telotristat ethyl (xermelo) Report issue

Small molecule Orphan Drug FDA Approved FDA Fast Track FDA Priority Review FDA
AACT ChEMBL DrugBank Drugs@FDA MeSH PubChem

Active Ingredient History

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Telotristat (telotristat etiprate) is an ethyl ester prodrug which is hydrolyzed to its active moiety LP-778902 both in vivo and in vitro. Telotristat etiprate is an orally bioavailable, small-molecule, tryptophan hydroxylase (TPH) inhibitor. It is the first investigational drug in clinical studies to target TPH, an enzyme that triggers the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells leading to carcinoid syndrome. Unlike existing treatments of carcinoid syndrome which reduce the release of serotonin outside tumor cells, telotristat etiprate reduces serotonin production within the tumor cells. By specifically inhibiting serotonin production telotristat may provide patients with more control over their disease. Telotristat etiprate has received Fast Track and Orphan Drug designation from the U.S. Food and Drug Administration and has been granted priority review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2017.   NCATS

Chemistry

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Pharmacology

Drug Pricing (per unit)

United States

$1106.3875 - $1450.0100
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Note: This drug pricing data is preliminary, incomplete, and may contain errors.

Alternative names

lp-778902 | lx1032 | lx1606 | lx-1606 | telotristat | telotristat ethyl | telotristat etiprate | xermelo

Organizations (14)

Research & Development (14)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Marketing (2)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Indications (14)

Approved Indications (2)


 

Diarrhea

Malignant Carcinoid Syndrome (approved 2017)

Experimental Indications - Clinical Trial Phases 1-4 (14)


 

Biliary Tract Neoplasms (Phase 2)

Carcinoid Heart Disease (Phase 3)

Colitis, Ulcerative (Phase 2)

Diarrhea (Phase 2)

Drug Interactions (Phase 1)

Healthy Volunteers (Phase 1)

Heart (Phase 1)

Intestinal Neoplasms (Phase 3)

Kidney Failure, Chronic (Phase 1)

Liver Diseases (Phase 1)

Malignant Carcinoid Syndrome (Phase 3)

Neoplasm Metastasis (Phase 3)

Neuroendocrine Tumors (Phase 3)

Pancreatic Neoplasms (Phase 2)

Overview

  • Highest Phase: Phase 3
  • # of Trials: 25
  • # of Trial Organizations: 14

Trials by Phase

Trial Phase Start Date Organizations Indications

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