Explore

Companies

Drugs

About·Data Management·Terms·Privacy

Stay informed

© 2026 VivoSeq. All rights reserved.

TNKase

(Tenecteplase)

Phase 3Protein / 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.[1] TNKase is currently being investigated across 14 indications[3], with its most advanced program in Phase 3.[1]

TNKase is one of 290 small molecule programs targeting Sudden Cardiac Arrest. It is currently in Phase 3.

14

Indications

74

Total Trials

24

Active Trials

289

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Sudden Cardiac ArrestActive, not recruiting

Cardiac ArrestActive, not recruiting

Retinal Artery OcclusionActive, not recruiting

StrokeActive, not recruiting

Acute Myocardial InfarctionUnknown

ST Elevation Myocardial InfarctionActive, not recruiting

Nervous System DiseaseActive, not recruiting

Myocardial InfarctionUnknown

Physical ActivityActive, not recruiting

Recurrent ThrombophlebitisUnknown

Sudden Cardiac ArrestPhase 3

Active, not recruiting

Cardiac ArrestPhase 3

Active, not recruiting

Retinal Artery OcclusionPhase 3

Active, not recruiting

StrokePhase 3

Active, not recruiting

Acute Myocardial InfarctionPreclinical

Unknown

ST Elevation Myocardial InfarctionPhase 3

Active, not recruiting

Nervous System DiseasePhase 2

Active, not recruiting

Myocardial InfarctionPreclinical

Unknown

Physical ActivityPhase 3

Active, not recruiting

Recurrent ThrombophlebitisPreclinical

Unknown

Showing 10 of 14 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

TNKase

Spikevax

Bnt162b2

COVID-19 Vaccine

Biaxin

Singulair

Stivarga

Aimovig

Aldactone

Nexavar

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

Timeline

Expected Milestones

Q3 2026

Phase 1Not yet recruiting

Ischemic Stroke

NCT06801054

Q4 2026

Phase 2/3Recruiting

Stroke

NCT05105633

Post-ApprovalRecruiting

Ischemic Stroke

NCT06010628

Phase 2Not yet recruiting

Ischemic Stroke

NCT07375966

Phase 3Recruiting

Heart Attack

NCT03998319

Phase 3Recruiting

Retinal Artery Occlusion

NCT04965038

Clinical

Trials by Indication[1]

Stroke19 trials

Tenecteplase in Wake-up Ischaemic Stroke Trial

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

A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well

Recruiting· Boehringer Ingelheim logo

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

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

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

Show 16 more trials

Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance

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

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

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

Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging

Not yet recruiting·FFirst Affiliated Hospital of Guangxi Medical University·Phase 3·NCT07475949·352 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

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

Completed·—··NCT05635786·319 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

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

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

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

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

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

Ischemic stroke19 trials

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

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

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

Show 16 more trials

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

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

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

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

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

Recruiting·—·Phase 3·NCT07047014·596 enrolled

Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke

Not yet recruiting·FFirst Affiliated Hospital of Guangxi Medical University··NCT07475936·392 enrolled

Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)

Recruiting·GGeneral Hospital of Shenyang Military Region·Phase 4·NCT06010628·1,440 enrolled

TNK-tPA Evaluation for Minor Ischemic Stroke With Proven Occlusion

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

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

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

Tenecteplase Versus Alteplase in Ischemic Stroke Management (TALISMAN)

Withdrawn·—·Phase 2/3·NCT02180204

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

Tenecteplase Versus Alteplase Before Endovascular Therapy for Ischemic Stroke

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

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

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

Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke

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

Tenecteplase5 trials

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

Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

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

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

Completed· Roche logo

Roche·Phase 3·NCT00395876·100 enrolled

Show 2 more trials

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

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

Thrombectomy3 trials

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

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

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

19 more indications

Cerebrovascular Event3 trials

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

Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5

Completed·—·Phase 3·NCT06196320·452 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

Pulmonary Embolism2 trials

Tenecteplase Pulmonary Embolism Italian Study

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

PEITHO Pulmonary Embolism Thrombolysis Study

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

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

Effectiveness1 trial

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

Recruiting·—··NCT07271342·10,000 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

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

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

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

COVID-191 trial

Tenecteplase in Patients With COVID-19

Completed·HHooman Poor·Phase 2·NCT04505592·13 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

Vessel Occlusion1 trial

Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)

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

Prospective1 trial

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

Recruiting·MMahidol University·Phase 4·NCT06498323·160 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

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

Thrombolysis1 trial

ACT-GLOBAL THROMBOLYSIS (ACT-WHEN-001) Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632

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

Regulatory

FDA Approval Timeline[4]

Jun 2, 2000

TNKASE

BLA BLA103909

Sources

References

[1]
ClinicalTrials.gov — 74 trial records for Tenecteplase. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tenecteplase compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tenecteplase. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA103909). U.S. Food & Drug Administration.
[5]
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[2]
Modality: Protein / enzyme[2]
Highest Phase: Phase 3[1]
Company: Roche

Related News