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Lexicon files investigational new drug application for diabetes drug

Lexicon Pharmaceuticals, a biopharmaceutical company, has submitted an investigational new drug application to the FDA for LX4211, an oral small molecule drug candidate for type 2 diabetes.

The initial Phase I clinical trial of LX4211 is planned as a double-blind, randomized, placebo-controlled, ascending single- and multiple-dose study in healthy volunteers. This study is designed to evaluate the safety, tolerability, and pharmacokinetics of LX4211.

Upon initiation of testing following the FDA review, LX4211 would constitute Lexicon’s fifth drug candidate to enter human clinical trials as part of its 10TO10 program.

Brian Zambrowicz, chief scientific officer of Lexicon, said: “The mechanism of action of LX4211 specifically blocks reabsorption of glucose by the kidney, which may help to improve glucose control in patients with type 2 diabetes. We believe that LX4211 will be favorably distinguished within an emerging new class of agents being developed for the treatment of diabetes.”