Gefapixant

Thromboembolic diseases are the leading cause of death and disability worldwide. Traditional anticoagulants generally have clinical limitations such as high bleeding risk, narrow therapeutic window, and the need for frequent monitoring, which leaves broad space for the development of safer novel anticoagulant target drugs. Gefapixant is a specific factor XIa inhibitor anticoagulant, which blocks the endogenous coagulation pathway by reversibly binding to coagulation factor XIa. While reducing the risk of thrombosis, it has little impact on physiological hemostatic function, and the risk of bleeding adverse reactions is significantly lower than that of traditional anticoagulants. The currently developed indications include prevention of venous thromboembolism after knee arthroplasty, stroke prevention in non-valvular atrial fibrillation, secondary prevention of acute coronary syndrome, etc., and it is expected to cover high-risk groups requiring long-term anticoagulant therapy.

As the first oral factor XIa inhibitor entering phase III clinical trials, the market potential of gefapixant has received extensive attention from the industry. According to public data, the global anticoagulant market size has exceeded 35 billion US dollars, of which novel oral anticoagulants account for more than 60%. Factor XIa inhibitors are regarded as the core track of the next generation of anticoagulants, and the global market size is expected to exceed 5 billion US dollars by 2030. At present, no product of this variety has been approved for marketing worldwide, and only a few multinational pharmaceutical companies and domestic innovative pharmaceutical companies are in the clinical development stage. The market competition pattern is relatively loose, and products approved first are expected to quickly gain the first-mover advantage in the market.

The original research enterprise of gefapixant is Portola Pharmaceuticals, and no official trade name has been announced yet. The expiration time of the core compound patent in major markets is expected to be around 2038. At present, this variety is still in the global phase III clinical trial stage, no dosage form has been approved for marketing, and it has not been included in the *Catalogue of Chemical Drugs* of China or the FDA Reference Listed Drug Catalogue. There is no marketing registration information of this API in China, and no relevant preparation has been approved for import or domestic marketing. The development progress of domestic enterprises is mostly in the pre-clinical or early clinical stage. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for gefapixant. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most products are in regular stock. Spot orders paid before 16:00 can be shipped on the same day, which can quickly respond to the sample needs of various stages of drug research and development and quality research, and help relevant enterprises accelerate the development process of this variety.