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news.Lexicon Pharmaceuticals has submitted an investigational new drug application to the FDA for LX1032, an oral drug candidate for managing gastrointestinal symptoms associated with carcinoid syndrome.
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The initial Phase I clinical trial of LX1032 is planned as a double-blind, randomized, placebo-controlled, ascending single-dose study in healthy volunteers. This study is designed to evaluate the safety, tolerability, and pharmacokinetics of LX1032. Lexicon expects to initiate clinical trials with LX1032 following the investigational new drug (IND) review by FDA.
Philip Brown, vice president of clinical development at Lexicon, said: “We believe LX1032 has the potential to be an important new therapy in an area of high unmet medical need. LX1032 may offer important benefits to patients with carcinoid syndrome, who have very limited treatment options.”