MedPath

Alteplase

Generic Name
Alteplase
Brand Names
Activase, Cathflo, Cathflo Activase
Drug Type
Biotech
CAS Number
105857-23-6
Unique Ingredient Identifier
1RXS4UE564

Overview

Alteplase is a recombinant tissue plasminogen activator (rt-PA) used as a thrombolytic agent. It cleaves plasminogen to form plasmin, an enzyme involved in the degradation of fibrin clots. In the absence of fibrin, the alteplase-mediated conversion of plasminogen is limited, thanks to the high affinity between alteplase and fibrin. Alteplase is a purified glycoprotein of 527 amino acids expressed in Chinese hamster ovary (CHO) cells. It was first approved by the FDA in 1987 for the management of thromboembolic disease, including acute myocardial infarction (AMI). The use of alteplase to manage AMI has decreased thanks to the availability of safer treatments such as angioplasty and stenting. However, its use for the treatment of acute ischemic stroke (AIS) has increased over the years. New thrombolytic agents derived from tissue plasminogen activator, such as desmoteplase, tenecteplase and reteplase, have also been developed. Alteplase is also available as Cathflo Activase (intracatheter instillation) for the restoration of function to central venous access devices.

Background

Alteplase is a recombinant tissue plasminogen activator (rt-PA) used as a thrombolytic agent. It cleaves plasminogen to form plasmin, an enzyme involved in the degradation of fibrin clots. In the absence of fibrin, the alteplase-mediated conversion of plasminogen is limited, thanks to the high affinity between alteplase and fibrin. Alteplase is a purified glycoprotein of 527 amino acids expressed in Chinese hamster ovary (CHO) cells. It was first approved by the FDA in 1987 for the management of thromboembolic disease, including acute myocardial infarction (AMI). The use of alteplase to manage AMI has decreased thanks to the availability of safer treatments such as angioplasty and stenting. However, its use for the treatment of acute ischemic stroke (AIS) has increased over the years. New thrombolytic agents derived from tissue plasminogen activator, such as desmoteplase, tenecteplase and reteplase, have also been developed. Alteplase is also available as Cathflo Activase (intracatheter instillation) for the restoration of function to central venous access devices.

Indication

Alteplase is indicated for the treatment of acute ischemic stroke (AIS) and for use in acute myocardial infarction (AMI) for the reduction of mortality and incidence of heart failure. Alteplase is also indicated for the lysis of acute massive pulmonary embolism, defined as acute pulmonary emboli obstructing blood flow to a lobe or multiple lung segments, and acute pulmonary emboli accompanied by unstable hemodynamics.

Associated Conditions

  • Acute Ischemic Stroke
  • Cardiac mortality
  • Heart Failure
  • Pulmonary Embolism Acute Massive
  • Central venous access device thrombosis

Clinical Trials

View More Clinical Trials

Sign in to access the complete clinical trial database with detailed study information.

Title
Posted
Study ID
Phase
Status
Sponsor
2013/06/14
Phase 1
Withdrawn
2013/04/18
Phase 2
Completed
King's College Hospital NHS Trust
2013/04/09
Phase 3
Completed
2013/01/17
N/A
UNKNOWN
Wuhan General Hospital of Guangzhou Military Command
2012/10/30
Phase 3
Completed
2012/08/22
Phase 4
UNKNOWN
Centre Hospitalier du Centre du Valais
2012/07/18
Phase 2
Completed
2012/04/20
Phase 1
Completed
2012/04/12
Phase 3
Terminated
2012/02/02
Phase 3
Completed

FDA Drug Approvals

View More FDA Approvals

Sign in to access additional FDA-approved drug information with detailed regulatory data.

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

View More EMA Approvals

Sign in to access additional EMA-approved drug information with detailed regulatory data.

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

View More HSA Approvals

Sign in to access additional HSA-approved drug information with detailed regulatory data.

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

View More NMPA Approvals

Sign in to access additional NMPA-approved drug information with detailed regulatory data.

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

View More PPB Approvals

Sign in to access additional PPB-approved drug information with detailed regulatory data.

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

View More TGA Approvals

Sign in to access additional TGA-approved drug information with detailed regulatory data.

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
© Copyright 2025. All Rights Reserved by MedPath