Simcere has dosed the first participant in a Phase I trial of SIM0811, a next-generation thrombolytic candidate for acute ischemic stroke
Written By: Samiksha Jadhav BPharm
Reviewed By: Pharmacally Editorial Team
On February 2, 2026, Simcere Pharmaceutical Group announced a key early-stage milestone for its stroke pipeline. The company’s investigational thrombolytic therapy, SIM0811, has entered a Phase I clinical trial at Qilu Hospital of Shandong University, with the first healthy volunteer successfully enrolled.
First-in-Human Phase I Trial Design
The randomized, double-blind, placebo-controlled Phase I study is being conducted in healthy adult Chinese volunteers. Led by Professors Chen Yuguo and Zhao Wei at Qilu Hospital, the trial is designed to evaluate the safety profile and pharmacokinetic characteristics of SIM0811 administered as an injection.
A Dual-Action Approach to Thrombolysis
SIM0811 is positioned as a new-generation small-molecule plasminogen allosteric activator with a differentiated dual mechanism of action. First, it modulates the conformation of plasminogen to enhance the activity of endogenous tissue plasminogen activator, accelerating clot breakdown without relying solely on high-dose exogenous tPA. Second, SIM0811 inhibits soluble epoxide hydrolase, delivering local anti-inflammatory and antioxidant effects at the thrombus site.
This combination is intended to address two major challenges in stroke care at once: effective thrombus dissolution and mitigation of reperfusion-related inflammation and vascular endothelial damage. By doing so, SIM0811 may help reduce bleeding risk while also offering potential neuroprotective benefits.
Preclinical Data and Therapeutic Window
In preclinical models, SIM0811 demonstrated stronger thrombolytic efficacy and antioxidant activity than other investigational compounds in the same class. These data suggest the potential to extend the current treatment window for thrombolytic therapy. While standard tPA-based treatment is typically limited to about 4.5 hours after stroke onset, SIM0811 is expected to remain effective for up to 24 hours, a shift that could significantly expand the number of patients eligible for acute intervention.
Future Combination Strategy
SIM0811 is an independently developed program within Simcere’s pipeline and may eventually be used in combination with the company’s multi-target neuroprotective agent Sanbaxine. Such a strategy could pair rapid reperfusion with broader neuronal protection, offering a more comprehensive approach to ischemic stroke management.
Reference
Novel Anti-Stroke Candidate SIM0811 Doses First Participant in Phase I Clinical Trial, 02 February 2026, Simcere