Heparine, in Patients With Moderate Pulmonary Embolism

Withdrawn·AAzienda U.S.L. 1 di Massa e Carrara·Phase 3·NCT02604238

Standard-dose Apixaban AFtEr Very Low-dose ThromboLYSis for Acute Intermediate-high Risk Acute Pulmonary Embolism

Terminated·—·Phase 4·NCT03988842·4 enrolled

A Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism

Completed·TTasly Biopharmaceuticals Co., Ltd.·Phase 2·NCT03108833·108 enrolled

Show 4 more trials

Reperfusion Treatment in Acute Pulmonary Embolism

Recruiting·SSahlgrenska University Hospital··NCT07003646·220 enrolled

Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE

Completed·SSupergene, LLC·Phase 3·NCT04688320·310 enrolled

Safe Delivery of Thrombolytic Treatment for Pulmonary Embolism Using ClotPro® Viscoelastic Tests

Completed·SSemmelweis University·N/A·NCT06667882·33 enrolled

A Reduced Dose of Thrombolytic Treatment for Patients With Intermediate High-risk Acute Pulmonary Embolism: a Randomized Controled Trial

Active, not recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT04430569·800 enrolled

Efficacy and Safety2 trials

The Efficacy and Safety of rhTNK-tPA in Comparison With Alteplase(Rt-PA) as Fibrinolytic Therapy of Acute STEMI

Completed·CCSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.·Phase 4·NCT02835534·818 enrolled

Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality

Terminated· Chiesi Farmaceutici S.p.A. logo

Chiesi Farmaceutici S.p.A.·Phase 3·NCT03594175·462 enrolled

Myocardial Infarction2 trials

Optimal Coronary Flow After PCI for Myocardial Infarction - a Pilot Study

Unknown status·VVastra Gotaland Region·Phase 3·NCT02894138·80 enrolled

EARLY Routine Catheterization After Alteplase Fibrinolysis vs. PPCI in ST-Segment-Elevation MYOcardial Infarction

Completed·RRenJi Hospital·Phase 4·NCT01930682·344 enrolled

23 more indications

Pleural effusion2 trials

Efficacy and Safety of Activase (Ateplase) vs Placebo in Complicated Pleural Effusions (CPE)/Empyemas

Completed·MMidwest Pulmonary and Critical Care·N/A·NCT00468104·100 enrolled

Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT06184321·30 enrolled

Hemodialysis2 trials

Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol

Completed·NNova Scotia Health Authority·N/A·NCT02474810·35 enrolled

Trial to Compare 1.0 Versus 2.0 mg Alteplase (tPA) Dosing in Restoring Hemodialysis Catheter Function

Unknown status·—·N/A·NCT02225782·150 enrolled

Acute Myocardial Infarction2 trials

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®)

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT02235389·59 enrolled

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)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02182011·49 enrolled

Outcome1 trial

Predictors of AIS Unfavorable Outcomes

Completed·KKafrelsheikh University·Phase 4·NCT06058884·592 enrolled

Prosthetic Valve Thrombosis1 trial

To Compare the Efficacy & Safety of Ultra-Slow (24 hr) Low Dose (25 mg) Infusion of Alteplase Over Slow (24hr) Infusion of Streptokinase in Mechanical Prosthetic Valve Thrombosis

Completed·—·N/A·NCT07360717·100 enrolled

Deep Vein Thrombosis1 trial

Treatment of Chronic Deep Vein Thrombosis (DVT) and Post-Thrombotic Syndrome (PTS) With the EkoSonic® Endovascular System

Completed·BBoston Scientific Corporation·Phase 4·NCT02159521·81 enrolled

Trial1 trial

A Trial of Low-dose Adjunctive alTeplase During prIMary PCI

Completed·NNHS Greater Glasgow and Clyde·Phase 2·NCT02257294·440 enrolled

Infusion1 trial

Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS

Completed·SSupergene, LLC·Phase 3·NCT03151993·336 enrolled

Physical Activity1 trial

A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT04915729·1,489 enrolled

Acute Respiratory Failure1 trial

Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure

Recruiting·SSouth West Sydney Local Health District·Phase 2·NCT05540834·70 enrolled

Abscess1 trial

Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses

Completed·KKaiser Permanente·Phase 2·NCT00284739·20 enrolled

Prophylaxis1 trial

t-PA Prophylaxis to Prevent Catheter-associated Thrombosis and Infection

Completed·MMedical College of Wisconsin·Phase 2·NCT03672006·20 enrolled

Empyema1 trial

Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion

Unknown status·OO'Brien, Jeana D., MD, FACP, FCCP·N/A·NCT00103766·75 enrolled

Thrombolysis1 trial

Peripheral Systemic Thrombolysis Versus Catheter Directed Thrombolysis for Submassive PE

Active, not recruiting·NNorthwell Health·Phase 4·NCT03581877·31 enrolled

Retinal Artery Occlusion1 trial

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

Completed·NNantes University Hospital·Phase 3·NCT03197194·70 enrolled

Hemorrhage1 trial

Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III

Completed·JJohns Hopkins University·Phase 3·NCT00784134·500 enrolled

MPA1 trial

A Study in Healthy Men to Compare 2 Different Formulations of Alteplase

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT04419493·30 enrolled

COVID-191 trial

Fibrinolytic Therapy to Treat ARDS in the Setting of COVID-19 Infection

Completed·—·Phase 2·NCT04357730·50 enrolled

Catheter1 trial

Study of Sodium Bicarbonate in Restoring Blocked Catheters

Withdrawn·UUniversity Health Network, Toronto·Phase 2·NCT03348826

Brain Infarction1 trial

Predictors of Post-alteplase Hemorrhagic Transformation of Brain Infarction

Completed·KKafrelsheikh University·Phase 4·NCT06337175·600 enrolled

TED1 trial

Tirofiban for Patients Treated With Alteplase

Terminated·—·Phase 2/3·NCT03357133·30 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Tissue Plasminogen Activator (tPA) in Neonates and Infants

Terminated·UUniversity of Louisville·Phase 1·NCT00265005·12 enrolled

Unspecified2 trials

SITS-IVT in Patients >80 Years Study

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT04260347·1,655 enrolled

Low-Dose Alteplase to Treat Blood Clots in Deep Leg Veins

Completed·RRichard Chang, M.D.·Phase 2·NCT00082355·30 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 13, 1987

CATHFLO ACTIVASE

BLA BLA103172

Sources

References

[1]
ClinicalTrials.gov — 73 trial records for Alteplase. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Activase drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Alteplase compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Alteplase. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (BLA BLA103172). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Tissue-Type Plasminogen Activator Exogenous Protein[3]
Modality: Protein / enzyme[3]
Highest Phase: Approved[1]
Company: Roche

Activase

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Stroke19 trials

Ischemic stroke16 trials

Pulmonary Embolism7 trials

Efficacy and Safety2 trials

Myocardial Infarction2 trials

Pleural effusion2 trials

Hemodialysis2 trials

Acute Myocardial Infarction2 trials

Outcome1 trial

Prosthetic Valve Thrombosis1 trial

Deep Vein Thrombosis1 trial

Trial1 trial

Infusion1 trial

Physical Activity1 trial

Acute Respiratory Failure1 trial

Abscess1 trial

Prophylaxis1 trial

Empyema1 trial

Thrombolysis1 trial

Retinal Artery Occlusion1 trial

Hemorrhage1 trial

MPA1 trial

COVID-191 trial

Catheter1 trial

Brain Infarction1 trial

TED1 trial

Safety and Efficacy1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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