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thrombolysis therapy
thrombolysis therapy is a Thrombolytic agent Small molecule drug developed by Leiden University Medical Center. It is currently in Phase 3 development for Acute myocardial infarction, Acute ischemic stroke, Pulmonary embolism. Also known as: systemic thrombolysis, full-dose systemic thrombolysis, thrombolysis, thrombolytic therapy.
Thrombolysis therapy dissolves blood clots by activating fibrinolytic enzymes to break down fibrin and restore blood flow in occluded vessels.
Thrombolysis therapy involves administering alteplase, a recombinant tissue plasminogen activator, to dissolve blood clots in conditions such as acute ischemic stroke and large vessel occlusion. Alteplase is administered via a 10% IV bolus followed by a 90% 1-hour IV drip at a dose of 0.9mg/kg.
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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 | thrombolysis therapy |
|---|---|
| Also known as | systemic thrombolysis, full-dose systemic thrombolysis, thrombolysis, thrombolytic therapy, Alteplase |
| Sponsor | Leiden University Medical Center |
| Drug class | Thrombolytic agent |
| Target | Fibrin; plasminogen/plasmin pathway |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Thrombolytic agents work by converting plasminogen to plasmin, a serine protease that degrades fibrin—the structural protein in blood clots. This enzymatic fibrinolysis restores perfusion in thrombotic occlusions of coronary, cerebral, or peripheral vessels. The approach is time-sensitive and most effective when administered early after clot formation.
Approved indications
- Acute myocardial infarction
- Acute ischemic stroke
- Pulmonary embolism
- Deep vein thrombosis
Common side effects
- Bleeding (major and minor)
- Intracranial hemorrhage
- Reperfusion arrhythmias
- Hypotension
- Allergic reactions
Key clinical trials
- Neuronavigation-assisted Stereotactic Minimally Invasive Puncture With Tenecteplase for Acute Lobar Intracerebral Hemorrhage (PHASE3)
- Low-Dose Tenecteplase for Acute Ischemic Stroke Treatment in Aging Patients (PHASE4)
- Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO) (PHASE3)
- Tenecteplase Before Interhospital Transfer in Acute Basilar Artery Occlusion at 4.5 to 24 Hours (PHASE4)
- Efficacy and Safety of Human Urinary Kallidinogenase Combined With Reteplase Intravenous Thrombolysis in the Treatment of Acute Ischemic Stroke (NA)
- The Intensive Care Platform Trial (PHASE4)
- Minocycline in Stroke Study at Maimonides (PHASE2, PHASE3)
- Endovascular Treatment for Mild Stroke With Acute Anterior Circulation Large Vessel Occlusion (NA)
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:
- thrombolysis therapy CI brief — competitive landscape report
- thrombolysis therapy updates RSS · CI watch RSS
- Leiden University Medical Center portfolio CI
Frequently asked questions about thrombolysis therapy
What is thrombolysis therapy?
How does thrombolysis therapy work?
What is thrombolysis therapy used for?
Who makes thrombolysis therapy?
Is thrombolysis therapy also known as anything else?
What drug class is thrombolysis therapy in?
What development phase is thrombolysis therapy in?
What are the side effects of thrombolysis therapy?
What does thrombolysis therapy target?
Related
- Drug class: All Thrombolytic agent drugs
- Target: All drugs targeting Fibrin; plasminogen/plasmin pathway
- Manufacturer: Leiden University Medical Center — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Acute myocardial infarction
- Indication: Drugs for Acute ischemic stroke
- Indication: Drugs for Pulmonary embolism
- Also known as: systemic thrombolysis, full-dose systemic thrombolysis, thrombolysis, thrombolytic therapy, Alteplase
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing