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TELOTRISTAT ETHYL
Telotristat Ethyl is a marketed drug primarily indicated for Carcinoid Syndrome Diarrhea, holding a niche position in this specialized market. Its key strength lies in its unique mechanism of action, which differentiates it from other treatments and supports its use in managing symptoms effectively. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | TELOTRISTAT ETHYL |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2017 |
Approved indications
- Carcinoid Syndrome Diarrhea
Common side effects
- Nausea
- Headache
- Increased gamma-glutamyl-transferase (GGT)
- Depression
- Peripheral edema
- Flatulence
- Decreased appetite
- Pyrexia
- Abdominal pain
- Constipation
- Increased alkaline phosphatase
- Increased alanine aminotransferase
Drug interactions
- CYP3A4 Substrates (e.g., midazolam)
- CYP2B6 Substrates (e.g., bupropion, efavirenz)
- Short-Acting Octreotide
Key clinical trials
- Telotristat Ethyl for the Treatment of Carcinoid Heart Disease in Patients With Metastatic Neuroendocrine Tumor (PHASE3)
- Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer (PHASE2)
- AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm (PHASE2)
- Real-world Evidence Study EvaLuating PAtient-Reported Outcomes With XERMELO
- Telotristat With Lutathera in Neuroendocrine Tumors (PHASE2)
- A Safety and Efficacy Study of XERMELO® + First-line Chemotherapy in Patients With Advanced Biliary Tract Cancer (PHASE2)
- 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 (PHASE2)
- Telotristat Ethyl for Reducing Intraoperative Carcinoid Crisis in Patients With Neuroendocrine Tumors (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- TELOTRISTAT ETHYL CI brief — competitive landscape report
- TELOTRISTAT ETHYL updates RSS · CI watch RSS