Quick answers
- What is Telotristat ethyl used for?
- The FDA-approved label (Xermelo, TerSera Therapeutics LLC, August 6, 2026) says: “Xermelo is indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Xermelo is a tryptophan hydroxylase inhibitor indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Telotristat ethyl have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Telotristat ethyl?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Telotristat ethyl been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Telotristat ethyl?
- 2 companies list prescription products of Telotristat ethyl in the FDA NDC Directory, including Lexicon Pharmaceuticals, Inc. and TerSera Therapeutics LLC.
What Telotristat ethyl is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Xermelo is indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Xermelo is a tryptophan hydroxylase inhibitor indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.
— FDA label: Xermelo, TerSera Therapeutics LLC, effective August 6, 2026. Read the full label on DailyMed →
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Xermelo |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Lexicon Pharmaceuticals, Inc.2 products
- TerSera Therapeutics LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA208794 XERMELO | Tersera | February 28, 2017 | 2, latest September 26, 2022 2022: Labeling · 2020: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1872453, 1872458 |
|---|---|
| SPL set ID of the quoted label | a4ac9d62-887c-4c8f-b04d-a5f31cec7c86 |
| FDA labels (SPL) | 3 |
| FDA applications | NDA208794 |
| Active ingredients (FDA) | TELOTRISTAT ETHYL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Xermelo, TerSera Therapeutics LLC, effective August 6, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →