Nicorandil

As the most common clinical manifestation of coronary heart disease, angina pectoris has a patient population of over ten million. In clinical treatment, in addition to the classic nitrates and β-receptor blockers, the emergence of potassium channel openers has filled the treatment gap for microvascular angina. Nicorandil is a nicotinamide ester anti-angina drug with dual mechanisms of potassium ion channel opening and nitrate-like effect. It can not only dilate large coronary arteries and increase coronary blood flow, but also improve coronary microcirculation and reduce myocardial oxygen consumption. Meanwhile, it has no nitrate resistance problem, so it is suitable for the long-term treatment of various types of angina pectoris, and has significant clinical benefits especially for ischemic symptoms caused by coronary microvascular disease.

At present, the global market size of nicorandil has exceeded 1.2 billion US dollars, with a compound annual growth rate of 6.2% in the past five years. The growth momentum mainly comes from the rising prevalence of coronary heart disease and the improvement of the diagnosis and treatment rate of microvascular angina. In terms of the domestic market, the terminal sales in public medical institutions exceeded 1.8 billion yuan in 2023, among which oral preparations accounted for more than 85%. In terms of the competitive landscape, the original research product still occupies nearly 40% of the market share. More than 10 domestic generic drug companies have obtained approval for marketing, and this variety has been included in multiple batches of national centralized drug procurement. The price of the winning preparations has dropped by more than 70%, driving the continuous expansion of the demand for upstream API.

The original research enterprise of nicorandil is Chugai Pharmaceutical Co., Ltd. of Japan, with the original brand name of Sigmal®. Its core compound patent in Japan expired in 2001, and there is no public protection information for its compound patent in China. At present, the main dosage form of the original research drug approved in China is tablet with a specification of 5mg, which has been included in the China Listed Drug Catalogue as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. In terms of domestic API registration, as of now, there are 18 nicorandil API registration numbers, 12 of which are in status A and can be legally supplied to preparation enterprises. More than 20 domestic enterprises have obtained approval for the marketing of nicorandil oral preparations. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the impurity research needs in the process of generic drug R&D and quality control of nicorandil, CATO can provide a full set of impurity reference standards for this API. Most of the products are available in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, helping enterprises efficiently complete consistency evaluation and quality research work.