XERMELO (telotristat etiprate)
Xermelo helps patients with carcinoid syndrome diarrhea when their symptoms are not fully managed by somatostatin analog therapy alone. It is used in combination with these standard treatments to provide better control over gastrointestinal symptoms in adults. This medication is specifically for those who continue to experience frequent diarrhea despite being on a stable regimen of other therapies.
How XERMELO Works
This drug works by inhibiting tryptophan hydroxylase, the enzyme responsible for the rate-limiting step in serotonin production. By blocking this enzyme, the medication reduces the over-production of peripheral serotonin that typically occurs in carcinoid syndrome. Lowering these serotonin levels helps decrease the frequency of diarrhea.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2017-02-28
- Patent Cliff
- 2031
- Routes
- ORAL
- Dosage Forms
- TABLET
XERMELO Approval History
What XERMELO Treats
1 indicationsXERMELO is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Carcinoid Syndrome Diarrhea
Clinical Trial Registry
21 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04810091 results posted | 2019-1205 NCI-2021-00852, 2019-1205 | Ph 3 | active not recruiting | Telotristat Ethyl for the Treatment of Carcinoid Heart Disease in Patients With Metastatic Neuroendocrine Tumor |
| NCT03910387 results posted | IRB00105292 NCI-2018-01977, Winship4441-18 | Ph 2 | completed | Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer |
| NCT03453489 results posted | 2017-144 NCI-2018-00294, 2017-144 | Ph 2 | completed | AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm |
| NCT03790111 TELE-ABC results posted | LX1606.1-207-BTC LX1606.207, LX1606.207 | Ph 2 | terminated | A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer |
| NCT04713202 NET-PACS | BTCRC-GI19-400 | Ph 2 | withdrawn | Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl |
| NCT04776876 | 2020-0083 NCI-2021-00021, 2020-0083 | Ph 2 | withdrawn | Retifanlimab (INCMGA00012) and Telotristat Ethyl for the Treatment of Advanced Neuroendocrine Tumors and Carcinoid Syndrome |
| NCT03442725 results posted | D-FR-01017-002 2017-003948-20 | Ph 1 | completed | Study to Compare a Dose of Telotristat Etiprate in Subjects With Renal Impairment With Matched Subjects With Normal Renal Function |
| NCT04065165 TELEFIRST | EORTC-1715-GITCG | Ph 3 | withdrawn | 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 |
| NCT02026063 TELEPATH results posted | LX1606.1-302-CS LX1606.302, 2013-002596-18 | Ph 3 | completed | Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms |
| NCT01456052 results posted | LX1606.1-204-UC LX1606.204, LX1032 | Ph 2 | completed | A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis |
| NCT01104415 results posted | LX1606.1-203-CS LX1606.203, LX1032, 2009-016973-13 | Ph 2 | completed | Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome |
| NCT02683577 results posted | D-FR-01017-001 2015-004120-64 | Ph 1 | completed | Study to Evaluate a Dose of Telotristat Etiprate in Male and Female With Mild, Moderate and Severe Hepatic Insufficiency and Matched Healthy Subjects |
| NCT00853047 results posted | LX1606.1-202-CS LX1606.202 | Ph 2 | completed | Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy |
| NCT03423446 | LX1606.1-111-HEP LX1606.111 | Ph 1 | completed | Study to Evaluate the Pharmacokinetics of Telotristat Ethyl in Subjects With Severe Hepatic Impairment |
| NCT01677910 results posted | LX1606.1-301-CS LX1606.301, 2012-003460-47 | Ph 3 | completed | TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome) |
| NCT02063659 TELECAST results posted | LX1606.1-303-CS LX1606.303, 2013-001543-31 | Ph 3 | completed | Telotristat Etiprate for Carcinoid Syndrome Therapy |
| NCT02195635 | LX1606.1-109-NRM LX1606.109 | Ph 1 | completed | Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects |
| NCT02157558 | LX1606.1-106-NRM LX1606.106 | Ph 1 | completed | An Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Fexofenadine in Healthy Subjects |
| NCT02155205 | LX1606.1-105-NRM LX1606.105 | Ph 1 | completed | A Thorough QT Study of Telotristat Etiprate |
| NCT02157584 | LX1606.1-107-NRM LX1606.107 | Ph 1 | completed | An Open-Label Food Effect Study of Telotristat Etiprate |
| NCT02147808 | LX1606.1-108-NRM LX1606.108 | Ph 1 | completed | A Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Midazolam in Healthy Subjects |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XERMELO FDA Label Details
Indications & Usage
FDA Label (PDF)XERMELO is indicated for the treatment of Carcinoid Syndrome Diarrhea.
Pro Intelligence Preview
Deep insights for XERMELO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 5 active patents
Trial Analysis
- • 22 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment