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.

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
New York	2
Massachusetts	2
Colorado	2
California	2
Illinois	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
General Hospital of Shenyang Military Region	3

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Urokinase

Last updated: April 25, 2026

What is urokinase’s current clinical-trial posture?

Urokinase (urokinase-type plasminogen activator, uPA) is an established thrombolytic/ fibrinolytic biologic used in settings that typically include acute thromboembolic disease and localized fibrinolysis (product- and jurisdiction-specific). It is also used as a dosing component in catheter-directed thrombolysis protocols in certain markets, depending on availability and regulatory approvals.

No complete, defensible “current clinical trials update” can be produced from the information available in this prompt. Without a sourced, time-bounded inventory of active/ongoing/terminated studies (registries, dates, trial phases, endpoints, and sites), any attempt to summarize “current posture” would be incomplete and not suitable for an investment or R&D decision.

How big is the urokinase market today and what segments matter?

Urokinase is not a single homogeneous product globally. Market supply and demand depend on:

• Regulatory status by geography (approved indications differ by country and manufacturer)
• Product form (systemic thrombolysis vs local catheter-directed use; formulation and route matter)
• Competition (alteplase, reteplase, tenecteplase, and other fibrinolytics often capture the bulk of guideline-driven use in many markets)

A complete market analysis with credible sizing (current year $ and units), segment splits (indication, route, and geography), and citation-backed projections requires sourced market research datasets or authoritative industry publications. The prompt provides none.

What is the projected market trajectory for urokinase?

A defensible projection requires:

• Baseline market size (current year)
• Evidence-based growth drivers (guidelines, hospital adoption, reimbursement dynamics)
• Volume constraints (manufacturing capacity, patent/regulatory pipeline, supply continuity)
• Competitive substitution rates vs newer fibrinolytics

No such dataset is included in the prompt. Producing a projection without a sourced baseline would fail the proof requirement.

What product-level risks and opportunities shape commercialization?

Without registry-anchored trial data and market sizing inputs, the only actionable, high-confidence elements that can be stated are structural commercialization drivers that directly affect urokinase in practice.

Key commercialization drivers

• Guideline and formulary positioning: where alteplase and related agents dominate, urokinase faces substitution pressure.
• Hospital-level protocols: catheter-directed thrombolysis protocols can preserve urokinase demand in specific use cases where it is stocked and reimbursed.
• Supply continuity and manufacturing quality: biologic consistency and supply reliability influence hospital procurement cycles.

Key commercialization constraints

• Therapeutic switching: fibrinolytic class substitution is common when non-urokinase options are preferred by guideline updates or payer policy.
• Biologics procurement behavior: tendering cycles can lock supply but also swing quickly after price or availability shifts.

Where do clinical and market signals typically intersect for urokinase?

The intersection is usually mediated through:

• Evidence generation: new comparative studies or optimization studies (dose, route, patient selection) that strengthen formulary adoption
• Safety and efficacy endpoints: bleeding risk profiles and net clinical benefit compared to alternatives
• Operational fit: protocol integration (infusion time, monitoring requirements, contraindication management)

A clinical-trial update tied to these endpoints requires registry data. A market projection tied to these signals requires sourced demand and adoption information. Neither is available in the prompt.

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Key Takeaways

• A complete, citation-backed clinical trials update for urokinase and a quantified market projection cannot be produced from the information provided in this prompt.
• Urokinase commercialization is strongly shaped by fibrinolytic substitution (alteplase and related agents), hospital formulary decisions, and protocol-specific demand (including catheter-directed use where applicable).
• Any investment or R&D decision should rely on registry-anchored trial status (phase, endpoints, dates) and sourced market sizing (current $/units, segments, and forecast methodology).

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FAQs

1. Is urokinase still actively researched in clinical trials?
   A current, sourced trial-status update cannot be produced from the provided prompt.

2. What are the primary commercial demand drivers for urokinase?
   Guideline and formulary inclusion, protocol adoption (systemic vs local use), and payer/reimbursement coverage.

3. How does urokinase compete with other fibrinolytics?
   It faces substitution pressure from other uPA derivatives and alteplase-class fibrinolytics in markets where they are preferred.

4. What determines urokinase’s market growth or decline?
   Changes in clinical practice patterns, hospital procurement behavior, and competitive positioning across indications and geographies.

5. Can market projection be calculated without current-year sizing data?
   Not with a proof-grade standard; projections require a baseline and sourced forecast assumptions.

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References

[1] No sources were provided in the prompt, and no external citations were available to cite specific clinical trials, market sizes, or forecasts.