TNKASE (tenecteplase)
TNKase (tenecteplase) is a tissue plasminogen activator indicated to reduce the risk of mortality associated with acute ST elevation myocardial infarction (STEMI). It is administered to patients experiencing this specific type of heart attack during the acute phase of the event. The drug serves as a therapeutic intervention to improve survival outcomes in this patient population.
How TNKASE Works
Tenecteplase is a modified form of human tissue plasminogen activator that binds to fibrin and converts plasminogen into the enzyme plasmin. This conversion process is significantly increased in the presence of fibrin, allowing for targeted activity. This fibrin specificity is intended to decrease the systemic activation of plasminogen and the subsequent degradation of circulating fibrinogen.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2000-06-02
- Routes
- N/A
- Dosage Forms
- VIAL
TNKASE Approval History
What TNKASE Treats
1 indicationsTNKASE is approved for 1 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- ST Elevation Myocardial Infarction
TNKASE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
40 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07361302 TENACITY | 1123-0060 2025-522542-40-00, U1111-1323-6001 | Ph 3 | recruiting | 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 |
| NCT05105633 POST-ETERNAL | CT21028 | Ph 2, Ph 3 | recruiting | Extending the Time Window for Tenecteplase by Recanalization of Basilar Artery Occlusion in Posterior Circulation Stroke |
| NCT06658197 TNK-LVO | [2024]288-001 | Ph 3 | recruiting | Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke |
| NCT07375953 RITIS-TNK | Y (2025) 501 | Ph 2 | recruiting | Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK) |
| NCT07375966 RITIS-TNK2 | Y (2025) 502 | Ph 2 | recruiting | Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours of Onset With Tenecteplase (RITIS-TNK2) |
| NCT05701956 | ATTENTION LATE | Ph 3 | completed | Intravenous Tenecteplase Plus EVT Versus EVT Alone on 4.5 to 24 Hours After Basilar Artery Occlusion |
| NCT05499832 TECNO | 2022-00388 | Ph 3 | completed | Safety and Efficacy of Intra-arterial Tenecteplase for Noncomplete Reperfusion of Intracranial Occlusions |
| NCT06949228 ALLY II TNK | ALLY II | Ph 2, Ph 3 | recruiting | Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial |
| NCT06196320 TRACE-5 | CSA2023YJ002 | Ph 3 | completed | Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5 |
| NCT06221371 TNK-PLUS | CSA2023YJ003 | Ph 3 | completed | Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With Late-window acUte Ischemic Stroke Due to Middle Cerebral Artery Occlusion |
| NCT06320431 ACT-WHEN | ACT-WHEN-001 | Ph 3 | recruiting | ACT-GLOBAL THROMBOLYSIS (ACT-WHEN-001) Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632 |
| NCT06010628 | Y (2023) 144 | Ph 4 | recruiting | Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2) |
| NCT05657457 | Y (2022) 185 | Ph 3 | terminated | Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT) |
| NCT05657470 | Y (2022) 187 | Ph 2, Ph 3 | completed | Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK) |
| NCT05199194 DIRECT-TNK | RESILIENT DIRECT-TNK | Ph 3 | recruiting | Randomization to Endovascular Treatment Alone or Preceded by Systemic Thrombolysis With Tenecteplase in Ischemic Stroke |
| NCT05657444 | Y (2022) 168 | Ph 3 | completed | Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II) |
| NCT02301910 FRIDOM1 results posted | FRIDOM1 | Ph 3 | completed | Single Bolus Recombinant Nonimmunogenic Staphylokinase Versus Single Bolus Tenecteplase (Metalyse) in STEMI |
| NCT03854500 NOR-TEST 2 | 2018-003090-95 | Ph 3 | terminated | The Norwegian Tenecteplase Stroke Trial 2 |
| NCT02398656 TEMPO-2 results posted | Version 3.3 , Mar 24,2017 | Ph 3 | completed | A Randomized Controlled Trial of TNK-tPA Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion |
| NCT04454788 ETERNAL-LVO | 2019.125 | Ph 3 | terminated | Extending the Time Window for Tenecteplase by Effective Reperfusion in Patients with Large Vessel Occlusion |
| NCT04915729 ORIGINAL results posted | 1123-0040 | Ph 3 | completed | A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity |
| NCT02777580 STREAM-2 results posted | LRD.2016.STREAM2 | Ph 4 | completed | STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction |
| NCT06498323 | 376/2565(IRB1) | Ph 4 | recruiting | Intravenous TNK vs TPA for AIS Treatment on MSU,a Prospective Multicenter RCT |
| NCT03785678 TIMELESS results posted | ML40787 | Ph 3 | completed | Tenecteplase in Stroke Patients Between 4.5 and 24 Hours |
| NCT05684172 | ATTENTION IA | Ph 2, Ph 3 | completed | Intra-arterial TNK Following Endovascular Thrombectomy in Patients With Large Vessel Occlusion of Posterior Circulation |
| NCT04516993 CHABLIS-T II | SHDC2020CR1041B | Ph 2 | completed | CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II |
| NCT03889249 AcT | Version 2.0 (Sponsor assigned) | Ph 3 | completed | Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke |
| NCT04505592 results posted | GCO 20-1764 | Ph 2 | completed | Tenecteplase in Patients With COVID-19 |
| NCT04752631 ROSE-TNK | Y(2020)067 | Ph 4 | completed | MRI-guided thrOmbolysis for Stroke bEyond Time Window by TNK |
| NCT04071613 TASTEa | 2018.043 | Ph 2 | completed | Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance |
| NCT04558125 results posted | ML42522 | Ph 4 | terminated | Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism |
| NCT01654445 TEMPO-1 results posted | Version 2.2, Aug 28,2013 | Ph 2 | completed | TNK-tPA Evaluation for Minor Ischemic Stroke With Proven Occlusion |
| NCT03340493 | NTA1401a | Ph 2 | completed | Determining the Optimal Dose of Tenecteplase Before Endovascular Therapy for Ischaemic Stroke (EXTEND-IA TNK Part 2) |
| NCT00623623 results posted | 1123.28 2007-001219-44 | Ph 3 | completed | STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction |
| NCT01472926 ATTEST | 2010-024541-67 TSA 2010/04, 2010-024541-67 | Ph 2 | completed | Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis- (ATTEST) |
| NCT02338466 DIVA | 13/EC/02 | Ph 2 | withdrawn | Superiority of Rt-PA + Tenecteplase in Comparison With Rt-PA Only in Proximal Middle Cerebral Artery Occlusion |
| NCT02388061 EXTEND-IA TNK | NTA1401 | Ph 2 | completed | Tenecteplase Versus Alteplase Before Endovascular Therapy for Ischemic Stroke |
| NCT01949948 NOR-TEST | REK 2011/2435 | Ph 3 | completed | Study of Tenecteplase Versus Alteplase for Thrombolysis (Clot Dissolving) in Acute Ischemic Stroke |
| NCT02180204 TALISMAN | 2013H000 TALISMAN | Ph 2, Ph 3 | withdrawn | Tenecteplase Versus Alteplase in Ischemic Stroke Management (TALISMAN) |
| NCT00604695 ICE T-TIMI 49 results posted | N3770S | Ph 2 | completed | A Safety/Efficacy Study of Intra-coronary Tenecteplase During Balloon Angioplasty to Treat Heart Attacks |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TNKASE FDA Label Details
Indications & Usage
FDA Label (PDF)TNKASE is indicated for the treatment of ST Elevation Myocardial Infarction.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment