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Alteplase for Injection
Alteplase for Injection is a Fibrinolytic Small molecule drug developed by Angde Biotech Pharmaceutical Co., Ltd.. It is currently in Phase 2 development for Ischemic stroke, Acute ischemic stroke. Also known as: Recombinant Human Tissue Plasminogen Active for Injection.
Alteplase for Injection is a tissue plasminogen activator that works by dissolving blood clots.
Alteplase for Injection is a tissue plasminogen activator that works by dissolving blood clots. Used for Ischemic stroke, Acute ischemic stroke.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Alteplase for Injection |
|---|---|
| Also known as | Recombinant Human Tissue Plasminogen Active for Injection |
| Sponsor | Angde Biotech Pharmaceutical Co., Ltd. |
| Drug class | Fibrinolytic |
| Target | tPA |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 2 |
Mechanism of action
It does this by converting plasminogen into plasmin, which then breaks down fibrin clots. This process helps to restore blood flow in conditions such as ischemic stroke.
Approved indications
- Ischemic stroke
- Acute ischemic stroke
Common side effects
- Hemorrhage
- Allergic reactions
- Hypotension
- Cardiac arrest
- Respiratory arrest
Key clinical trials
- Outcomes After Intravenous Alteplase / Tenecteplase With or Without Shuxuetong Injection in Routine Clinical Practice
- Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER). (PHASE3)
- Phase III Clinical Trial of rhTNK-tPA in Treating Acute Ischemic Stroke With Extended Time Window. (PHASE3)
- Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With Late-window acUte Ischemic Stroke Due to Middle Cerebral Artery Occlusion (PHASE3)
- Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ischemic Stroke (PHASE3)
- Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND (PHASE3)
- CHemical OptImization of Cerebral Embolectomy 2 (CHOICE 2). (PHASE3)
- Efficacy and Safety Study of Proposed Biosimilar Product Reveliza vs Actilise in Patients With ST-segment Elevation Myocardial Infarction (PHASE3)
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:
- Alteplase for Injection CI brief — competitive landscape report
- Alteplase for Injection updates RSS · CI watch RSS
- Angde Biotech Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about Alteplase for Injection
What is Alteplase for Injection?
How does Alteplase for Injection work?
What is Alteplase for Injection used for?
Who makes Alteplase for Injection?
Is Alteplase for Injection also known as anything else?
What drug class is Alteplase for Injection in?
What development phase is Alteplase for Injection in?
What are the side effects of Alteplase for Injection?
What does Alteplase for Injection target?
Related
- Drug class: All Fibrinolytic drugs
- Target: All drugs targeting tPA
- Manufacturer: Angde Biotech Pharmaceutical Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Ischemic stroke
- Indication: Drugs for Acute ischemic stroke
- Also known as: Recombinant Human Tissue Plasminogen Active for Injection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing