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Urokinase | CAS No: 9039-53-6 | GMP-certified suppliers
A medication that facilitates fibrinolysis and is indicated for acute massive pulmonary emboli, coronary artery thrombi, peripheral arterial thromboemboli, and intravenous catheter occlusion.
Therapeutic categories
Primary indications
- 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
Product Snapshot
- Urokinase is available as a lyophilized powder injection for parenteral administration
- It is primarily used for thrombolytic therapy targeting acute massive pulmonary emboli, coronary artery thrombi, peripheral arterial occlusions, and catheter patency restoration
- The product is approved for clinical use in the US and Canadian markets
Clinical Overview
Clinically, urokinase is indicated for the lysis of acute massive pulmonary emboli, thrombi obstructing coronary arteries, occlusive thromboemboli in peripheral arteries and vascular grafts, and for restoring patency to occluded intravenous catheters. These indications reflect its role as a potent fibrinolytic agent in acute thrombotic conditions.
Pharmacodynamically, urokinase activates plasminogen to plasmin, initiating localized fibrinolysis and clot dissolution. Its duration of action is relatively short due to a brief plasma half-life, necessitating controlled administration protocols. Safety considerations include the risk of bleeding complications, hypersensitivity reactions such as anaphylaxis, infusion-related effects, and the potential for cholesterol embolization due to disruption of atherosclerotic plaques.
Absorption, distribution, metabolism, and excretion (ADME) parameters of urokinase are characterized by intravenous administration, rapid clearance, and metabolism largely via proteolytic degradation. It is not orally bioavailable; thus, administration is limited to parenteral routes under controlled clinical settings.
Urokinase was granted FDA approval in January 1978 and remains a recognized agent within the fibrinolytic category. It is classified under blood and blood-forming organ drugs and plasminogen activators, highlighting its mechanism and therapeutic role. Notable clinical contexts include emergency management of life-threatening thrombosis and catheter clearance.
When sourcing urokinase API, considerations should include verifying biological activity assays, ensuring absence of contaminating proteases, and maintaining adherence to regulatory standards governing biologics. Batch consistency, sterility, and endotoxin levels are critical parameters affecting safety and efficacy in clinical use.
Identification & chemistry
| Generic name | Urokinase |
|---|---|
| Molecule type | Biotech |
| CAS | 9039-53-6 |
| UNII | 83G67E21XI |
| DrugBank ID | DB00013 |
Pharmacology
| Summary | Urokinase is a serine protease that facilitates fibrinolysis by converting plasminogen into plasmin, an active protease responsible for clot degradation. It primarily targets plasminogen and associated regulatory proteins involved in fibrinolytic pathways. The drug is utilized to lyse thrombi in vascular occlusions and to restore catheter patency. |
|---|---|
| Mechanism of action | Urokinase is a serine protease. It cleaves plasminogen to form the active fibrinolytic protease, plasmin. |
| Pharmacodynamics | Urokinase is a serine protease that activates plasminogen to an active fibrinolytic protease. The duration of action is short due to the short half life. Patients should be counselled regarding the risk of bleeding, anaphylaxis, infusion reactions, and cholesterol embolization.[L12138 |
Targets
| Target | Organism | Actions |
|---|---|---|
| Plasminogen | Humans | activator |
| Urokinase plasminogen activator surface receptor | Humans | inducer, modulator |
| Plasminogen activator inhibitor 1 | Humans | substrate, inducer |
ADME / PK
| Absorption | Urokinase is delivered intravenously, so the bioavailability is high. |
|---|---|
| Half-life | Urokinase has a half life of 12.6±6.2 minutes. |
| Protein binding | Data regarding the protein binding of urokinase in plasma is not readily available. |
| Metabolism | Because urokinase is a protein, it is expected to be metabolized by proteases to smaller proteins and amino acids. |
| Route of elimination | Urokinase is eliminated in the bile and urine. |
| Volume of distribution | The volume of distribution of urokinase is 11.5L. |
| Clearance | Data regarding the clearance of urokinase is not readily available. |
Formulation & handling
- Urokinase is a biotech peptide administered via intravenous or intra-arterial injection, available primarily as a lyophilized powder for reconstitution.
- Handling requires protection from moisture and appropriate reconstitution immediately prior to use to maintain activity and stability.
- Avoid concurrent use with herbs or supplements that have anticoagulant or antiplatelet effects due to potential interaction risks.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient has reached patent expiry in both the US and Canada, resulting in established market availability with multiple generic formulations. Its lifecycle is characterized by mature market presence and competitive pricing. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Urokinase is manufactured primarily by Microbix Biosystems Inc., with packaging also handled by Hospira Inc. and ImaRx Therapeutics. The branded product Kinlytic is available in the US and Canadian markets. There is limited information on patent status, but given the established presence of branded products, generic competition may be present or forthcoming. |
|---|
Safety
| Toxicity | Patients experiencing an overdose may present with bleeding. Treat patients with symptomatic and supportive measures which may include application of local pressure, administration of whole blood or plasma, and administration of aminocaproic acid. |
|---|
- Exposure may increase risk of bleeding
- Implement appropriate controls to minimize contact
- Handle with care to avoid accidental overdose
Urokinase is a type of Thrombolytics
Thrombolytics, a subcategory of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in the field of medicine, particularly in the treatment of thrombotic disorders. Thrombolytics are highly effective in dissolving blood clots that form within blood vessels, thereby restoring blood flow and preventing potential complications.
These pharmaceutical agents work by activating the body's natural fibrinolytic system, which is responsible for breaking down fibrin, a protein involved in clot formation. Thrombolytics primarily target specific components of the clot, such as plasminogen, and convert them into active enzymes called plasmin. Plasmin subsequently degrades fibrin, leading to clot dissolution.
The therapeutic application of thrombolytics is vast, encompassing conditions like acute myocardial infarction (heart attack), deep vein thrombosis, pulmonary embolism, and ischemic stroke. Rapid administration of these APIs is critical to maximize their effectiveness and minimize the risk of complications.
Thrombolytics are available in various forms, including injectable formulations that can be administered intravenously or directly at the site of clot formation. Different thrombolytic agents, such as alteplase, tenecteplase, and reteplase, possess unique pharmacokinetic profiles and varying abilities to dissolve clots.
It is crucial to note that thrombolytics require careful monitoring and should be administered under the guidance of medical professionals due to potential adverse effects, such as bleeding complications. Therefore, their usage is strictly regulated, and patient-specific factors are considered before initiating thrombolytic therapy.
In summary, thrombolytics are an essential subclass of pharmaceutical APIs that effectively dissolve blood clots, restoring blood flow and preventing complications associated with thrombotic disorders. Their therapeutic application spans various medical conditions, and their administration should be carefully managed to ensure patient safety.
Urokinase (Thrombolytics), classified under Anticoagulants
Anticoagulants are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used to prevent and treat blood clotting disorders. These medications play a crucial role in various medical conditions, including deep vein thrombosis (DVT), pulmonary embolism (PE), and atrial fibrillation (AF). Anticoagulants work by inhibiting the formation of blood clots or by preventing existing clots from getting larger.
There are different types of anticoagulants available, including direct thrombin inhibitors, vitamin K antagonists, and factor Xa inhibitors. Direct thrombin inhibitors, such as dabigatran, directly target the enzyme thrombin to hinder clot formation. Vitamin K antagonists, like warfarin, interfere with the production of clotting factors that rely on vitamin K. Factor Xa inhibitors, such as rivaroxaban and apixaban, inhibit the activity of factor Xa, a crucial component in the clotting cascade.
Anticoagulants are commonly prescribed to patients at risk of developing blood clots or those with existing clotting disorders. They are often used during surgeries, such as hip or knee replacements, to minimize the risk of post-operative clot formation. Patients with AF, a condition characterized by irregular heart rhythm, may also be prescribed anticoagulants to prevent stroke caused by blood clots.
While anticoagulants offer significant benefits in preventing and treating clot-related conditions, they also carry potential risks, including bleeding complications. Patients taking anticoagulants require careful monitoring to ensure the right dosage is administered, as excessive anticoagulation can lead to hemorrhage. Regular blood tests and close medical supervision are essential to manage the delicate balance between preventing clots and avoiding excessive bleeding.
In conclusion, anticoagulants are a crucial category of pharmaceutical APIs used to prevent and treat blood clotting disorders. They function by inhibiting clot formation or preventing existing clots from enlarging. While highly beneficial, their use requires careful monitoring to minimize the risk of bleeding complications.
Urokinase API manufacturers & distributors
Compare qualified Urokinase API suppliers worldwide. We currently have 1 companies offering Urokinase API, with manufacturing taking place in 1 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Kraeber & Co GmbH | Producer | Germany | Germany | CoA, GDP, GMP, ISO9001, MSDS | 12 products |
When sending a request, specify which Urokinase API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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