Drug

Alteplase

Regulatory activity · FDA

Emerging researchLate-stage developmentSteady momentum

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.

RxNorm8410UNII1RXS4UE564

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

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

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

Intravenous Adjuvant With Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Acute Ischemic Stroke Patients With Large Vessel Occlusion: a Multicenter, Open Label, Randomized Controlled Trial.

Clinical trial2026-02-28Primary completion · 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

UNII

1RXS4UE564

Regulatory jurisdictions

fda

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

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).