Linzagolix

For patients with type 2 diabetes, the emergence of GLP-1 receptor agonist drugs has provided a brand-new path for long-term blood glucose management, which also brings weight loss benefits. As a new generation of oral small-molecule GLP-1 receptor agonist, linzagolide highly selectively activates GLP-1 receptors, promotes insulin secretion and inhibits glucagon release in a glucose-dependent manner, while delaying gastric emptying and reducing appetite. It can effectively reduce patients' body weight while achieving stable blood glucose control. At present, it is mainly used for blood glucose control in adults with type 2 diabetes, especially suitable for the patient group with poor compliance with injectable GLP-1 preparations, providing a new option for clinical oral hypoglycemic therapy.

The global market size of oral small-molecule GLP-1 drugs is expected to exceed USD 20 billion by 2030, with a compound annual growth rate of more than 45%. As the first domestic oral small-molecule GLP-1 drug of domestic origin that has completed phase III clinical trials in China, linzagolide has outstanding market competitive potential by virtue of its lower incidence of gastrointestinal adverse reactions than similar products. At present, more than 10 domestic enterprises have laid out linzagolide-related generic and improved new drug pipelines, and the core market competition will be concentrated in the fields of cost control of API mass production processes and impurity compliance research.

Linzagolide is independently developed by Jiangsu Hengrui Pharma Co., Ltd., and the original research trade name is Ruizeping®. Its core compound patent will expire in 2042. The main currently approved dosage form is tablet, with three specifications including 0.2 mg, 0.4 mg and 1.2 mg, which has been included in the NMPA Catalogue of Chemical Drugs as the reference listed drug. In terms of API registration, Hengrui Pharma's linzagolide API has completed registration with the CDE under the registration number Y20230000718. The original research preparation has been approved for marketing in China, and no other enterprise has obtained a registration number for linzagolide API. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of linzagolide impurity reference standards. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day. All products meet the regulatory requirements of multiple countries such as the Chinese Pharmacopoeia and FDA, and can provide stable impurity research support for enterprises in the whole process of API R&D, production and registration application.