Irsogladine

Gastric mucosal injury is the core pathological basis of diseases such as peptic ulcer and chronic gastritis, and conventional acid suppression therapy is often difficult to cover the full-process demand for mucosal repair. As a gastric mucosal protective API, irsogladine exerts effects from the two dimensions of barrier repair and injury defense by strengthening the tight junctions between gastric mucosal epithelial cells, increasing endogenous prostaglandin synthesis and mucus secretion, and does not affect the physiological function of gastric acid secretion. It is suitable for the treatment of mucosal injury in patients with acute and chronic gastritis, gastric ulcer and duodenal ulcer, and can also be used to relieve gastric mucosal discomfort caused by factors such as drugs and stress.

The global irsogladine market size has maintained a steady growth trend in recent years. In 2023, the overall market size was approximately USD 120 million, with a compound annual growth rate of around 4.7%. The growth drivers mainly come from the rising prevalence of chronic gastric diseases and the increasing clinical recognition of mucosal protective drugs. In terms of the competitive landscape, East Asia is the core consumer market, and China is the main API supplier, with the production capacity of local enterprises accounting for more than 60% of the global total production capacity. With the advancement of the volume-based procurement policy, the demand for cost-effective and compliant APIs in the domestic preparation market continues to rise, and the stability of API supply and impurity compliance have become the core considerations for downstream preparation enterprises when selecting suppliers.

The original research enterprise of irsogladine is Nippon Shinyaku Co., Ltd., with the original brand name "Gaslon". The core compound patent expired globally in 2008. The main dosage form approved by the original research is tablet, with specifications including 2mg and 4mg, and its tablets have been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China. In terms of domestic API registration, at present, the irsogladine APIs of a number of enterprises have obtained CDE registration numbers with the status of A (already used in marketed preparations). A number of domestic enterprises have been approved to produce irsogladine tablets, with high clinical accessibility. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of irsogladine impurity reference standards, covering the whole chain of synthetic starting materials, intermediates and degradation impurities. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA, and can fully meet the impurity reference standard needs in the whole process of API R&D, registration and declaration, and quality control.