Drugs / Telotristat etiprate
Telotristat etiprate
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Xermelo | — | 2017-09-17 | europa.eu ↗ |
| Approved | US (FDA) | XERMELO | — | 2017-02-28 | fda.gov ↗ |
Trials 13 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT03442725 | Feb → Apr 2018 | impaired renal function disease | Ipsen | Completed | No outcome recorded |
| Phase 1 | NCT02683577 | Feb → Jul 2016 | — | Ipsen | Completed | No outcome recorded |
| Phase 1 | NCT02195635 | Jul → Oct 2014 | — | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02157558 | Jul → Aug 2014 | — | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02155205 | May → Aug 2014 | — | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02147808 | May → Aug 2014 | — | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT03453489 | Jun 2018 → Oct 2020 | carcinoid syndrome, neuroendocrine neoplasm | Barbara Ann Karmanos Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT01456052 | Jan 2012 → Sep 2013 | ulcerative colitis | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01104415 | Jun 2010 → Feb 2014 | carcinoid syndrome | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00853047 | Mar 2009 → Jun 2014 | carcinoid syndrome | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT02063659 | Mar 2014 → Mar 2016 | carcinoid syndrome | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02026063 | Jan 2014 → Sep 2018 | carcinoid syndrome | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01677910 | Jan 2013 → Mar 2016 | carcinoid syndrome | Lexicon Pharmaceuticals | Completed | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | telotristat etiprate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02683577 ↗ |
| Known as | LX1606 | “Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome” NCT01104415 ↗2“Single Dose of Telotristat Etiprate (LX1606) 1500 mg Compared With Placebo” NCT02155205 ↗ “500 mg telotristat etiprate (LX1606) administered orally.” NCT01456052 ↗ |
| Known as | telotristat ethyl | “telotristat etiprate (telotristat ethyl) treatment” NCT03453489 ↗ |
| Action | Inhibit | “Telotristat etiprate, a tryptophan hydroxylase inhibitor” PMID 27041406 ↗ Mar 2016 |
| Route | Oral | “Telotristat etiprate capsules; orally 3 times daily.” NCT00853047 ↗ |