Tribenoside

In the clinical treatment of peripheral vascular diseases, mucosa protective agents and drugs for improving vascular function always occupy an important position. As a capillary protective agent for peripheral vascular diseases, tribenoside exerts its pharmacological effects by reducing capillary permeability, inhibiting the release of inflammatory mediators such as histamine, and improving venous return rate. Clinically, it is mainly used to treat symptoms such as lower limb heaviness, soreness, distension, pain and edema caused by chronic venous insufficiency, and can also be used to relieve local swelling and pain in the acute stage of hemorrhoid attack. The applicable population includes elderly patients with primary venous insufficiency, people with venous diseases induced by long-term standing occupations, and patients with acute hemorrhoid attack.

The global market size related to tribenoside was approximately USD 210 million in 2023, with a compound annual growth rate of 3.8% in the recent five years. The core growth drivers are the increase in the prevalence of chronic venous diseases caused by the intensification of population aging, and the improvement of the accessibility of drugs for peripheral vascular diseases in primary medical institutions. The domestic market is currently dominated by generic preparations, with the original research product accounting for less than 20%. No enterprise has passed the consistency evaluation of this variety, and there is still a large space for domestic substitution in the API supply end.

The original research enterprise of tribenoside is RoviPharm, an Italian company, with the original brand name "Cyclo 3 Fort". Its core compound patent in Europe expired in 2018, and there is no public authorization information for the compound patent in China. The main marketed dosage form of the original research product is hard capsule, with a specification of 150 mg tribenoside per capsule. The original hard capsule has been included in the FDA Orange Book Reference Preparation Catalog, but has not been included in the Chinese Catalog of Reference Preparations for Chemical Drugs. At present, there is no approved tribenoside preparation product on the market in China, and no valid A status registration number has been retrieved on the CDE API registration platform. (Data as of March 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of tribenoside impurity reference standards. Most products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. The products fully meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for pharmaceutical enterprises in the whole process of API R&D, quality research and preparation declaration.