Mebeverine

Irritable bowel syndrome (IBS) is a highly prevalent functional gastrointestinal disorder in clinical practice, with a global prevalence of approximately 5% to 10%. Patients often experience recurrent symptoms such as abdominal pain, abdominal distension, and altered bowel habits. For a long time, there has been a lack of clinical treatment options that can targetedly relieve smooth muscle spasm with mild adverse reactions. Mebeverine is a musculotropic antispasmodic and a highly selective calcium antagonist for gastrointestinal smooth muscle. It can directly act on the colonic smooth muscle, relax the spasmodic smooth muscle by inhibiting calcium ion influx, while not affecting normal gastrointestinal motility and causing no atropine-like side effects. Clinically, it is mainly used for the symptomatic treatment of abdominal pain, spasm and gastrointestinal dysfunction related to irritable bowel syndrome, and can also be used for smooth muscle spasm caused by other intestinal diseases, applicable to children over 10 years old and adults.

The global market size of mebeverine was approximately USD 720 million in 2023, with a compound annual growth rate of 3.8% from 2019 to 2023. The growth momentum mainly comes from the improved diagnosis rate of irritable bowel syndrome and the released demand for antispasmodic drugs in primary medical institutions. The domestic market is still dominated by the original research product at present, with a small number of generic drug enterprises laying out in this field. After mebeverine was included in the National Medical Insurance Catalog in 2021, the growth rate of hospital terminal sales has exceeded 20% for three consecutive years. In 2023, the sales of domestic sample hospitals exceeded RMB 120 million. With the advancement of the consistency evaluation of generic drugs, there is still a large room for improvement in market penetration in the future.

The original research enterprise of mebeverine is UCB of Belgium, and the original brand name is Duspatalin. Its core compound patent expired worldwide in 1999. The main dosage form approved for the original product is mebeverine hydrochloride tablets with the specification of 135mg, and another 200mg sustained-release capsule dosage form is marketed in European and American markets. Both the tablets and sustained-release capsules of this product have been included in the FDA Reference Listed Drug Catalog, and mebeverine hydrochloride tablets are also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. Up to now, 2 entries of mebeverine hydrochloride active pharmaceutical ingredients in China have obtained A-status registration numbers, and more than 10 other enterprises have obtained approval for marketing of their generic preparations. (Data as of June 2025, please refer to the official website of CDE for the latest information.)

CATO can provide a full set of mebeverine impurity reference standards. Most of the products are available from stock. In-stock products ordered before 16:00 can be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the R&D needs related to API production, quality research and consistency evaluation.