This drug has been discontinued in the U.S.[1] Amlexanox is the active ingredient in a common topical treatment for recurrent aphthous ulcers of the mouth (canker sores),[2] reducing both healing time[3] and pain.
[8] It has been shown to selectively inhibit TBK1 and IKK-ε, producing reversible weight loss and improved insulin sensitivity, reduced inflammation and attenuated hepatic steatosis without affecting food intake in obese mice.
[9] It produced a statistically significant reduction in glycated hemoglobin and fructosamine in obese patients with type 2 diabetes and nonalcoholic fatty liver disease[10] The chemical itself is an odorless, white to yellowish-white powder.
[8] The patent for its use as a treatment for aphthous ulcers was issued in November 1994 to inventors Kakubhai R. Vora, Atul Khandwala and Charles G. Smith, and assigned to Chemex Pharmaceuticals, Inc.[11] A 2011 review found a one-week supply of amlexanox 5% paste to cost $30.
[12] Because it is an inhibitor of the protein kinases TBK1 and IKK-ε,[9] which are implicated in the etiology of type II diabetes and obesity,[13] amlexanox may be a candidate for human clinical trials testing in relation to these diseases.