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.

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

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/04
N/A
Recruiting
Sahlgrenska University Hospital
2024/10/31
Not Applicable
Completed
2024/10/29
Phase 1
Recruiting
Capital Medical University
2024/10/26
Phase 3
Not yet recruiting
2024/10/23
Phase 4
Recruiting
2024/03/29
Phase 4
Recruiting
2024/02/05
Not Applicable
Not yet recruiting
2024/01/08
N/A
Recruiting
The First Affiliated Hospital of Zhengzhou University
2023/12/28
Early Phase 1
Recruiting
2023/10/12
N/A
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Genentech, Inc.
50242-041
INTRAVENOUS
2.2 mg in 2 mL
10/13/2020

EMA Drug Approvals

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

HSA Drug Approvals

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

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Recombinant Human TNK Tissue-type Plasminogen Activator for Injection(rhTNK-tPA)
国药准字S20150001
生物制品
注射剂
11/13/2019
Alteplase for Injection
国药准字SJ20160055
生物制品
注射剂
8/23/2021
Alteplase for Injection
国药准字SJ20160054
生物制品
注射剂
8/23/2021
Recombinant Human Tissue-type Plasminogen Activator Derivative for Injection
国药准字S20070023
生物制品
注射剂
1/29/2022

PPB Drug Approvals

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

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