Wednesday, July 8, 2026

Drug profile · INN

tenecteplase

tenecteplase (METALYSE) is a tissue-type plasminogen activator exogenous protein. Current US regulatory status: approved.

FDA: approved EMA: approved Blood and blood forming organs (B01) B01AD11
US status approved
Patents linked 0
Pipeline programs 9
News articles 0
Drug details — tenecteplase
US status
approved
Class
Blood and blood forming organs (B01)
Route
Patents
0
Programs
9
Data quality
0.83

Quick answer

tenecteplase (METALYSE) is a tissue-type plasminogen activator exogenous protein. Current US regulatory status: approved.

Key facts

INN tenecteplase
Brand METALYSE
Mechanism Tissue-type plasminogen activator exogenous protein
Target Tissue-type plasminogen activator
Therapeutic class Blood and blood forming organs (B01)
Formulation VIAL
ATC code B01AD11

Mechanism of action

Tissue-type plasminogen activator exogenous protein

Primary target: Tissue-type plasminogen activator

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. DR230297 Phase 3 · Tour Hekla · Acute ischaemic stroke due to basilar artery occlusion.
  2. Metalyse 5 000 units (25 mg) powder for solution for injection Phase 3 · Boehringer Ingelheim · Acute Ischemic Stroke
  3. Metalyse 5 000 units (25 mg) powder for solution for injection Phase 3 · PARItec · Adult patients with a LVOS with large core within 9 hours of
  4. Tenecteplase Phase 3 · Hospital Authority · Ischemic Stroke
  5. Tenecteplase (0.0938mg/kg) Phase 3 · Chinese Academy of · Stroke
  6. [2025]372-001 Phase 3 · Chinese Academy of · Acute Ischemic Stroke
  7. Tenecteplase Phase 2 · Neuroscience Trials Australia · Ischemic Stroke
  8. low-dose tenecteplase intravenous thrombolysis Approved · Chinese Academy of · Acute Ischemic Stroke Patients

Related & competitor drugs

  1. apixaban Blood and blood forming organs (B01)
  2. berotralstat Blood and blood forming organs (B06)
  3. bivalirudin Blood and blood forming organs (B01)
  4. c1 inhibitor (human) Blood and blood forming organs (B06)
  5. clopidogrel Blood and blood forming organs (B01)
  6. dabigatran etexilate Blood and blood forming organs (B01)

Frequently asked questions

What is tenecteplase?

tenecteplase (METALYSE) is a tissue-type plasminogen activator exogenous protein. Current US regulatory status: approved.

What is the brand name for tenecteplase?

METALYSE is a marketed brand name for tenecteplase. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of tenecteplase?

tenecteplase has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.