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. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Actilyse alteplase (rch) 50mg powder for injection vial with diluent vial | 17905 | Medicine | A | 9/26/1991 | |
ACTILYSE CATHFLO alteplase (rch) 2 mg powder for injection vial | 142795 | Medicine | A | 6/4/2008 | |
ACTILYSE alteplase (rch) 10mg powder for injection vial with water for injections 10mL vial | 64240 | Medicine | A | 10/14/1998 | |
ACTILYSE alteplase (rch) 20mg powder for injection, vial with diluent vial | 43375 | Medicine | A | 5/6/1993 |
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