Drugs / tasimelteon
tasimelteon
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | HETLIOZ | — | 2020-12-01 | fda.gov ↗ |
| Approved | EU (EMA) | Hetlioz | — | 2015-07-03 | europa.eu ↗ |
| Approved | US (FDA) | HETLIOZ | — | 2014-01-31 | fda.gov ↗ |
Trials 26 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05922995 | Sep → Dec 2023 | REM sleep behavior disorder | Brigham and Women's Hospital | Terminated | No outcome recorded |
| Phase 19 trials | ||||||
| Phase 1 | NCT06323655 | Jul → Aug 2018 | — | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02776215 | Oct 2016 → Dec 2017 | Smith-Magenis syndrome, autism spectrum disorder, non-24-hour sleep-wake syndrome | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01637636 | Jun → Aug 2012 | — | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01578057 | Apr → Jun 2012 | — | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01526746 | Feb → Jun 2012 | impaired renal function disease | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01540500 | Feb → Mar 2012 | — | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01477619 | Nov 2011 → Jan 2012 | — | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01402076 | Aug 2011 | — | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01271387 | Jan → Aug 2011 | — | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03291041 | Jul 2016 → Nov 2017 | circadian rhythm sleep disorder, jet lag type | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00490945 | Jul 2004 → Mar 2005 | circadian rhythm sleep disorder | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT02231008 | Sep 2015 → Nov 2018 | Smith-Magenis syndrome, circadian rhythm sleep disorder | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/3 | NCT01428661 | Sep 2011 → Jan 2013 | major depressive disorder | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 311 trials | ||||||
| Phase 3 | NCT06953869 | Apr 2025 → Nov 2027 expected | insomnia | Vanda Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT06701396 | Oct 2024 → Jun 2025 overdue | circadian rhythm sleep disorder, delayed sleep phase type | Vanda Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT05361707 | Jul 2021 → Jul 2025 | autism spectrum disorder, sleep disorder | Vanda Pharmaceuticals | Unknown | No outcome recorded |
| Phase 3 | NCT04652882 | Dec 2020 → Jun 2026 overdue | circadian rhythm sleep disorder | Vanda Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT03373201 | Oct 2017 → Mar 2018 | circadian rhythm sleep disorder, jet lag type | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01429116 | Oct 2011 → Jan 2015 | non-24-hour sleep-wake syndrome | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01430754 | Sep 2011 → Dec 2012 | non-24-hour sleep-wake syndrome | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01218789 | Oct 2010 → Dec 2024 | non-24-hour sleep-wake syndrome | Vanda Pharmaceuticals | Unknown | No outcome recorded |
| Phase 3 | NCT01163032 | Aug 2010 → Nov 2012 | non-24-hour sleep-wake syndrome | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00548340 | Nov 2007 → Feb 2008 | insomnia | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00291187 | Feb → Aug 2006 | insomnia | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02130999 | May 2014 | non-24-hour sleep-wake syndrome | Vanda Pharmaceuticals | Completed | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tasimelteon | “Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials.” PMID 19054552 ↗ Dec 200824“VEC-162 (tasimelteon) 20 mg capsules PO daily for five weeks” NCT00548340 ↗ |
| Known as | BMS-214,778 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103822 ↗ |
| Known as | HETLIOZ | “Efficacy of Tasimelteon (HETLIOZ®) in the Treatment of Jet Lag Disorder” PMID 32754110 ↗ Jul 2020 |
| Known as | Hetlioz lq | ChEMBL registry synonym — accepted as the source's own label CHEMBL2103822 ↗ |
| Known as | VEC-162 | “Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials.” PMID 19054552 ↗ Dec 2008 |
| Action | Activate | “the melatonin agonist tasimelteon (VEC-162) for treatment of transient insomnia associated with shifted sleep and wake time.” PMID 19054552 ↗ Dec 2008 |
| Modality | Small molecule | — CHEMBL2103822 ↗ |
| Route | Oral | “20 mg taken orally 30 minutes prior to bedtime.” NCT00291187 ↗ |