Urokinase thrombolysis

Capital Medical University · Phase 3 active Small molecule

Urokinase thrombolysis is a Fibrinolytic agent Small molecule drug developed by Capital Medical University. It is currently in Phase 3 development for Acute ischemic stroke, Pulmonary embolism. Also known as: Urokinase.

Urokinase thrombolysis works by activating plasminogen to plasmin, which breaks down blood clots.

Urokinase thrombolysis works by activating plasminogen to plasmin, which breaks down blood clots. Used for Acute ischemic stroke, Pulmonary embolism.

Likelihood of approval

56.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

• Baseline phase 3 → approval rate +58.3pp
  Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
• Cardiovascular Phase 3 risk -2.0pp
  Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Urokinase thrombolysis
Also known as	Urokinase
Sponsor	Capital Medical University
Drug class	Fibrinolytic agent
Target	Plasminogen
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 3

Mechanism of action

This process involves the conversion of plasminogen to plasmin, which then degrades fibrin clots. Urokinase is a type of tissue plasminogen activator (tPA) that plays a crucial role in the fibrinolytic pathway. By activating plasminogen, urokinase helps to dissolve blood clots and restore blood flow.

Approved indications

• Acute ischemic stroke
• Pulmonary embolism

Common side effects

• Hemorrhage
• Allergic reactions
• Fever
• Nausea and vomiting

Key clinical trials

• TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral Hemorrhage (NA)
• Urokinase for Thrombolysis in Acute Ischemic Stroke (NA)
• Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO) (NA)
• 'Thrombectomy in High-Risk Pulmonary Embolism - Device Versus Thrombolysis Netherlands': TORPEDO-NL (NA)
• The MRI-based Evaluation of Safety and Efficacy of EVT and SMT: A Retrospective, Multicenter Study
• CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II (PHASE2)
• Thrombolysis of Urokinase for Minor Stroke (PHASE3)
• The Therapeutical Role of Continuous Intra-femoral Artery Infusion of Urokinase on Diabetic Foot Ulcers (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Urokinase thrombolysis CI brief — competitive landscape report
• Urokinase thrombolysis updates RSS · CI watch RSS
• Capital Medical University portfolio CI

Frequently asked questions about Urokinase thrombolysis

What is Urokinase thrombolysis?

Urokinase thrombolysis is a Fibrinolytic agent drug developed by Capital Medical University, indicated for Acute ischemic stroke, Pulmonary embolism.

How does Urokinase thrombolysis work?

Urokinase thrombolysis works by activating plasminogen to plasmin, which breaks down blood clots.

What is Urokinase thrombolysis used for?

Urokinase thrombolysis is indicated for Acute ischemic stroke, Pulmonary embolism.

Who makes Urokinase thrombolysis?

Urokinase thrombolysis is developed by Capital Medical University (see full Capital Medical University pipeline at /company/capital-medical-university).

Is Urokinase thrombolysis also known as anything else?

Urokinase thrombolysis is also known as Urokinase.

What drug class is Urokinase thrombolysis in?

Urokinase thrombolysis belongs to the Fibrinolytic agent class. See all Fibrinolytic agent drugs at /class/fibrinolytic-agent.

What development phase is Urokinase thrombolysis in?

Urokinase thrombolysis is in Phase 3.

What are the side effects of Urokinase thrombolysis?

Common side effects of Urokinase thrombolysis include Hemorrhage, Allergic reactions, Fever, Nausea and vomiting.

What does Urokinase thrombolysis target?

Urokinase thrombolysis targets Plasminogen and is a Fibrinolytic agent.

Related

• Drug class: All Fibrinolytic agent drugs
• Target: All drugs targeting Plasminogen
• Manufacturer: Capital Medical University — full pipeline
• Therapeutic area: All drugs in Cardiovascular
• Indication: Drugs for Acute ischemic stroke
• Indication: Drugs for Pulmonary embolism
• Also known as: Urokinase