ACTIVASE (alteplase)
ACTIVASE is indicated for the treatment of Acute Ischemic Stroke; Acute Myocardial Infarction; Heart Failure; Pulmonary Embolism.
How ACTIVASE Works
Alteplase is a serine protease that facilitates the conversion of plasminogen into plasmin, a process significantly enhanced by the presence of fibrin. When administered, the drug binds to fibrin within a thrombus and converts the entrapped plasminogen into plasmin. This reaction triggers localized fibrinolysis, which breaks down the clot while limiting systemic proteolysis. By targeting the fibrin structure of a thrombus, the drug effectively dissolves blood clots in the systemic circulation.
Details
- Status
- Prescription
- First Approved
- 1987-11-13
- Revenue
- $323M (Q4-2025)
- Routes
- SINGLE-USE
- Dosage Forms
- VIAL
ACTIVASE Approval History
What ACTIVASE Treats
4 indicationsACTIVASE is approved for 4 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Ischemic Stroke
- Acute Myocardial Infarction
- Heart Failure
- Pulmonary Embolism
ACTIVASE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ACTIVASE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ACTIVASE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ACTIVASE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
36 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06658197 TNK-LVO | [2024]288-001 | Ph 3 | recruiting | Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke |
| NCT05728333 ADJUVANT | ADJUVANT | Ph 2, Ph 3 | recruiting | Intravenous Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Stroke |
| NCT06337175 | 000000230988 | Ph 4 | completed | Predictors of Post-alteplase Hemorrhagic Transformation of Brain Infarction |
| NCT04430569 PEITHO-3 | P160924 P160924, PHRCN-16-0580 | Ph 3 | recruiting | Pulmonary Embolism International THrOmbolysis Study-3 |
| NCT03151993 results posted | FRIDA Stroke Trial | Ph 3 | completed | Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS |
| NCT04688320 results posted | FORPE | Ph 3 | completed | Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE |
| NCT04879615 | HOPE | Ph 3 | completed | 24 Hours Treatment with Alteplase in Patients with Ischemic Stroke |
| NCT03854500 NOR-TEST 2 | 2018-003090-95 | Ph 3 | terminated | The Norwegian Tenecteplase Stroke Trial 2 |
| NCT04915729 ORIGINAL results posted | 1123-0040 | Ph 3 | completed | A Study in Chinese Patients to Compare How Tenecteplase and Alteplase Given After a Stroke Improve Recovering of Physical Activity |
| NCT06653946 | 010120190 | Ph 4 | recruiting | the Predictors of Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients |
| NCT03581877 | 18-0805 | Ph 4 | active not recruiting | Peripheral Systemic Thrombolysis Versus Catheter Directed Thrombolysis for Submassive PE |
| NCT05856851 PEARL | SYSKY-2023-390-02 | Ph 3 | recruiting | Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy |
| NCT03594175 READY1 results posted | CUSA-081-HEM-01 2019-002124-32 | Ph 3 | terminated | Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality |
| NCT05540834 VETtiPAT-ARF | ICU001 | Ph 2 | recruiting | Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure |
| NCT02604238 MONALYSE | Azienda USL1 Massa e Carrara | Ph 3 | withdrawn | Efficacy and Safety of Half Dose Alteplase Added to Heparine, in Patients With Moderate Pulmonary Embolism |
| NCT03197194 THEIA | RC17_0061 | Ph 3 | completed | A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety of IV THrombolysis (Alteplase) in Patients With acutE Central retInal Artery Occlusion |
| NCT06058884 | 23091988 | Ph 4 | completed | Predictors of AIS Unfavorable Outcomes |
| NCT04256473 DUMAS | DUMAS-1.1 | Ph 2 | completed | Dual Thrombolytic Therapy With Mutant Pro-urokinase and Low Dose Alteplase for Ischemic Stroke |
| NCT05910125 AGREE | SYSKY-2022-252-02 | Ph 4 | not yet recruiting | Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke |
| NCT03889249 AcT | Version 2.0 (Sponsor assigned) | Ph 3 | completed | Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke |
| NCT03661411 ARAMIS | k（2018）22-1 | Ph 4 | completed | Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke |
| NCT02835534 | CP-2015-01 | Ph 4 | completed | The Efficacy and Safety of rhTNK-tPA in Comparison With Alteplase(Rt-PA) as Fibrinolytic Therapy of Acute STEMI |
| NCT02159521 ACCESS PTS results posted | EKOS-11 | Ph 4 | completed | Treatment of Chronic Deep Vein Thrombosis (DVT) and Post-Thrombotic Syndrome (PTS) With the EkoSonic® Endovascular System |
| NCT03988842 SAFE-LYSE results posted | Pro00054951 | Ph 4 | terminated | Standard-dose Apixaban AFtEr Very Low-dose ThromboLYSis for Acute Intermediate-high Risk Acute Pulmonary Embolism |
| NCT03108833 ERUPTE | TASLY-B1448 | Ph 2 | completed | A Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism |
| NCT03357133 MR TEA | 2017032 | Ph 2, Ph 3 | terminated | Tirofiban for Patients Treated With Alteplase |
| NCT03541668 | TASLY-B1440-CTP-Ⅲa | Ph 3 | completed | Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST) |
| NCT02257294 T-TIME | GN12CA450 12/170/45 | Ph 2 | completed | A Trial of Low-dose Adjunctive alTeplase During prIMary PCI |
| NCT02930837 results posted | 135.331 | Ph 3 | completed | Safety and Efficacy of Alteplase When Administered in Chinese Patients With Acute Ischemic Hemispheric Stroke Where Thrombolysis is Initiated Between 3 and 4.5 Hours After Stroke Onset |
| NCT00784134 CLEAR III results posted | IVH06 5U01NS062851-05 | Ph 3 | completed | Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III |
| NCT01525290 WAKE-UP | WAKE-UP | Ph 3 | completed | Efficacy and Safety of MRI-based Thrombolysis in Wake-up Stroke |
| NCT01472926 ATTEST | 2010-024541-67 TSA 2010/04, 2010-024541-67 | Ph 2 | completed | Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis- (ATTEST) |
| NCT02072226 PRISMS results posted | ML29093 | Ph 3 | terminated | A Study of the Efficacy and Safety of Alteplase in Participants With Mild Stroke |
| NCT01930682 EARLY-MYO | BI135.326 12410708300 | Ph 4 | completed | EARLY Routine Catheterization After Alteplase Fibrinolysis vs. PPCI in ST-Segment-Elevation MYOcardial Infarction |
| NCT01949948 NOR-TEST | REK 2011/2435 | Ph 3 | completed | Study of Tenecteplase Versus Alteplase for Thrombolysis (Clot Dissolving) in Acute Ischemic Stroke |
| NCT02180204 TALISMAN | 2013H000 TALISMAN | Ph 2, Ph 3 | withdrawn | Tenecteplase Versus Alteplase in Ischemic Stroke Management (TALISMAN) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ACTIVASE FDA Label Details
Indications & Usage
FDA Label (PDF)ACTIVASE is indicated for the treatment of Acute Ischemic Stroke; Acute Myocardial Infarction; Heart Failure; Pulmonary Embolism.
Pro Intelligence Preview
Deep insights for ACTIVASE
Revenue Insights
- • Q4-2025: $323M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.