Acotiamide

The global patient base of functional dyspepsia is huge, accounting for approximately 30% to 40% of the outpatient population in gastroenterology departments, and there has been a long-term lack of etiology-specific treatment regimens in clinical practice. Acotiamide, as the world's first approved new prokinetic acetylcholinesterase inhibitor, selectively inhibits the activity of acetylcholinesterase and prolongs the action time of acetylcholine in the synaptic cleft of the gastrointestinal tract, thereby enhancing gastric motility, improving the diastolic function of the gastric fundus, and promoting gastric emptying, without affecting gastric acid secretion. This drug is mainly used to improve symptoms such as postprandial fullness, upper abdominal distension and pain, and early satiation caused by functional dyspepsia. Its applicable population covers adult patients with non-organic dyspepsia, especially cases with poor response to conventional prokinetic drugs, filling the gap in etiological treatment of functional dyspepsia.

The global market size of acotiamide was approximately USD 280 million in 2023, with a compound annual growth rate of 11.2% in the recent 5 years. The growth drivers mainly come from the rising prevalence of functional dyspepsia and the increasing clinical demand for specific therapeutic drugs. As a country with a high incidence of functional dyspepsia, China's overall market growth rate is higher than the global average, and its domestic market size was approximately RMB 320 million in 2023. At present, the domestic preparation market is dominated by the original research product, and 3 domestic enterprises have been approved for generic drugs. With the gradual increase of generic drug penetration rate, the market size is expected to further expand in the future.

The original research enterprise of acotiamide is Astellas Pharma Inc. of Japan, and the original trade name is "Acofide". Its core compound patent expired in Japan in 2022, and the core compound patent in China expired in 2023. The main dosage form of the original research product is tablet, with a specification of 100 mg per tablet. It has been included in the *Catalogue of Chemical Reference Preparations* of China and also listed in the FDA Reference Preparations Catalogue. Up to now, there have been more than 10 registration entries of acotiamide API on the API registration platform of China's CDE, many of which are in "A" status, and acotiamide tablets from multiple domestic enterprises have been approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for acotiamide API, which can cover the needs of the whole R&D process including synthetic process research, quality research, stability study, etc. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can directly support the submission of application materials.