Trimebutine

Gastrointestinal dysfunction is a digestive system disease with high incidence worldwide. Patients often suffer from the alternating onset of abdominal pain, diarrhea and constipation, and there has been a long-term clinical lack of dual-direction regulating drugs acting on both gastrointestinal smooth muscle and peripheral opioid receptors. Trimebutine is an active pharmaceutical ingredient for gastrointestinal motility regulation. It can selectively activate μ and κ opioid receptors in the gastrointestinal tract, inhibit calcium ion influx to reduce excessive contraction of smooth muscle, and open potassium ion channels to relieve smooth muscle spasm, so as to dual-directionally adjust the rhythm of gastrointestinal movement. It is mainly used clinically for the symptomatic treatment of irritable bowel syndrome and functional dyspepsia, covering adult patients and adolescent patients over 12 years old, and is one of the core varieties of primary care medications in the gastroenterology department.

At present, the global market size of trimebutine is approximately USD 320 million, with a compound annual growth rate of 4.7% in the recent three years. The Chinese market accounts for 41% of the global market, and its growth rate is 2.1 percentage points higher than the global average. In terms of the competitive landscape, domestic generic drug supply dominates the market. After the implementation of volume-based procurement, the price of preparations decreased by 62%, which further drove the increase in demand for active pharmaceutical ingredients. Currently, the annual domestic demand for trimebutine active pharmaceutical ingredient is stable at around 180 tons, with manufacturers concentrated in East China and South China, and the production capacity of leading enterprises accounts for more than 55%.

The original research enterprise of trimebutine is Sawai Pharmaceutical Co., Ltd. of Japan, with the original brand name "Cerekinon". Its core compound patent expired in Japan in 2000, and the Chinese compound patent also expired in 2000. At present, the main approved dosage forms include tablets with specifications of 0.1g and 0.2g, and capsules with specification of 0.1g. The original research tablet has been included in the Catalogue of Listed Drugs in China as a reference listed drug, and has also been included in the FDA Reference Listed Drug Catalogue. Up to now, 12 domestic enterprises' trimebutine active pharmaceutical ingredients have obtained A status identification through CDE registration, and the approved preparation products on the market cover three categories: tablets, capsules and dry suspensions, with a total number of approvals exceeding 30. (Data as of October 2025, please refer to the official CDE website for the latest information)

For the R&D and quality control needs of trimebutine active pharmaceutical ingredient, CATO provides a full set of impurity reference standards for this API, which can fully cover the whole process of quality control scenarios such as related substance test and content determination. Most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, which can effectively help pharmaceutical enterprises shorten the R&D cycle and reduce the cost of quality research.