Clascoterone

Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease with a high incidence rate, and there are long-standing clinical pain points of insufficient bronchodilation effect and medication restriction caused by adverse reactions. Glycopyrronium bromide is a long-acting muscarinic antagonist (LAMA) class of active pharmaceutical ingredient. By competitively blocking the M3 receptors on airway smooth muscles, it continuously relaxes bronchial smooth muscles to achieve a 24-hour long-acting airway dilation effect. It is mainly used for the maintenance treatment of adult COPD, including symptom relief for patients with chronic bronchitis and emphysema. It can significantly reduce the risk of acute exacerbations and improve patients' exercise tolerance and quality of life.

Currently, long-acting bronchodilators account for more than 60% of the global COPD treatment market. As a new generation of LAMA drugs, the global formulation market size of glycopyrronium bromide was approximately USD 1.28 billion in 2023, with a compound annual growth rate of 8.2% in the past three years, which is higher than the average growth rate of traditional varieties of the same class. The domestic market is still dominated by original research products at present, with few enterprises developing generic drugs. With the acceleration of the R&D progress of domestic generic drugs, the market penetration rate is expected to increase from the current 3.7% to more than 10% in the next 3-5 years.

The original research enterprise of glycopyrronium bromide is Boehringer Ingelheim, and the original brand name is Spiriva Respimat. Its compound patent in China will expire in 2026. The main dosage form approved for the original research product is inhalation spray, with a specification of 2.5 μg of glycopyrronium bromide per actuation. This product has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs (Third Batch)* of China. At present, no domestic glycopyrronium bromide formulation has been approved for marketing in China, and no enterprise has submitted an A-status registration number for glycopyrronium bromide on the CDE API registration platform. (Data as of June 2025, please refer to the official CDE website for the latest information.)

CATO can provide a full set of impurity reference standards for glycopyrronium bromide, which can accurately meet the needs of qualitative and quantitative impurity research in different R&D stages. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most products are available from stock, and stock orders placed before 16:00 can be shipped on the same day, helping enterprises accelerate the R&D and registration process.