Is Acotiamide hydrochloride available in China?

As of October 2025, Acotiamide has not yet been officially launched in mainland China, and the original drug has not been approved by the National Medical Products Administration (NMPA). This means that there are currently no acotiamide products legally sold in the domestic market, and they are not included in China's medical insurance catalog. Despite this, many domestic pharmaceutical companies and scientific research institutions have begun to pay attention to the introduction and imitation of this drug, and are expected to gradually promote localized research and development in the future.

Acotiamide was developed by JapanZeria Pharmaceuticals in cooperation with Astellas. It was the first to be approved in Japan in 2013 for the treatment of functional dyspepsia (FD). Subsequently, Russia also approved the listing in 2018. Its main trade names are Acofide (Japan) and Dyspevict (Russia), both of which are used to improve indigestion symptoms such as postprandial fullness, upper abdominal distension, and early satiety. The advantage of this drug is that it has a non-dopamine receptor mechanism of action, which avoids the risk of arrhythmias associated with traditional prokinetic drugs such as domperidone.

In the field of treatment of functional dyspepsia in China, old drugs such as itopride, domperidone, and mosapride are still the mainstay. Because acotiamide is a new acetylcholinesterase inhibitor and acts on gastrointestinal nerve endings, it can enhance the reactivity of gastric smooth muscle and is more effective in patients with postprandial fullness-type functional dyspepsia. Therefore, its potential to enter the Chinese market has received widespread attention in the industry.

At present, some domestic research institutions are already carrying out pharmacological comparisons and preclinical experiments to explore compounds with similar structures to acotiamide. This means that the feasibility of research and development of domestic generic drugs is in the evaluation stage. However, since the drug involves new pharmacological mechanisms and intellectual property protection, its introduction period may be longer.

For patients, acotiamide cannot be purchased through formal channels in China. Some cross-border pharmacies or overseas medical institutions can provide the Japanese version of Acofide or the Russian version of Dyspevict, but these channels have compliance risks and large price differences.

Reference: https://www.rad-ar.or.jp/siori/english/search/result?n=33322