City Therapeutics, Inc., a leading biopharmaceutical company in RNA interference-based medicine, announced it has submitted a Clinical Trial Application to the UK Medicines and Healthcare Products Regulatory Agency to begin a Phase 1 study of CITY-FXI, an investigational RNAi therapy that targets Factor XI. CITY-FXI is being developed as a safer anticoagulant designed to reduce bleeding risk compared with existing treatments.
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Andy Orth, chief executive officer of City Therapeutics, said this submission marks the company’s shift to a clinical-stage organization and reflects the team’s ability to advance product candidates efficiently. Orth added that the company aims to use its innovative RNAi platform to build a robust pipeline of high-value therapeutics and believes its expertise positions it to drive the next generation of RNAi treatments.
Anticoagulation remains a critical unmet medical need because thrombosis contributes to roughly one in four deaths worldwide. Current standard therapies are often associated with serious bleeding risks and adherence challenges, leaving many patients without adequate protection from thromboembolic conditions.
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Baisong Mei, M.D., Ph.D., chief medical officer of City Therapeutics, noted that patients with naturally low FXI levels are less prone to conditions like deep vein thrombosis, pulmonary embolism, and stroke. Mei explained that RNAi-mediated FXI suppression is a direct and potentially highly effective method to reduce FXI production and protect against thrombosis. CITY-FXI is designed to meet the need for long-term, safe, and effective anticoagulation.
In preclinical testing, CITY-FXI showed strong potency, long-lasting effects, and high specificity without off-target activity. Following regulatory clearance of the CTA, City Therapeutics plans to start the Phase 1 clinical study to evaluate the therapy in humans.
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