Pranlukast

Long-term control of chronic allergic diseases such as asthma and allergic rhinitis has always been a key clinical demand in the field of respiratory and allergic reactions. As a leukotriene receptor antagonist, pranlukast competitively blocks the binding of cysteinyl leukotrienes to receptors in airway smooth muscle and other sites, effectively inhibiting bronchoconstriction, increased vascular permeability and mucosal edema induced by inflammatory mediators. Clinically, it is mainly used for the prevention and long-term treatment of bronchial asthma, and can also be used for symptom control of allergic rhinitis. The applicable population covers adults and adolescent asthma patients who meet the medication indications, especially patients who cannot tolerate glucocorticoids or have poor response to β2 receptor agonists.

The global market size of leukotriene modifiers has exceeded 4.5 billion US dollars in 2023. As a second-generation drug in this category, pranlukast's share in the East Asian market is increasing year by year, with a compound annual growth rate of approximately 4.2%. Since the original research patent has expired for many years, the layout of domestic generic drugs has been gradually improved. At present, 6 enterprises have obtained the approval documents for pranlukast preparations. The supply end of active pharmaceutical ingredients presents a pattern where domestic manufacturers coexist with imported original research products. After the coverage of centralized procurement, the terminal price of preparations has dropped by 73%, further promoting the improvement of clinical accessibility.

The original research enterprise of pranlukast is Ono Pharmaceutical Co., Ltd. of Japan, and the original research trade name is "Pranlukast". Its core compound patent expired in 2009 in both the Japanese and Chinese markets. The main dosage form approved by the original research is capsule, with a specification of 112.5mg. It has been included in the Pharmaceutical Catalogue of the Ministry of Health, Labour and Welfare of Japan, and is also a reference preparation variety announced by China. According to the domestic API registration platform, the pranlukast API registration numbers submitted by 3 domestic enterprises have been approved as Class A, and the registration applications of another 2 enterprises are under review. A number of domestic manufacturers have obtained approval for the marketing of pranlukast capsule preparations. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for pranlukast, most of which are in stock. Orders placed for in-stock products before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully support the quality research of API enterprises, preparation consistency evaluation and registration declaration related work, providing reliable reference standard support for the quality control of the whole life cycle of drugs.