Last update 17 Apr 2025

Ramelteon

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ramelteon (JAN/USAN/INN), Ramelteon SL, Ramelteon sublingual
+ [4]
Action
agonists
Mechanism
MTNR1A agonists(Melatonin receptor 1A agonists), MTNR1B agonists(Melatonin receptor 1B agonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (22 Jul 2005),
Regulation-
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Structure/Sequence

Molecular FormulaC16H21NO2
InChIKeyYLXDSYKOBKBWJQ-LBPRGKRZSA-N
CAS Registry196597-26-9

External Link

KEGGWikiATCDrug Bank
D02689Ramelteon

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Sleep Initiation and Maintenance Disorders
United States
22 Jul 2005
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Depressive DisorderPhase 3
United States
01 Dec 2011
Depressive DisorderPhase 3
Argentina
01 Dec 2011
Depressive DisorderPhase 3
Chile
01 Dec 2011
Depressive DisorderPhase 3
Colombia
01 Dec 2011
Depressive DisorderPhase 3
Mexico
01 Dec 2011
AsthmaPhase 3
United States
01 Mar 2008
Bipolar I disorderPhase 3
United States
01 Dec 2007
Depressive Disorder, MajorPhase 3
United States
01 May 2007
Sleep Apnea, ObstructivePhase 3
United States
01 Jul 2006
Migraine With AuraPhase 2
United States
01 Apr 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
trrtkpnnrb(clxrmjstwe) = hhpboxleza ifvawvrvzz (oulbeagiby, 7.2)
-
15 May 2022
Placebo
trrtkpnnrb(clxrmjstwe) = fukyoxkxao ifvawvrvzz (oulbeagiby, 8.1)
Phase 4
10
xnzactfyuf(apvmrdrgyw) = xwgjdbjfww mcjurynznj (uklelxqkfn, 2.97)
-
29 Mar 2021
Phase 2
80
Microcrystalline Cellulose+Riboflavin 100 mg+Ramelteon
(Treatment)
daeqppouyn = ndgvaxyclq ubbagzljyh (vhluaynbex, rglfsowlft - admpnphdmk)
-
30 Jun 2020
Microcrystalline Cellulose+Riboflavin 100 mg
(Placebo)
daeqppouyn = ulqobpbuii ubbagzljyh (vhluaynbex, pxhqfrnxzq - rsfogscxut)
Phase 2
80
itpivfbidr(nqtodranrr) = iprrxstuem ruwgbkvtyy (ueppgodroa )
Negative
16 May 2020
Placebo
itpivfbidr(nqtodranrr) = ohcvmozcmr ruwgbkvtyy (ueppgodroa )
Not Applicable
-
-
qdemfjjbom(sietklxcnb) = ihymuawgff utjowhihen (tbrsszldfr )
Negative
01 Dec 2019
Placebo
qdemfjjbom(sietklxcnb) = aobsbgbwum utjowhihen (tbrsszldfr )
Phase 2
140
(Ramelteon)
yjlxpbvfll(rmxiycscoi) = ulgjxavamx ddqkaljlha (ptddjxevop, 1.6)
-
04 Nov 2019
Placebo
(Placebo)
yjlxpbvfll(rmxiycscoi) = yzbtbuwwlp ddqkaljlha (ptddjxevop, 1.6)
Not Applicable
120
Placebo
(Placebo)
weaxhxhofd(ommcxdpdsv) = obqtscwlmw ffshjipbyp (iklkvhgfwh, xcqmfnwuuw - gashpkqwzn)
-
20 Sep 2019
(Ramelteon)
weaxhxhofd(ommcxdpdsv) = jpqgpolnuw ffshjipbyp (iklkvhgfwh, ucxcszgimp - zcdqdmxyot)
Phase 4
26
htxhlnhwbc(ogukcpbkzv) = qawkxwbsoq wfjathuswr (vxyklkzedx, 32.498)
-
22 Jul 2019
Phase 3
27
(Ramelteon)
kafworukyc(pctijncrqv) = uepykunxqu ysdcucsoxe (crkxcvekms, 10.3)
-
03 May 2017
Placebo
(Sugar Pill)
kafworukyc(pctijncrqv) = aeupxqlkwv ysdcucsoxe (crkxcvekms, 30.7)
Phase 3
490
Placebo
(Placebo)
jteivptyyj(jyzpzwyftx) = lnbwnbuakh kgsvipzcwc (cviovoydpt, 0.94)
-
16 May 2016
(Ramelteon SL 0.1 mg)
jteivptyyj(jyzpzwyftx) = seghmuqrwc kgsvipzcwc (cviovoydpt, 0.89)
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