Drugs / Telotristat Ethyl
Telotristat Ethyl
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Xermelo | — | 2017-09-17 | europa.eu ↗ |
Trials 10 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03423446 | Nov 2017 → Jun 2018 | — | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03302845 | Sep → Oct 2017 | — | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02157584 | Jun → Jul 2014 | — | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT04672876 | Jan → Oct 2022 | neuroendocrine neoplasm | University of Chicago | Withdrawn | No outcome recorded |
| Phase 2 | NCT04713202 | Mar 2021 → Feb 2023 | carcinoid syndrome, diarrheal disease, neuroendocrine neoplasm | Chandrikha Chandrasekhara | Withdrawn | No outcome recorded |
| Phase 2 | NCT04776876 | Mar → Sep 2021 | carcinoid syndrome, neuroendocrine carcinoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT03910387 | Apr 2019 → Jun 2022 | pancreatic adenocarcinoma | Emory University | Completed | No outcome recorded |
| Phase 2 | NCT03790111 | Mar 2019 → Jan 2022 | biliary tract cancer | TerSera Therapeutics LLC | Terminated | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04810091 | May 2021 → Aug 2025 overdue | neuroendocrine neoplasm | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04065165 | Apr 2020 → Jul 2023 | carcinoid heart disease, small intestine neuroendocrine neoplasm | European Organisation for Research and Treatment of Cancer - EORTC | Withdrawn | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | telotristat ethyl | “This study is designed to evaluate the effect of food on the pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to administration of single dose...” NCT02157584 ↗ |
| Known as | LX1606 Hippurate | “A Phase 1, Randomized, Single Center, Open Label, 2 Sequence, 2 Period, Crossover Study to Evaluate the Effect of Food on the Single Dose Pharmacokinetics of Telotristat...” NCT02157584 ↗ |
| Known as | XERMELO | “XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) three times a day plus first line therapy for 7 days, then XERMELO (telotristat ethyl) tablets...” NCT03790111 ↗ |
| Route | Oral | “telotristat ethyl orally (PO)” NCT03910387 ↗ |