Acotiamide

In view of the clinical situation that there are limited medication options for patients with functional dyspepsia worldwide, acotiamide, as the first approved prokinetic acetylcholinesterase inhibitor, reversibly inhibits the degradation of acetylcholine and prolongs the action time of acetylcholine in the stomach, thereby promoting gastric emptying, improving the diastolic function of the gastric fundus, and reducing abnormal gastric acid secretion. This drug is mainly indicated for functional dyspepsia symptoms such as postprandial fullness, upper abdominal distension and pain, and early satiety. It is one of the few therapeutic drugs currently available that specifically targets the pathogenesis of this disease, and is particularly suitable for adult patients who have poor response to conventional acid suppressants and prokinetic agents. It has high safety in clinical application and a low incidence of adverse reactions.

Acotiamide was first approved in Japan in 2013 and entered the Chinese market in 2020. At present, its global market size has exceeded USD 320 million, with a compound annual growth rate of 11.7% in the past three years. China is a country with a high incidence of functional dyspepsia, with a patient population of more than 200 million. The domestic market is in a stage of rapid volume expansion. Currently, the original research product still occupies the main market share, and 3 domestic pharmaceutical companies have been approved for the production of generic drugs. There is no relevant implemented centralized procurement policy yet. It is expected that the penetration rate of generic drugs will continue to increase after the patent expires, and the demand for upstream API will see steady growth.

CATO can provide a full set of impurity reference standards for acotiamide API. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA. The core specifications are in sufficient stock, which can quickly respond to the full-process demands of API enterprises in R&D, registration and quality control, and reduce the time and compliance costs in the impurity research stage.