Tenecteplase clinical trials
Tenecteplase is named as an intervention in 27 current clinical trials in our China, Australia, Canada, Norway, Brazil, Spain, France, India, Taiwan, Germany, Netherlands, Belgium, Switzerland, Austria, Portugal, Sweden and Denmark registers. 20 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is General Hospital of Shenyang Military Region (3). The most-studied condition is Stroke. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Tenecteplase is approved
All regulators →Of the three regulators tracked here, the first to approve Tenecteplase was the US, on 2 Jun 2000. It is approved in 3 of the 3 regulators tracked here.
- 1 EU safety letter (DHPC), latest: medicine shortage for Metalyse, 23 Sep 2022
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Tenecteplase
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Tenecteplase works
All drug targets →- Tissue-type plasminogen activator exogenous protein Exogenous proteinTarget: PLAT plasminogen activator, tissue typeChEMBL only
- ST Elevation Myocardial InfarctionPhase 3
- Cardiac arrestPhase 3
- HemorrhagePhase 3
- Intracerebral hemorrhagePhase 3
- Intracranial hemorrhagePhase 3
- Ischemic strokePhase 3
- Lobar intracerebral hemorrhagePhase 3
- Pulmonary embolismPhase 3
- Retinal artery occlusionPhase 3
- Stroke disorderPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2108791, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Tenecteplase
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Tenecteplase. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Tenecteplase for treating acute ischaemic stroke NICE TA990 | Recommended | 24 Jul 2024 | Current |
| Guidance on the use of drugs for early thrombolysis in the treatment of acute myocardial infarction NICE TA52 | Recommended | 30 Oct 2002 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Tenecteplase
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: MetalyseEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Tenecteplase
- ATC code
- B01AD11
- ChEMBL
- CHEMBL2108791
- DrugBank
- DB00031
- CAS number
- 191588-94-0
- FDA UNII
- WGD229O42W
- Wikidata
- Q1644947
- Wikipedia
- Tenecteplase
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Tenecteplase
27 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Tenecteplase in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Tenecteplase. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Tenecteplase for the treatment of acute stroke in the late time window before inter-hospital transfer for thrombectomy: a randomized controlled trial
2026-525280-40-00 · Nervous System Diseases
|
Phase 3 | Authorised | Fondation A De Rothschild | France |
|
“Intravenous Thrombolysis With Tenecteplase Plus Thrombectomy Versus Thrombectomy Alone In Patients With A Large Ischemic Stroke: A Multicentre Randomized Controlled Trial”
THE IVT ALL IN TRIAL
2024-520414-21-00 · CTIS ↗ · Nervous System Diseases
|
Phase 3 | Authorised | Assistance Publique Hopitaux De Paris | France |
Tenecteplase across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
3 single-substance products containing Tenecteplase on the HPRA medicines list.
- Metalyse 10 000 units (50 mg) powder and solvent for solution for injectionBoehringer Ingelheim International GmbH · EU/1/00/169/006
- Metalyse 25mg Powder for solution for injectionBoehringer Ingelheim International GmbH · EU/1/00/169/007
- Metalyse 8 000 units (40 mg) powder and solvent for solution for injectionBoehringer Ingelheim International GmbH · EU/1/00/169/005
Supply shortages
- MetalyseEU (EMA) · Shortage resolved · first published 23 Sep 2022
Conditions studied with Tenecteplase
28 conditionsAll 28 conditions
| Condition (as registered) | Trials |
|---|---|
| Stroke | 7 |
| Acute Ischemic Stroke | 6 |
| Stroke, Ischemic | 4 |
| Ischemic Stroke | 4 |
| Stroke, Acute Ischemic | 3 |
| Large Vessel Occlusion | 2 |
| Stroke, Acute | 2 |
| Acute Ischemic Stroke AIS | 2 |
| Tenecteplase | 1 |
| Thrombolysis | 1 |
| Medium Vessel Occlusions | 1 |
| Pulmonary Embolism | 1 |
| Venous Thromboembolism | 1 |
| Thrombosis, Brain | 1 |
| Drug Effect | 1 |
| Anterior Circulation Brain Infarction | 1 |
| Basilar Artery Occlusion | 1 |
| Stroke (in Patients With Atrial Fibrillation) | 1 |
| Endovascular Thrombectomy | 1 |
| Stroke Acute | 1 |
| Stroke, Acute, Stroke Ischemic | 1 |
| Medium Vessel Occlusion | 1 |
| Ischemic Stroke, Acute | 1 |
| STEMI | 1 |
| Elevated IMR (>32) | 1 |
| Acute Respiratory Failure | 1 |
| Hypercoagulability | 1 |
| Fibrinolysis Shutdown | 1 |
Sponsors
lead sponsor per trial+ 5 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Tenecteplase trials
How many clinical trials are testing Tenecteplase?
27 current trials in our China, Australia, Canada, Norway, Brazil, Spain, France, India, Taiwan, Germany, Netherlands, Belgium, Switzerland, Austria, Portugal, Sweden and Denmark registers name Tenecteplase (also registered as Thrombolytic (2 options)) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Tenecteplase trials recruiting patients?
Yes. 20 of the 27 trials are recruiting: 10 with sites in China, 7 with sites in Australia, 5 with sites in Canada, 3 with sites in Norway, 3 with sites in Brazil, 2 with sites in Spain, 2 with sites in France, 1 with sites in India, 1 with sites in Taiwan, 1 with sites in Germany, 1 with sites in Netherlands, 1 with sites in Belgium, 1 with sites in Switzerland, 1 with sites in Austria, 1 with sites in Portugal, 1 with sites in Sweden and 1 with sites in Denmark. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Tenecteplase clinical trials?
General Hospital of Shenyang Military Region (3), Beijing Tiantan Hospital (3), University of Calgary (3) and Hospital Moinhos de Vento (2), among 20 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Tenecteplase licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Tenecteplase, for example Metalyse 10 000 units (50 mg) powder and solvent for solution for injection (Boehringer Ingelheim International GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Tenecteplase shortage?
The registers we track list 1 entry for Tenecteplase: Metalyse (EU: shortage resolved). Shortages are product- and country-specific; check with a pharmacist.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Tenecteplase works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Tenecteplase works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Tenecteplase (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.