What is tenecteplase approved for?

Acute ST-elevation myocardial infarction, and it has also gained FDA approval for acute ischaemic stroke.

Is tenecteplase safer than alteplase?

In myocardial infarction it caused fewer non-cerebral bleeds, but the risk of serious and intracranial haemorrhage remains and is the main danger for both drugs.

Can tenecteplase be used for stroke?

Yes; multiple randomised trials support its use and it has stroke approval, but it is still an emergency hospital treatment with strict time limits and screening.

Is tenecteplase available without a prescription?

No. It is a hospital-administered emergency drug requiring clinician supervision and monitoring for bleeding, not a consumer or research product.

EMA-approvedaka TNKase

Tenecteplase — Complete Research Guide (2026)

Last updated 2026-06-30

TL;DR

Tenecteplase (also known as TNKase) is a peptide catalogued under Enzymes (Modified tPA). Neutral reference entry; EU status: EU-approved prescription medicine.

What is Tenecteplase?

Tenecteplase (brand TNKase) is a bioengineered, FDA-approved recombinant variant of tissue plasminogen activator given as a single intravenous bolus.

It is approved for acute ST-elevation myocardial infarction and has also gained FDA approval for acute ischaemic stroke; it is a licensed medicine, not a research chemical.

Its evidence base is strong, built on large human randomised trials such as ASSENT-2 in myocardial infarction and multiple stroke trials versus alteplase.

How does Tenecteplase work?

Tenecteplase is a triple-substitution mutant of alteplase that converts fibrin-bound plasminogen to plasmin to dissolve the clot, with greater fibrin specificity and resistance to plasminogen activator inhibitor-1.

These modifications give it a longer plasma half-life, allowing effective single-bolus dosing rather than a prolonged infusion.

What does the research say about Tenecteplase?

In acute myocardial infarction, single-bolus tenecteplase produced 30-day mortality equivalent to accelerated alteplase while causing fewer non-cerebral bleeding complications. ^[1]
Before endovascular thrombectomy for large-vessel stroke, tenecteplase achieved higher rates of early reperfusion than alteplase. ^[2]
In a broad acute ischaemic stroke population, tenecteplase was non-inferior to alteplase for functional outcome with a similar safety profile. ^[5]

Clinical research & studies

The references below are the primary sources cited throughout this guide. Each links directly to PubMed or the regulator. Where evidence is preclinical (animal or in-vitro), that is stated rather than implied.

[1] Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial — Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) Investigators, Lancet 1999. (Randomised controlled trial)
[2] Tenecteplase versus Alteplase before Thrombectomy for Ischemic Stroke — Campbell BCV et al., The New England Journal of Medicine 2018. (Randomised controlled trial (EXTEND-IA TNK))
[3] Tenecteplase versus alteplase for management of acute ischaemic stroke (NOR-TEST): a phase 3, randomised, open-label, blinded endpoint trial — Logallo N et al., Lancet Neurology 2017. (Randomised controlled trial)
[4] A randomized trial of tenecteplase versus alteplase for acute ischemic stroke — Parsons M et al., The New England Journal of Medicine 2012. (Randomised controlled trial)
[5] Intravenous tenecteplase compared with alteplase for acute ischaemic stroke in Canada (AcT): a pragmatic, multicentre, open-label, registry-linked, randomised, controlled, non-inferiority trial — Menon BK et al., Lancet 2022. (Randomised controlled non-inferiority trial)

Dosing context

This is not medical advice or a usage recommendation. Dosing figures are reported research context only, cited from the published literature.

Tenecteplase is an emergency hospital-administered fibrinolytic given as a weight-based single intravenous bolus, which in myocardial infarction must be delivered as early as possible after symptom onset.

In acute ischaemic stroke, trials and its stroke labelling use a single weight-based bolus given within a tight time window under specialist supervision; figures here are context only, not dosing guidance.

Side effects & safety profile

As with all fibrinolytics, the dominant hazard is serious bleeding, including symptomatic intracranial and other major haemorrhage, which can be fatal.

Contraindications mirror those of alteplase: active internal bleeding, recent surgery or serious trauma, prior intracranial haemorrhage, recent stroke, intracranial lesions, and severe uncontrolled hypertension.

It is used only in emergency settings with strict screening; the convenience of a single bolus does not reduce the underlying haemorrhage risk.

Stacking & combinations

In myocardial infarction and stroke pathways tenecteplase is paired with antiplatelet and anticoagulant drugs under protocol, which raises bleeding risk and is a clinical decision, not a self-directed combination.

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Frequently asked questions

It is a bioengineered variant with greater fibrin specificity and a longer half-life, so it can be given as one intravenous bolus instead of an infusion.

References

[1] Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial — Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) Investigators, Lancet 1999. PMID: 10475182. View sourceStudy: Randomised controlled trialSingle-bolus tenecteplase was equivalent to accelerated alteplase for 30-day mortality with fewer non-cerebral bleeds.
[2] Tenecteplase versus Alteplase before Thrombectomy for Ischemic Stroke — Campbell BCV et al., The New England Journal of Medicine 2018. PMID: 29694815. View sourceStudy: Randomised controlled trial (EXTEND-IA TNK)Tenecteplase produced higher pre-thrombectomy reperfusion and better functional outcomes than alteplase in large-vessel-occlusion stroke.
[3] Tenecteplase versus alteplase for management of acute ischaemic stroke (NOR-TEST): a phase 3, randomised, open-label, blinded endpoint trial — Logallo N et al., Lancet Neurology 2017. PMID: 28780236. View sourceStudy: Randomised controlled trialTenecteplase showed similar efficacy and safety to alteplase in a predominantly mild stroke population.
[4] A randomized trial of tenecteplase versus alteplase for acute ischemic stroke — Parsons M et al., The New England Journal of Medicine 2012. PMID: 22435369. View sourceStudy: Randomised controlled trialTenecteplase was associated with better reperfusion and clinical outcomes than alteplase in a small imaging-selected stroke trial.
[5] Intravenous tenecteplase compared with alteplase for acute ischaemic stroke in Canada (AcT): a pragmatic, multicentre, open-label, registry-linked, randomised, controlled, non-inferiority trial — Menon BK et al., Lancet 2022. PMID: 35779553. View sourceStudy: Randomised controlled non-inferiority trialTenecteplase was non-inferior to alteplase for functional outcome in a broad stroke population with a comparable safety profile.

This article is for educational and research purposes only. Peptides discussed here are not approved for human consumption by the FDA, EMA, or equivalent regulators outside of specific clinical contexts. Always consult a licensed medical professional before any therapeutic use.