Is reteplase better than alteplase?

For myocardial-infarction mortality the large GUSTO-III trial found them equivalent, not that reteplase is superior, though reteplase can achieve faster vessel opening.

Can reteplase be used for stroke?

It is not an approved stroke treatment. A 2024 Chinese trial suggested benefit over alteplase but with more bleeding, so this remains investigational and off-label.

What is the main danger of reteplase?

Serious bleeding, especially intracranial haemorrhage, which can be fatal; strict contraindications and emergency screening apply.

Is reteplase something a person can obtain or use on their own?

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

EMA-approvedaka Retavase

Reteplase — Complete Research Guide (2026)

Last updated 2026-06-30

TL;DR

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

What is Reteplase?

Reteplase (recombinant plasminogen activator, r-PA; brand Retavase) is an FDA-approved fibrinolytic given as a double intravenous bolus.

It is approved for acute ST-elevation myocardial infarction; it is not approved for stroke, where its use remains investigational despite a 2024 Chinese trial (RAISE).

Its cardiac evidence base is solid, resting on large human randomised trials including GUSTO-III and INJECT.

How does Reteplase work?

Reteplase is a non-glycosylated deletion mutant of tissue plasminogen activator that activates fibrin-bound plasminogen to plasmin to break down the clot.

Removal of several structural domains gives it a longer half-life than alteplase, enabling double-bolus dosing, but somewhat lower fibrin specificity.

What does the research say about Reteplase?

In acute myocardial infarction, double-bolus reteplase produced 30-day mortality equivalent (not superior) to accelerated alteplase. ^[1]
Reteplase achieved higher early coronary artery patency than front-loaded alteplase in a randomised angiographic comparison. ^[3]
In a Chinese randomised stroke trial, reteplase improved excellent functional outcome versus alteplase but increased bleeding, an off-label and not yet widely approved use. ^[4]

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] A comparison of reteplase with alteplase for acute myocardial infarction — The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO III) Investigators, The New England Journal of Medicine 1997. (Randomised controlled trial)
[2] Randomised, double-blind comparison of reteplase double-bolus administration with streptokinase in acute myocardial infarction (INJECT): trial to investigate equivalence — International Joint Efficacy Comparison of Thrombolytics (INJECT), Lancet 1995. (Randomised controlled equivalence trial)
[3] Randomized comparison of coronary thrombolysis achieved with double-bolus reteplase (recombinant plasminogen activator) and front-loaded, accelerated alteplase (recombinant tissue plasminogen activator) in patients with acute myocardial infarction. The RAPID II Investigators — Bode C et al., Circulation 1996. (Randomised controlled trial)
[4] Reteplase versus Alteplase for Acute Ischemic Stroke — Li S et al., The New England Journal of Medicine 2024. (Randomised controlled trial (RAISE))
[5] Recombinant plasminogen activators: a comparative review of the clinical pharmacology and therapeutic use of alteplase and reteplase — Moser M et al., BioDrugs 1998. (Narrative pharmacology review)

Dosing context

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

Reteplase is a hospital emergency fibrinolytic administered as two intravenous boluses given 30 minutes apart, initiated as early as possible after myocardial-infarction symptom onset.

This is provided as context only; administration requires trained clinicians, monitoring, and immediate capacity to manage bleeding.

Side effects & safety profile

The dominant risk is serious bleeding, including symptomatic intracranial haemorrhage and major systemic bleeds, which can be fatal.

Contraindications include active internal bleeding, prior intracranial haemorrhage, recent stroke, recent major surgery or trauma, intracranial neoplasm or aneurysm, and severe uncontrolled hypertension.

It is used strictly in emergency care with eligibility screening; the stroke data come from outside standard approvals and should not be taken as endorsing routine stroke use.

Stacking & combinations

In myocardial-infarction protocols reteplase is combined with aspirin and heparin under physician control, which increases bleeding risk and is a clinical, not self-directed, decision.

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Frequently asked questions

Acute ST-elevation myocardial infarction. It is given as two intravenous boluses and is not approved for stroke.

References

[1] A comparison of reteplase with alteplase for acute myocardial infarction — The Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO III) Investigators, The New England Journal of Medicine 1997. PMID: 9340503. View sourceStudy: Randomised controlled trialReteplase and alteplase produced equivalent 30-day mortality in acute myocardial infarction, with no superiority for reteplase.
[2] Randomised, double-blind comparison of reteplase double-bolus administration with streptokinase in acute myocardial infarction (INJECT): trial to investigate equivalence — International Joint Efficacy Comparison of Thrombolytics (INJECT), Lancet 1995. PMID: 7623530. View sourceStudy: Randomised controlled equivalence trialDouble-bolus reteplase was at least as effective as streptokinase for 35-day mortality in acute myocardial infarction.
[3] Randomized comparison of coronary thrombolysis achieved with double-bolus reteplase (recombinant plasminogen activator) and front-loaded, accelerated alteplase (recombinant tissue plasminogen activator) in patients with acute myocardial infarction. The RAPID II Investigators — Bode C et al., Circulation 1996. PMID: 8790022. View sourceStudy: Randomised controlled trialReteplase achieved higher 90-minute coronary patency than accelerated alteplase in acute myocardial infarction.
[4] Reteplase versus Alteplase for Acute Ischemic Stroke — Li S et al., The New England Journal of Medicine 2024. PMID: 38884332. View sourceStudy: Randomised controlled trial (RAISE)In a Chinese trial, reteplase increased excellent functional outcome versus alteplase at 90 days but with more bleeding, an off-label use.
[5] Recombinant plasminogen activators: a comparative review of the clinical pharmacology and therapeutic use of alteplase and reteplase — Moser M et al., BioDrugs 1998. PMID: 18020578. View sourceStudy: Narrative pharmacology reviewReviews the pharmacology and clinical use of alteplase and reteplase, including reteplase's double-bolus dosing and comparable myocardial-infarction efficacy.

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.