Zileuton

Bronchial asthma is a chronic airway inflammatory disease. Traditional treatment mostly relies on glucocorticoids and β2 receptor agonists, but some patients still suffer from poor symptom control. Zileuton is the first marketed oral selective 5-lipoxygenase inhibitor. It blocks the metabolism of arachidonic acid via the 5-lipoxygenase pathway to generate leukotrienes, thereby inhibiting leukotriene-mediated airway inflammation, bronchoconstriction and mucus hypersecretion reactions from the source. It is clinically mainly used for the preventive treatment of asthma in adults and adolescents over 12 years old, and is not suitable for relieving acute asthma attacks, especially applicable to patients with aspirin-induced asthma, exercise-induced asthma and poor compliance with inhaled corticosteroids.

The global asthma drug market size has exceeded USD 30 billion, among which leukotriene pathway-related drugs account for approximately 12%. As one of the representative drugs of this pathway, zileuton has a stable market size of around USD 230 million. As the original research patent has expired for many years, generic drug supplies currently occupy the main market share globally, with the United States and India being the main producing regions of generic drug active pharmaceutical ingredients; there are no domestically produced preparations launched in the domestic market at present, and clinical demand mainly relies on import channels, leaving potential market space to be released.

The original research enterprise of zileuton is AbbVie Inc., with the original brand name Zyflo. It was initially approved for marketing by the FDA in 1996, and its core compound patent expired in 2008. The main dosage forms approved by the original research are tablets, with specifications including 600mg conventional tablets and 600mg extended-release tablets, among which the 600mg extended-release tablets have been included in the FDA Reference Listed Drug Catalog. There are currently no approved zileuton preparations marketed in China, and no valid API DMF information registered on the CDE platform has been queried. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for zileuton API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the use needs of impurity reference standards in the process of drug R&D, quality research and production.