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Drug

Alteplase

Established medicine
ClassTissue-type plasminogen activator exogenous proteinResearchOngoing clinical research
Also known as Activase, Plasminogen activator (human tissue-type protein moiety), T-PA, Tissue plasminogen activator+12 more

Activase, Plasminogen activator (human tissue-type protein moiety), T-PA, Tissue plasminogen activator, Tissue plasminogen activator alteplase, Tissue-type plasminogen activator, r-tPA, rt-PA, rt-PA - Tissue-type plasminogen activator, rtPA, t-plasminogen activator, tPA, Alteplasa, ALTEPLASE,RECOMBINANT, Alteplase, recombinant, Tissue plasminogen activator, recombinant.

RxNorm8410ChEMBLCHEMBL1201593ATCB01AD02ATCS01XA13UNII1RXS4UE564
4
Research papers
14
Active clinical trials
Tissue-type plasminogen activator
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy (PEARL): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial

Clinical trial2026-08-12Status changed to Completed · ClinicalTrials.gov

Utility of Continuous Intrathecal TPA Infusion for IVH Clearance With Ventricular Irrigation

Clinical trial2026-07-08Results expected Q2 2028 · ClinicalTrials.gov

A Randomized Trial of Alteplase Versus Placebo Through an Indwelling Pleural Catheter for Management of Symptomatic Septated MPE

Clinical trial2026-06-12Results expected Q1 2027 · ClinicalTrials.gov

A Multicenter Randomized Controlled Trial Comparing Tissue Plasminogen Activator With Dual Antiplatelet Therapy for Patients With Hyperacute Single Perforating Artery Infarction

Clinical trial2026-06-05Results expected Q1 2028 · ClinicalTrials.gov

A Phase 2 Safety, Dose-finding and Efficacy Study Evaluating Viscoelastic Testing (VET) Guided Tissue Plasminogen Activator (tPA) Treatment in Critically-ill Pro-thrombotic Acute Respiratory Failure

Clinical trial2026-05-01Primary completion · ClinicalTrials.gov

A Reduced Dose of Thrombolytic Treatment for Patients With Intermediate High-risk Acute Pulmonary Embolism: a Randomized Controled Trial

Clinical trial2026-04-13Primary completion · ClinicalTrials.gov

Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusive Stroke(TNK-LVO) :a Phase 3, Multicentre, Open-label, Randomised Controlled Trial

Clinical trial2026-04-09Results expected Q4 2026 · ClinicalTrials.gov

Recall (Class II): ALTEPLASE

Regulatory2024-05-20FDA

Intrapleural Fibrinolytic Therapy versus Early Medical Thoracoscopy for Treatment of Pleural Infection. Randomized Controlled Clinical Trial.

Research2020-08-01Annals of the American Thoracic Society

Endovascular therapy for ischemic stroke with perfusion-imaging selection.

Research2015-02-11The New England journal of medicine

Effects of 0.6 mg/kg intravenous alteplase on vascular and clinical outcomes in middle cerebral artery occlusion: Japan Alteplase Clinical Trial II (J-ACT II).

Research2010-01-14Stroke

Alteplase at 0.6 mg/kg for acute ischemic stroke within 3 hours of onset: Japan Alteplase Clinical Trial (J-ACT).

Research2006-06-08Stroke

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Alteplase
Aliases & brands
ActivasePlasminogen activator (human tissue-type protein moiety)T-PATissue plasminogen activatorTissue plasminogen activator alteplaseTissue-type plasminogen activatorr-tPArt-PArt-PA - Tissue-type plasminogen activatorrtPAt-plasminogen activatortPAAlteplasaALTEPLASE,RECOMBINANTAlteplase, recombinantTissue plasminogen activator, recombinant
RxNorm CUI
8410
ChEMBL ID
CHEMBL1201593
ATC codes
B01AD02S01XA13
UNII
1RXS4UE564
Primary mechanism
Tissue-type plasminogen activator exogenous protein
Regulatory jurisdictions
fda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Tissue-type plasminogen activator
PLAT · P00750
EXOGENOUS PROTEINTissue-type plasminogen activator exogenous protein

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
FDA
Total events
1
fdaU.S. Food and Drug Administration· 1 event
2024-05-20RecallSafety
Recall (Class II): ALTEPLASE
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

120 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
120
registered trials across all phases
LATEST COMPLETION 2025
14
Active studies
12
Recruiting
83
Late-stage (III+)
70
Completed
36
Discontinued
PHASE DISTRIBUTIONn = 120
Early Phase 11Phase 110Phase 1 / 22Phase 224Phase 2 / 37Phase 342Phase 420Phase N / A14

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Utility of Continuous Intrathecal TPA Infusion for IVH Clearance With Ventricular Irrigation

Not yet recruitingPH IVDavid Dornbosn=802029

A Multicenter Randomized Controlled Trial Comparing Tissue Plasminogen Activator With Dual Antiplatelet Therapy for Patients With Hyperacute Single Perforating Artery Infarction

RecruitingPH IVNippon Medical Schooln=5002029

Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke: An Open-label, Blinded Endpoint, Randomized Controlled Trial

Not yet recruitingPH IVSun Yat-Sen Memorial Hospital of Sun Yat-Sen Universityn=4722027

Peripheral Low Dose Systemic Thrombolysis Versus Catheter Directed Acoustic Pulse Thrombolysis for Treatment of Submassive Pulmonary Embolism

Active, not recruitingPH IVNorthwell Healthn=312025

the Predictors of Different ECASS-based Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients Treated With Alteplase

RecruitingPH IVKafrelsheikh Universityn=7162024

Recent completions

Trials that read out recently, adding to the completed evidence base.

To Compare the Efficacy & Safety of Ultra-Slow (24 hr) Low Dose (25 mg) Infusion of Alteplase Over Slow (24hr) Infusion of Streptokinase in Mechanical Prosthetic Valve Thrombosis : A Randomized Controlled Trial

CompletedN/AU. N. Mehta Institute of Cardiology and Research Centern=1002025

Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy (PEARL): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial

CompletedPH IIISun Yat-Sen Memorial Hospital of Sun Yat-Sen Universityn=3242025

Adjunctive, Low-dose Intracoronary Recombinant Tissue Plasminogen Activator (tPA) Versus Placebo for Primary PCI in Patients With ST-segment Elevation Myocardial Infarction

CompletedPH IIIPopulation Health Research Instituten=2102025

Treatment with Intravenous Alteplase in Ischemic Stroke Patients with Onset Time Between 4.5 and 24 Hours

CompletedPH IIISecond Affiliated Hospital, School of Medicine, Zhejiang Universityn=3722024

EXtending the Time Window for Thrombolysis in Posterior Circulation Stroke Without Early CT Signs

CompletedPH IIISecond Affiliated Hospital, School of Medicine, Zhejiang Universityn=2342024

The Utility of Intra-Catheter Fibrinolytics in Draining Chronic Subdural Hematomas: A Randomized Controlled Trial Pilot Study

CompletedPH IVHamilton Health Sciences Corporationn=402024

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20062020
Major research themes3
Endovascular Procedures1Thrombectomy1Thrombolytic Therapy1
Journals, researchers & institutions
Top journals
  • Stroke2
  • Annals of the American Thoracic Society1
  • The New England journal of medicine1
Leading researchers
  • Minematsu K2
  • Mori E2
  • Nakagawara J2
  • Yamaguchi T2
  • Ang T1
  • Badve M1
  • Barber PA1
  • Bladin CF1
Leading institutions
free-text, unnormalised
  • Beth Israel Deaconess Medical Center1
  • Mayo Clinic1
  • National Cardiovascular Center1
  • Tohoku University Graduate School of Medicine1
  • Tulane University Health Sciences Center1
  • University of Florida Health1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.