Overview
Urokinase is an endogenous peptide that is cleaved in the presence of plasmin between lysine 158 and isoleucine 159 to yield active urokinase. Urokinase remains connected between these 2 chains by a sulfhydryl bond. Urokinase was granted FDA approval on 16 January 1978.
Indication
In Canada, urokinase is indicated for lysis of acute massive pulmonary emboli, acute thrombi obstructing coronary arteries, occlusive thromboemboli in peripheral arteries and grafts, and restoration of patency to intravenous catheters.
Associated Conditions
- Obstruction; Catheter, Infusion Catheter (Vascular)
- Pulmonary Embolism
- Pulmonary Embolism Acute Massive
- Thromboembolism of the Coronary Artery
- Thromboembolism of the Graft
- Thromboembolism of the Peripheral Artery
Research Report
Urokinase (DB00013): A Comprehensive Pharmacological and Clinical Monograph
Foundational Characteristics and Molecular Profile
Identification and Nomenclature
Urokinase is a biotech therapeutic agent classified as a serine protease, known systematically as urokinase-type plasminogen activator (uPA).[1] It is a naturally occurring enzyme in humans and other animals, first discovered in 1947 by McFarlane and Pilling, though not named at that time.[1] As a therapeutic agent, it is identified by the DrugBank Accession Number DB00013 and the Chemical Abstracts Service (CAS) Number 9039-53-6.[1]
The drug is recognized under a variety of synonyms and international nonproprietary names, including Urokinasum (Latin) and Uroquinasa (Spanish).[3] Commercially, it has been marketed under brand names such as Kinlytic™, Abbokinase®, and Abbokinase® Open-Cath.[5] Other identifiers include Urinary Plasminogen Activator, Actosolv, Breokinase, and Ukidan.[3] For regulatory and classification purposes, it is assigned the Anatomical Therapeutic Chemical (ATC) code B01AD04 by the World Health Organization and the Unique Ingredient Identifier (UNII) 83G67E21XI.[1]
Physicochemical and Biochemical Properties
Urokinase is supplied for clinical use as a sterile, white or nearly white, amorphous, lyophilized powder.[7] As a protein-based therapy, its properties are defined by its complex biomolecular structure rather than a simple chemical formula.[4] The low molecular weight form of the protein, which is the principal active ingredient in therapeutic formulations like Kinlytic™, has an average molecular weight of approximately 31,126.5 Da and a chemical formula of
C1376H2145N383O406S18.[4] It is important to note that some commercial preparations may contain a mixture of this low molecular weight form (approximately 33 kDa) and a high molecular weight form (approximately 54 kDa).[10]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/02 | Not Applicable | Not yet recruiting | Capital Medical University | ||
2025/01/31 | Phase 4 | Completed | National Healthcare Group, Singapore | ||
2024/02/29 | Phase 4 | Recruiting | Second Affiliated Hospital of Nanchang University | ||
2024/01/08 | N/A | Recruiting | The First Affiliated Hospital of Zhengzhou University | ||
2021/03/11 | N/A | Completed | |||
2020/06/09 | Phase 3 | Completed | The First Affiliated Hospital of Zhengzhou University | ||
2019/06/25 | N/A | Withdrawn | General Hospital of Shenyang Military Region | ||
2018/07/06 | Phase 3 | Completed | |||
2018/05/30 | Phase 3 | Completed | |||
2016/08/03 | N/A | Completed | General Hospital of Shenyang Military Region |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
No FDA approvals found for this drug. |
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 |
---|---|---|---|---|---|
UROKINASE-GREEN CROSS INJ. 60,000 iu/vial | SIN11140P | INJECTION, POWDER, FOR SOLUTION | 60000 iu/vial | 10/5/1999 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
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 |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
KINLYTIC OPEN-CATH | Microbix Biosystems Inc | 00886777 | Powder For Solution - Intravenous | 5000 UNIT / VIAL | 12/31/1991 |
KINLYTIC (UROKINASE FOR INJECTION) | Microbix Biosystems Inc | 00749702 | Powder For Solution - Intravenous | 250000 UNIT / VIAL | 12/31/1988 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
UROQUINASA SYNER MEDICA 500.000 U.I. POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION | Syner-Medica B.V. | 84739 | POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
UROQUINASA SYNER MEDICA 25.000 U.I. POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION | Syner-Medica B.V. | 84737 | POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
UROQUINASA SYNER MEDICA 100.000 U.I. POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION | Syner-Medica B.V. | 84736 | POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
UROQUINASA SYNER MEDICA 10.000 U.I. POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION | Syner-Medica B.V. | 84735 | POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
UROQUINASA SYNER MEDICA 250.000 U.I. POLVO PARA SOLUCION INYECTABLE Y PARA PERFUSION | Syner-Medica B.V. | 84738 | POLVO PARA SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
UROKINASE TEOFARMA 100.000 UI. POLVO Y DISOLVENTE PARA SOLUCION PARA PERFUSION | Teofarma S.R.L. | 55422 | POLVO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
UROKINASE TEOFARMA 250.000 UI. POLVO Y DISOLVENTE PARA SOLUCION PARA PERFUSION | Teofarma S.R.L. | 52638 | POLVO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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