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news.The US Food and Drug Administration (FDA) has granted orphan drug designation for Lexicon Pharmaceuticals's telotristat etiprate (LX1032) for the treatment of carcinoid syndrome.
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Telotristat etiprate is an orally-delivered serotonin synthesis inhibitor (SSI) drug that acts to reduce serotonin levels.
Lexicon chief medical officer and clinical development senior vice president Pablo Lapuerta said they are preparing for a global Phase 3 development plan in patients with carcinoid syndrome.
LX1032 has already received orphan drug designation from the European Medicines Agency and fast track status from the FDA.
The company is also planning a Phase 2 trial of telotristat etiprate in mild to moderate ulcerative colitis.
Lexicon currently has four drug programs in mid-stage development for diabetes, irritable bowel syndrome, carcinoid syndrome and rheumatoid arthritis.