Cisapride

Gastrointestinal motility disorder is a common clinical problem in the digestive system. Traditional prokinetic drugs often have limitations such as single action target and frequent adverse reactions. Cisapride is a third-generation benzamide prokinetic drug for gastrointestinal motility. It selectively agonizes the 5-HT₄ receptors in the myenteric nerve plexus, promotes the release of acetylcholine, and coordinates the motility of the entire gastrointestinal tract from the esophagus to the proximal colon. It has no dopamine receptor antagonistic effect, and will not cause central and extrapyramidal adverse reactions. Clinically, it is mainly used for the treatment of functional dyspepsia, gastroesophageal reflux disease, chronic idiopathic constipation, gastroparesis and other diseases, and is applicable to adult patients with symptoms such as abdominal distension, abdominal pain, acid regurgitation and constipation caused by insufficient gastrointestinal motility.

The global market size of cisapride is approximately USD 320 million. Driven by the rising prevalence of chronic digestive system diseases in recent years, the compound annual growth rate has remained at 4.1%. In terms of the domestic market, with the implementation of tiered diagnosis and treatment and the improvement of diagnosis and treatment capacity for digestive tract diseases at the primary level, the sales volume of domestic cisapride preparations exceeded RMB 780 million in 2023, with generic drugs accounting for nearly 92% of the market share. The supply of active pharmaceutical ingredients is dominated by local enterprises. At present, cisapride has been included in the centralized procurement catalogs of multiple provinces, and the winning bid price has decreased by an average of 47% compared with the maximum online listing price, further expanding its clinical accessibility.

The original research enterprise of cisapride is Janssen Pharmaceuticals of the United States, and the original brand name is "Prepulsid". The core compound patent expired in 1999. The main dosage form of the original marketed product is tablet, with specifications of 5 mg and 10 mg, which has been included in the FDA Reference Listed Drug Catalog and China's *Catalogue of Reference Preparations for Chemical Drugs (29th Batch)*. At present in China, cisapride active pharmaceutical ingredients from 12 enterprises have obtained Class A status through CDE registration, and cisapride tablets and capsules from another 17 enterprises have been approved for marketing. (Data as of November 2024, please refer to the official CDE website for the latest information)

In response to the quality research needs of this variety, CATO can provide a full set of cisapride impurity reference standards. Most products are available from stock. Stock orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the R&D needs of different scenarios such as qualitative and quantitative research of impurities and consistency evaluation of generic drugs.