Diazoxide

For clinically refractory diseases such as congenital hyperinsulinism and malignant hypertension, diazoxide is an irreplaceable treatment option. As a benzothiazine derivative, its mechanism of action is different from that of conventional antihypertensive drugs. It activates ATP-sensitive potassium channels to relax vascular smooth muscle and reduce peripheral resistance, while inhibiting insulin secretion from pancreatic β cells, thus having dual pharmacological activities of lowering blood pressure and increasing blood glucose. At present, it is mainly used clinically to manage persistent hypoglycemia symptoms in infants and young children with congenital hyperinsulinism, as well as for emergency blood pressure reduction in hypertensive crisis and subacute hypertension, and it is a key drug in the fields of pediatric rare diseases and acute and severe illnesses.

The global diazoxide market size was approximately USD 120 million in 2023, with a compound annual growth rate of 4.7% in the past five years. The core growth driver comes from the improvement in the diagnosis rate of congenital hyperinsulinism in the rare disease field. The current market supply is dominated by the originator drug, with a small number of generic manufacturers entering the market. Previously, there were multiple supply shortages of diazoxide preparations in China. With the acceleration of domestic generic drug R&D progress, supply stability is gradually improving.

The originator enterprise of diazoxide is Teva Pharmaceuticals USA, with the originator brand name Proglycem®. The core compound patent expired globally around 2000. The main marketed dosage forms of the originator product are oral suspension (50mg/ml) and oral capsules (50mg, 100mg), which have been included in the FDA Reference Listed Drug Catalog and also included in the China Listed Chemical Drug Catalog. As of November 2024, China NMPA has approved 3 diazoxide oral preparations for marketing. There are a total of 6 diazoxide API registration records on the CDE API Registration Platform, of which 3 have obtained Grade A status through the joint review and approval with preparations. (Data as of November 2024, please refer to the official CDE website for the latest information)

In response to the quality research needs of diazoxide APIs and related preparations, CATO can provide a full set of impurity reference standards for this API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can directly support API registration and declaration as well as routine quality testing scenarios.