Russian-made coagulation factor Xa inhibitor tedixaban: Clinical data and prospects. Results of the Expert Council meeting

Venous thromboembolic complications (VTE) constitute a significant cause of morbidity and mortality globally. In light of the widespread use of direct oral anticoagulants, the ongoing development of novel factor Xa inhibitors remains pertinent for enhancing the pharmacological properties of these agents, broadening options for preventing and treating thrombotic complications, and advancing Russian-based pharmaceutical technologies. On May 18, 2026, an Expert Council meeting titled "Russian-made Coagulation Factor Xa Inhibitor Tedixaban: Clinical Data and Prospects" convened in Moscow, gathering specialists in clinical pharmacology, cardiology, vascular surgery, and infectious diseases. The primary objective of the meeting was to examine current data regarding tedixaban, analyze the findings of completed clinical trials, and delineate priority areas for its future clinical research. Presentations at the meeting included information on the development of the first original Russian selective factor Xa inhibitor, along with insights into the drug's pharmacological attributes and safety profile as determined from preclinical studies. Additionally, the outcomes of phase II and III clinical trials involving patients after major joint replacement were discussed, supporting the efficacy and favorable safety profile of tedixaban in VTE prevention. The findings of a multicenter, prospective, randomized controlled trial assessing the drug in hospitalized COVID-19 patients were presented, providing a foundation for its incorporation into the current clinical guidelines issued by the Ministry of Health of Russia. The meeting also underscored the potential to expand approved indications for tedixaban, including its use in patients with atrial fibrillation, and investigations into its effectiveness in treating established VTE. Pharmacogenetic study outcomes that might inform the personalized selection of direct oral anticoagulants, including tedixaban, were also discussed. In conclusion, the experts summarized recent data on the clinical application of tedixaban, identified key avenues for continued development of its clinical program, and articulated an executive summary reflecting the current understanding of the drug's role in the prevention of thrombotic complications.