Cinitapride

For gastrointestinal symptoms such as early satiety, abdominal distension and nausea that recur in patients with functional dyspepsia, the clinical application of highly selective 5-HT4 receptor agonists provides a safer intervention path for gastrointestinal motility disorder diseases. As a third-generation prokinetic drug, cinitapride promotes the release of acetylcholine by activating 5-HT4 receptors in the gastrointestinal tract, and also has a mild dopamine D2 receptor antagonistic effect. It can improve gastric emptying and small intestinal transit function at the same time. Clinically, it is mainly used for the symptomatic treatment of mild to moderate functional dyspepsia and gastroesophageal reflux disease. It is also suitable for elderly patients and people with diabetic gastroparesis, and the risk of cardiac adverse reactions is significantly lower than that of previous generations of similar drugs.

The global prevalence of functional dyspepsia exceeds 20%, and the proportion of prokinetic drug prescriptions among patients seeking medical treatment in China reaches 46%. Cinitapride is a first-line drug recommended by clinical guidelines. In 2023, its terminal sales in domestic public medical institutions exceeded 870 million yuan, and the compound growth rate in the past three years has remained above 18%. At present, the domestic market is dominated by generic drugs. More than 12 enterprises have submitted registration applications for APIs and preparations. After the implementation of centralized procurement, the terminal price of products has dropped by more than 60%, and the demand for upstream API supply continues to expand.

The original developer of cinitapride is Faes Farma, Spain, and the original brand name is Cinitaprida. Its core European compound patent expired in 2021, and the Chinese compound patent expired in 2022. The original dosage form is a tablet with a specification of 1mg, which has been included in the EU EMA reference preparation catalogue. At present, the original preparation has not been imported into China. In China, 7 enterprises have obtained A status for their cinitapride APIs through CDE registration, and 11 enterprises have obtained marketing approval for 1mg cinitapride tablets, which are deemed to have passed the consistency evaluation of generic drugs. (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 cinitapride API. Most products are available in stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the requirements of pharmacopoeias of multiple countries and drug regulatory regulations such as China Pharmacopoeia and FDA, and can fully meet the full-process needs of API R&D, quality research and compliance declaration.