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Activase (ALTEPLASE)
Activase (Alteplase) is a recombinant tissue plasminogen activator (tPA) developed by Genentech, used to treat acute myocardial infarction, ischemic stroke, and pulmonary embolism. It works by binding to plasminogen and converting it into plasmin, which then breaks down blood clots. As a patented product, its commercial status is proprietary, and it requires careful administration due to potential bleeding risks. Key safety considerations include the risk of intracranial hemorrhage and the need for close monitoring. Activase has been FDA-approved since 1996.
At a glance
| Generic name | ALTEPLASE |
|---|---|
| Sponsor | Roche |
| Target | Plasminogen |
| Modality | Enzyme |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 1996 |
Approved indications
- Restoration of function to central venous access devices
Common side effects
- Major hemorrhage
- Sepsis
- Venous thrombosis
- Pulmonary or arterial emboli
- Intracranial hemorrhage
- Gastrointestinal bleeding
- Death
- Injection site hemorrhage
- Subclavian and upper extremity deep venous thrombosis
- Fever
- Lethargy
- Hypotension
Drug interactions
- drugs affecting coagulation and/or platelet function
Key clinical trials
- Neuronavigation-assisted Stereotactic Minimally Invasive Puncture With Tenecteplase for Acute Lobar Intracerebral Hemorrhage (PHASE3)
- 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)
- A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well (PHASE3)
- Unknown Time of Onset Stroke RePerfusIon Without Advanced Imaging (PHASE3)
- Intravenous Tenecteplase in Very Old Patients With Acute Ischemic Stroke
- Reperfusion Completion Via Local Arterial Infusion of Tenecteplase After Incomplete Mechanical Thrombectomy (PHASE3)
- Use of Tissue Plasminogen Activator in the Clearance of Chronic Subdural Hematomas (PHASE4)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Activase CI brief — competitive landscape report
- Activase updates RSS · CI watch RSS
- Roche portfolio CI