Pro-UK (recombinant human pro-urokinase for injection) / Tasly - LARVOL DELTA

A multi-center, prospective, post-marketing "real world" clinical study on the efficacy and safety of rhPro-UK in the treatment of acute ischemic stroke (treatment within 4.5 hours of onset ) (ChiCTR) - P4 | N=12000 | Not yet recruiting | Sponsor: Linyi People's Hospital (Shandong Provincial Clinical Research Center for Geriatric Diseases); Linyi People's Hospital

New P4 trial • Real-world evidence • Cardiovascular • Ischemic stroke

Intravenous rhPro-UK Before Stroke Thrombectomy in the Extended Time Window (BRIDGE-PUK EXTEND) (clinicaltrials.gov) - P3 | N=820 | Recruiting | Sponsor: First Affiliated Hospital Xi'an Jiaotong University | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Ischemic stroke

Effect of Intracoronary Recombinant Human Prourokinase on Myocardial Perfusion and Clinical Outcomes in STEMI Patients Undergoing Primary PCI: A Randomized Controlled Trial. (PubMed, Rev Cardiovasc Med) - P=N/A | "In this prospective, single-blind, randomized, controlled clinical trial, 136 ST-segment elevation myocardial infarction (STEMI) patients undergoing emergency percutaneous coronary intervention (PCI) at Anqing Municipal Hospital (August 2021-June 2023) were randomized 1:1:1 to intracoronary rhPro-UK (n = 44), tirofiban (n = 44), or saline groups (n = 48). Intracoronary rhPro-UK administration during emergency PCI in STEMI patients reduces post-reperfusion inflammation and fibrosis, limits infarct size, and improves clinical outcomes. Chinese Clinical Trial Registry (ChiCTR; http://www.chictr.org.cn; Identifier: ChiCTR2100047095)."

Clinical • Clinical data • Journal • Cardiovascular • Fibrosis • Immunology • Myocardial Infarction • Oncology • CXCL8 • IL6 • ST2 • TNFA

Adjuvant therapy with total salvianolic acid injection enhances the safety and efficacy of recombinant prourokinase in ischemic stroke by mitigating blood-brain barrier disruption. (PubMed, J Transl Med) - "rhPro-UK exhibits a superior safety profile over rt-PA regarding BBB disruption. TSI potentiates rhPro-UK-mediated protection to improve BBB integrity during late-phase thrombolysis by suppressing NOX-2-derived oxidative stress and subsequent MMP-2 activation. This combinatory strategy represents a promising therapeutic approach to enhance the safety and efficacy of delayed thrombolysis within the standard 4.5‑hour window for ischemic stroke."

Journal • Cardiovascular • CNS Disorders • Hematological Disorders • Ischemic stroke • Thrombosis • CDH5 • MMP2 • MMP9 • OCLN

Study on the Effect of Intracoronary Thrombolysis with Recombinant Human Pro-urokinase (rhPro-UK) on TIMI Flow and Prognosis in STEMI Patients (PUK-ICT) (ChiCTR) - P=N/A | N=2585 | Recruiting | Sponsor: The First Hospital of Lanzhou University; The First Hospital of Lanzhou University | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Myocardial Infarction

Comparative efficacy and safety between intravenous recombinant human prourokinase and alteplase in acute ischemic stroke treatment: a meta-analysis of randomized controlled trials. (PubMed, Minerva Med) - "Intravenous rhPro-UK demonstrated comparable efficacy and safety to alteplase in AIS, supporting its role as a potential alternative thrombolytic, particularly in regions with limited access to alteplase."

Clinical • Journal • Retrospective data • Review • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Comparative efficacy and safety of different doses of intravenous thrombolytics in acute ischemic stroke: a GRADE-assessed network meta-analysis of randomized controlled trials. (PubMed, J Thromb Thrombolysis) - "We searched PubMed, Scopus, Web of Science, and Cochrane CENTRAL until March 2025 to identify randomized controlled trials (RCTs) evaluating alteplase (tPA), tenecteplase (TNK), reteplase, and recombinant human prourokinase (rhPro-UK) at any dose in patients with AIS. TNK (0.32 mg/kg) showed the lowest risk probability for any ICH and parenchymal hemorrhage. Some safety outcomes showed dose-dependent effects: lower-dose tPA and intermediate-dose TNK reduced ICH risk compared to higher doses, while mortality and functional independence remained comparable across doses."

Journal • Retrospective data • Review • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

A Multicenter, Randomized, Single-Blind, Alteplase-Positive Controlled Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of Recombinant Human Prourokinase for Injection (rhProuk) in the Treatment of Acute ST-Segment Elevation Myocardial Infarction (STEMI) (ChiCTR) - P3 | N=302 | Sponsor: General Hospital of Northern Theater Command; Suzhou RxD Pharmaceuticals, Inc.

New P3 trial • Cardiovascular • Myocardial Infarction

Dose-specific Effects of Recombinant Human Prourokinase versus Alteplase in Acute Ischemic Stroke: A Network Meta-analysis (AAN 2026) - "Higher doses did not demonstrate additional benefit. These findings suggest that rhPro-UK, at the 15+20 mg regimen, may be a reasonable alternative to alteplase, but evidence does not show clear superiority."

Retrospective data • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Meta-analysis of Randomized Controlled Trials on Intravenous Recombinant Pro-urokinase in Acute Ischemic Stroke: Efficacy and Safety Evaluation (AAN 2026) - "Rates of sICH (RR 0.75, 95% CI [0.24–2.39], P=0.63), 90-day mortality (RR 1.16, 95% CI [0.81–1.68], P=0.42), and Barthel Index scores (RR 1.00, 95% CI [0.97–1.03], P=0.95) were also comparable Conclusions rhPro-UK is non-inferior to alteplase for AIS treatment within 4.5 hours. Its targeted fibrinolytic mechanism supports its potential as an alternative thrombolytic agent, but further large-scale RCTs are needed for validation."

Retrospective data • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Evaluation of recombinant human prourokinase for acute pulmonary embolism: A phase 2, randomized clinical trial. (PubMed, Med) - P2a | "rhPro-UK tended to result in early hemodynamic improvement comparable to rt-PA and seemed to have a numerically lower risk of non-major bleeding events. The ClinicalTrials.gov identifier is NCT03108833."

Clinical • Journal • P2 data • Cardiovascular • Pulmonary Embolism • Respiratory Diseases

Intravenous rhPro-UK Before Stroke Thrombectomy in the Extended Time Window (BRIDGE-PUK EXTEND) (clinicaltrials.gov) - P3 | N=820 | Not yet recruiting | Sponsor: First Affiliated Hospital Xi'an Jiaotong University

New P3 trial • Cardiovascular • Ischemic stroke

Magnetic drug-loaded microbubbles for treating lower limb venous thrombosis under controllable rotating magnetic field. (PubMed, Front Bioeng Biotechnol) - "This study aimed to develop a poly (lactic-co-glycolic acid) (PLGA)-based magnetic loaded iron oxide (Fe3O4) and single-chain urokinase-type plasminogen activator (proUK) for enhancing thrombolysis under a controlled rotating magnetic field, specifically targeting acute lower limb venous thrombosis...Furthermore, in vivo experiments using a rabbit model of hindlimb venous thrombosis validated the efficacy of this approach, with Color Doppler Flow Imaging showing restored blood flow and elevated D-dimer levels indicating effective thrombus dissolution. This novel magnetic drug delivery system, combined with a rotating magnetic field, demonstrates excellent thrombolysis efficiency and presents a promising and safe therapeutic strategy for acute venous thrombosis."

Journal • Cardiovascular • Hematological Disorders • Thrombosis

COMPARATIVE EFFICACY AND SAFETY OF RECOMBINANT HUMAN PROUROKINASE VERSUS ALTEPLASE IN ACUTE ISCHEMIC STROKE: A SYSTEMATIC REVIEW AND META-ANALYSIS (WSC 2025) - "No statistically significant differences were observed between RhPro-UK and alteplase in all-cause mortality (OR 1.16; 95% CI 0.66–2.03; p = 0.61; I² = 10%), intracranial hemorrhage (OR 1.04; 95% CI 0.73–1.48; p = 0.81; I² = 0%), or functional independence (mRS 0–1: OR 0.91; 95% CI 0.77–1.08; p = 0.27; I² = 0%; mRS 0–2: OR 0.95; 95% CI 0.79–1.14; p = 0.56; I² = 0%). Likewise, no significant differences were identified in NIHSS improvement (OR 0.94; 95% CI 0.79–1.11; p = 0.45; I² = 0%) or recurrent stroke (OR 0.72; 95% CI 0.31–1.66; p = 0.44; I² = 0%).ConclusionsWhile RhPro-UK presents a theoretically advantageous pharmacological profile, current evidence does not support its superiority over alteplase in AIS treatment."

Retrospective data • Review • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Prourokinase for acute ischemic stroke: A meta-analysis of randomized controlled trials. (PubMed, Medicine (Baltimore)) - "While Pro-UK offers a theoretical advantage in reducing systemic bleeding due to its clot-specific action, current evidence does not significantly improve key clinical outcomes. The limited number and heterogeneity of existing randomized controlled trials underscore the need for more robust, large-scale trials to confirm its safety and efficacy in acute ischemic stroke."

Clinical • Journal • Retrospective data • Review • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Safety Outcomes Following Intravenous Thrombolysis in Acute Ischemic Stroke: A Systematic Review and Network Meta-analysis. (PubMed, CNS Drugs) - "Alteplase 0.6 mg/kg, rhPro-UK 35 mg, and nSta 10 mg were safer IVT options. Tenecteplase 0.25 mg/kg and alteplase 0.6 mg/kg were preferable beyond 4.5 h with tissue window assessment."

Journal • Retrospective data • Review • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Intravenous recombinant human prourokinase for acute ischemic stroke: a network meta-analysis. (PubMed, Minerva Med) - "Both 35 mg and 50 mg rhPro-UK improve early neurological outcomes. However, 40 mg rhPro-UK + ALT may offer the most favorable efficacy-safety profile. Further trials are warranted to optimize dosing strategies."

Journal • Retrospective data • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Study on the Effect of Intracoronary Thrombolysis with Recombinant Human Pro-urokinase (rhPro-UK) on TIMI Flow and Prognosis in STEMI Patients (PUK-ICT) (ChiCTR) - P=N/A | N=2585 | Not yet recruiting | Sponsor: The First Hospital of Lanzhou University; The First Hospital of Lanzhou University

New trial • Cardiovascular • Myocardial Infarction

Efficacy and safety of 35 mg of recombinant human prourokinase for thrombolysis in acute ischemic stroke: a meta-analysis of randomized controlled trials. (PubMed, Int J Clin Pharm) - "This meta-analysis suggested that 35 mg of rhPro-UK does not significantly differ from 50 mg of rhPro-UK or alteplase in terms of clinical outcomes among AIS patients. However, the 35-mg dose of rhPro-UK has the potential advantages of enhancing early neurological recovery and reducing the risk of systemic bleeding. Subgroup analysis revealed that 35 mg of rhPro-UK might be associated with a lower risk of SAEs than 50 mg of rhPro-UK."

Journal • Retrospective data • Review • Cardiovascular • Ischemic stroke

Comparative efficacy and safety of prourokinase versus alteplase for acute ischemic stroke within 4.5 hours: a systematic review and meta-analysis of randomized controlled trials. (PubMed, Neurol Res) - "However, concerns about cost and safety have led to an interest in alternative thrombolytics like prourokinase (rhPro-UK). Its advantages, including lower cost and ease of administration, make it a viable alternative. Future large-scale trials are recommended."

Journal • Retrospective data • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

Recombinant Human Pro-Urokinase vs. Alteplase Within 4.5 hours of Acute Ischemic Stroke: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, J Stroke Cerebrovasc Dis) - "This meta-analysis found no statistically significant differences between rhPro-UK and alteplase in terms of functional outcomes, early neurological improvement, or safety profiles in patients with acute ischemic stroke. rhPro-UK shows promise as a cost-effective alternative, but further large-scale RCTs are required to confirm its role in AIS management."

Journal • Retrospective data • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke

IS RECOMBINANT HUMAN PROUROKINASE SUPERIOR TO ALTEPLASE IN THE TREATMENT OF ACUTE ISCHEMIC STROKE WITHIN 4.5 HOURS AFTER STROKE ONSET? A SYSTEMATIC REVIEW AND META-ANALYSIS (ESOC 2025) - "This study aimed to compare recombinant human prourokinase (rhPro-UK) and alteplase for AIS treatment. Prourokinase demonstrated no superiority over alteplase, with the exception of a slight advantage in early NIHSS score improvement, and exhibited an acceptable and comparable safety profile."

Retrospective data • Review • Cardiovascular • Ischemic stroke

EFFICACY AND SAFETY OF INTRAVENOUS RECOMBINANT HUMAN PROUROKINASE VS RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR IN THE TREATMENT OF ACUTE ISCHEMIC STROKE WITHIN 4.5 HOURS OF STROKE ONSET: A META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS (ESOC 2025) - "Intravenous rtPro-Uk appears to be a non-inferior alternative to alteplase for AIS within 4.5 hours, offering comparable efficacy with reduced risk of systemic bleeding."

Retrospective data • Cardiovascular • Ischemic stroke

Efficacy and Safety of Recombinant Human Prourokinase in Acute Ischemic Stroke: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. (PubMed, Brain Sci) - " IV rhPro-UK provides non-inferior efficacy to both alteplase and standard care with a better safety profile at 35 mg, while IA rhPro-UK enhances functional outcomes in middle cerebral artery occlusions, albeit with safety concerns. Further trials are needed to confirm long-term outcomes, optimal dosing, and broader applicability."

Journal • Retrospective data • Review • Cardiovascular • Hematological Disorders • Ischemic stroke

Exploring the efficacy of recombinant human pro-urokinase in catheter-directed thrombolysis for acute lower extremity deep venous thrombosis patients. (PubMed, BMC Cardiovasc Disord) - "CDT with rhPro-UK significantly improves venous patency, reduces limb swelling, optimizes coagulation function, and minimizes complications compared to UK. Its fibrin-targeted mechanism enhances clinical efficacy and safety, supporting its adoption as a superior thrombolytic for acute DVT."

Journal • Cardiovascular • Hematological Disorders • Thrombosis