Nifekalant

Arrhythmia is a high-incidence acute and severe disease in the cardiovascular field, among which life-threatening ventricular arrhythmia is even a difficulty in clinical treatment. Traditional antiarrhythmic drugs generally have side effects such as negative inotropy and proarrhythmia, so their clinical application has obvious limitations. Nifekalant is a class III potassium channel blocker. It exerts an antiarrhythmic effect by selectively blocking the rapid delayed rectifier potassium current (Ikr) of cardiomyocytes to prolong the action potential duration, and has no obvious negative inotropic effect. It is mainly used for life-threatening ventricular tachycardia and ventricular fibrillation that are ineffective or unavailable for other drugs, especially suitable for arrhythmia patients with left ventricular dysfunction, and is a key first-aid drug in emergency and intensive care scenarios.

At present, the global market size of antiarrhythmic drugs maintains a steady growth. As a new generation of class III antiarrhythmic drugs, the domestic market size of nifekalant has exceeded 800 million yuan in 2023, with a compound growth rate of more than 22% in the past three years, and the growth rate is significantly higher than that of the overall antiarrhythmic drug market. At present, generic preparations of many enterprises have been approved for marketing in the domestic market. After winning the bid in the centralized procurement, the price has dropped significantly, the clinical accessibility has been significantly improved, and the demand for upstream API has continued to rise. In addition to the approved domestic API enterprises, there are still many enterprises arranging relevant registration and declaration, and the market competition pattern has gradually moved from monopoly to diversification.

The original research enterprise of nifekalant is Japan's Mitsubishi Tanabe Pharma, and the original research trade name is "シベノール" (English trade name: Sibnel). The expiration time of its core compound patent in Japan and major European and American markets is 2021, and the expiration time of the Chinese compound patent is 2020. The main dosage form approved by the original research is injection, with a specification of 50mg per vial. The original research injection has been included in the China Listed Drug Catalogue as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. As of the time of retrieval, more than 10 domestic enterprises have obtained A-status registration numbers for nifekalant API through CDE approval, and more than 15 other enterprises have obtained approval for the marketing of nifekalant injection. (Data as of October 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for nifekalant API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, which can fully support the full-process needs of API R&D, quality research and registration declaration, and help enterprises efficiently promote the implementation of relevant projects.