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
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2019/06/25 | N/A | Withdrawn | General Hospital of Shenyang Military Region | ||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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