Itopride

Functional dyspepsia, as a digestive system disease with high clinical incidence, often manifests as postprandial fullness, early satiety, upper abdominal pain and other symptoms, which has long plagued about 10% to 30% of the global population. Itopride is a third-generation prokinetic agent that exerts therapeutic effects through a dual mechanism of action: on the one hand, it antagonizes dopamine D2 receptors and stimulates the release of acetylcholine; on the other hand, it inhibits the activity of acetylcholinesterase and reduces the decomposition of acetylcholine, thereby enhancing the contractility of the stomach and duodenum and accelerating gastric emptying. Meanwhile, it also has a moderate antiemetic effect. Clinically, it is mainly used to treat various symptoms caused by functional dyspepsia, and can also be used for discomfort related to insufficient gastrointestinal motility caused by chronic gastritis. The applicable population covers adult patients with functional dyspepsia and chronic gastritis accompanied by gastrointestinal motility disorders.

At present, the global market size of prokinetic agents is growing steadily. Itopride, with the advantages of lower extrapyramidal reactions and no obvious cardiovascular adverse reactions, has an increasing market share year by year. Domestic data show that in recent years, the in-hospital sales of itopride have remained in the range of 700 million to 900 million yuan all year round, and the retail market size has also exceeded 200 million yuan. In terms of competitive landscape, the domestic preparation market is jointly dominated by original research drugs and local generic pharmaceutical enterprises. More than 10 enterprises have obtained the production qualification of itopride preparations. After the implementation of the centralized procurement policy, its terminal price has dropped significantly, and the clinical accessibility has been greatly improved.

The original research enterprise of itopride is Abbott Japan Co., Ltd. of Japan, and the original trade name is "Ganaton". Its core compound patent expired in Japan in 2008, and the relevant compound patent in China also expired in 2008. The dosage form approved by the original research in China is itopride hydrochloride tablets with a specification of 50mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by the National Medical Products Administration. At present, there are more than 30 registration numbers of itopride hydrochloride API in China, most of which have been converted to A status, which can meet the domestic preparation production demand. Meanwhile, a variety of dosage forms such as itopride hydrochloride tablets, capsules and dispersible tablets have been approved for marketing in China. (Data as of April 2025, please refer to the official website of CDE for the latest information)

In response to the needs of itopride quality research and production quality control, CATO can provide a full set of impurity reference standards for this API. The full series of products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most products are in stock all the year round. Orders placed before 16:00 can be shipped on the same day, which can efficiently support pharmaceutical enterprises in impurity research, stability study, quality standard establishment and other related work.