NDAORALTABLETPriority Review
Approved
Feb 2017
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
7
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XERMELO (telotristat ethyl) is an oral small molecule tryptophan hydroxylase inhibitor approved in 2017 for carcinoid syndrome diarrhea. It reduces serotonin production in neuroendocrine tumors, thereby decreasing diarrheal symptoms in patients with carcinoid syndrome who are inadequately controlled on somatostatin analogs.
$18MPart D
Peak4.4 years to LOEProduct is in peak lifecycle stage with modest Part D spending (~$18M in 2023), indicating a niche rare disease market with stable but limited commercial footprint.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain
Started Oct 2020
0Pancreatic CancerNeuroendocrine TumorsCachexia; Cancer
Lanreotide Combined With Telotristat Ethyl or Placebo for the First-line Treatment in Patients With Advanced Well Differentiated Small Intestinal Neuroendocrine Tumours (siNET) With Highly-functioning Carcinoid Syndrome
Started Apr 2020
0Small Intestinal NETCarcinoid Heart Disease
Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer
Started Apr 2019
23 enrolled
Locally Advanced Unresectable Pancreatic AdenocarcinomaMetastatic Pancreatic AdenocarcinomaRecurrent Pancreatic Adenocarcinoma+2 more
A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer
Started Mar 2019
53 enrolled
Biliary Tract Cancer (BTC)
Study to Evaluate the Pharmacokinetics of Telotristat Ethyl in Subjects With Severe Hepatic Impairment
Started Nov 2017
16 enrolled
Hepatic Impairment
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.