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US FDA grants fast track status to LX1033

Lexicon Pharmaceuticals has won Fast Track status from the US FDA to develop LX1033, an orally-delivered small molecule drug candidate to treat diarrhea-predominant irritable bowel syndrome (IBS-d).

Fast Track facilitates the development and expedites the review of new drugs intended to serve unmet medical needs in serious or life-threatening conditions.

Lexicon Pharmaceuticals senior vice president and chief medical officer said Pablo Lapuerta said, "We are pleased with the FDA’s grant of Fast Track status for LX1033 in IBS-d, recognizing this important area of unmet medical need and the potential benefits that LX1033 could provide for those suffering from this disease."

Currently being evaluated in a Phase 2 clinical trial for IBS-d, LX1033 is an inhibitor of tryptophan hydroxylase (TPH) that functions in the gastrointestinal tract.