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 13 indications[4].[1]

Activase is one of 282 small molecule programs targeting Acute Respiratory Failure. It is currently in Approved.

Indications

Total Trials

Active Trials

281

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Acute Respiratory FailureRecruiting

Eye DiseaseUnknown

Acute Myocardial InfarctionActive, not recruiting

Kidney DiseaseActive, not recruiting

Recurrent ThrombophlebitisUnknown

Congestive Heart FailureUnknown

Hematopoietic and Lymphoid Cell NeoplasmRecruiting

Brain InfarctionActive, not recruiting

Pulmonary EmbolismTerminated

Heart FailureUnknown

Acute Respiratory FailurePhase 2

Recruiting

Eye DiseasePreclinical

Unknown

Acute Myocardial InfarctionPreclinical

Active, not recruiting

Kidney DiseasePreclinical

Active, not recruiting

Recurrent ThrombophlebitisPreclinical

Unknown

Congestive Heart FailurePreclinical

Unknown

Hematopoietic and Lymphoid Cell NeoplasmPhase 1

Recruiting

Brain InfarctionApproved

Active, not recruiting

Pulmonary EmbolismApproved

Terminated

Heart FailurePreclinical

Unknown

Showing 10 of 13 indications

Competition

Competitive Landscape

198 competitors in Heart Failure

#DrugCompanyPhaseTrials

Activase

Roche

Approved

74 2

Bayer Aspirin

Bayer

Preclinical

2 3

Brethine

Sanofi

Preclinical

1 4

Adriamycin

Savaysa

Xifaxan

2 7

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 8

Oraverse

LLife Extension Foundation Inc.

Preclinical

1 9

Tamiflu

CConrado Roberto Hoffmann Filho

Preclinical

1 10

Potassium Iodide

MMeda Pharmaceuticals

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Recruiting

Ischemic Stroke

NCT06194968

Phase 2Recruiting

Acute Respiratory Failure

NCT05540834

Q1 2027

Phase 1Recruiting

Hematopoietic and Lymphoid Cell Neoplasm

NCT06184321

Q2 2027

Phase 3Recruiting

Stroke

NCT06658197

Q3 2027

Post-ApprovalNot yet recruiting

Stroke

NCT05910125

Clinical

Trials by Indication[1]

Stroke18 trials

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

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 15 more trials

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

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

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

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

Unknown status·TThomas Jefferson University··NCT02447094·300 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

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

Terminated· Roche logo

Roche·Phase 3·NCT02072226·313 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

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

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

Ischemic stroke15 trials

24 Hours Treatment with Alteplase in Patients with Ischemic Stroke

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

Show 12 more trials

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

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

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

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

Tenecteplase Versus Alteplase in Ischemic Stroke Management (TALISMAN)

Withdrawn·—·Phase 2/3·NCT02180204

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

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

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

Unknown status·—··NCT04978181·30 enrolled

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

Pulmonary Embolism7 trials

A Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism

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

Reperfusion Treatment in Acute Pulmonary Embolism

Recruiting·SSahlgrenska University Hospital··NCT07003646·220 enrolled

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

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

Show 4 more trials

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

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

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 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

Stroke, Acute Ischemic3 trials

INtra-arterial AltEplase folloWing successfuL reperfusIoN After mEchanical Thrombectomy

Recruiting·1115 People's Hospital·Phase 3·NCT07727395·416 enrolled

Intravenous Adjuvant With Tirofiban Versus Thrombolysis Before Mechanical Thrombectomy in Acute Ischemic Stroke Patients With Large Vessel Occlusion: a Multicenter, Open Label, Randomized Controlled Trial.

Completed·XXinqiao Hospital of Chongqing·Preclinical·NCT05728333·1,014 enrolled

Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy (PEARL): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial

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

Acute Myocardial Infarction2 trials

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

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

25 more indications

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

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

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

Brain Infarction1 trial

Predictors of Post-alteplase Hemorrhagic Transformation of Brain Infarction

Completed·KKafrelsheikh University·Phase 4·NCT06337175·600 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

TED1 trial

Tirofiban for Patients Treated With Alteplase

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

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

Pleural effusion1 trial

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

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

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

Prophylaxis1 trial

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

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

Catheter1 trial

Study of Sodium Bicarbonate in Restoring Blocked Catheters

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

COVID-191 trial

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

Completed·—·Phase 2·NCT04357730·50 enrolled

Abscess1 trial

Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses

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

Hemorrhage1 trial

Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III

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

Thrombolysis1 trial

Peripheral Systemic Thrombolysis Versus Catheter Directed Thrombolysis for Submassive PE

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

Hematopoietic and Lymphoid Cell Neoplasm1 trial

A Randomized Trial of Alteplase Versus Placebo Through an Indwelling Pleural Catheter for Management of Symptomatic Septated MPE

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

ACTIVASE, CATHFLO ACTIVASE

NDA BLA103172

Nov 13, 1987

CATHFLO ACTIVASE

BLA BLA103172

Apr 3, 1995

ACTIVASE, CATHFLO ACTIVASE

NDA BLA103172

Jun 18, 1996

ACTIVASE, CATHFLO ACTIVASE

NDA BLA103172

Sep 4, 2001

ACTIVASE, CATHFLO ACTIVASE

NDA BLA103172

May 15, 2002

ACTIVASE, CATHFLO ACTIVASE

NDA BLA103172

Jan 4, 2005

ACTIVASE, CATHFLO ACTIVASE

NDA BLA103172

Feb 13, 2015

ACTIVASE, CATHFLO ACTIVASE

NDA BLA103172

Jun 30, 2017

ACTIVASE, CATHFLO ACTIVASE

NDA BLA103172

Feb 28, 2018

ACTIVASE, CATHFLO ACTIVASE

NDA BLA103172

Feb 28, 2018

ACTIVASE, CATHFLO ACTIVASE

NDA BLA103172

Oct 8, 2020

ACTIVASE, CATHFLO ACTIVASE

NDA BLA103172

Sep 1, 2022

ACTIVASE, CATHFLO ACTIVASE

NDA BLA103172

Sources

References

[1]
ClinicalTrials.gov — 74 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 (NDA 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

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Stroke18 trials

Ischemic stroke15 trials

Pulmonary Embolism7 trials

Stroke, Acute Ischemic3 trials

Acute Myocardial Infarction2 trials

Efficacy and Safety2 trials

Myocardial Infarction2 trials

Hemodialysis2 trials

Safety and Efficacy1 trial

Brain Infarction1 trial

Outcome1 trial

Prosthetic Valve Thrombosis1 trial

TED1 trial

Trial1 trial

Infusion1 trial

Physical Activity1 trial

Retinal Artery Occlusion1 trial

Pleural effusion1 trial

Acute Respiratory Failure1 trial

MPA1 trial

Prophylaxis1 trial

Catheter1 trial

COVID-191 trial

Abscess1 trial

Hemorrhage1 trial

Deep Vein Thrombosis1 trial

Thrombolysis1 trial

Empyema1 trial

Hematopoietic and Lymphoid Cell Neoplasm1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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