Will Acotiamide be available in 2025?

Acotiamide (Acotiamide) is an innovative drug mainly targeted at Functional Dyspepsia (FD). Functional dyspepsia is a common gastrointestinal functional disease. Patients often present with upper abdominal fullness, abdominal discomfort, loss of appetite and even early satiety after meals. These symptoms not only affect the quality of life, but also cause problems in long-term treatment. Acotiamide improves the motility function of the gastrointestinal tract by acting on the acetylcholine metabolism pathway, helping to promote gastric emptying, thereby alleviating symptoms related to indigestion.

The drug was launched in Japan under the trade name Acofide as early as 2013 and has been recognized by clinicians. Since then, a few countries such as Russia have successively approved its use, but it has not yet been widely available in markets such as Europe, the United States, and China. Domestic patients have long been able to rely on traditional prokinetic drugs or obtain the Japanese and Russian versions of acotiamide through overseas channels. Entering 2025, many patients are concerned about whether it will be officially approved in China. According to the current international pharmaceutical administration and public information, acotiamide does not appear in the list of imported drugs approved by the China Food and Drug Administration, and it has not clearly entered the public process of new drug listing review. This means that large-scale domestic listings in the short term in 2025 are unlikely.

However, it is worth noting that as the country’s demand for drugs to treat digestive system diseases has increased in recent years, the proportion of functional dyspepsia diagnosed and treated in outpatient clinics has increased year by year, and drugs with new mechanisms such as acotiamide have huge market potential. Whether there will be multinational pharmaceutical companies promoting registration in China in the next few years, we still need to continue to pay attention to the dynamics of policies and companies. For patients in need, they still mainly rely on Japanese original drugs or Russian channel versions.

In summary, acotiamide, as a new prokinetic drug, has been used overseas, but there is still uncertainty about its launch in China in 2025.

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