Canagliflozin

For patients with type 2 diabetes, long-term poor blood glucose control is prone to cause multi-system complications such as cardiovascular and renal complications. The advent of sodium-glucose co-transporter 2 (SGLT2) inhibitors provides a new path for clinical treatment. Canagliflozin is the first approved SGLT2 inhibitor hypoglycemic API for marketing. It reduces blood glucose by inhibiting the reabsorption of glucose by SGLT2 in the proximal renal tubule and increasing urinary glucose excretion, and does not depend on insulin secretion function. In addition to being used alone or in combination with other hypoglycemic agents to control blood glucose in adult patients with type 2 diabetes, it can also reduce the risk of major adverse cardiovascular events in patients with concomitant cardiovascular diseases, and has a renal protective effect at the same time, which is especially suitable for patients with type 2 diabetes combined with high cardiovascular risk factors or chronic kidney disease.

The global canagliflozin market size reached approximately USD 1.3 billion in 2020. With the continuous rise in the prevalence of diabetes and the continuous enrichment of drug evidence-based evidence, its clinical application scenarios are gradually expanding. Although the launch of generic drugs after the expiration of the core patent has impacted the market share of the original drug, the global market demand still maintains a compound annual growth rate of about 3%. In terms of the domestic market, after being included in the National Medical Insurance Catalog in 2019, the clinical utilization rate of canagliflozin has increased rapidly. In 2023, the sales volume in domestic sample hospitals exceeded RMB 700 million. At present, more than 20 enterprises have been approved for generic preparations, and the competitive pattern shows a situation of coexistence of original research drugs and generic drugs, and the localization substitution process of the API supply side is also continuing to accelerate.

The original research enterprise of canagliflozin is Johnson & Johnson of the United States, and the original research trade name is Invokana (Yikean). Its core compound patent in the United States expired in 2020, and the validity period of the Chinese compound patent is until 2025. The main dosage form approved for the original research is tablet, with specifications of 100mg and 300mg, which has been included in the Chinese Chemical Reference Preparation Catalog and the FDA Reference Preparation Catalog. Up to now, nearly 30 domestic enterprises have completed the registration of canagliflozin API in CDE and obtained Class A status, and more than 20 enterprises have been approved for marketing of canagliflozin tablets, and the supply system has been relatively mature. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of canagliflozin impurity reference standards, most of which are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products fully comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard requirements of various links such as API R&D, quality research and registration declaration.