TNKase

(Tenecteplase)

ApprovedProtein / enzyme

Tenecteplase is used to dissolve dangerous blood clots in patients having a heart attack, helping to restore blood flow to the heart muscle and prevent permanent damage.[2] TNKase is currently approved and in use across 9 indications[4].[1]

TNKase is one of 130 small molecule programs targeting Stroke. It is currently in Approved.

Indications

Total Trials

Active Trials

129

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

StrokeCompleted

Recurrent ThrombophlebitisUnknown

Acute Ischemic StrokeNot yet recruiting

ProspectiveRecruiting

Heart AttackRecruiting

Stroke, IschemicRecruiting

ThrombectomyRecruiting

Acute Ischemic Stroke AISRecruiting

Ischemic StrokeRecruiting

StrokeApproved

Completed

Recurrent ThrombophlebitisPreclinical

Unknown

Acute Ischemic StrokePhase 3

Not yet recruiting

ProspectiveApproved

Recruiting

Heart AttackPhase 3

Recruiting

Stroke, IschemicApproved

Recruiting

ThrombectomyPhase 3

Recruiting

Acute Ischemic Stroke AISPhase 3

Recruiting

Ischemic StrokePhase 3

Recruiting

Competition

Competitive Landscape

147 competitors in Stroke

#DrugCompanyPhaseTrials

TNKase

Roche

Approved

17 2

Zometa

Pfizer

Preclinical

1 3

Savella

AbbVie

Preclinical

1 4

Proamatine

Repatha

Periactin

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 7

Zantac 150

CChattem

Preclinical

1 8

Alka-Seltzer

AAbbott

Preclinical

1 9

Haldol

DDePuy Orthopaedics

Preclinical

1 10

Inderal

Mylan Pharmaceuticals Inc

Preclinical

—

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

Timeline

Expected Milestones

Q4 2026

Phase 2/3Recruiting

Stroke

NCT05105633

Phase 2Not yet recruiting

Ischemic Stroke

NCT07375966

Phase 3Recruiting

Heart Attack

NCT03998319

Phase 3Recruiting

Retinal Artery Occlusion

NCT04965038

Q2 2027

Phase 3Recruiting

Cerebrovascular Event

NCT06954155

Phase 3Recruiting

Stroke

NCT06658197

Clinical

Trials by Indication[1]

Ischemic stroke17 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

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

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

Show 14 more trials

Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK)

Not yet recruiting·GGeneral Hospital of Shenyang Military Region·Phase 2·NCT07375953·120 enrolled

Study of Tenecteplase (TNK) in Acute Ischemic Stroke (TNK-S2B)

Terminated·UUniversity of Virginia·Phase 2·NCT00252239·112 enrolled

A Randomized Controlled Trial of TNK-tPA Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion

Completed·UUniversity of Calgary·Phase 3·NCT02398656·1,274 enrolled

Tenecteplase Versus Alteplase in Ischemic Stroke Management (TALISMAN)

Withdrawn·—·Phase 2/3·NCT02180204

Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours of Onset With Tenecteplase (RITIS-TNK2)

Not yet recruiting·GGeneral Hospital of Shenyang Military Region·Phase 2·NCT07375966·198 enrolled

Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke

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

Randomization to Endovascular Treatment Alone or Preceded by Systemic Thrombolysis With Tenecteplase in Ischemic Stroke

Recruiting·HHospital Moinhos de Vento·Phase 3·NCT05199194·398 enrolled

Tenecteplase Thrombolytic Therapy for Acute Ischemic Stroke in China

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

Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ischemic Stroke

Recruiting·—·Phase 3·NCT07047014·596 enrolled

Penumbral Based Novel Thrombolytic Therapy in Acute Ischemic Stroke

Completed·UUniversity of Alberta·Phase 2·NCT02101606·20 enrolled

Safety Of A Second Dose Of Tenecteplase In Selected Acute Ischemic Stroke Patients Not Responding To The First Dose

Not yet recruiting·—·Phase 1·NCT06801054·20 enrolled

Tenecteplase Versus Alteplase Before Endovascular Therapy for Ischemic Stroke

Completed·NNeuroscience Trials Australia·Phase 2·NCT02388061·202 enrolled

Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With Late-window acUte Ischemic Stroke Due to Middle Cerebral Artery Occlusion

Completed·—·Phase 3·NCT06221371·391 enrolled

TNK-tPA Evaluation for Minor Ischemic Stroke With Proven Occlusion

Completed·UUniversity of Calgary·Phase 2·NCT01654445·50 enrolled

Stroke17 trials

CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II

Completed·HHuashan Hospital·Phase 2·NCT04516993·224 enrolled

Tenecteplase in Stroke Patients Between 4.5 and 24 Hours

Completed· Roche logo

Roche·Phase 3·NCT03785678·458 enrolled

Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II)

Completed·GGeneral Hospital of Shenyang Military Region·Phase 3·NCT05657444·380 enrolled

Show 14 more trials

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

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

Tenecteplase in Wake-up Ischaemic Stroke Trial

Unknown status·UUniversity Hospital of North Norway·Phase 3·NCT03181360·600 enrolled

Extending the Time Window for Tenecteplase by Recanalization of Basilar Artery Occlusion in Posterior Circulation Stroke

Recruiting·UUniversity of Melbourne·Phase 2/3·NCT05105633·688 enrolled

Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance

Completed·MMelbourne Health·Phase 2·NCT04071613·104 enrolled

MRI-guided thrOmbolysis for Stroke bEyond Time Window by TNK

Completed·GGeneral Hospital of Shenyang Military Region·Phase 4·NCT04752631·80 enrolled

The Norwegian Tenecteplase Stroke Trial 2

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

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

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

Determining the Optimal Dose of Tenecteplase Before Endovascular Therapy for Ischaemic Stroke (EXTEND-IA TNK Part 2)

Completed·NNeuroscience Trials Australia·Phase 2·NCT03340493·300 enrolled

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

Completed·—··NCT05635786·319 enrolled

Tenecteplase for Intravenous Stroke Thrombolysis in Recent DOAC Users

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 3·NCT07092709·912 enrolled

Tenecteplase in ReperfUsion Therapy for Posterior Circulation Stroke With Extended Time Window: the TRUST Trial

Not yet recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 3·NCT07073469·330 enrolled

Precision Reperfusion Therapy for Disabling Minor Stroke With Large Vessel Occlusion Beyond Time Window

Not yet recruiting·FFirst Hospital of China Medical University·Phase 3·NCT07476898·864 enrolled

Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis

Completed·NNHS Greater Glasgow and Clyde·Phase 3·NCT02814409·1,858 enrolled

Randomization to Extend Stroke Intravenous ThromboLysis In Evolving Non-Large Vessel Occlusion With TNK (RESILIENT

Recruiting·HHospital Moinhos de Vento·Phase 3·NCT05199662·466 enrolled

Acute Ischemic Stroke6 trials

Efficacy and Safety of Tenecteplase Thrombolysis as Bridging Thrombolysis Prior to Inter-hospital Transfer for Endovascular Therapy in Anterior Circulation Large Vessel Occlusion Stroke Within 4.5-24 Hours: A Multicenter Randomized Controlled Clinical Trial

Not yet recruiting·FFujian Medical University Union Hospital·Phase 3·NCT07912970·1,266 enrolled

A Prospective Multicenter Observational Study of the Safety and Effectiveness of Tenecteplase (rhTNK-tPA) for Acute Ischemic Stroke Across Different Transfer Pathways

Not yet recruiting·FFujian Medical University Union Hospital··NCT07897955·2,000 enrolled

TENACITY - A Phase III, Prospective, Randomized, Open-label, Blinded Endpoint Assessment (PROBE) to Assess Efficacy and Safety of i.v. Tenecteplase vs Standard of Care in Patients With Acute Ischemic Stroke (Including Wake-up Stroke), Last Known Well >4.5 h With Imaging Evidence of Salvageable Ischemic Tissue

Recruiting· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT07361302·1,325 enrolled

Show 3 more trials

Intravenous Tenecteplase for Acute Ischemic Stroke With Unknown Time of Onset Under Non-Contrast CT Selection: A Multicenter, Prospective, Randomized, Open-label, Blinded Endpoint Trial

Recruiting·FFirst Affiliated Hospital of Guangxi Medical University·Phase 3·NCT07475949·352 enrolled

A Multicenter, Prospective, Observational, Real-World Registry Study of Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke

Recruiting·FFirst Affiliated Hospital of Guangxi Medical University··NCT07475936·392 enrolled

Tenecteplase Before inteRhospital Transfer for Endovascular Treatment in pAtientS With acUte Anterior ciRculation Large vEssel Occlusion at 4.5 to 24 Hours

Recruiting·XXuanwu Hospital, Beijing·Phase 3·NCT07253181·572 enrolled

Tenecteplase4 trials

A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters

Completed· Roche logo

Roche·Phase 3·NCT00395876·100 enrolled

A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters

Completed· Roche logo

Roche·Phase 3·NCT00396318·251 enrolled

Single Bolus Recombinant Nonimmunogenic Staphylokinase Versus Single Bolus Tenecteplase (Metalyse) in STEMI

Completed·SSupergene, LLC·Phase 3·NCT02301910·382 enrolled

Show 1 more trial

Superiority of Rt-PA + Tenecteplase in Comparison With Rt-PA Only in Proximal Middle Cerebral Artery Occlusion

Withdrawn·UUniversity Hospital Center of Martinique·Phase 2·NCT02338466

Heart Attack3 trials

A Safety/Efficacy Study of Intra-coronary Tenecteplase During Balloon Angioplasty to Treat Heart Attacks

Completed·—·Phase 2·NCT00604695·40 enrolled

Which Therapy for Acute Heart Attacks? (The WEST Study)

Completed·UUniversity of Alberta·Phase 2/3·NCT00121446·300 enrolled

A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients.

Recruiting·UUniversity of Sydney·Phase 3·NCT03998319·445 enrolled

22 more indications

Thrombectomy3 trials

Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial

Recruiting·—·Phase 2/3·NCT06949228·132 enrolled

Tenecteplase Compared to Alteplase for Patients With Large Vesel Oclusion Suspicion Before Thrombectomy

Unknown status·HHospital Universitari Vall d'Hebron Research Institute·Phase 3·NCT05626972·500 enrolled

Reperfusion Completion Via Local Arterial Infusion of Tenecteplase After Incomplete Mechanical Thrombectomy

Not yet recruiting·CChuansheng Zhao·Phase 3·NCT07471282·344 enrolled

Cerebrovascular Event3 trials

Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5

Completed·—·Phase 3·NCT06196320·452 enrolled

Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND

Recruiting·—·Phase 3·NCT06954155·330 enrolled

Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-III

Completed·—·Phase 3·NCT05141305·516 enrolled

Myocardial Infarction2 trials

STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00623623·1,899 enrolled

STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction

Completed·KKU Leuven·Phase 4·NCT02777580·609 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 Trial Evaluating the Efficacy and Safety of Tenecteplase Together With Unfractionated Heparin Prior to Early Percutaneous Coronary Intervention (PCI) as Compared to Standard Primary PCI in Patients With Acute Myocardial Infarction (ASSENT 4 PCI)

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT00168792·1,671 enrolled

Hemodialysis2 trials

A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters

Completed· Roche logo

Roche·Phase 3·NCT00396032·150 enrolled

A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis (HD) Catheters

Completed· Roche logo

Roche·Phase 3·NCT00396253·223 enrolled

Pulmonary Embolism2 trials

PEITHO Pulmonary Embolism Thrombolysis Study

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT00639743·1,005 enrolled

Tenecteplase Pulmonary Embolism Italian Study

Terminated·UUniversity Of Perugia·Phase 2·NCT00222651·180 enrolled

Basilar Artery Occlusion1 trial

Intravenous Tenecteplase Plus EVT Versus EVT Alone on 4.5 to 24 Hours After Basilar Artery Occlusion

Completed·TThe First Affiliated Hospital of University of Science and Technology of China·Phase 3·NCT05701956·330 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Intra-arterial Tenecteplase for Noncomplete Reperfusion of Intracranial Occlusions

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 3·NCT05499832·156 enrolled

Effectiveness1 trial

Observational RegIstry of Effectiveness and Safety of teNecTeplase in reAl worLd Settings in China

Recruiting·—··NCT07271342·10,000 enrolled

COVID-191 trial

Tenecteplase in Patients With COVID-19

Completed·HHooman Poor·Phase 2·NCT04505592·13 enrolled

Vessel Occlusion1 trial

Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)

Completed·GGeneral Hospital of Shenyang Military Region·Phase 2/3·NCT05657470·80 enrolled

Prospective1 trial

Intravenous TNK vs TPA for AIS Treatment on MSU,a Prospective Multicenter RCT

Recruiting·MMahidol University·Phase 4·NCT06498323·160 enrolled

Cardiac Arrest1 trial

Thrombolysis Using Tenecteplase (Metalyse®) in Cardiac Arrest - The TROICA Trial

Terminated· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00157261·1,050 enrolled

Endovascular Thrombectomy1 trial

Intra-arterial TNK Following Endovascular Thrombectomy in Patients With Large Vessel Occlusion of Posterior Circulation

Completed·TThe First Affiliated Hospital of University of Science and Technology of China·Phase 2/3·NCT05684172·208 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 Distress Syndrome1 trial

Treatment of Acute Respiratory Distress Syndrome With Tenecteplase: A Dose Escalation Pilot Study

Withdrawn·WWake Forest University Health Sciences·Phase 1·NCT00431379

Retinal Artery Occlusion1 trial

Early Reperfusion Therapy With Intravenous Thrombolysis for Recovery of VISION in Acute Central Retinal Artery Occlusion

Recruiting·UUniversity Hospital Tuebingen·Phase 3·NCT04965038·422 enrolled

Acute Basilar Artery Occlusion1 trial

Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT)

Terminated·GGeneral Hospital of Shenyang Military Region·Phase 3·NCT05657457·145 enrolled

Large Vessel Occlusion1 trial

Extending the Time Window for Tenecteplase by Effective Reperfusion in Patients with Large Vessel Occlusion

Terminated·UUniversity of Melbourne·Phase 3·NCT04454788·242 enrolled

Stroke, Acute Ischemic1 trial

Intra-Arterial Treatment of Medium-sized Primary Vessel Occlusions: A Randomized Controlled Trial (IMP-ACT)Embedded in A Multi-faCtorial,mulTi-arm, Multi-staGe,Randomised,gLOBal Adaptive pLatform Trial for Stroke NCT06352632

Not yet recruiting·UUniversity of Calgary·Phase 3·NCT07906275·800 enrolled

Acute Ischemic Stroke AIS1 trial

A Multicentre, Prospective, Randomized, Open Label, Blinded-endpoint Trial to Optimize the Use of Intravenous Tenecteplase in Participants With Acute Ischemic Stroke (ACT-GLOBAL THROMBOLYSIS (ACT WHEN-001) Within A Multi-faCtorial, mulTi-arm, Multi-staGe, Randomised, gLOBal Adaptive pLatform Trial for Stroke (ACT-GLOBAL) NCT06352632

Recruiting·UUniversity of Calgary·Phase 3·NCT06320431·4,000 enrolled

Stroke, Ischemic1 trial

Intravenous Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2): a Prospective, Randomized, Open Label, Blinded Endpoint, and Multi-center Study

Recruiting·GGeneral Hospital of Shenyang Military Region·Approved·NCT06010628·1,440 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 2, 2000

TNKASE

BLA BLA103909

Sources

References

[1]
ClinicalTrials.gov — 77 trial records for Tenecteplase. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — TNKase drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tenecteplase compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tenecteplase. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (BLA BLA103909). 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

TNKase

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Trials by Indication[1]

Ischemic stroke17 trials

Stroke17 trials

Acute Ischemic Stroke6 trials

Tenecteplase4 trials

Heart Attack3 trials

Thrombectomy3 trials

Cerebrovascular Event3 trials

Myocardial Infarction2 trials

Acute Myocardial Infarction2 trials

Hemodialysis2 trials

Pulmonary Embolism2 trials

Basilar Artery Occlusion1 trial

Safety and Efficacy1 trial

Effectiveness1 trial

COVID-191 trial

Vessel Occlusion1 trial

Prospective1 trial

Cardiac Arrest1 trial

Endovascular Thrombectomy1 trial

Physical Activity1 trial

Acute Respiratory Distress Syndrome1 trial

Retinal Artery Occlusion1 trial

Acute Basilar Artery Occlusion1 trial

Large Vessel Occlusion1 trial

Stroke, Acute Ischemic1 trial

Acute Ischemic Stroke AIS1 trial

Stroke, Ischemic1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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