TNKASE (tenecteplase) / Roche, Boehringer Ingelheim - LARVOL DELTA

Toward AI-Powered Neurovascular Intervention: From Imaging to XR-Robotic Convergence. (PubMed, Stroke) - "We also highlight key translational and ethical challenges, including regulatory and policy considerations, which must be addressed for safe adoption. Together, these developments point toward a future of precision-driven and globally accessible neurovascular intervention."

Journal • Review • Cardiovascular • CNS Disorders • Ischemic stroke

ORIENTAL: Observational RegIstry of Effectiveness and Safety of teNecTeplase in reAl worLd Settings in China (clinicaltrials.gov) - P=N/A | N=10000 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital

New trial • Real-world evidence • Cardiovascular

Safety and efficacy of intravenous tenecteplase in patients with acute ischemic stroke in extended time window: systematic review and meta-analysis. (PubMed, Eur J Med Res) - "TNK 0.25 mg/kg appears to significantly achieve early neurological improvement with no effect in achieving excellent or favorable functional outcomes; however, it showed a significant increase in symptomatic intracranial hemorrhage. Patients who performed endovascular thrombectomy after administering TNK 0.25 mg/kg had statistically significantly higher rates of symptomatic intracranial hemorrhage; on the other hand, current evidence endorses the use of tenecteplase 0.25 mg/kg in patients with ischemic strokes whose baseline mRs ranges from 0 to 1. Further RCTs are necessary to validate these findings. Prospero registration number: CRD42025636473."

Journal • Retrospective data • Review • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Tenecteplase vs Alteplase in Mechanical Prosthetic Heart Valve Thrombosis: The TENET Randomized Clinical Trial. (PubMed, JAMA Cardiol) - "Furthermore, the relative ease of drug administration with tenecteplase may translate to greater clinical benefit in a real-world setting. Clinical Trials Registry of India: CTRI/2022/10/046127."

Clinical • Journal • Cardiovascular • Hematological Disorders • Thrombosis

Switching from alteplase to tenecteplase for stroke thrombolysis: short-term effects on treatment metrics and early functional outcomes. (PubMed, BMC Neurol) - No abstract available

Journal • Cardiovascular • Ischemic stroke

Rescue PCI in the Pharmaco-invasive Era of STEMI: Insights from the STREAM-2 Trial. (PubMed, Eur Heart J Acute Cardiovasc Care) - "Contemporary PI with half-dose tenecteplase in older patients requiring rescue intervention led to less ST resolution and worse 30-day outcomes compared to those with successful fibrinolysis receiving scheduled angiography. Notably, delays to deploying rescue PCI in CH patients were shortened over those previously achieved thereby resulting in similar outcomes to those randomized in the ambulance. Our results reinforce the benefits of functional hub and spoke models with rapid transfer to a PCI-capable facility."

Journal • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Congestive Heart Failure • Heart Failure • Hematological Disorders • Myocardial Infarction

STEPS: Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage (clinicaltrials.gov) - P=N/A | N=768 | Recruiting | Sponsor: Tongji Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Cerebral Hemorrhage • Hematological Disorders

TNK-PLUS: Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With Late-window acUte Ischemic Stroke Due to Middle Cerebral Artery Occlusion (clinicaltrials.gov) - P3 | N=391 | Completed | Sponsor: Beijing Tiantan Hospital | Recruiting ➔ Completed | Trial completion date: May 2025 ➔ Oct 2025 | Trial primary completion date: Dec 2024 ➔ Oct 2025

Trial completion • Trial completion date • Trial primary completion date • Cardiovascular • Ischemic stroke

Thrombolysis With the Nonimmunogenic Staphylokinase for Acute Ischemic Stroke in FORPI Registry: An Observational Study. (PubMed, Stroke) - "These safety and efficacy outcomes were comparable with FRIDA (Fortelyzin Randomized Investigation Compared With Alteplase) randomized clinical trial results. The presented data suggest that intravenous thrombolysis with the nonimmunogenic staphylokinase is safe and effective in routine clinical practice when used within 4.5 hours of AIS symptoms onset. These findings should encourage the wider usage of thrombolytic therapy with the nonimmunogenic staphylokinase for suitable patients."

Clinical • Journal • Observational data • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Ischemic stroke

Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice (clinicaltrials.gov) - P=N/A | N=2008 | Recruiting | Sponsor: Dongzhimen Hospital, Beijing | Not yet recruiting ➔ Recruiting | Trial primary completion date: Apr 2025 ➔ Dec 2025

Enrollment open • Trial primary completion date • Cardiovascular • Ischemic stroke

Tenecteplase Versus Alteplase for First-Pass Reperfusion in Basilar Artery Occlusion Stroke Thrombectomy. (PubMed, Ann Neurol) - "In this multicenter BAO cohort, TNK increased the odds of achieving FPE compared with TPA. As FPE strongly predicted functional recovery, these findings suggest TNK may confer a reperfusion advantage with potential clinical benefit, although a direct outcome effect was not demonstrated. ANN NEUROL 2025."

Journal • Cardiovascular • CNS Disorders

A bismuth-based nanoplatform with synergistic fibrin/NET disruption and antioxidant/anti-inflammatory capabilities for enhanced thrombolysis and prevention of deep vein thrombosis recurrence. (PubMed, J Nanobiotechnology) - "Therapeutically, a dual-drug antithrombotic effect was achieved through the breakdown of fibrin by tenecteplase (TNK) and the inhibition of NET structures by hydroxychloroquine (HCQ). The vicious cycle of NET-mediated thrombosis-associated immune dysregulation, a locally abnormal thrombotic microenvironment, and endothelial dysfunction was ultimately broken. This work provides a promising two-pronged approach to the treatment of DVT by increasing the effectiveness of thrombolysis while reducing the risk of reocclusion."

Journal • Cardiovascular • Hematological Disorders • Inflammation • Pulmonary Embolism • Respiratory Diseases • Thrombosis • Venous Thromboembolism

Comparative Safety of Tenecteplase and Alteplase in Direct Oral Anticoagulant-Pretreated Patients With Acute Ischemic Stroke. (PubMed, Clin Pharmacol Ther) - "Time-split Cox analysis confirmed that excess risk was confined to the first 24 hours. Among patients pretreated with DOACs, tenecteplase was associated with higher early risk of hemorrhagic transformation and mortality than alteplase, underscoring the need for vigilance during the first 24 hours after treatment."

Journal • Cardiovascular • Cerebral Hemorrhage • Gastroenterology • Hematological Disorders • Ischemic stroke • Subarachnoid Hemorrhage

Prehospital thrombolysis with tenecteplase in out-of-hospital cardiac arrest: a retrospective cohort study. (PubMed, Scand J Trauma Resusc Emerg Med) - "Prehospital thrombolysis with Tenecteplase was not associated with improved survival or ROSC in OHCA and may be linked to worse outcomes. These findings highlight a lack of sustained benefit associated with empiric thrombolysis based on suspected thromboembolic cause in OHCA, and raise questions about its routine prehospital use without definitive diagnosis."

Journal • Retrospective data • Cardiovascular

TREASURE: Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours (clinicaltrials.gov) - P3 | N=572 | Not yet recruiting | Sponsor: Xuanwu Hospital, Beijing

New P3 trial • Cardiovascular • Ischemic stroke

Letter to the Editor, Regarding "Comparative Efficacy and Safety of Different Tenecteplase Doses With Alteplase in Acute Ischemic Stroke: A Systematic Review With Pairwise and Network Meta-Analysis to Determine the Optimal Dose" Recently Published by Waseem and Colleagues. (PubMed, Brain Behav) - No abstract available

Journal • Retrospective data • Cardiovascular • Ischemic stroke

Tenecteplase for Ischemic Stroke due to Large Vessel Occlusion at 4.5 to 24 Hours: A Meta-Analysis of Randomized Controlled Trials. (PubMed, Brain Behav) - "This meta-analysis of randomized controlled trials manifested that tenecteplase within a 4.5- to 24-h time window of large vessel occlusion stroke was superior to control for an excellent functional outcome (mRS 0-1) without safety concerns."

Clinical • Journal • Retrospective data • Review • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Tenecteplase versus alteplase in bridging therapy in patients with large vessel occlusion stroke: a meta-analysis. (PubMed, Front Neurol) - "However, TNK might be more effective than ALT in achieving early recanalization, and it may also reduce the risks of ICH. Unique Identifier: CRD42025643339, Publicly Accessible URL: https://www.crd.york.ac.uk/PROSPERO/."

Journal • Retrospective data • Review • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

TRACE-BEYOND: Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND (clinicaltrials.gov) - P3 | N=330 | Recruiting | Sponsor: Beijing Tiantan Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Ischemic stroke

Stroke of Insight: Recognition, Work-Up, and Treatment of Acute Ischemic Stroke. (PubMed, Emerg Med Clin North Am) - "A rapid, accurate history and examination may help screen for large-vessel occlusions, navigate among potential stroke mimics, and even detect subtle clinical chameleons. Awareness of the utility of advanced perfusion and MRI modalities allows clinicians to offer interventions even to those without a clear time of symptom onset."

Journal • Review • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

TECNO: Safety and Efficacy of Intra-arterial Tenecteplase for Noncomplete Reperfusion of Intracranial Occlusions (clinicaltrials.gov) - P3 | N=156 | Active, not recruiting | Sponsor: Insel Gruppe AG, University Hospital Bern | Recruiting ➔ Active, not recruiting | Trial primary completion date: Oct 2026 ➔ Oct 2025

Enrollment closed • Trial primary completion date • Cardiovascular • Ischemic stroke

A Translational Multi Model Platform for Preclinical Evaluation of Thrombolytics in Acute Ischemic Stroke (Neuroscience 2025) - "OBJECTIVE We established a translational preclinical platform using complementary rodent models of ischemic stroke to assess new thrombolytic candidates, with rt-PA or tenecteplase (TNK) as clinical benchmarks...In diabetic mice, Alteplase showed no benefit on lesion volume, while Microlyse remained effective, indicating broader applicability. In the collagenase model, TNK and some anticoagulants significantly increased bleeding.CONCLUSIONS This multi-model platform offers a robust, translationally relevant tool for evaluating novel stroke therapies, enabling:• Efficacy comparison with rt-PA or TNK• Simulation of high-risk or non-responder subpopulations• Early detection of safety or interaction risksIntegrated into a comprehensive workflow, these models have already supported development of several agents, including Microlyse, now advancing to clinical evaluation."

Preclinical • Cerebral Hemorrhage • CNS Disorders

Safety of tenecteplase versus alteplase for intravenous thrombolysis in acute ischemic stroke patients with direct oral anticoagulation: experience from a German stroke center. (PubMed, Neurol Res Pract) - "We report no increased rate of (s)ICH for TNK based IVT compared with rt-PA in AIS-patients with DOAC, indicating a similar safety profile. Moderate to high drug-specific DOAC levels were no surrogates for hemorrhagic complications, supporting the implementation of specific Standard Operating Procedures for IVT in DOAC-treated patients. Contrary to previous studies, we did not observe an increased rate of early recanalization of LVO in TNK-treated patients in this small single-center cohort."

Journal • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Basilar Artery Occlusion Stroke Managed With Tenecteplase Versus Alteplase Before Endovascular Treatment (BAO-TNK). (PubMed, Ann Clin Transl Neurol) - "In BAO stroke, TNK and TPA administered within 4.5 h pre-EVT were associated with similar functional outcomes, reperfusion success and hemorrhage rates."

Clinical • Journal • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Rare case of thrombolysis for ischemic stroke with a concurrent perforated duodenal ulcer. (PubMed, J Surg Case Rep) - "This case represents an unconventional, simultaneous approach to the treatment of both initial conditions. Both treatment methods-thrombolysis and surgical procedure-can be successfully applied in selected cases."

Journal • Cardiovascular • Gastroenterology • Ischemic stroke • Pain • Peptic Ulcer • Venous Ulcer