Active ingredient
Telotristat Ethyl
3 finished FDA listings contain Telotristat Ethyl as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TELOTRISTAT ETHYL, TELOTRISTAT ETIPRATE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 2
- Strengths listed
- 250 mg/1
- Brand names in FDA listings
- Xermelo
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1872441
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 208794 | TERSERA | 2017-02-28 | 3 |
Official labeling on DailyMed
- XERMELO (TELOTRISTAT ETHYL) TABLET [TERSERA THERAPEUTICS LLC] · version 6 · 2026-08-10
- XERMELO (TELOTRISTAT ETHYL) TABLET [LEXICON PHARMACEUTICALS, INC.] · version 6 · 2025-10-03
- XERMELO (TELOTRISTAT ETHYL) TABLET [LEXICON PHARMACEUTICALS, INC.] · version 3 · 2025-10-03
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.