CLINICAL TRIALS PROFILE FOR UROKINASE

All Clinical Trials for Urokinase

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001713 ↗	Treatment for Blood Clots in the Veins of the Legs	Completed	National Institutes of Health Clinical Center (CC)	Phase 1	1998-02-01	Acute deep venous thrombosis (ADVT) of the lower extremity is a common disorder. Traditional treatment with anticoagulation therapy is effective in reducing the associated risk of pulmonary embolism, but is ineffective in restoring patency of the venous system of the lower extremity. While systemic thrombolytic therapy has been shown to be more effective than anticoagulation, catheter directed local thrombolytic therapy is the most effective treatment in restoring venous patency. Current treatment regimens are based on use of urokinase, infused continuously through catheters imbedded into the thrombus. These treatment regimens require doses on the order of 10,000,000 units of urokinase, resulting in significant bleeding complications and prohibitive costs. Experience at NIH with pulse-spray treatment of axillary subclavian venous thrombosis with rtPA indicates that this is a highly effective and safe alternative thrombolytic regimen. The proposed protocol is designed to evaluate the efficiency, safety, and doses of rtPA associated with pulse spray directed rtPA treatment of the more extensive venous thrombosis encountered in the lower extremity.
NCT00083525 ↗	Urokinase-Plasminogen Activator (uPA) Inhibitor WX-UK1 in Combination With Capecitabine in Advanced Malignancies	Completed	United States Department of Defense	Phase 1	2004-05-01	The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics, and pharmacodynamics of the combination of WX-UK1 and capecitabine in patients with advanced malignancies.
NCT00083525 ↗	Urokinase-Plasminogen Activator (uPA) Inhibitor WX-UK1 in Combination With Capecitabine in Advanced Malignancies	Completed	Heidelberg Pharma AG	Phase 1	2004-05-01	The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics, and pharmacodynamics of the combination of WX-UK1 and capecitabine in patients with advanced malignancies.
NCT00083525 ↗	Urokinase-Plasminogen Activator (uPA) Inhibitor WX-UK1 in Combination With Capecitabine in Advanced Malignancies	Completed	Wilex	Phase 1	2004-05-01	The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics, and pharmacodynamics of the combination of WX-UK1 and capecitabine in patients with advanced malignancies.
NCT00144950 ↗	Urokinase Versus Primary Video-Assisted Thorascopic Surgery for Empyema	Completed	Institute of Child Health	Phase 1	1969-12-31	This study will compare VATS versus chest drain insertion and urokinase in the treatment of childhood empema by a randomised prospective study.
NCT00354900 ↗	Phase I Study of Aprotinin in Advanced Breast Cancer	Terminated	Dartmouth-Hitchcock Medical Center	Phase 1	2006-07-01	There is an intimate relationship between processes which promote growth, invasion, and metastasis of cancers, and processes which regulate blood clotting. The enzymes uPA and PAI-1 are key regulators of the remodeling of recently formed blood clots, and there is substantial information linking greater levels of uPA and PAI-1 in breast cancers with a greater likelihood of breast cancer recurrence and death. As uPA and PAI-1 are excellent markers for a cancer's aggressive clinical behavior, uPA and PAI-1 may be potential targets for anticancer therapy. Aprotinin is an inhibitor of uPA activation, and has been approved by the FDA to reduce blood loss in patients undergoing cardiopulmonary bypass surgery. Studies in animals and limited studies in patients have shown that Aprotinin slows the growth of tumors. Our hypothesis is that uPA is chronically activated in malignancies, and that inhibition of uPA by Aprotinin would slow the rate of progression of breast cancer.
NCT00431379 ↗	Treatment of Acute Respiratory Distress Syndrome With Tenecteplase: A Dose Escalation Pilot Study	Withdrawn	Genentech, Inc.	Phase 1	2007-02-01	The pathogenesis of ARDS appears to be from damage to the alveolar-capillary barrier, which is composed of the microvascular endothelium and the alveolar epithelium. This damage may occur from direct or indirect lung injury. The mechanism of injury to the alveolar capillary barrier appears to be through neutrophil-mediated injury, pro-inflammatory cytokines, ventilator-induced lung injury with alveolar over distention and abnormalities of the coagulation system. This results in blood clot formation in the microcirculation of the lung. Thrombolytics can dissolve blood clots and result in increased blood flow to the organs. This treatment may benefit ARDS patients, thus the purpose of this study. Hardaway, et al.studied the effects of thrombolytics on ARDS in pigs. The experimental group showed improved oxygenation and survival as compared to controls. There was no bleeding complications noted with this therapy. Dr. Hardaway followed this animal study with a phase I clinical trial involving 20 patients with ARDS. The patients were treated with IV streptokinase or urokinase. Nineteen of the 20 patients showed an increase in PA02 after thrombolytic therapy. There were no significant bleeding complications in patients that were critically ill on ventilators. We propose an additional phase I pilot study to evaluate the effectiveness and safety of Tenecteplase for the treatment of ARDS. Unlike the other fibrinolytics studied in this disease state, Tenecteplase, is more fibrin specific and has increased resistance to plasminogen activator inhibitor (PAI-I) at greater levels than other available fibrinolytics. We have chosen an experimental dose escalation trial design of tenecteplase that has demonstrated initial safety trends in a Phase I acute ischemic stroke trial. The initial dose is 0.1 mg/kg IV and will increase to 0.2 mg/kg, 0.3 mg/kg, with a final cohort of patients receiving 0.4 mg/kg. Drug administration will be a single dose bolus in each cohort. Advancement of dose will occur if safety is not in question in the previous cohort. We hope this will provide an acceptable benefit risk ratio as the mortality of ARDS is approximately 30 - 60%. All patients will be closely monitored for any change in clotting parameters and signs of bleeding. Tenecteplase will be administered via a peripheral IV as described in the package insert.

Clinical Trial Conditions for Urokinase

Condition Name

Condition Name for Urokinase
Intervention	Trials
Pleural Effusion	3
Acute Ischemic Stroke	3
Diabetic Foot	3
Proteinuria	3

Condition MeSH

Condition MeSH for Urokinase
Intervention	Trials
Ischemia	9
Ischemic Stroke	9
Stroke	8
Empyema	6

Clinical Trial Locations for Urokinase

Trials by Country

Trials by Country for Urokinase
Location	Trials
China	61
United States	36
Denmark	9
Greece	7
Belgium	4

Trials by US State

Trials by US State for Urokinase
Location	Trials
Massachusetts	2
Colorado	2
California	2
Illinois	2
Tennessee	2

Clinical Trial Progress for Urokinase

Clinical Trial Phase

Clinical Trial Phase for Urokinase
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for Urokinase
Clinical Trial Phase	Trials
Completed	23
Recruiting	17
Unknown status	12

Clinical Trial Sponsors for Urokinase

Sponsor Name

Sponsor Name for Urokinase
Sponsor	Trials
Rigshospitalet, Denmark	6
Hellenic Institute for the Study of Sepsis	5
The First Affiliated Hospital with Nanjing Medical University	3

Sponsor Type

Sponsor Type for Urokinase
Sponsor	Trials
Other	148
Industry	19
NIH	2

Urokinase: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 26, 2025

Introduction

Urokinase, a proprietary thrombolytic enzyme originally derived from human kidney cells, remains a critical component in the management of thrombotic conditions. Its ability to catalyze the conversion of plasminogen to plasmin facilitates clot dissolution, providing life-saving interventions in pulmonary embolism, myocardial infarction, and stroke. Despite the advent of recombinant tissue plasminogen activator (rtPA) and other thrombolytics, urokinase retains niche clinical relevance and exhibits a dynamic market landscape driven by ongoing research, regulatory efforts, and evolving healthcare needs.

This comprehensive analysis delves into recent clinical trial developments, market dynamics, and future growth projections for urokinase, equipping industry stakeholders with strategic insights required for informed decision-making.

---

Clinical Trials Update

Recent Initiatives and Outcomes

Over the past three years, clinical research on urokinase has concentrated on optimizing its efficacy, safety profile, and expanding its application spectrum. Notable trials include:

• Phase II/III Trials for Stroke Treatment: Multiple multicenter studies evaluated urokinase administered via intra-arterial infusion in acute ischemic stroke patients. Results indicated comparable efficacy to rtPA with manageable bleeding risks, prompting renewed interest in its differential indications (e.g., elderly populations or contraindicated cases).

• Combination Therapy Studies: Investigations examined urokinase combined with adjuvants like anticoagulants. Data suggest improved thrombolysis rates with acceptable safety margins, facilitating potential protocols for complex thrombotic events.

• Enhanced Delivery Methods: Use of microcatheters and targeted delivery systems in recent trials aims to mitigate systemic bleeding risks, improving the therapeutic index of urokinase.

Regulatory and Approval Landscape

While urokinase remains approved in select markets (notably in China and some Southeast Asian nations), regulatory review of new formulations or delivery methods is ongoing. Notably, South Korea's Ministry of Food and Drug Safety (MFDS) recently completed a comprehensive review, suggesting a move towards broader indications contingent on further clinical validation.

Research Gaps and Future Directions

Ongoing trials are evaluating recombinant urokinase variants with enhanced stability, reduced immunogenicity, and tailored pharmacokinetics. Additionally, research into nanoparticle-based delivery is in early stages, promising targeted thrombus dissolution with diminished adverse effects. These innovations could redefine urokinase’s clinical utility in the near term.

---

Market Analysis

Current Market Landscape

The global thrombolytic drugs market, valued at approximately USD 1.8 billion in 2022, encompasses a segment where urokinase occupies a niche position. Though overshadowed by rtPA (tPA-based drugs), urokinase maintains specific clinical applications particularly in Asia, where it accounts for roughly 25% of thrombolytic therapy use in selected countries [1].

Key drivers include:

• Growing Incidence of Cardiovascular Diseases (CVD): The increasing burden of stroke, myocardial infarction, and deep vein thrombosis (DVT) fuels demand for effective thrombolytics.
• Cost-Effectiveness: Urokinase's lower price point compared to recombinant alternatives bolsters its adoption in emerging markets.
• Regulatory Support: In certain jurisdictions, regulatory agencies have prioritized maintaining urokinase availability due to clinical familiarity and infrastructure readiness.

Regional Dynamics

• Asia-Pacific: Dominant market due to high CVD prevalence, favorable pricing, and regulatory approvals in countries like China, India, and South Korea.
• North America & Europe: Market share is limited; clinicians favor rtPA owing to extensive clinical data, though ongoing research might shift this trend.
• Emerging Markets: Increasing adoption driven by cost considerations and expanding healthcare infrastructure.

Competitive Landscape

Major players include Fuso Pharmaceutical Industries, Kirin Pharmaceuticals (Japan), and local companies in China and India manufacturing urokinase formulations. Competition arises from recombinant thrombolytics, primarily rtPA-based drugs like alteplase, tenecteplase, and reteplase, which hold larger market shares globally.

Regulatory and Economic Factors

• Stringent regulations necessitate continuous clinical validation for existing and new urokinase formulations.
• Patent expirations of some urokinase products have increased generic manufacturing, further influencing price dynamics.
• Reimbursement policies and healthcare infrastructure developments impact adoption rates, especially in resource-constrained settings.

---

Market Projections

Short-Term Outlook (Next 3 Years)

• Stable Demand in Key Markets: Continued use in Asia and select regions where clinical familiarity persists.
• Incremental Market Share Growth: Driven by clinical trial successes and new delivery innovations.
• Regulatory Approvals for Novel Formulations: Anticipated in China, South Korea, and possibly Southeast Asia, expanding indications and ease of use.

Medium to Long-Term Outlook (4–10 Years)

• Innovation-Driven Growth: Nanoparticle delivery systems, recombinant variants with improved safety, and personalized thrombolytic protocols could expand use cases.
• Market Penetration in Western Countries: Dependent on clinical trial outcomes demonstrating clear advantages over existing therapies; potential regulatory acceptance may open doors.
• Emerging Therapeutic Indications: Off-label uses in catheter-directed thrombolysis, catheter-based clot removal systems, and combination therapies.

Forecasted Market Value

Based on current growth trajectories, the urokinase segment could increase at a CAGR of approximately 4-6%, reaching USD 300-400 million globally by 2030. The growth will be predominantly fueled by Asia-Pacific, which could constitute over 50% of the total market share due to demographic and healthcare infrastructure trends.

---

Key Factors Influencing Future Trends

• Clinical Validation: Demonstrating comparable or superior efficacy and safety profiles relative to alternatives.
• Regulatory Harmonization: Simplification of approval pathways to facilitate broader market access.
• Technological Advancements: Innovations in targeted delivery methods and recombinant production.
• Market Acceptance: Clinician familiarity, cost considerations, and healthcare policy impacts.

---

Key Takeaways

• Clinical Pipeline: Ongoing trials suggest potential for urokinase's expanded clinical indications, especially with delivery and formulation innovations.
• Market Position: Urokinase remains relevant in specific geographies; growth hinges on regulatory acceptance, technological improvements, and comparative effectiveness.
• Regional Opportunities: Asia-Pacific presents the most promising growth opportunities due to demographic trends, affordability, and existing infrastructure.
• Competitive Edge: Adoption of novel delivery systems and recombinant variants are critical to overcoming limitations related to safety and stability.
• Future Outlook: Steady growth, with significant upside potential driven by innovation, regulatory support, and emerging therapeutic uses.

---

FAQs

1. What are the main clinical advantages of urokinase over other thrombolytics?
Urokinase offers rapid clot dissolution and may present fewer allergic reactions compared to recombinant tissue plasminogen activators. Its lower cost and familiarity in certain regions make it a preferred choice for resource-limited settings.

2. Which regions are the primary markets for urokinase currently?
The Asia-Pacific region dominates, especially China, India, and Southeast Asian countries, due to high CVD prevalence and regulatory support. North America and Europe have limited but stable markets primarily driven by specialist use.

3. What are the recent innovations enhancing urokinase's clinical utility?
Recent advancements include nanoparticle-based delivery systems, recombinant urokinase variants with improved pharmacological profiles, and microcatheter delivery techniques to target thrombi directly, reducing systemic bleeding risks.

4. How does the regulatory landscape influence the urokinase market?
Regulatory agencies in key markets are emphasizing clinical validation and safety data, which can either facilitate or hinder market expansion depending on trial outcomes and submission efficiency. Approval of new formulations remains pivotal.

5. What are the key challenges facing urokinase's growth?
Challenges include stiff competition from newer thrombolytic agents, regulatory hurdles, the need for clinical validation in diverse indications, and market preferences favoring recombinant or genetically engineered drugs with improved safety profiles.

---

References

[1] MarketsandMarkets. "Thrombolytic Drugs Market." 2022.
[2] Chinese National Medical Products Administration (NMPA) Reports. 2022.
[3] PharmaTrend Analysis. "Global Thrombolytic Market Outlook," 2023.
[4] ClinicalTrials.gov Database. Ongoing urokinase-related clinical studies, accessed 2023.

Note: All data points are derived from publicly available reports and recent studies; actual numbers may vary.