Delving into the Latest Updates on Recombinant human prourokinase with Synapse

Overview

Basic Info

Drug Type

Enzyme

Synonyms

Pro-UK, Prourokinase recombinant, Recombinant human urokinase

+ [2]

Target

PLG

Action

stimulants

Mechanism

PLG stimulants(Plasminogen stimulants)

Therapeutic Areas

Cardiovascular DiseasesNervous System Diseases

Active Indication

Acute Ischemic StrokeMyocardial Infarction

Inactive Indication

Pulmonary Embolism

Originator Organization

Tasly Pharmaceutical Group Co., Ltd.

Active Organization

Shanghai Tasly Pharmaceutical Co. Ltd.Capital Medical University

Shanghai Huashan Hospital

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (02 Apr 2011),

Myocardial Infarction

Regulation-

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Intravenous thrombolysis is the first-line therapy in patients with acute ischemic stroke within 4·5 hours of symptom onset, and recombinant tissue plasminogen activator (alteplase) is the preferred thrombolytic agent for this purpose.
RhPro-UK is a specific plasminogen activator. rhPro-UK only acts on occlusive thrombus and has little effect on hemostatic thrombus. In addition, rhPro-UK does not form covalent complexes with protease inhibitors in plasma, so the concentrations of rhpro-UK and protease inhibitors in the blood do not decrease compared with alteplase. Therefore, rhPro-UK therapies have a potential advantage of less systemic bleeding in treated subjects. Data from several previous studies suggest that rhPro-UK is efficacious when used to treat patients with acute myocardial infarction. On April 2, 2011, rhPro-UK injection was approved by the National Medical Products Administration to treat acute myocardial infarction. Since then, rhPro-UK has been widely used to treat myocardial infarction in China.
Since 2016, a phase 2 clinical trial was carried to explore the dosing of rhPro-UK in patients with acute ischemic stroke, followed by another study with a sample size of 680 patients to initially validate the efficacy and safety of the proposed dose of 35mg. The results of these studies suggested that rhPro-UK was effective, and there were no safety concerns. To further prove the efficacy and safety of rhPro-UK in patients with acute ischemic stroke, investigators conducted this phase 3 study (PROST-2).

Start Date29 Jan 2023

Sponsor / Collaborator

Shanghai Tasly Pharmaceutical Co. Ltd.

CTR20230020

/ CompletedPhase 3

注射用重组人尿激酶原（rhPro-UK）静脉溶栓治疗发病0-4.5小时急性缺血性脑卒中的多中心、随机、开放标签、终点盲评、阳性药平行对照Ⅲc期临床试验

[Translation] A multicenter, randomized, open-label, endpoint-blind, active-drug parallel-controlled phase IIIc clinical trial of intravenous thrombolysis with recombinant human prourokinase for injection (rhPro-UK) for the treatment of acute ischemic stroke within 0-4.5 hours of onset

以注射用阿替普酶（rt-PA）作为对照，评价注射用rhPro-UK静脉溶栓治疗发病0-4.5小时急性缺血性脑卒中的有效性及安全性。

[Translation]

To evaluate the efficacy and safety of rhPro-UK intravenous thrombolytic therapy for acute ischemic stroke within 0-4.5 hours of onset, using alteplase for injection (rt-PA) as a control.

Start Date29 Jan 2023

Sponsor / Collaborator

Shanghai Tasly Pharmaceutical Co. Ltd.

NCT05507645

/ CompletedPhase 3IIT

Recombinant Human Prourokinase（rhPro-UK）for Injection Versus Standard Medical Treatment for Acute Mild Ischemic Stroke (NIHSS≤5) Within 4.5 Hours After Symptom Onset

The purpose of this study is to investigate the safety and efficacy of rhPro-UK (35mg) versus standard medical treatment in acute mild ischemic stroke within 4.5 hours of symptom onset.

Start Date15 Nov 2022

Sponsor / Collaborator

Beijing Tiantan Hospital

100 Clinical Results associated with Recombinant human prourokinase

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100 Translational Medicine associated with Recombinant human prourokinase

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100 Patents (Medical) associated with Recombinant human prourokinase

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63

Literatures (Medical) associated with Recombinant human prourokinase

01 Aug 2025·Journal of Stroke & Cerebrovascular Diseases

Recombinant human pro-urokinase vs. alteplase within 4.5 hours of acute ischemic stroke: A systematic review and meta-analysis of randomized controlled trials

Review

Author: Ashraf, Hadiah ; Mesmar, Ahmad ; Hashmi, Tallal Mushtaq ; Fonarow, Gregg C ; Ahmed, Raheel ; Zia, Rohma ; Ahmed, Mushood ; Burhan, Muhammad ; Shafiq, Aimen

BACKGROUND:

Recombinant human pro-urokinase (rhPro-UK) has emerged as a potential alternative to alteplase for patients with acute ischemic stroke (AIS) presenting within 4.5 hours of symptom onset. This meta-analysis evaluates and compares the efficacy and safety of rhPro-UK with alteplase in this patient population.

METHODS:

A comprehensive search was conducted on PubMed, Cochrane and Embase from inception to November 30, 2025, to identify eligible RCTs comparing intravenous rhPro-UK with alteplase in AIS patients treated within 4.5 hours of symptom onset. A random-effects meta-analysis was conducted using RevMan Web.

RESULTS:

Three RCTs encompassing 2,289 patients (rhPro-UK: 1141; alteplase: 1148) met the inclusion criteria. The pooled analysis demonstrated no significant difference between rhPro-UK and alteplase in achieving excellent functional outcome (mRS 0-1 at 90d: RR = 1.04, 95 % CI = 0.98 to 1.10; P = 0.17) and good functional outcome (mRS 0-2 at 90d: RR = 1.0, 95 % CI = 0.96 to 1.05; P = 0.86). No statistically significant difference was observed for early neurological improvement (RR 1.05, 95 % CI 0.96 to 1.15), symptomatic intracranial hemorrhage (RR = 0.52, 95 % CI = 0.19 to 1.43), all-cause mortality (RR 1.10, 95 % CI 0.64 to 1.91) and severe adverse events (RR = 0.92, 95 % CI = 0.75 to 1.13).

CONCLUSION:

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.

International Journal of Clinical Pharmacy

Efficacy and safety of 35 mg of recombinant human prourokinase for thrombolysis in acute ischemic stroke: a meta-analysis of randomized controlled trials

Review

Author: Dai, Haibin ; Wang, Suhong ; He, Ping ; Chen, Jie ; Zhou, Haodong

BACKGROUND:

Compared with alteplase, recombinant human prourokinase (rhPro-UK)-a next-generation specific plasminogen activator-offers advantages such as weight-independent dosing and cost effectiveness. While a 35-mg dose of rhPro-UK has been recommended in previous randomized controlled trials (RCTs), its efficacy and safety profile have yet to be fully elucidated, as no relevant systematic reviews or meta-analyses have been conducted to date.

AIM:

This meta-analysis aimed to evaluate the safety and efficacy of 35 mg of rhPro-UK compared with those of control treatments, including 50 mg of rhPro-UK and alteplase monotherapy, in patients with acute ischemic stroke (AIS).

METHOD:

Two independent reviewers systematically searched the PubMed, Embase, Cochrane Library, Scopus, and ClinicalTrials.gov electronic databases up to May 24, 2025, to identify RCTs assessing the effects of 35 mg rhPro-UK versus control therapies in AIS patients. Study quality was assessed using the Cochrane RoB 2 tool. A random effects model was employed for the meta-analysis using Stata 18.0.

RESULTS:

Four RCTs involving 2412 patients were included. The 35-mg dose of rhPro-UK demonstrated comparable safety and efficacy to those of the other treatments. Notably, this dose was associated with the potential advantages of increasing early neurological recovery at 24 h (SMD = - 0.29, 95% CI - 0.55 to - 0.03, P = 0.03) and reducing systemic bleeding risk at 90 days (RR = 0.59, 95% CI 0.48-0.73, P < 0.001). Subgroup analysis suggested that 35 mg of rhPro-UK might be associated with lower odds of SAEs than 50 mg of rhPro-UK (I² = 0%, P = 0.039); however, there was no significant difference in rt-PA (I² = 0%, P = 0.413) at 90 days.

CONCLUSION:

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.

03 Jun 2025·NEUROLOGICAL RESEARCH

Safety and efficacy of 35mg of intravenous recombinant human prourokinase for acute ischemic stroke: a systematic review and meta-analysis

Review

Author: Fernandes, João Vitor Andrade ; de Oliveira Ramos, João Victor ; de Almeida Holanda, Maurus Marques

OBJECTIVE:

Acute ischemic stroke (AIS) requires thrombolytic therapy to restore blood flow. This meta-analysis assesses the efficacy and safety of 35 mg intravenous recombinant human prourokinase (rhPro-UK).

METHODS:

A systematic search was conducted in PubMed and Embase up to 27 January 2025, identifying randomized controlled trials (RCTs) comparing rhPro-UK with standard therapy. Primary outcomes included changes in the National Institutes of Health Stroke Scale (NIHSS), Barthel Index, and Modified Rankin Scale (mRS). Secondary outcomes comprised early neurological improvement, intracranial hemorrhage, symptomatic intracranial hemorrhage (SIH), serious adverse events (SAEs), and mortality. A random-effects model was applied for meta-analysis with 95% confidence intervals.

RESULTS:

Six RCTs were included. RhPro-UK significantly reduced NIHSS scores at 24 hours (MD = -0.43 [-0.85 to -0.02], p = 0.041) and 7 days (MD = -0.85 [-1.39 to -0.31], p = 0.002). No significant differences were found in mRS scores (0-1: OR = 1.045 [0.893-1.223], p = 0.586; 0-2: OR = 0.965 [0.805-1.158], p = 0.705) or Barthel Index (OR = 1.003 [0.732-1.374], p = 0.986). The rate of SIH was similar between groups (RD = 0.001 [-0.004 to 0.006], p = 0.673). No significant differences were observed in intracranial hemorrhage (OR = 0.819 [0.598-1.140], p = 0.236), SAEs (OR = 0.907 [0.713-1.153], p = 0.426), or mortality (OR = 1.168 [0.790-1.726], p = 0.437).

CONCLUSIONS:

RhPro-UK improves short-term neurological outcomes without increasing hemorrhagic risk, SAEs, or mortality.

100 Deals associated with Recombinant human prourokinase

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External Link

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Ischemic Stroke	China	Shanghai Tasly Pharmaceutical Co. Ltd.	16 Sep 2025
Myocardial Infarction	China	Shanghai Tasly Pharmaceutical Co. Ltd.	02 Apr 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Embolism	Phase 2	China	Shanghai Tasly Pharmaceutical Co. Ltd.	06 Jun 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05700591 (PROST-2, Neurology) Manual	Phase 3	Acute Ischemic Stroke	1,552	recombinant human prourokinase	gcgmrinkee(olvwpixewf) = xwdtsyjfii belwegujtv (lcnbrkziaz ) View more	Positive	11 Dec 2024
				alteplase	gcgmrinkee(olvwpixewf) = mamdlcmajb belwegujtv (lcnbrkziaz ) View more
rhpro-UK STROKEIIa (ISC2019)	Phase 2	Acute Ischemic Stroke	190	Intravenous rhpro-UK 50mg	cvxfedkkiv(qzrdcpmhze) = xdklhtakbg ercfwdtoly (bxnjsxildv )	Positive	01 Feb 2019
				Intravenous rhpro-UK 35mg	cvxfedkkiv(qzrdcpmhze) = gkjvqjjlgo ercfwdtoly (bxnjsxildv )

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