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

Safety and Efficacy of Early Aspirin Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT): Rationale and Design of a Multicenter, Randomized, Placebo-Controlled Clinical Trial. (PubMed, J Am Heart Assoc) - P3 | "The trial will evaluate the safety and efficacy of early antiplatelet therapy with oral aspirin in patients with acute ischemic stroke treated with IVT and may provide a promising strategy for improving the functional outcomes in this patient population."

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

Safety Outcomes of Tenecteplase Compared With Alteplase in Acute Ischemic Stroke: A Multicenter Retrospective Real-World Study. (PubMed, J Pharm Pract) - "Stroke severity and mechanical thrombectomy were stronger predictors of selected adverse outcomes than the choice of thrombolytic agent. These findings support tenecteplase as an alternative to alteplase for AIS thrombolysis."

Journal • Real-world evidence • Retrospective data • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Intravenous Tenecteplase Plus EVT Versus EVT Alone on 4.5 to 24 Hours After Basilar Artery Occlusion (clinicaltrials.gov) - P3 | N=330 | Completed | Sponsor: The First Affiliated Hospital of University of Science and Technology of China | Recruiting ➔ Completed | Trial completion date: Mar 2026 ➔ May 2025

Trial completion • Trial completion date • Cardiovascular

ESO annual stroke evidence update 2025. (PubMed, Eur Stroke J) - "In 2025, trial evidence supported no routine role for EVT in MeVO, reinforced tenecteplase as bridging thrombolysis in eligible LVO patients undergoing EVT and strengthened the signal for early intensive blood pressure lowering in acute ICH. Priority research questions include identifying subgroups that may benefit from EVT in MeVO, defining the role of adjunct intra-arterial thrombolysis after successful EVT and clarifying which imaging-based selection pathways are most feasible and effective across different stroke systems."

Journal • Review • Alzheimer's Disease • Atrial Fibrillation • Cardiovascular • Cognitive Disorders • Ischemic stroke

Updates in Central Retinal Artery Occlusion. (PubMed, J Neuroophthalmol) - "CRAO should be managed as an acute ischemic stroke of the eye. Thrombolysis within 4.5 hours offers the highest potential for visual recovery, but further prospective, randomized studies are needed to determine efficacy, safety, and optimal management strategies. Improving public awareness, implementing streamlined multidisciplinary protocols, and expanding access to specialized care are essential to enabling timely intervention."

Journal • Review • Cardiovascular • Ischemic stroke • Ophthalmology • Retinal Disorders

IV Tenecteplase Before Thrombectomy Compared With Thrombectomy Alone in Patients With Stroke Due to a Large Vessel Occlusion. (PubMed, Neurology) - P, P=N/A | "Among patients treated within 4.5 hours of symptom onset, TNK + EVT was associated with better functional outcome than EVT, without safety concerns. This benefit does not seem to be time dependent. These findings support the routine use of tenecteplase before EVT in the early time window."

Clinical • Journal • Retrospective data • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders

Development and Validation of a Harmonization Pipeline for Multi-Site Computed Tomography Perfusion Cerebral Blood Flow Maps-An Analysis of the AcT Trial. (PubMed, Clin Neuroradiol) - "Our harmonization pipeline rescaled multi-site CBF maps to physiological range, reducing inter-site variability and errors in infarct core estimation and large-core classification. Multi-site harmonization should become standard in CTP datasets to avoid erroneous conclusions about infarct size and growth."

Harmonization • Journal • Cardiovascular • Ischemic stroke

Relearning Bradford Hill through our final patient in the Tenecteplase in Central Retinal Artery Occlusion Study. (PubMed, Acta Ophthalmol) - No abstract available

Journal • Retinal Disorders

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

Trial completion • Trial completion date • Cardiovascular • Ischemic stroke

Response to the letter to the editor regarding "safety of tenecteplase versus alteplase for intravenous thrombolysis in acute ischemic stroke patients with direct oral anticoagulation". (PubMed, Neurol Res Pract) - No abstract available

Journal • Cardiovascular • Ischemic stroke

Letter to the editor regarding "Safety of tenecteplase versus alteplase for intravenous thrombolysis in acute ischemic stroke patients with direct oral anticoagulation: experience from a German stroke center" by Mers et al. (PubMed, Neurol Res Pract) - No abstract available

Journal • Cardiovascular • Ischemic stroke

Trialist: Endovascular Treatment With or Without Preceding Intravenous Tenecteplase in Patients with Late-Window Acute Ischemic Stroke Due to Middle Cerebral Artery Occlusion (TNK-PLUS): A Multi-Center, Prospective, Open-Label, Blinded Endpoint, Phase 3, Randomized Controlled Trial (ISC 2026) - No abstract available

Clinical • Late-breaking abstract • P3 data • Cardiovascular • Ischemic stroke

Cost Burden and Characterization of Tenecteplase Waste in Acute Ischemic Stroke: A Risk-Based Analysis Across Four Certified Stroke Centers (ISC 2026) - "Increased preference of tenecteplase (TNK) over alteplase has resulted in concerns over excess medication waste costs, as prior to FDA approval of TNK for AIS in March 2025, no reimbursement program was available for this medication.Objectives: This study aimed to characterize rates of TNK waste across four urban hospitals including a Comprehensive Stroke Center (CSC), Thrombectomy Certified Center (TSC), and two Primary Certified Centers (PSCs) when utilized for AIS in the emergency department (ED). Pharmacist bedside mixing of TNK may lead to lower rates of TNK waste, reducing overall cost burden to the healthcare system."

Cardiovascular • Ischemic stroke

Tenecteplase versus Alteplase for Acute Ischemic Stroke Beyond 4.5-Hour Window: A Bayesian Network Meta-Analysis of Randomized Controlled Trials (ISC 2026) - "Both tenecteplase and alteplase improve excellent functional outcomes compared with BMT in patients with AIS beyond 4.5 hours. Functional outcomes did not differ significantly between tenecteplase and alteplase. However, alteplase was associated with a higher risk of sICH, whereas tenecteplase appeared safer and ranked as the most effective option for functional recovery."

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

Early vs. Late Time Window Tenecteplase for Basilar Artery Occlusion, With or Without Thrombectomy: a Subgroup Analysis from the TRACE-5 Trial (ISC 2026) - "The primary outcome was a score of 0-1 on the modified Rankin scale or return to baseline mRS (if baseline premorbid mRS=2-3) at 90 days. Safety outcomes were symptomatic intracranial hemorrhage and death.Results The trial presented topline results at the WSC, this subgroup analysis result will be ready by ISC 2026.Conclusions This subgroup analysis will help better understand the treatment effect of tenecteplase for basilar artery occlusion in different time windows, with or without endovascular thrombectomy."

Late-breaking abstract • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

LYS241: A Novel Humanized Antibody Counteracting tPA-Mediated Neurotoxicity and BBB Disruption in Stroke (ISC 2026) - "LYS241 was administered both as a monotherapy and in combination with alteplase (rtPA) or tenecteplase (TNK), within either an acute or extended therapeutic window following stroke. These findings highlight its potential as a standalone therapy or in combination with thrombolysis and/or thrombectomy . LYS241 is currently progressing through IND/CTA-enabling studies in preparation for a first-in-human clinical trial."

First-in-human • Cardiovascular • CNS Disorders • Ischemic stroke • Vascular Neurology

Freezing Tenecteplase Aliquots Reduces Cost and Achieves Similar Outcomes in Acute Ischemic Stroke Patients (ISC 2026) - "A significant cost-savings may be achieved by freezing 50mg vials of TNK into 25mg aliquots. Patients receiving previously frozen TNK were associated with similar outcomes as patients receiving freshly reconstituted TNK."

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

Effect of IAT plus MT versus MT alone on excellent functional outcome (mRS 0-1) at 90 days (ISC 2026) - "IAT + MT significantly increased the likelihood of achieving the excellent functional outcome (RR = 1.23, 95% CI 1.11 – 1.36), with consistent benefit for tenecteplase and alteplase, and among the individuals with varying stroke severity. Outcomes suggest that adjunctive IAT after MT improves the likelihood of complete functional recovery without increasing mortality or symptomatic hemorrhage, although there is a slight increase in total ICH risk that might be noted. Additional risk-benefit analysis is necessary for the refinement of candidate, agent, and dose selection."

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

Comparison of Tenecteplase Versus Alteplase Treatment for Intravenous Thrombolysis Using Regression Discontinuity Analysis (ISC 2026) - "Baseline presentation characteristics, including age, NIHSS, ASPECTS, and last know well to thrombolysis time, were not significantly different between groups at the switch cutoff date, supporting the RD assumption (Figure 1A-1D). In RD analysis, we observed no discontinuity in ICH at the TNK cutoff, indicating no statistically significant difference between tPA and TNK among patients near the cutoff (risk difference:-0.03; 95%[-0.14,0.09]) (Figure 1.E), nor in the secondary outcomes of sICH (risk difference:-0.10; 95%[-0.21,0.0008]), functional independence at 90 days (risk difference:0.27; 95%[-0.19,0.73]), or mortality (risk difference:-0.06; 95%[-0.16,0.03]).Conclusion Our pseudo-randomized study design corroborated findings from RCT conducted outside the US, demonstrating equivalent safety and efficacy measures in tenecteplase and alteplase for treatment of acute ischemic stroke."

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

Alteplase vs. Tenecteplase: Comparison of Treatment Times and Hemorrhagic Complications in a large US health care system (ISC 2026) - "IV TNK is $1715.53 cheaper on average in our large multi-state system compared to alteplase. Therefore, the IV TNK cohort studied here (n=781) represents 1.34 million dollars in savings"

Cardiovascular • Hematological Disorders • Ischemic stroke

Trialist: Tenecteplase for acute non-large vessel occlusion at 4.5-24 hours (ISC 2026) - No abstract available

Late-breaking abstract

Trialist: Intravenous Tenecteplase Plus Endovascular Thrombectomy Versus Endovascular Thrombectomy Alone on 4.5 to 24 Hours After Stroke Due to Basilar Artery Occlusion -a Multicenter, Randomized Controlled, Clinical Trial (ATTENTION LATE) (ISC 2026) - No abstract available

Clinical • Late-breaking abstract • Cardiovascular

Thrombolysis for Pediatric Stroke: Tenecteplase (ISC 2026) - No abstract available

Clinical • Cardiovascular • Pediatrics

Efficacy and Safety of Human Urinary Kallidinogenase for Acute Ischemic Stroke Patients Receiving Reperfusion Treatment (UNITE): A Study Protocol for a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (ISC 2026) - P=N/A | "This study is aimed to investigate the efficacy and safety of HUK combined with reperfusion therapy in a large prospective randomized study patient cohort. UNITE (NCT06848894) is a multi-center, randomized, double-blind, placebo-controlled clinical trial enrolling approximately 1,204 adults with anterior-circulation AIS within 24 hours of onset who have already received intravenous thrombolysis (rt-PA or tenecteplase) and/or endovascular treatment... UNITE is the first large, double-blind randomized trial exploring adjunctive HUK after reperfusion therapy among patients with AIS. If HUK meaningfully increases the proportion of favorable function without causing adverse effects, the results could provide compelling evidence for implementing neuroprotective interventions following reperfusion treatment."

Clinical • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Inflammation • Ischemic stroke • Respiratory Diseases

Strategy for Improving Stroke Treatment Response (SISTER): A Phase-2 Clinical Trial of TS23, a novel mechanism for improving outcomes in acute ischemic stroke (ISC 2026) - P2 | "Introduction: Plasminogen activators (Alteplase and Tenecteplase) for acute ischemic stroke (AIS), while effective, suffer from limitations and untoward effects. SISTER will rigorously test the safety and preliminary efficacy of TS23 among patients with AIS within 4.5-24 hours of last known well. If the trial is successful, pivotal testing of TS23 for AIS will be planned."

Clinical • P2 data • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke • Thrombosis