Canagliflozin is the first-in-class US Food and Drug Administration (FDA)–approved inhibitor of sodium glucose cotransporter 2 (SGLT2). Its mechanism of action is to lower renal resorption of glucose, thereby boosting urinary excretion of glucose, reducing plasma glucose levels, and enhancing weight loss.
In January 2013, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 10 to 5 to approve canagliflozin, based on the unmet need for new agents in the type 2 diabetes arsenal, the absence of hypoglycemia, and the potential for weight loss. The approval for canagliflozin is for use with diet and exercise, to improve glycemic control in adults with type 2 diabetes.
The FDA has approved orally administered canagliflozin to improve glycemic control in adults with type 2 diabetes, in conjunction with diet and exercise. Safety and efficacy trials showed improvement in hemoglobin A1c and fasting plasma glucose levels. However, the FDA stated that current data were insufficient to be certain about possibly elevated stroke risk.
