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P1 data, PK/PD data, Journal: Pharmacokinetics, pharmacodynamics, and safety of frunexian in healthy Chinese volunteer adults: A randomized dose-escalation phase I study. (Pubmed Central) - Apr 5, 2024
The purpose of this study was to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of frunexian (formerly known as EP-7041 and HSK36273) injection, a small molecule inhibitor of activated coagulation factor XI (FXIa), in healthy Chinese adult volunteers...The correlations between PK and PD biomarkers (aPTT/baseline and FXI clotting activity/baseline) were described by the two Emax models, with the EC50 values of 8940 and 1300?ng/mL, respectively. Frunexian exhibits good safety and PK/PD properties, suggesting it is a promising candidate for anticoagulant drug.
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Trial completion date, Trial primary completion date: COVID-19 ThromboprophylaXIs Study of Novel FXIa Inhibitor Frunexian (EP-7041) in ICU Patients (clinicaltrials.gov) - Oct 25, 2022
P2, N=90, Not yet recruiting,
Trial completion date: Dec 2024 --> May 2025 | Trial primary completion date: Dec 2023 --> May 2024 Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
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Journal: EP-7041, a Factor XIa Inhibitor as a Potential Antithrombotic Strategy in Extracorporeal Membrane Oxygenation: A Brief Report. (Pubmed Central) - Sep 30, 2020
Selective inhibition of the contact pathway of coagulation could reduce bleeding risk, and because factor XI is linked with the inflammatory and complement systems, it can also be viewed as a biologically plausible target for the prevention of abnormal thrombosis during extracorporeal membrane oxygenation. We introduce initial information on EP-7041, a parenteral, potent, and selective, small-molecule activated factor XIa inhibitor with pharmacodynamic and pharmacokinetic characteristics that appear well suited for use in a critical care environment.
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[VIRTUAL] Anticoagulation with the Novel, Small-molecule Factor XIa (fXIa) Antagonist, EP-7041, Prevents Oxygenator Clotting but Conserves Hemostasis in a Canine Extracorporeal Circulation (ECMO) Model (Virtual Meeting Room 6) - May 14, 2020 - Abstract #ISTH2020ISTH_194;
We introduce initial information on EP-7041, a parenteral, potent, and selective, small-molecule activated factor XIa inhibitor with pharmacodynamic and pharmacokinetic characteristics that appear well suited for use in a critical care environment. Compared with heparin, anticoagulation with EP-7041, a short-acting, potent and selective, small-molecule Factor XIa antagonist, prevents oxygenator clotting but maintains hemostasis in a canine ECMO model.
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Trial completion: Study to Evaluate Safety, PK and PD of Single and Multiple Ascending Doses of EP-7041 in Healthy Subjects (clinicaltrials.gov) - May 31, 2017
P1, N=80, Completed,
Compared with heparin, anticoagulation with EP-7041, a short-acting, potent and selective, small-molecule Factor XIa antagonist, prevents oxygenator clotting but maintains hemostasis in a canine ECMO model. Recruiting --> Completed
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