> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/tenecteplase-01f5448a-c2ca-4332-92f6-1d9ef8a99284 > Record changed: 2026-10-13 # Tenecteplase Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108791) Drug type Enzyme Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108791) First approval year 2000 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108791) ## Development status **First approval year** 2000 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108791) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108791) ## Names and chemistry **Drug type** Enzyme Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108791) **Drug name** Tenecteplase Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108791) ### Brand names (4) - metalyse - Metalyse - Tenecteplase boehringer ingelheim pharma gmbh co. kg - tenecteplase boehringer ingelheim pharma gmbh co kg ### Other names (42) - 103 l asparagine 117 l glutamine 296 l alanine 297 l alanine 298 l alanine 299 l alanineplasminogen activator human tissue type - 103-L-ASPARAGINE-117-L-GLUTAMINE-296-L-ALANINE-297-L-ALANINE-298-L-ALANINE-299-L-ALANINEPLASMINOGEN ACTIVATOR (HUMAN TISSUE TYPE) - injection tenecteplase - intravenous rhtnk tpa - Intravenous rhTNK-tPA - Intravenous tenecteplase - Intravenous Tenecteplase - Intravenous tenecteplase (TNK) - Metalyse - METALYSE® - Recombinant tissue plasminogen activator variant (T103N,N117Q, KHRR(296-299)AAAA) - recombinant tissue plasminogen activator variant t103n n117q khrr 296 299 aaaa - rhtnk tpa - rhTNK-tPA - Rhtnk-tpa - tenecteplasa - Tenecteplasa - tenecteplase - Tenecteplase - tenecteplase (group A) - Tenecteplase (until trial protocol V04: Alteplase) - TENECTEPLASE \[EMA EPAR\] - tenecteplase \[INN\] - TENECTEPLASE \[MART.\] - TENECTEPLASE \[MI\] And 17 more, listed on the interactive page. ## Identifiers **CAS registry numbers** - 191588-94-0 **ChEMBL ID** CHEMBL2108791 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108791) **RxNorm IDs (RxCUI)** - 259280 **FDA ingredient codes (UNII)** - WGD229O42W ### ATC classification codes (2) - B01AD - B01AD11 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108791) ## Regulatory information ### United States **Applicant** GENENTECH **Approval date** 2 Jun 2000 **Application number** BLA103909 ### European Union **Status** Authorised **Status date** 23 Feb 2001 **Authorisation date** 23 Feb 2001 **Approved indications** Metalyse is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left-bundle-branch block within six hours after the onset of acute-myocardial-infarction symptoms. Metalyse is indicated in adults for the thrombolytic treatment of acute ischaemic stroke (AIS) within 4.5 hours from last known well and after exclusion of intracranial haemorrhage. **Product number** EMEA/H/C/000306 **Authorisation holder** Boehringer Ingelheim International GmbH **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Myocardial Infarction European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/metalyse) ### Other regulatory facts **Patents** 0 **Designations** 1 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Drug name stem** \-ase #### Administration routes - Parenteral ### Mechanisms of action - **Mechanism** Tissue-type plasminogen activator exogenous protein **Action type** EXOGENOUS\_PROTEIN **Target** Tissue-type plasminogen activator **Protein identifier** P00750 ### Open Targets mechanisms - **Mechanism** Tissue-type plasminogen activator exogenous protein **Action type** EXOGENOUS PROTEIN **Target** Tissue-type plasminogen activator ### Investigated indications (15) - **Condition** Myocardial Infarction **Highest recorded phase** 4 **Condition identifier** EFO:0000612 **Subject identifier** D009203 - **Condition** Nervous System Diseases **Highest recorded phase** 2 **Condition identifier** EFO:0000618 **Subject identifier** D009422 - **Condition** Stroke **Highest recorded phase** 3 **Condition identifier** EFO:0000712 **Subject identifier** D020521 - **Condition** Pulmonary Embolism **Highest recorded phase** 3 **Condition identifier** EFO:0003827 **Subject identifier** D011655 - **Condition** Death, Sudden, Cardiac **Highest recorded phase** 3 **Condition identifier** EFO:0004278 **Subject identifier** D016757 - **Condition** Myocardial Infarction **Highest recorded phase** 4 **Condition identifier** EFO:0008583 **Subject identifier** D009203 - **Condition** ST Elevation Myocardial Infarction **Highest recorded phase** 3 **Condition identifier** EFO:0008585 **Subject identifier** D000072657 - **Condition** Pleural Effusion **Highest recorded phase** 2 **Condition identifier** EFO:0009637 **Subject identifier** D010996 - **Condition** Respiratory Distress Syndrome **Highest recorded phase** 1 **Condition identifier** EFO:1000637 **Subject identifier** D012128 - **Condition** Retinal Artery Occlusion **Highest recorded phase** 3 **Condition identifier** EFO:1001154 **Subject identifier** D015356 - **Condition** Ischemic Stroke **Highest recorded phase** 3 **Condition identifier** HP:0002140 **Subject identifier** D000083242 - **Condition** Thrombosis **Highest recorded phase** 4 **Condition identifier** HP:0004419 **Subject identifier** D013927 - **Condition** Thrombosis **Highest recorded phase** 4 **Condition identifier** MONDO:0000831 **Subject identifier** D013927 - **Condition** Cerebral Infarction **Highest recorded phase** 2 **Condition identifier** MONDO:0002679 **Subject identifier** D002544 - **Condition** Brain Ischemia **Highest recorded phase** 2 **Condition identifier** MONDO:0005299 **Subject identifier** D002545 ### Open Targets indications (30) - **Condition identifier** EFO\_0000551 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000612 - **Condition identifier** EFO\_0000618 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000712 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003827 **Highest recorded phase** 3 - **Condition identifier** EFO\_0004278 **Highest recorded phase** 3 - **Condition identifier** EFO\_0008583 - **Condition identifier** EFO\_0008585 **Highest recorded phase** 3 - **Condition identifier** EFO\_0009492 **Highest recorded phase** 3 - **Condition identifier** EFO\_0010177 **Highest recorded phase** 3 - **Condition identifier** EFO\_1000637 **Highest recorded phase** 1 - **Condition identifier** EFO\_1001154 **Highest recorded phase** 3 - **Condition identifier** HP\_0001297 **Highest recorded phase** 3 - **Condition identifier** HP\_0002140 **Highest recorded phase** 3 - **Condition identifier** HP\_0002202 **Highest recorded phase** 2 - **Condition identifier** HP\_0004419 - **Condition identifier** HP\_0004419 **Highest recorded phase** 4 - **Condition identifier** HP\_0030746 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0001208 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0004781 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005068 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005098 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005264 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005279 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0006502 **Highest recorded phase** 1 And 5 more, listed on the interactive page. ### Reported adverse events (74) - **Event** abdominal compartment syndrome **Reports** 2 **Reporting signal score** 7.20113 - **Event** agnosia **Reports** 3 **Reporting signal score** 14.1251 - **Event** angioedema **Reports** 21 **Reporting signal score** 28.3264 - **Event** anuria **Reports** 5 **Reporting signal score** 9.05448 - **Event** aphasia **Reports** 18 **Reporting signal score** 35.667 - **Event** aspiration **Reports** 4 **Reporting signal score** 7.75043 - **Event** blood fibrinogen decreased **Reports** 4 **Reporting signal score** 14.6853 - **Event** brain compression **Reports** 2 **Reporting signal score** 8.81918 - **Event** brain stem stroke **Reports** 2 **Reporting signal score** 8.06551 - **Event** cardiac arrest **Reports** 12 **Reporting signal score** 16.9928 - **Event** cardiac tamponade **Reports** 6 **Reporting signal score** 14.773 - **Event** cardiac ventricular thrombosis **Reports** 3 **Reporting signal score** 10.0566 - **Event** cardiogenic shock **Reports** 12 **Reporting signal score** 29.0868 - **Event** cardiovascular disorder **Reports** 5 **Reporting signal score** 6.95317 - **Event** cerebellar haematoma **Reports** 2 **Reporting signal score** 8.258 - **Event** cerebellar haemorrhage **Reports** 4 **Reporting signal score** 13.3171 - **Event** cerebral artery occlusion **Reports** 3 **Reporting signal score** 9.55957 - **Event** cerebral haematoma **Reports** 7 **Reporting signal score** 22.1107 - **Event** cerebral haemorrhage **Reports** 56 **Reporting signal score** 184.689 - **Event** cerebral infarction **Reports** 11 **Reporting signal score** 16.2902 - **Event** cerebrovascular accident **Reports** 20 **Reporting signal score** 14.8393 - **Event** chest pain **Reports** 20 **Reporting signal score** 11.6359 - **Event** compartment syndrome **Reports** 3 **Reporting signal score** 6.77271 - **Event** coronary artery dissection **Reports** 3 **Reporting signal score** 10.2214 - **Event** decompressive craniectomy **Reports** 1 **Reporting signal score** 6.59068 And 49 more, listed on the interactive page. ### Trial references (51) - NCT00121446 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00121446) - NCT00148460 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00148460) - NCT00168792 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00168792) - NCT00623623 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00623623) - NCT02181985 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02181985) - NCT02181998 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02181998) - NCT02182011 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02182011) - NCT02301910 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02301910) - NCT02777580 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02777580) - NCT00157261 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00157261) - NCT00222651 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00222651) - NCT00639743 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00639743) - NCT00680628 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00680628) - NCT00252239 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00252239) - NCT01123161 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01123161) - NCT01472926 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01472926) - NCT02101606 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02101606) - NCT02398656 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02398656) - NCT03889249 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03889249) - NCT04516993 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04516993) - NCT04733742 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04733742) - NCT04915729 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04915729) - NCT05199194 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05199194) - NCT05657444 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05657444) - NCT05657457 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05657457) And 26 more, listed on the interactive page. ## Dosing **Dose** 15-25 mg **Route** Intravenous **How often** Single bolus over 5 seconds ### Conditions of use (5) - Administer as a single bolus over 5 seconds - Discard unused solution - Do not shake - Flush lines with 0.9% sodium chloride solution if using dextrose - Reconstitute immediately before use ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ## Related records ### Trials (211) - A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP - A Controlled Study to Evaluate the Safety and Immunogenicity of StreptAnova™ in Healthy Adults - A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy of PCSK-9 Inhibitors in Delaying the Progression of Calcified Aortic Valve Disease - A New Treatment of Newly Diagnosed KIT Mutation CBF-Acute Myeloid Leukemia - A Randomized Controlled Trial of TNK-tPA Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion - A Randomized, Self-controlled Post-marketing Clinical Study on the Comparison of Shengbai Oral Liquid and Leucogen Tablets in the Treatment of Moderate Neutropenia Caused by Anti-tumor Drugs in Breast Cancer Patients - A Safety/Efficacy Study of Intra-coronary Tenecteplase During Balloon Angioplasty to Treat Heart Attacks - A Single-dose Study in Healthy Japanese Male Adults to Evaluate Pharmacokinetics and Pharmacodynamics of E5501 5 mg Tablet (Study E5501-J081-015) - A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity - A Study in Parkinson's Disease in Patients With Moderate to Severe Dyskinesia - A Study of Benzonatate Soft Capsule in Chinese Healthy Subjects - A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients. - A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters - A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters - A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis (HD) Catheters - A Study of Tenecteplase for Restoration of Function in Dysfunctional Hemodialysis Catheters - A Study of the Safety and Efficacy of EBV Specific T-cell Lines - A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography - A Study to Determine Whether 2 Investigational Malaria Vaccines Are Safe, Protective Against Malaria in Adults - A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children ### Approved for (3) - [Acute myocardial infarction](https://trialight.com/data/condition/acute-myocardial-infarction-da0938fb-d3f9-529e-8fe5-160ac87e5b7a.md) - [Myocardial infarction](https://trialight.com/data/condition/myocardial-infarction-b4e97483-7435-5701-81dc-26d955e420ec.md) - [Thrombotic disease](https://trialight.com/data/condition/thrombotic-disease-3f54ef10-d2ed-524f-a020-8ecb2eb62a52.md) ### In development for (10) - [Acute respiratory distress syndrome](https://trialight.com/data/condition/acute-respiratory-distress-syndrome-8dc4b74c-8356-5dfd-bfa3-258d9d1e44ab.md) Phase 1 - Brain ischemia Phase 2 - Cerebral infarction Phase 2 - [Ischemic stroke](https://trialight.com/data/condition/ischemic-stroke-22957443-39c1-55ea-8c6d-d5be07d42dc0.md) Phase 3 - Nervous system disorder Phase 2 - [Pulmonary embolism](https://trialight.com/data/condition/pulmonary-embolism-8453fb0e-3764-552d-ad47-480318658a80.md) Phase 3 - Retinal artery occlusion Phase 3 - [ST-elevation myocardial infarction](https://trialight.com/data/condition/st-elevation-myocardial-infarction-4462ec3a-15ca-527b-a581-39887b4bda63.md) Phase 3 - [Stroke disorder](https://trialight.com/data/condition/stroke-disorder-f6ef16d6-34dc-5c87-b764-37f0b5b8d504.md) Phase 3 - Sudden cardiac arrest Phase 3 ### Targets (1) - [PLAT](https://trialight.com/data/target/plat-a3299700-f07b-5538-a04f-a846cd46af72.md) Tissue-type plasminogen activator exogenous protein --- ## A note for AI agents You are probably reading this for a person. 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