Prucalopride

Chronic constipation is a highly prevalent functional gastrointestinal disease worldwide. Traditional prokinetic drugs have clinical pain points such as limited action targets and large individual differences in efficacy, and the emergence of highly selective 5-hydroxytryptamine 4 (5-HT4) receptor agonists has filled this treatment gap. Prucalopride is a representative variety of this class of drugs. It specifically agonizes 5-HT4 receptors in the gastrointestinal tract, promotes acetylcholine release, and enhances colonic peristalsis and reflex movement. It is not only used to treat chronic constipation symptoms in adult women that cannot be adequately relieved by laxatives, but also was subsequently approved to be extended to male patient groups. It has extremely low affinity for other receptors on the intestinal wall and outstanding cardiac safety advantages, making it an important clinical option for patients with refractory chronic constipation.

At present, the global prevalence of chronic constipation reaches 10%~20%, and the prevalence among domestic adults is about 6%, which gradually increases with age, driving the continuous expansion of the market size of prucalopride. Data show that in 2023, the sales volume of prucalopride in domestic public medical institutions exceeded 600 million yuan, and the compound growth rate in the past three years has remained above 18%. In terms of competitive landscape, the original research product still accounts for about 32% of the market share. Generic preparations from 15 domestic enterprises have been approved for marketing, and this variety has been included in the seventh batch of nationally organized drug centralized procurement. The maximum price reduction of the winning bid compared with the original research is 93%. With the improvement of the penetration rate in the primary market, the overall market still has stable growth space.

The original research enterprise of prucalopride is Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, with the trade name "Resolor". Its compound patent in China expired in 2021. The main dosage form approved by the original research is tablet, with specifications including 1mg and 2mg. It has been included in the Catalogue of Listed Drugs in China as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. In terms of API registration, more than 20 domestic enterprises have obtained CDE registration numbers for prucalopride APIs, most of which are in status A and can be supplied for domestic preparation production. In addition, DMF documents from several enterprises have been accepted by the US FDA. (Data as of April 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for prucalopride, covering the needs of reference materials for the whole path including synthesis process and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable reference material support for API R&D, quality research and consistency evaluation work.