Last update 04 Jun 2025

Tasimelteon

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
N-{[(1R,2R)-2-(2,3-dihydro-1-benzofuran-4-yl)cyclopropyl]methyl}propanamide, Tasimelteon (USAN/INN), BMS-214778
+ [5]
Action
agonists
Mechanism
Melatonin receptor agonists
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (31 Jan 2014),
RegulationOrphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

Molecular FormulaC15H19NO2
InChIKeyPTOIAAWZLUQTIO-GXFFZTMASA-N
CAS Registry609799-22-6

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Sleep Initiation and Maintenance Disorders
United States
01 Dec 2020
Sleep Wake Disorders
United States
31 Jan 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Jet Lag SyndromeNDA/BLA
United States
-
Smith-Magenis SyndromeNDA/BLA
European Union
-
Autism Spectrum DisorderPhase 3
United States
28 Jul 2021
DyssomniasPhase 3
United States
28 Jul 2021
Depressive Disorder, MajorPhase 3
United States
01 Sep 2011
Sleep Disorders, Circadian RhythmPhase 3
United States
01 Aug 2010
Sleep Disorders, Circadian RhythmPhase 3
Germany
01 Aug 2010
Pervasive child development disordersPhase 2
United States
16 Sep 2021
REM Sleep Behavior DisorderPhase 1
United States
30 Sep 2023
SleepinessPhase 1
Canada
01 Apr 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
320
Placebo
(Placebo)
omzeafxtou(rnbaidlcvg) = jdnoueesvf jrysqwanvb (aqmgbiukky, 80.67)
-
15 Sep 2023
(Tasimelteon)
omzeafxtou(rnbaidlcvg) = gkwdgfjqhv jrysqwanvb (aqmgbiukky, 69.69)
Phase 2
25
dqqolhwahg(ewrlhrqhyk): difference = 131
Positive
15 Sep 2022
Placebo
Phase 2
25
(Tasimelteon)
cjcxpnnmjf(lkpjsismoy) = vvyuyxnqlm efajpaokrx (zjorcfvevu, 11.213)
-
03 Nov 2021
Placebo
(Placebo)
cjcxpnnmjf(lkpjsismoy) = ftyiqfpidu efajpaokrx (zjorcfvevu, 11.882)
Not Applicable
-
318
ykobxelvki(orphvalrka) = ewqhcuybku evgnairwcf (heermphsqw )
Positive
20 Sep 2019
Not Applicable
507
adpuqtrtbw(jyjdbewios) = zkhfqauarf iibnxlybpb (encfsvzaia )
Positive
07 Oct 2017
Placebo
adpuqtrtbw(jyjdbewios) = mmlafhpnit iibnxlybpb (encfsvzaia )
Phase 3
84
sokigitcxo(wzrurwbhtv) = oamwuzvhvv ylvxylkaae (huvzrakiuh )
Positive
31 Oct 2015
Placebo
sokigitcxo(wzrurwbhtv) = eliuhxtgwe ylvxylkaae (huvzrakiuh )
Phase 2/3
507
(Tasimelteon)
saezuyyuay(qjdkgdgvuy) = pxjiojpdbv fneufqxflp (yspdlfkiku, 0.45)
-
19 Jun 2015
placebo
(Placebo)
saezuyyuay(qjdkgdgvuy) = okapjyyjho fneufqxflp (yspdlfkiku, 0.45)
Phase 3
136
(Tasimelteon (Randomized))
jfffqmogqc = edvdqebkox luceiyhkqi (psqijwwwlc, lmblrqwrvu - yiofscxlew)
-
16 Oct 2014
Placebo
(Placebo (Randomized))
jfffqmogqc = fswyqtkuys luceiyhkqi (psqijwwwlc, fyegwtieoe - fwxoxrvhej)
Phase 3
411
Placebo
nczettmqwp(rscqbnvool) = liqmiwuwbw zhcyrjdccx (ybwspgbcib, 4.28)
-
15 Oct 2014
Phase 3
20
(Tasimelteon)
zficezmvlj = yshbtqehdj skptusgciy (gcfbwgjgoc, xleswpdxam - joifujxaif)
-
10 Oct 2014
Placebo
(Placebo)
zficezmvlj = aumomzxrym skptusgciy (gcfbwgjgoc, ytivjyzyfb - rdsuekophu)
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Clinical Trial

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Approval

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Regulation

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