Docusate Sodium

Chronic constipation, a highly prevalent functional gastrointestinal disease worldwide, has long troubled people of all age groups, especially elderly patients and post-operative bedridden populations. The problem that traditional stimulant laxatives are prone to cause dependence has not been fully solved. Docusate sodium, a commonly used anionic surfactant laxative in clinical practice, has a unique mechanism of action. It reduces the surface tension of feces in the intestinal tract, promotes the penetration of water and fat into feces to soften it, and does not affect the physiological peristalsis of gastrointestinal smooth muscle at the same time. It can be used alone for the symptomatic treatment of mild functional constipation, and can also be combined with opioids for the prevention of opioid-related constipation in tumor patients, with high safety. There is also clear clinical evidence supporting the short-term use of docusate sodium in children.

From the perspective of market performance, the global market size of docusate sodium has stabilized at around USD 320 million in recent years, with a steady compound annual growth rate of 2.1%. Driven by the rising prevalence of constipation and the expansion of the elderly population in the domestic market, the sales of docusate sodium preparations in public hospitals in 2023 exceeded RMB 120 million, with a three-year compound annual growth rate of 7.8%. In terms of competitive landscape, the domestic preparation market is currently dominated by generic drugs, with fewer than 10 manufacturers and no enterprise having passed the consistency evaluation. On the API supply side, only 2 domestic enterprises have obtained registration numbers, and the overall competition intensity is low. As clinical requirements for the safety of laxatives continue to increase, there is still considerable room for market expansion.

The original developer of docusate sodium is Procter & Gamble, with the original brand name Colace®. The core compound patent expired globally in 1974. The main dosage forms approved for the original product include oral solution (10mg/ml), capsules (50mg, 100mg, 250mg), and suppositories (283mg). Its 100mg capsule has been included in the FDA Reference Listed Drug Catalog, and has also been included in China's *Catalog of Reference Preparations for Chemical Drugs (29th Batch)*. In terms of API registration, there are currently 2 A-status registration numbers of docusate sodium that have been publicized on the domestic CDE platform, all of which are approved by domestic enterprises, and a number of domestic enterprises have obtained marketing approval for docusate sodium oral preparations. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of docusate sodium impurity reference standards, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference substance needs of enterprises in the whole process of API R&D, quality research, declaration and registration, etc.