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Fibrinolytic therapy
Fibrinolytic therapy is a Fibrinolytic agent / Thrombolytic Small molecule drug developed by All India Institute of Medical Sciences. It is currently in Phase 3 development for Acute myocardial infarction (ST-elevation MI), Acute ischemic stroke, Pulmonary embolism. Also known as: Thrombolytic therapy, DNAse / tPA combination therapy..
Fibrinolytic therapy dissolves blood clots by activating plasminogen to plasmin, which breaks down fibrin and restores blood flow.
Fibrinolytic therapy dissolves blood clots by activating plasminogen to plasmin, which breaks down fibrin and restores blood flow. Used for Acute myocardial infarction (ST-elevation MI), Acute ischemic stroke, Pulmonary embolism.
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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 | Fibrinolytic therapy |
|---|---|
| Also known as | Thrombolytic therapy, DNAse / tPA combination therapy. |
| Sponsor | All India Institute of Medical Sciences |
| Drug class | Fibrinolytic agent / Thrombolytic |
| Target | Plasminogen / Fibrin |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Fibrinolytic agents (thrombolytics) work by converting the inactive zymogen plasminogen into its active form, plasmin, which then degrades fibrin—the structural protein that holds blood clots together. This enzymatic degradation dissolves existing thrombi and restores perfusion to ischemic tissues. Common fibrinolytic agents include tissue plasminogen activator (tPA), streptokinase, and urokinase.
Approved indications
- Acute myocardial infarction (ST-elevation MI)
- Acute ischemic stroke
- Pulmonary embolism
- Deep vein thrombosis
Common side effects
- Bleeding (major and minor)
- Intracranial hemorrhage
- Allergic reaction
- Hypotension
- Arrhythmia (reperfusion)
Key clinical trials
- ULTRAsound-assisted Catheter-guided Thrombolysis for Intermediate-high Risk Patients With PE (NA)
- The Effect of Oral DLBS1033 in Patients With Diabetic Polyneuropathy (PHASE2, PHASE3)
- Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults (PHASE3)
- Does Intraperitoneal Washout Further Reduce Pain After Low-Pressure vNOTES Hysterectomy? (NA)
- TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage (NA)
- Single Center Post-Market Study of Thrombolytic Therapy Using the Versus™ Catheter
- Early Catheter-directed Treatment of High Risk Pulmonary Embolism (NA)
- Pleural Irrigation With Normal Saline Versus Intrapleural Fibrinolytic (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:
- Fibrinolytic therapy CI brief — competitive landscape report
- Fibrinolytic therapy updates RSS · CI watch RSS
- All India Institute of Medical Sciences portfolio CI
Frequently asked questions about Fibrinolytic therapy
What is Fibrinolytic therapy?
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Is Fibrinolytic therapy also known as anything else?
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What does Fibrinolytic therapy target?
Related
- Drug class: All Fibrinolytic agent / Thrombolytic drugs
- Target: All drugs targeting Plasminogen / Fibrin
- Manufacturer: All India Institute of Medical Sciences — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Acute myocardial infarction (ST-elevation MI)
- Indication: Drugs for Acute ischemic stroke
- Indication: Drugs for Pulmonary embolism
- Also known as: Thrombolytic therapy, DNAse / tPA combination therapy.