{"id":"tenecteplase","rwe":[{"pmid":"41859852","year":"2026","title":"Comparative risk of intracerebral haemorrhage between Tenecteplase and alteplase across doses in acute ischaemic stroke: a network meta-analysis of randomized controlled trials.","finding":"","journal":"Neurological research","studyType":"Clinical Study"},{"pmid":"41839498","year":"2026","title":"Tenecteplase for thrombolysis of acute ischemic stroke in a 68-year-old woman.","finding":"","journal":"CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne","studyType":"Clinical Study"},{"pmid":"41832410","year":"2026","title":"Familial pulmonary embolism in two siblings with first presentation as sudden cardiac arrest: a clinical case report from the Indian subcontinent.","finding":"","journal":"International journal of emergency medicine","studyType":"Clinical Study"},{"pmid":"41826932","year":"2026","title":"Thrombolytic therapy in vertebrobasilar dolichoectasia patients with acute posterior circulation cerebral infarction: a case series analysis.","finding":"","journal":"Thrombosis journal","studyType":"Clinical Study"},{"pmid":"41824817","year":"2026","title":"Efficacy and safety of tenecteplase versus urokinase in the treatment of acute ischemic stroke.","finding":"","journal":"Medicine","studyType":"Clinical Study"}],"_fda":{"id":"f5fbdeb3-d456-45dc-8c37-4e15ca1c66ea","set_id":"739a3c53-caf6-40d6-a6af-84ce733a948b","openfda":{"rxcui":["284422","313212"],"spl_id":["f5fbdeb3-d456-45dc-8c37-4e15ca1c66ea"],"brand_name":["TNKase"],"spl_set_id":["739a3c53-caf6-40d6-a6af-84ce733a948b"],"package_ndc":["50242-120-47","50242-037-06","50242-901-09"],"product_ndc":["50242-120"],"generic_name":["TENECTEPLASE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"manufacturer_name":["Genentech, Inc."],"application_number":["BLA103909"],"is_original_packager":[true]},"version":"16","pregnancy":["8.1 Pregnancy Risk Summary There are risks to the mother and fetus from acute ST elevation myocardial infarction, which is a medical emergency in pregnancy and can be fatal if left untreated (see Clinical Considerations ). Published data consisting of a small number of case reports involving the use of related thrombolytic agents in pregnant women have not identified an increased risk of major birth defects. There are no data on the use of tenecteplase during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. TNKase does not elicit maternal and direct embryo toxicity in rabbits following a single IV administration. In developmental toxicity studies conducted in rabbits, the no observable effect level (NOEL) of a single IV administration of TNKase on maternal or developmental toxicity (5 mg/kg) was approximately 7 times human exposure (based on AUC) at the dose for STEMI. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Myocardial infarction is a medical emergency which can be fatal if left untreated. Life-sustaining therapy for the pregnant woman should not be withheld because of potential concerns regarding the effects of tenecteplase on the fetus."],"description":["11 DESCRIPTION Tenecteplase is a tissue plasminogen activator (tPA) produced by recombinant DNA technology using a mammalian cell line (Chinese Hamster Ovary cells). Tenecteplase is a 527-amino acid glycoprotein developed by introducing the following modifications to the complementary DNA (cDNA) for natural human tPA: a substitution of threonine 103 with asparagine, and a substitution of asparagine 117 with glutamine, both within the kringle 1 domain, and a tetra-alanine substitution at amino acids 296–299 in the protease domain. It has a molecular weight of 58,742 daltons. Biological potency is determined by an in vitro clot lysis assay and is expressed in tenecteplase specific units. The specific activity of tenecteplase has been defined as 200 units/mg. TNKase (tenecteplase) for injection is a sterile, white to pale yellow, lyophilized powder for intravenous bolus administration after reconstitution with Sterile Water for Injection, USP. Each single-dose vial of TNKase nominally contains 50 mg of tenecteplase, arginine (522 mg), phosphoric acid (approximately 160 mg), and polysorbate 20 (4.0 mg). Following reconstitution with the supplied 10 mL single-dose vial of Sterile Water for Injection, USP, the final concentration is 5 mg/mL with a pH of approximately 7.3."],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied TNKase (tenecteplase) for injection is supplied as a sterile, white to pale yellow lyophilized powder in a 50 mg single-dose vial under partial vacuum. Each 50 mg single-dose vial of TNKase is packaged with one 10 mL single-dose vial of Sterile Water for Injection, USP for reconstitution, and the B-D ® 10 mL syringe with TwinPak™ Dual Cannula Device: NDC 50242-120-47. 16.2 Stability and Storage Store lyophilized TNKase at room temperature up to 30°C (86°F) or refrigerated at 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date stamped on the vial."],"geriatric_use":["8.5 Geriatric Use In the ASSENT-2 study, 41% (3500/8458) of patients who were treated with TNKase were aged 65 years or older. In this population, rates of 30-day mortality, stroke, intracranial hemorrhage and major bleeds requiring blood transfusion or leading to hemodynamic complications were higher than in those aged less than 65 years."],"pediatric_use":["8.4 Pediatric Use The safety and effectiveness of TNKase in pediatric patients have not been established."],"effective_time":"20251215","clinical_studies":["14 CLINICAL STUDIES 14.1 Acute Myocardial Infarction ASSENT-2 The Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) study was an international, randomized, double-blind trial that compared 30-day mortality rates in 16,949 patients assigned to receive an IV bolus dose of TNKase or an accelerated infusion of Activase ® (alteplase). Eligibility criteria included onset of chest pain within 6 hours of randomization and ST-segment elevation or left bundle branch block on electrocardiogram (ECG). Patients were to be excluded from the trial if they received GP IIb/IIIa inhibitors within the previous 12 hours. TNKase was dosed using actual or estimated weight in a weight-tiered fashion as described in Dosage and Administration (2.1) . All patients were to receive 150–325 mg of aspirin administered as soon as possible, followed by 150–325 mg daily. Intravenous heparin was to be administered as soon as possible: for patients weighing ≤ 67 kg, heparin was administered as a 4000-unit IV bolus followed by infusion at 800 U/hr; for patients weighing > 67 kg, heparin was administered as a 5000-unit IV bolus followed by infusion at 1000 U/hr. Heparin was continued for 48 to 72 hours with infusion adjusted to maintain aPTT at 50–75 seconds. The use of GP IIb/IIIa inhibitors was discouraged for the first 24 hours following randomization. The results of the primary endpoint (30-day mortality rates with non-parametric adjustment for the covariates of age, Killip class, heart rate, systolic blood pressure and infarct location) along with selected other 30-day endpoints are shown in Table 2 . Table 2 ASSENT-2 Mortality, Stroke, and Combined Outcome of Death or Stroke Measured at Thirty Days 30-Day Events TNKase (n = 8461) Accelerated Activase (n = 8488) Relative Risk TNKase/Activase (95% CI) Mortality 6.2% 6.2% 1.00 (0.89, 1.12) Intracranial Hemorrhage (ICH) 0.9% 0.9% 0.99 (0.73, 1.35) Any Stroke 1.8% 1.7% 1.07 (0.86, 1.35) Death or Nonfatal Stroke 7.1% 7.0% 1.01 (0.91, 1.13) Rates of mortality and the combined endpoint of death or stroke among pre-specified subgroups, including age, gender, time to treatment, infarct location, and history of previous myocardial infarction, demonstrate consistent relative risks across these subgroups. There was insufficient enrollment of non-Caucasian patients to draw any conclusions regarding relative efficacy in racial subsets. Rates of in-hospital procedures, including percutaneous transluminal coronary angioplasty (PTCA), stent placement, intra-aortic balloon pump (IABP) use, and coronary artery bypass graft (CABG) surgery, were similar between the TNKase and Activase (alteplase) groups. TIMI-10B TIMI 10B was an open-label, controlled, randomized, dose-ranging, angiography study which utilized a blinded core laboratory for review of coronary arteriograms. Patients (n = 837) presenting within 12 hours of symptom onset were treated with fixed doses of 30, 40, or 50 mg of TNKase or the accelerated infusion of Activase and underwent coronary arteriography at 90 minutes. The primary endpoint was the rate of TIMI Grade 3 flow at 90 minutes. The results showed that the 40 mg and 50 mg doses were similar to accelerated infusion of Activase in restoring patency. TIMI Grade 3 flow and TIMI Grade 2/3 flow at 90 minutes are shown in Table 3 . The exact relationship between coronary artery patency and clinical activity has not been established. Table 3 TIMI 10B Patency Rates TIMI Grade Flow at 90 Minutes Activase ≤100 mg (n=311) TNKase 30 mg (n=302) TNKase 40 mg (n=148) TNKase 50 mg (n=76) TIMI Grade 3 Flow 62.7% 54.3% 62.8% 65.8% (95% CI) (57.1%, 68.1%) (48.5%, 60.0%) (54.5%, 70.6%) (54.0%, 76.3%) TIMI Grade 2/3 Flow 81.7% 76.8% 79.1% 88.2% (95% CI) (76.9%, 85.8%) (71.6%, 81.5%) (71.6%, 85.3%) (78.7%, 94.4%) The angiographic results from TIMI 10B and the safety data from ASSENT-1, an additional uncontrolled safety study of 3,235 TNKase-treated patients, provided the framework to develop a weight-tiered TNKase dose regimen. Exploratory analyses suggested that a weight-adjusted dose of 0.5 to 0.6 mg/kg of TNKase resulted in a better patency to bleeding relationship than fixed doses of TNKase across a broad range of patient weights. ASSENT 4 PCI The Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention (ASSENT 4 PCI) was a phase IIIb/IV study designed to assess the safety and effectiveness of a strategy of administering full dose TNKase with a single bolus of 4000 U of unfractionated heparin in patients with STEMI, in whom primary percutaneous coronary intervention (PCI) was planned, but in whom a delay of 1-3 hours was anticipated before PCI. The trial was prematurely terminated with 1667 randomized patients (75 of whom were in the United States) due to a numerically higher mortality in the patients receiving TNKase prior to primary PCI versus PCI without TNKase (median time from randomization to balloon was 115 minutes in patients who were treated with TNKase plus PCI versus 107 minutes in patients who were treated with PCI alone). The incidence of the 90-day primary endpoint, a composite of death or cardiogenic shock or congestive heart failure (CHF) within 90 days, was 18.6% in patients treated with TNKase plus PCI versus 13.4% in those treated with PCI alone (p = 0.0045; RR 1.39 (95% CI 1.11–1.74)). There were trends toward worse outcomes in the individual components of the primary endpoint between TNKase plus PCI versus PCI alone (mortality 6.7% vs. 4.9%, respectively; cardiogenic shock 6.3% vs. 4.8%, respectively; and CHF 12.0% vs. 9.2%, respectively). In addition, there were trends towards worse outcomes in recurrent MI (6.1% vs. 3.7%, respectively; p = 0.03) and repeat target vessel revascularization (6.6% vs. 3.4%, respectively; p = 0.004) in patients receiving TNKase plus PCI versus PCI alone [see Warnings and Precautions (5.5) ] . There was no difference in in-hospital major bleeding between the two groups (5.6% vs. 4.4% for TNKase plus PCI vs. PCI alone, respectively). For patients treated with TNKase plus PCI, in-hospital rates of intracranial hemorrhage and total stroke were similar to those observed in previous trials (0.97% and 1.8%, respectively); however, none of the patients treated with PCI alone experienced a stroke (ischemic, hemorrhagic or other)."],"pharmacodynamics":["12.2 Pharmacodynamics Following administration of 30, 40, or 50 mg of TNKase, there are decreases in circulating fibrinogen (4%–15%) and plasminogen (11%–24%)."],"pharmacokinetics":["12.3 Pharmacokinetics Distribution In patients with STEMI, TNKase administered as a single IV bolus exhibits a biphasic disposition from the plasma. Volume of distribution at central compartment ranges from 4.22 to 5.43 L, approximating plasma volume. Steady-state volume of distribution was approximately 50% greater (6.12 to 8.01 L), suggestive of some extravascular distribution. Elimination After IV bolus administration, the terminal phase half-life of tenecteplase was 90 to 130 minutes. In 99 of 104 patients treated with TNKase, TNKase has linear PK with mean maximum concentrations increased in a dose-proportional manner and mean plasma clearance was similar for the 30, 40, and 50 mg doses ranging from 99 to 119 mL/min. Metabolism Liver metabolism is the major clearance mechanism for tenecteplase. Body weight A stepwise linear regression analysis indicated that total body weight explained 19% of the variability in plasma clearance and 11% of the variability in volume of distribution."],"adverse_reactions":["6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the label: Bleeding [see Contraindications (4) , Warnings and Precautions (5.1) ] Hypersensitivity [see Warnings and Precautions (5.6) ] The most common adverse reactions are bleeding and hypersensitivity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Roche at 1-800-526-6367 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Immunogenicity Four of 625 (0.64%) patients tested for antibody formation to TNKase had a positive antibody titer at 30 days in studies with TNKase. The observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to TNKase with the incidence of antibodies to other products may be misleading."],"contraindications":["4 CONTRAINDICATIONS TNKase is contraindicated in patients with [see Warnings and Precautions (5.1) ] : Active internal bleeding History of cerebrovascular accident Intracranial or intraspinal surgery or trauma within 2 months Intracranial neoplasm, arteriovenous malformation, or aneurysm Known bleeding diathesis Severe uncontrolled hypertension Active internal bleeding ( 4 ) History of cerebrovascular accident ( 4 ) Intracranial or intraspinal surgery or trauma within 2 months ( 4 ) Intracranial neoplasm, arteriovenous malformation, or aneurysm ( 4 ) Known bleeding diathesis ( 4 ) Severe uncontrolled hypertension ( 4 )"],"drug_interactions":["7 DRUG INTERACTIONS During TNKase therapy, results of coagulation tests and/or measures of fibrinolytic activity may be unreliable unless specific precautions are taken to prevent in vitro artifacts. ( 7.1 ) 7.1 Drug/Laboratory Test Interactions During TNKase therapy, results of coagulation tests and/or measures of fibrinolytic activity may be unreliable unless specific precautions are taken to prevent in vitro artifacts. Tenecteplase is an enzyme that, when present in blood in pharmacologic concentrations, remains active under in vitro conditions. This can lead to degradation of fibrinogen in blood samples removed for analysis."],"mechanism_of_action":["12.1 Mechanism of Action Tenecteplase is a modified form of human tissue plasminogen activator (tPA) that binds to fibrin and converts plasminogen to plasmin. In the presence of fibrin, in vitro studies demonstrate that tenecteplase-mediated conversion of plasminogen to plasmin is increased relative to its conversion in the absence of fibrin. This fibrin specificity decreases systemic activation of plasminogen and the resulting degradation of circulating fibrinogen as compared to a molecule lacking this property. The clinical significance of fibrin-specificity on safety (e.g., bleeding) or efficacy has not been established."],"storage_and_handling":["16.2 Stability and Storage Store lyophilized TNKase at room temperature up to 30°C (86°F) or refrigerated at 2°C to 8°C (36°F to 46°F). Do not use beyond the expiration date stamped on the vial."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Tenecteplase is a modified form of human tissue plasminogen activator (tPA) that binds to fibrin and converts plasminogen to plasmin. In the presence of fibrin, in vitro studies demonstrate that tenecteplase-mediated conversion of plasminogen to plasmin is increased relative to its conversion in the absence of fibrin. This fibrin specificity decreases systemic activation of plasminogen and the resulting degradation of circulating fibrinogen as compared to a molecule lacking this property. The clinical significance of fibrin-specificity on safety (e.g., bleeding) or efficacy has not been established. 12.2 Pharmacodynamics Following administration of 30, 40, or 50 mg of TNKase, there are decreases in circulating fibrinogen (4%–15%) and plasminogen (11%–24%). 12.3 Pharmacokinetics Distribution In patients with STEMI, TNKase administered as a single IV bolus exhibits a biphasic disposition from the plasma. Volume of distribution at central compartment ranges from 4.22 to 5.43 L, approximating plasma volume. Steady-state volume of distribution was approximately 50% greater (6.12 to 8.01 L), suggestive of some extravascular distribution. Elimination After IV bolus administration, the terminal phase half-life of tenecteplase was 90 to 130 minutes. In 99 of 104 patients treated with TNKase, TNKase has linear PK with mean maximum concentrations increased in a dose-proportional manner and mean plasma clearance was similar for the 30, 40, and 50 mg doses ranging from 99 to 119 mL/min. Metabolism Liver metabolism is the major clearance mechanism for tenecteplase. Body weight A stepwise linear regression analysis indicated that total body weight explained 19% of the variability in plasma clearance and 11% of the variability in volume of distribution."],"indications_and_usage":["1 INDICATIONS AND USAGE TNKase ® is indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI). TNKase is a tissue plasminogen activator, indicated to reduce the risk of death associated with acute ST elevation myocardial infarction (STEMI). ( 1 )"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Bleeding: Increases the risk of bleeding. Avoid intramuscular injections. Monitor for bleeding. ( 5.1 ) Thromboembolism: The use of thrombolytics can increase the risk of thrombo-embolic events in patients with high likelihood of left heart thrombus. ( 5.2 ) Cholesterol Embolization: Has been reported in patients treated with thrombolytic agents. ( 5.3 ) Arrhythmias: It is recommended that anti-arrhythmic therapy for bradycardia and/or ventricular irritability be available when TNKase is administered. ( 5.4 ) Increased Risk of Heart Failure and Recurrent Ischemia when used with Planned Percutaneous Coronary Intervention (PCI) in STEMI: In patients with a large ST segment elevation myocardial infarction, physicians should choose either thrombolysis or PCI as the primary treatment strategy for reperfusion. Rescue PCI or subsequent elective PCI may be performed after administration of thrombolytic therapies if medically appropriate. ( 5.5 ) Hypersensitivity: Monitor patients treated with TNKase during and for several hours after infusion. If symptoms of hypersensitivity occur, initiate appropriate therapy (e.g., antihistamines, corticosteroids). ( 5.6 ) 5.1 Bleeding TNKase can cause bleeding, including intracranial hemorrhage and fatal bleeding. Concomitant use of other drugs that impair hemostasis increases the risk of bleeding. Should serious bleeding that is not controlled by local pressure occur, discontinue any concomitant heparin or antiplatelet agents immediately and treat appropriately. Avoid intramuscular injections and nonessential handling of the patient for the first few hours following treatment with TNKase. Perform arterial and venous punctures carefully and only as required. To minimize bleeding from noncompressible sites, avoid internal jugular and subclavian venous punctures. If an arterial puncture is necessary during TNKase infusion, use an upper extremity vessel that is accessible to manual compression. Apply pressure for at least 30 minutes. 5.2 Thromboembolism The use of thrombolytics can increase the risk of thrombo-embolic events in patients with high likelihood of left heart thrombus, such as patients with mitral stenosis or atrial fibrillation. 5.3 Cholesterol Embolization Cholesterol embolism has been reported in patients treated with thrombolytic agents. Investigate cause of any new embolic event and treat appropriately. 5.4 Arrhythmias Coronary thrombolysis may result in arrhythmias associated with reperfusion. These arrhythmias (such as sinus bradycardia, accelerated idioventricular rhythm, ventricular premature depolarizations, ventricular tachycardia) may be managed with standard anti-arrhythmic measures. It is recommended that anti-arrhythmic therapy for bradycardia and/or ventricular irritability be available when TNKase is administered. 5.5 Increased Risk of Heart Failure and Recurrent Ischemia when used with Planned Percutaneous Coronary Intervention (PCI) in STEMI. In a trial of patients with STEMI, there were trends toward worse outcomes in the individual components of the primary endpoint between TNKase plus PCI versus PCI alone (mortality 6.7% vs. 4.9%, respectively; cardiogenic shock 6.3% vs. 4.8%, respectively; and CHF 12% vs. 9.2%, respectively). In addition, there were trends towards worse outcomes in recurrent MI (6.1% vs. 3.7%, respectively; p = 0.03) and repeat target vessel revascularization (6.6% vs. 3.4%, respectively; p = 0.0045) in patients receiving TNKase plus PCI versus PCI alone [see Clinical Studies (14.1) ] . In patients with large ST segment elevation myocardial infarction, physicians should choose either thrombolysis or PCI as the primary treatment strategy for reperfusion. Rescue PCI or subsequent elective PCI may be performed after administration of thrombolytic therapies if medically appropriate; however, the optimal use of adjunctive antithrombotic and antiplatelet therapies in this setting is unknown. 5.6 Hypersensitivity Hypersensitivity, including urticarial / anaphylactic reactions, have been reported after administration of TNKase (e.g., anaphylaxis, angioedema, laryngeal edema, rash, and urticaria). Monitor patients treated with TNKase during and for several hours after infusion. If symptoms of hypersensitivity occur, initiate appropriate therapy (e.g., antihistamines, corticosteroids)."],"clinical_studies_table":["<table width=\"70%\" ID=\"T2\"><caption>Table 2 ASSENT-2 Mortality, Stroke, and Combined Outcome of Death or Stroke Measured at Thirty Days</caption><col width=\"40%\" align=\"left\" valign=\"top\"/><col width=\"18%\" align=\"center\" valign=\"top\"/><col width=\"18%\" align=\"center\" valign=\"top\"/><col width=\"24%\" align=\"center\" valign=\"top\"/><thead><tr><th styleCode=\"Lrule\" valign=\"bottom\">30-Day Events</th><th valign=\"bottom\">TNKase (n = 8461)</th><th valign=\"bottom\">Accelerated Activase (n = 8488)</th><th styleCode=\"Rrule\">Relative Risk TNKase/Activase (95% CI)</th></tr></thead><tbody><tr><td styleCode=\"Lrule\">Mortality</td><td>6.2%</td><td>6.2%</td><td styleCode=\"Rrule\">1.00 (0.89, 1.12)</td></tr><tr><td styleCode=\"Lrule\">Intracranial Hemorrhage (ICH)</td><td>0.9%</td><td>0.9%</td><td styleCode=\"Rrule\">0.99 (0.73, 1.35)</td></tr><tr><td styleCode=\"Lrule\">Any Stroke</td><td>1.8%</td><td>1.7%</td><td styleCode=\"Rrule\">1.07  (0.86, 1.35)</td></tr><tr><td styleCode=\"Lrule\">Death or Nonfatal Stroke</td><td>7.1%</td><td>7.0%</td><td styleCode=\"Rrule\">1.01 (0.91, 1.13)</td></tr></tbody></table>","<table width=\"80%\" ID=\"T3\"><caption>Table 3 TIMI 10B Patency Rates TIMI Grade Flow at 90 Minutes</caption><col width=\"28%\" align=\"left\" valign=\"top\"/><col width=\"18%\" align=\"center\" valign=\"top\"/><col width=\"18%\" align=\"center\" valign=\"top\"/><col width=\"18%\" align=\"center\" valign=\"top\"/><col width=\"18%\" align=\"center\" valign=\"top\"/><thead><tr><th styleCode=\"Lrule\"/><th>Activase &#x2264;100 mg (n=311)</th><th>TNKase 30 mg (n=302)</th><th>TNKase 40 mg (n=148)</th><th styleCode=\"Rrule\">TNKase 50 mg (n=76)</th></tr></thead><tbody><tr><td styleCode=\"Lrule\">TIMI Grade 3 Flow</td><td>62.7%</td><td>54.3%</td><td>62.8%</td><td styleCode=\"Rrule\">65.8%</td></tr><tr><td styleCode=\"Lrule\">(95% CI)</td><td>(57.1%, 68.1%)</td><td>(48.5%, 60.0%)</td><td>(54.5%, 70.6%)</td><td styleCode=\"Rrule\">(54.0%, 76.3%)</td></tr><tr><td styleCode=\"Lrule\">TIMI Grade 2/3 Flow</td><td>81.7%</td><td>76.8%</td><td>79.1%</td><td styleCode=\"Rrule\">88.2%</td></tr><tr><td styleCode=\"Lrule\">(95% CI)</td><td>(76.9%, 85.8%)</td><td>(71.6%, 81.5%)</td><td>(71.6%, 85.3%)</td><td styleCode=\"Rrule\">(78.7%, 94.4%)</td></tr></tbody></table>"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Studies in animals have not been performed to evaluate the carcinogenic potential, mutagenicity, or the effect on fertility."],"spl_unclassified_section":["TNKase ® (tenecteplase) Manufactured by: Genentech, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990 U.S. License No. 1048 TNKase ® is a registered trademark of Genentech, Inc. © 2023 Genentech, Inc."],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Initiate treatment as soon as possible after the onset of STEMI symptoms. ( 2.1 ) TNKase is for intravenous administration only, administered as a single bolus over 5 seconds. Individualize dosage based on patient's weight. ( 2.1 ) 2.1 Recommended Dosage Initiate treatment as soon as possible after the onset of STEMI symptoms. TNKase is for intravenous (IV) administration only, administered as a single bolus over 5 seconds. Individualize dosage based on the patient's weight (see Table 1 ). Table 1: Recommended Dosage Patient Weight (kg) TNKase (mg) Volume TNKase From one vial of TNKase reconstituted with 10 mL Sterile Water for Injection. to be administered (mL) < 60 30 6 ≥ 60 to < 70 35 7 ≥ 70 to < 80 40 8 ≥ 80 to < 90 45 9 ≥ 90 50 10 2.2 Preparation Follow the below steps to prepare TNKase for administration: Remove the shield assembly from the supplied B-D ® 10 mL syringe with TwinPak™ Dual Cannula Device (see Figure 1 ) and aseptically withdraw 10 mL of Sterile Water for Injection, USP, from the supplied diluent vial using the red hub cannula syringe filling device. Only use the supplied Sterile Water for Injection, USP for reconstitution. Note: Do not discard the shield assembly. Aseptically reconstitute the vial with 10 mL Sterile Water for Injection, USP by directing the stream into the lyophilized powder to obtain a final concentration of 5 mg/mL. Slight foaming upon reconstitution is not unusual; any large bubbles will dissipate if the product is allowed to stand undisturbed for several minutes. Gently swirl until contents are completely dissolved. DO NOT SHAKE. The reconstituted preparation results in a colorless to pale yellow transparent solution. Determine the appropriate dose of TNKase [see Dosage and Administration (2.1) ] and withdraw this volume (in milliliters) from the reconstituted vial with the syringe. Discard any unused solution. Stand the shield vertically on a flat surface (with green side down) and passively recap the red hub cannula. Remove the entire shield assembly, including the red hub cannula, by twisting counterclockwise. Note: The shield assembly also contains the clear-ended blunt plastic cannula; retain for split septum intravenous access. Figure 1 Figure 1 2.3 Administration Follow the below steps for administration of TNKase; Inspect the product prior to administration for particulate matter and discoloration. Administer TNKase as reconstituted at 5 mg/mL. Precipitation may occur when TNKase is administered in an intravenous line containing dextrose. Flush dextrose-containing lines with a saline-containing solution prior to and following single bolus administration of TNKase. Administer reconstituted TNKase as a single intravenous bolus over 5 seconds. Because TNKase contains no antibacterial preservatives, reconstitute immediately before use. If the reconstituted TNKase is not used immediately, refrigerate the TNKase vial at 2°C to 8°C (36°F to 46°F) and use within 8 hours. Although the supplied syringe is compatible with a conventional needle, this syringe is designed to be used with needleless intravenous systems. From the information below, follow the instructions applicable to the intravenous system in use. Split septum intravenous system : Remove the green cap. Attach the clear-ended blunt plastic cannula to the syringe. Remove the shield and use the blunt plastic cannula to access the split septum injection port. Because the blunt plastic cannula has two side ports, air or fluid expelled through the cannula will exit in two sideways directions; direct away from face or mucous membranes. Luer-Lok ® system: Connect syringe directly to intravenous port. Conventional needle (not supplied in this kit): Attach a large bore needle, e.g., 18 gauge, to the syringe's universal Luer-Lok ® . Dispose of the syringe, cannula and shield per established procedures. 2.4 Chemical Incompatibilities TNKase is incompatible with dextrose containing solutions. When used together, precipitation may occur. Flush dextrose containing lines with saline-containing solution before using TNKase."],"spl_product_data_elements":["TNKase tenecteplase TNKase tenecteplase TENECTEPLASE TENECTEPLASE ARGININE PHOSPHORIC ACID POLYSORBATE 20 Sterile Water Water WATER"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS For injection: 50 mg as a white to pale yellow lyophilized powder in a single-dose vial for reconstitution with the co-packaged 10 mL single-dose vial of Sterile Water for Injection, USP (diluent). For Injection: 50 mg as a white to pale yellow lyophilized powder in a single-dose vial for reconstitution with the co-packaged 10 mL Sterile Water for Injection USP (diluent). ( 3 )"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are risks to the mother and fetus from acute ST elevation myocardial infarction, which is a medical emergency in pregnancy and can be fatal if left untreated (see Clinical Considerations ). Published data consisting of a small number of case reports involving the use of related thrombolytic agents in pregnant women have not identified an increased risk of major birth defects. There are no data on the use of tenecteplase during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. TNKase does not elicit maternal and direct embryo toxicity in rabbits following a single IV administration. In developmental toxicity studies conducted in rabbits, the no observable effect level (NOEL) of a single IV administration of TNKase on maternal or developmental toxicity (5 mg/kg) was approximately 7 times human exposure (based on AUC) at the dose for STEMI. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Myocardial infarction is a medical emergency which can be fatal if left untreated. Life-sustaining therapy for the pregnant woman should not be withheld because of potential concerns regarding the effects of tenecteplase on the fetus. 8.2 Lactation Risk Summary There are no data on the presence of tenecteplase in either human or animal milk, the effects on the breastfed infant, or the effect on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TNKase and any potential adverse effects on the breastfed infant from the TNKase or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of TNKase in pediatric patients have not been established. 8.5 Geriatric Use In the ASSENT-2 study, 41% (3500/8458) of patients who were treated with TNKase were aged 65 years or older. In this population, rates of 30-day mortality, stroke, intracranial hemorrhage and major bleeds requiring blood transfusion or leading to hemodynamic complications were higher than in those aged less than 65 years."],"dosage_and_administration_table":["<table ID=\"T1\" width=\"55%\"><caption>Table 1: Recommended Dosage</caption><col width=\"30%\" align=\"center\" valign=\"bottom\"/><col width=\"25%\" align=\"center\" valign=\"bottom\"/><col width=\"45%\" align=\"center\" valign=\"bottom\"/><thead><tr><th styleCode=\"Lrule\">Patient Weight (kg)</th><th>TNKase (mg)</th><th styleCode=\"Rrule\">Volume TNKase<footnote>From one vial of TNKase reconstituted with 10 mL Sterile Water for Injection.</footnote> to be administered (mL)</th></tr></thead><tbody><tr><td styleCode=\"Lrule\">&lt; 60</td><td>30</td><td styleCode=\"Rrule\">6</td></tr><tr><td styleCode=\"Lrule\">&#x2265; 60 to &lt; 70</td><td>35</td><td styleCode=\"Rrule\">7</td></tr><tr><td styleCode=\"Lrule\">&#x2265; 70 to &lt; 80</td><td>40</td><td styleCode=\"Rrule\">8</td></tr><tr><td styleCode=\"Lrule\">&#x2265; 80 to &lt; 90</td><td>45</td><td styleCode=\"Rrule\">9</td></tr><tr><td styleCode=\"Lrule\">&#x2265; 90</td><td>50</td><td styleCode=\"Rrule\">10</td></tr></tbody></table>","<table width=\"65%\"><col width=\"35%\" align=\"left\" valign=\"top\"/><col width=\"65%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Split septum intravenous system</content>: </td><td styleCode=\"Rrule\"><list listType=\"unordered\" styleCode=\"disc\"><item>Remove the green cap.</item><item>Attach the clear-ended blunt plastic cannula to the syringe.</item><item>Remove the shield and use the blunt plastic cannula to access the split septum injection port. </item><item>Because the blunt plastic cannula has two side ports, air or fluid expelled through the cannula will exit in two sideways directions; direct away from face or mucous membranes.</item></list></td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Luer-Lok<sup>&#xAE;</sup> system:</content></td><td styleCode=\"Rrule\">Connect syringe directly to intravenous port.</td></tr><tr><td styleCode=\"Lrule Rrule\"><content styleCode=\"bold\">Conventional needle (not supplied in this kit):</content></td><td styleCode=\"Rrule\">Attach a large bore needle, e.g., 18 gauge, to the syringe&apos;s universal Luer-Lok<sup>&#xAE;</sup>.</td></tr></tbody></table>"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Kit Carton NDC 50242-120-47 Tenecteplase TNKase ® 50 mg For use in myocardial infarction Kit Contents: Each kit contains one 50 mg vial of TNKase, one 10 mL vial of preservative-free Sterile Water for Injection, USP, one BD ® 10 mL syringe with TwinPak™ Dual Cannula Device, and package insert containing full prescribing information. Vial Contents: The preservative-free single-use vial of TNKase contains 52.5 mg Tenecteplase, 0.55 g L-arginine, 0.17 g phosphoric acid, and 4.3 mg polysorbate 20, under partial vacuum. No U.S. standard of potency. Rx only US License No.: 1048 Genentech 10200128 PRINCIPAL DISPLAY PANEL - Kit Carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Studies in animals have not been performed to evaluate the carcinogenic potential, mutagenicity, or the effect on fertility."]},"tags":[{"label":"Biologic","category":"modality"},{"label":"Plasminogen","category":"target"},{"label":"PLG","category":"gene"},{"label":"B01AD11","category":"atc"},{"label":"Active","category":"status"},{"label":"Acute myocardial infarction","category":"indication"},{"label":"Ankylosing spondylitis","category":"indication"},{"label":"Genentech","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Fibrinolytic Agents","category":"pharmacology"},{"label":"Hematologic Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":254.406,"date":"","count":81,"signal":"Cerebral haemorrhage","source":"DrugCentral FAERS","actionTaken":"Reported 81 times (LLR=254)"},{"llr":253.918,"date":"","count":84,"signal":"No adverse event","source":"DrugCentral FAERS","actionTaken":"Reported 84 times (LLR=254)"},{"llr":214.637,"date":"","count":60,"signal":"Haemorrhage intracranial","source":"DrugCentral FAERS","actionTaken":"Reported 60 times (LLR=215)"},{"llr":125.242,"date":"","count":28,"signal":"Neurological decompensation","source":"DrugCentral FAERS","actionTaken":"Reported 28 times (LLR=125)"},{"llr":102.864,"date":"","count":21,"signal":"Haemorrhagic transformation stroke","source":"DrugCentral FAERS","actionTaken":"Reported 21 times (LLR=103)"},{"llr":89.67,"date":"","count":45,"signal":"Haemorrhage","source":"DrugCentral FAERS","actionTaken":"Reported 45 times (LLR=90)"},{"llr":88.943,"date":"","count":25,"signal":"Wrong product administered","source":"DrugCentral FAERS","actionTaken":"Reported 25 times (LLR=89)"},{"llr":72.557,"date":"","count":104,"signal":"Off label use","source":"DrugCentral FAERS","actionTaken":"Reported 104 times (LLR=73)"},{"llr":72.456,"date":"","count":30,"signal":"Cerebral infarction","source":"DrugCentral FAERS","actionTaken":"Reported 30 times (LLR=72)"},{"llr":67.98,"date":"","count":26,"signal":"Ischaemic stroke","source":"DrugCentral FAERS","actionTaken":"Reported 26 times (LLR=68)"},{"llr":67.448,"date":"","count":81,"signal":"Death","source":"DrugCentral FAERS","actionTaken":"Reported 81 times (LLR=67)"},{"llr":66.262,"date":"","count":18,"signal":"Cerebral haematoma","source":"DrugCentral FAERS","actionTaken":"Reported 18 times (LLR=66)"}],"commonSideEffects":[{"effect":"Cerebral haemorrhage","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"No adverse event","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Haemorrhage intracranial","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Neurological decompensation","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Haemorrhagic transformation stroke","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Wrong product administered","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Cerebral infarction","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Ischaemic stroke","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"Cerebral haematoma","drugRate":"","severity":"common","_validated":false,"_confidence":0.3}]},"trials":[],"aliases":[],"company":"Roche","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=TENECTEPLASE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:31:29.279219+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:31:36.112927+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T03:31:29.350610+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TENECTEPLASE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:31:36.598115+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:31:28.180398+00:00"},"mechanism.oneSentence":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"12.1 Mechanism of Action Tenecteplase is a modified form of human tissue plasminogen activator (tPA) that binds to fibrin and converts plasminogen to plasmin. In the presence of fibrin, in vitro studies demonstrate that tenecteplase-mediated conversion of plasminogen to plasmin is increased relative to its conversion in the absence of fibrin. This fibrin specificity decreases systemic activation of plasminogen and the resulting degradation of circulating fibrinogen as compared to a molecule lack","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:31:50.688351+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Tissue-type plasminogen activator exogenous protein","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:31:37.643304+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2108791/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:31:37.295860+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the label: Bleeding [see Contraindications (4) , Warnings and Precautions (5.1) ] Hypersensitivity [see Warnings and Precautions (5.6) ] The most common adverse reactions are bleeding and hypersensitivity. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Roche at 1-800-526-6367 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Immunogenicity Four of 625 (0.64%) patients tested for antibody formation t","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:31:53.067654+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"BLA103909","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:31:28.180425+00:00"}},"allNames":"tnkase","offLabel":[],"synonyms":["tenecteplase","metalyse","tnkase"],"timeline":[{"date":"2000-06-02","type":"positive","source":"DrugCentral","milestone":"FDA approval (Genentech)"},{"date":"2001-02-23","type":"positive","source":"DrugCentral","milestone":"EMA approval (Boehringer Ingelheim International Gmbh)"}],"aiSummary":"Tnkase (Tenecteplase) is a recombinant plasminogen activator developed by Genentech, currently owned by the same company. It works by targeting plasminogen to activate plasmin, which breaks down blood clots. Tnkase is approved for treating acute myocardial infarction and ankylosing spondylitis, with FDA approval in 2000. The commercial status of Tnkase is patented, and its safety considerations include the risk of bleeding and thrombocytopenia. As a recombinant protein, Tnkase's mechanism of action is complex, but it ultimately aims to restore blood flow by dissolving clots.","approvals":[{"date":"2000-06-02","orphan":false,"company":"GENENTECH","regulator":"FDA"},{"date":"2001-02-23","orphan":false,"company":"BOEHRINGER INGELHEIM INTERNATIONAL GMBH","regulator":"EMA"}],"brandName":"Tnkase","ecosystem":[{"indication":"Acute myocardial infarction","otherDrugs":[{"name":"alteplase","slug":"alteplase","company":"Genentech"},{"name":"reteplase","slug":"reteplase","company":"Ekr Therap"}],"globalPrevalence":null},{"indication":"Ankylosing spondylitis","otherDrugs":[{"name":"aceclofenac","slug":"aceclofenac","company":""},{"name":"adalimumab","slug":"adalimumab","company":"Abbvie Inc"},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""}],"globalPrevalence":64000000}],"mechanism":{"target":"fibrin","novelty":"Follow-on","targets":[{"gene":"PLG","source":"DrugCentral","target":"Plasminogen","protein":"Plasminogen"}],"modality":"Peptide","explanation":"Tenecteplase is a modified version of tPA that specifically binds to fibrin, which helps convert plasminogen to plasmin more efficiently in the presence of fibrin. This specificity reduces the systemic activation of plasminogen and the degradation of circulating fibrinogen compared to non-fibrin-specific molecules.","oneSentence":"Tenecteplase binds to fibrin and converts plasminogen to plasmin, enhancing fibrin-specific plasmin generation.","technicalDetail":"In the presence of fibrin, tenecteplase-mediated conversion of plasminogen to plasmin is increased relative to its conversion in the absence of fibrin. This fibrin specificity decreases systemic activation of plasminogen and the resulting degradation of circulating fibrinogen."},"commercial":{"launchDate":"2000","_launchSource":"DrugCentral (FDA 2000-06-02, GENENTECH)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5066","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=TENECTEPLASE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TENECTEPLASE","fields":["publications"],"source":"PubMed/NCBI"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T15:49:54.050925","_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T03:31:54.454510+00:00","fieldsConflicting":9,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"alteplase","drugSlug":"alteplase","fdaApproval":"1996-06-18","relationship":"same-class"},{"drugName":"urokinase","drugSlug":"urokinase","fdaApproval":"","relationship":"same-class"},{"drugName":"reteplase","drugSlug":"reteplase","fdaApproval":"1996-10-30","relationship":"same-class"}],"genericName":"tenecteplase","indications":{"approved":[{"name":"Acute myocardial infarction","source":"DrugCentral","snomedId":57054005,"regulator":"FDA"},{"name":"Ankylosing spondylitis","source":"DrugCentral","snomedId":9631008,"regulator":"FDA","usPrevalence":null,"globalPrevalence":64000000,"prevalenceMethod":"curated","prevalenceSource":"Arthritis Care Res (Hoboken), 2016 (PMID:26713432)"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"alteplase","brandName":"alteplase","genericName":"alteplase","approvalYear":"1996","relationship":"same-class"},{"drugId":"urokinase","brandName":"urokinase","genericName":"urokinase","approvalYear":"","relationship":"same-class"},{"drugId":"reteplase","brandName":"reteplase","genericName":"reteplase","approvalYear":"1996","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07471256","phase":"PHASE3","title":"Neuronavigation-assisted Stereotactic Minimally Invasive Puncture With Tenecteplase for Acute Lobar Intracerebral Hemorrhage","status":"NOT_YET_RECRUITING","sponsor":"Beijing Tiantan Hospital","startDate":"2026-03-31","conditions":["Intracerebral Hemorrhage Lobar"],"enrollment":636,"completionDate":"2028-12-31"},{"nctId":"NCT07294209","phase":"PHASE4","title":"Low-Dose Tenecteplase for Acute Ischemic Stroke Treatment in Aging Patients","status":"RECRUITING","sponsor":"Southwest Hospital, China","startDate":"2025-12-19","conditions":["Acute Ischemic Stroke Patients"],"enrollment":798,"completionDate":"2028-12-31"},{"nctId":"NCT07469293","phase":"PHASE3","title":"Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO)","status":"NOT_YET_RECRUITING","sponsor":"Southwest Hospital, China","startDate":"2026-03-25","conditions":["Acute Ischemic Stroke"],"enrollment":488,"completionDate":"2028-12-31"},{"nctId":"NCT07203625","phase":"PHASE4","title":"Tenecteplase Before Interhospital Transfer in Acute Basilar Artery Occlusion at 4.5 to 24 Hours","status":"RECRUITING","sponsor":"Xuanwu Hospital, Beijing","startDate":"2026-01-20","conditions":["Acute Ischemic Stroke","Basilar Artery Occlusion"],"enrollment":316,"completionDate":"2027-12-31"},{"nctId":"NCT07253181","phase":"PHASE3","title":"Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours","status":"RECRUITING","sponsor":"Xuanwu Hospital, Beijing","startDate":"2026-01-06","conditions":["Acute Ischemic Stroke","Large Vessel Occlusion","Transportation of Patients"],"enrollment":572,"completionDate":"2028-03-30"},{"nctId":"NCT07475936","phase":"","title":"Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke","status":"NOT_YET_RECRUITING","sponsor":"First Affiliated Hospital of Guangxi Medical University","startDate":"2026-04","conditions":["Acute Ischemic Stroke","Tenecteplase"],"enrollment":392,"completionDate":"2027-12"},{"nctId":"NCT07361302","phase":"PHASE3","title":"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","status":"RECRUITING","sponsor":"Boehringer Ingelheim","startDate":"2026-02-17","conditions":["Acute Ischemic Stroke"],"enrollment":1325,"completionDate":"2027-10-02"},{"nctId":"NCT07476898","phase":"PHASE3","title":"Precision Reperfusion Therapy for Disabling Minor Stroke With Large Vessel Occlusion Beyond Time Window","status":"NOT_YET_RECRUITING","sponsor":"First Hospital of China Medical University","startDate":"2026-03-01","conditions":["Stroke"],"enrollment":864,"completionDate":"2028-08-01"},{"nctId":"NCT07475949","phase":"PHASE3","title":"Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging","status":"NOT_YET_RECRUITING","sponsor":"First Affiliated Hospital of Guangxi Medical University","startDate":"2026-04","conditions":["Acute Ischemic 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Beijing","startDate":"2023-09-28","conditions":["Ischemic Stroke, Acute"],"enrollment":2408,"completionDate":"2025-09-03"},{"nctId":"NCT06241677","phase":"NA","title":"Intravenous Thrombolytic Therapy in Acute Ischemic Stroke Patients on DOAC","status":"RECRUITING","sponsor":"Chinese University of Hong Kong","startDate":"2024-04-15","conditions":["CVA (Cerebrovascular Accident)"],"enrollment":260,"completionDate":"2029-03-31"},{"nctId":"NCT07419997","phase":"","title":"A Multicenter, Retrospective, Observational Cohort Study on Intravenous Thrombolysis Beyond the Time Window for Acute Ischemic Stroke","status":"RECRUITING","sponsor":"Xuanwu Hospital, Beijing","startDate":"2025-12-29","conditions":["Stroke"],"enrollment":2600,"completionDate":"2026-12-29"},{"nctId":"NCT07375966","phase":"PHASE2","title":"Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours of Onset With Tenecteplase 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Occlusion"],"enrollment":330,"completionDate":"2025-05-04"},{"nctId":"NCT07369999","phase":"PHASE3","title":"Effects of Butylphthalide Enhanced With Tenecteplase on Neurological Function in Mild Disabling Acute Ischemic Stroke","status":"NOT_YET_RECRUITING","sponsor":"Xiangya Hospital of Central South University","startDate":"2026-02-01","conditions":["Mild Disabling Acute Ischemic Stroke"],"enrollment":1062,"completionDate":"2029-06-30"},{"nctId":"NCT05499832","phase":"PHASE3","title":"Safety and Efficacy of Intra-arterial Tenecteplase for Noncomplete Reperfusion of Intracranial Occlusions","status":"COMPLETED","sponsor":"Insel Gruppe AG, University Hospital Bern","startDate":"2023-03-21","conditions":["Ischemic Stroke"],"enrollment":156,"completionDate":"2025-10-09"},{"nctId":"NCT06658197","phase":"PHASE3","title":"Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke","status":"RECRUITING","sponsor":"Xuanwu Hospital, Beijing","startDate":"2025-12-25","conditions":["Stroke, Ischemic","Stroke, Acute","Thrombosis, Brain","Drug Effect"],"enrollment":850,"completionDate":"2027-06-01"},{"nctId":"NCT07283159","phase":"PHASE2","title":"Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)","status":"RECRUITING","sponsor":"General Hospital of Shenyang Military Region","startDate":"2026-01-20","conditions":["Ischemic Stroke"],"enrollment":200,"completionDate":"2027-12-30"},{"nctId":"NCT07357987","phase":"PHASE3","title":"Intra-arterial Tenecteplase for Acute Medium Vessel Occlusion Stroke","status":"NOT_YET_RECRUITING","sponsor":"Beijing Tiantan Hospital","startDate":"2026-01-22","conditions":["Ischemic Stroke","Medium Vessel Occlusion","Tenecteplase","Endovascular Treatment"],"enrollment":488,"completionDate":"2027-12-31"},{"nctId":"NCT07302854","phase":"PHASE2,PHASE3","title":"Intra-arterial Recombinant Human Tenecteplase Tissue-type Plasminogen Activator (rhTNK-tPA) Thrombolysis for 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