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Intravenous Tenecteplase
Intravenous Tenecteplase is a Fibrinolytic agent / Tissue plasminogen activator (tPA) Small molecule drug developed by NHS Greater Glasgow and Clyde. It is currently in Phase 3 development for Acute myocardial infarction (ST-elevation MI), Acute ischemic stroke. Also known as: Metalyse, TNK.
Tenecteplase is a tissue plasminogen activator (tPA) that converts plasminogen to plasmin, which breaks down fibrin clots to restore blood flow.
Tenecteplase is a tissue plasminogen activator (tPA) that converts plasminogen to plasmin, which breaks down fibrin clots to restore blood flow. Used for Acute myocardial infarction (ST-elevation MI), Acute ischemic stroke.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Intravenous Tenecteplase |
|---|---|
| Also known as | Metalyse, TNK |
| Sponsor | NHS Greater Glasgow and Clyde |
| Drug class | Fibrinolytic agent / Tissue plasminogen activator (tPA) |
| Target | Plasminogen / Fibrin |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Tenecteplase is a genetically engineered variant of natural tissue plasminogen activator (tPA) with enhanced fibrin specificity and longer half-life. It binds to fibrin in thrombi and catalyzes the conversion of plasminogen to plasmin, which degrades the fibrin matrix of blood clots. This fibrinolytic action rapidly restores blood flow in occluded vessels, making it effective for acute thrombotic events.
Approved indications
- Acute myocardial infarction (ST-elevation MI)
- Acute ischemic stroke
Common side effects
- Bleeding (major and minor)
- Intracranial hemorrhage
- Hypotension
- Reperfusion arrhythmias
- Allergic reactions
Key clinical trials
- Low-Dose Tenecteplase for Acute Ischemic Stroke Treatment in Aging Patients (PHASE4)
- Tenecteplase Before Interhospital Transfer in Acute Basilar Artery Occlusion at 4.5 to 24 Hours (PHASE4)
- Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours (PHASE3)
- Precision Reperfusion Therapy for Disabling Minor Stroke With Large Vessel Occlusion Beyond Time Window (PHASE3)
- Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging (PHASE3)
- Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke
- Advancing Reperfusion Therapy for Ischemic Stroke: Direct Transfer to Angiography Suite for Patients With Suspected Large Vessel Occlusion (NA)
- Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Intravenous Tenecteplase CI brief — competitive landscape report
- Intravenous Tenecteplase updates RSS · CI watch RSS
- NHS Greater Glasgow and Clyde portfolio CI
Frequently asked questions about Intravenous Tenecteplase
What is Intravenous Tenecteplase?
How does Intravenous Tenecteplase work?
What is Intravenous Tenecteplase used for?
Who makes Intravenous Tenecteplase?
Is Intravenous Tenecteplase also known as anything else?
What drug class is Intravenous Tenecteplase in?
What development phase is Intravenous Tenecteplase in?
What are the side effects of Intravenous Tenecteplase?
What does Intravenous Tenecteplase target?
Related
- Drug class: All Fibrinolytic agent / Tissue plasminogen activator (tPA) drugs
- Target: All drugs targeting Plasminogen / Fibrin
- Manufacturer: NHS Greater Glasgow and Clyde — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Acute myocardial infarction (ST-elevation MI)
- Indication: Drugs for Acute ischemic stroke
- Also known as: Metalyse, TNK
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing