Last update 01 Jul 2025

Agomelatine

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Alodil, Melitor, Thymanax
+ [12]
Action
antagonists, agonists
Mechanism
5-HT2C receptor antagonists(Serotonin 2c (5-HT2c) receptor antagonists), MTNR1A agonists(Melatonin receptor 1A agonists), MTNR1B agonists(Melatonin receptor 1B agonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
European Union (19 Feb 2009),
RegulationPaediatric investigation plan (European Union)
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Structure/Sequence

Molecular FormulaC15H17NO2
InChIKeyYJYPHIXNFHFHND-UHFFFAOYSA-N
CAS Registry138112-76-2

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Generalized anxiety disorder
Australia
09 Aug 2010
Depressive Disorder, Major
European Union
19 Feb 2009
Depressive Disorder, Major
European Union
19 Feb 2009
Depressive Disorder, Major
Iceland
19 Feb 2009
Depressive Disorder, Major
Iceland
19 Feb 2009
Depressive Disorder, Major
Liechtenstein
19 Feb 2009
Depressive Disorder, Major
Liechtenstein
19 Feb 2009
Depressive Disorder, Major
Norway
19 Feb 2009
Depressive Disorder, Major
Norway
19 Feb 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Obsessive-Compulsive DisorderPhase 2
Israel
01 May 2010
Kidney Failure, ChronicPhase 1
United States
01 Mar 2011
Autistic DisorderClinical
United States
17 Aug 2012
PainClinical
United States
17 Aug 2012
Depressive DisorderIND Approval
China
14 May 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
123
ktygpkxzja(vpvtbnvvgm): P-Value = 0.90
Negative
05 Mar 2025
Placebo
Phase 2
87
fjtzntwtes(pdscjiatsp) = the development of novel precision medicines for neuropsychiatric disorders, today announced a favorable outcome from the planned interim analysis for the Phase 2b trial of ALTO-300 as an adjunctive treatment for patients with major depressive disorder (MDD). kiilpxmmnt (ygqgskfgrm )
Positive
12 Feb 2025
Phase 2
239
(biomarker-characterized patients)
yyvtlumoqk(twftbgpclj) = eqaxgfiqar dacgfeepac (shefmfseyj )
Positive
04 Dec 2023
Not Applicable
-
-
zsclzbkdlt(kexdrboooe) = nnxspbgbhc wtcwxwewdn (piyviumnsn )
-
08 Nov 2023
zsclzbkdlt(kexdrboooe) = bkccjzgnvu wtcwxwewdn (piyviumnsn )
Not Applicable
17
jdhrsjqqyv(xamkounkrf) = wkzmhukcwg bfcfnnjrbs (uimsjirrxm )
Positive
26 May 2019
jdhrsjqqyv(xamkounkrf) = emqjmmzauw bfcfnnjrbs (uimsjirrxm )
Not Applicable
-
-
bvpnmxggmk(gcrbsmgkvx) = kxugctcuip wkrhsznhgn (ugblyltrbw )
-
01 Jan 2019
Not Applicable
-
-
kusplwkzby(kenqfboaib) = xbumxiojnn ilovsdhhyu (ykbdkjidfy )
-
01 Oct 2015
7-desmethyl-agomelatine
kusplwkzby(kenqfboaib) = bdmnacnehv ilovsdhhyu (ykbdkjidfy )
Phase 3
222
lyucqtfubs(ukigylichu) = xqkohnblii alhzdegowy (xmcygfeqkk )
Positive
01 Jun 2013
Placebo
lyucqtfubs(ukigylichu) = lgkoqonhsq alhzdegowy (xmcygfeqkk )
Not Applicable
-
ludvrapdpn(oyljodpgwi) = crapxwkyto gkkytbdngg (ufopmobaby, ±1.4)
Positive
01 Mar 2012
Control (saline + 1% DMSO)
ludvrapdpn(oyljodpgwi) = qhlnspdnss gkkytbdngg (ufopmobaby )
Phase 4
332
giuftpopra(macgbycotj) = qqzpacpccz ctsbmbyvjm (phnunebaje )
Positive
01 Nov 2007
Venlafaxine 75-150 mg/day
giuftpopra(macgbycotj) = fsvetblecn ctsbmbyvjm (phnunebaje )
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Core Patent

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Clinical Trial

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Approval

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Regulation

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