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Xermelo Approval History

  • FDA approved: Yes (First approved February 28th, 2017)
  • Brand name: Xermelo
  • Generic name: telotristat ethyl
  • Dosage form: Tablets
  • Company: Lexicon Pharmaceuticals, Inc.
  • Treatment for: Carcinoid Syndrome Diarrhea

Xermelo (telotristat ethyl) is an oral tryptophan hydroxylase inhibitor indicated for use in combination with somatostatin analog (SSA) therapy for the treatment of carcinoid syndrome diarrhea in patients with metastatic neuroendocrine tumors.

Development History and FDA Approval Process for Xermelo

DateArticle
Feb 28, 2017Approval FDA Approves Xermelo (telotristat ethyl) as First and Only Oral Treatment for Carcinoid Syndrome Diarrhea in Cancer Patients with Metastatic Neuroendocrine Tumors
Sep 14, 2016FDA Extends PDUFA Date for Telotristat Etiprate for the Treatment of Carcinoid Syndrome
May 31, 2016Lexicon Announces FDA Priority Review of NDA for Telotristat Etiprate for the Treatment of Carcinoid Syndrome
Mar 30, 2016Lexicon Submits New Drug Application to FDA for Telotristat Etiprate for the Treatment of Carcinoid Syndrome
Mar  9, 2015Lexicon Pharmaceuticals Completes Enrollment in Pivotal Phase 3 Clinical Trial of Telotristat Etiprate
Oct 12, 2012Second Phase 2 Trial Of Telotristat Etiprate Shows Positive Results In Carcinoid Syndrome
Aug  9, 2011Phase 2 Trial of Lexicon's LX1032, Telotristat Etiprate, Shows Positive Results in Carcinoid Syndrome

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