Last update 19 Jul 2025

Esmirtazapine maleate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(S)-1,2,3,4,10,14b-hexahydro-2-methylpyrazino(2,1-a)pyrido(2,3-c)(2)benzazepine, Esmirtazapine, Esmirtazapine maleate (USAN)
+ [4]
Action
antagonists
Mechanism
5-HT2A receptor antagonists(Serotonin 2a (5-HT2a) receptor antagonists)
Active Indication-
Originator Organization
Active Organization-
License Organization-
Drug Highest PhaseDiscontinuedPhase 3
First Approval Date-
Regulation-
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Structure/Sequence

Molecular FormulaC21H23N3O4
InChIKeyRPUBHMMISKEXSR-MLCLTIQSSA-N
CAS Registry680993-85-5

External Link

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Neurocognitive DisordersPhase 3-04 Mar 2008
Sleep Initiation and Maintenance DisordersPhase 3-07 Dec 2006
Menopausal symptomsPhase 3-15 Sep 2004
Vasomotor symptomPhase 3-15 Sep 2004
Vascular DiseasesPhase 3--
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
oflhvvykty(fjqzschpbd) = qgxltedkzq wjqzdxtbhz (ztajcdhhdi, 35.0 - 62.5)
Positive
30 Apr 2020
Phase 3
526
awaqrkfosj(mbybvbtdzt) = iizkklrxdf xgjyqsjypv (lqalgmuwcs )
Positive
01 Jul 2015
Placebo
taegeqqvjg(zalpletfob) = budsuddvic zakpevbyyl (pstaqfllii )
Phase 3
419
gmqeporpyb(ynmdwilmhm) = vjrodtfjqh jdljhekkbd (nxontijoyh )
Positive
01 Jul 2015
gmqeporpyb(ynmdwilmhm) = jjsqxziyue jdljhekkbd (nxontijoyh )
Phase 3
419
(Esmirtazapine 3.0 mg)
hmjnuwmran(encjxryxvb) = qwiucxnhem csekqvveta (cqelfmtwpn, 25.7)
-
06 Aug 2014
(Esmirtazapine 4.5 mg)
hmjnuwmran(encjxryxvb) = hjtpqounmp csekqvveta (cqelfmtwpn, 26.5)
Phase 3
538
(Esmirtazapine 0.5 mg)
bflajdjbut(gghggrubkc) = uahmezezil hsrspyhwwg (zldphutswk, 36.5)
-
05 Aug 2014
(Esmirtazapine 1.5 mg)
bflajdjbut(gghggrubkc) = abyizvuplk hsrspyhwwg (zldphutswk, 30.7)
Phase 3
460
(Esmirtazapine 4.5 mg)
ecxyrbjxmi(jxcpsimqqp) = xzsfduqxdu frmzmhyghq (aguehzbzrv, 71.9)
-
01 Aug 2014
Placebo
(Placebo)
ecxyrbjxmi(jxcpsimqqp) = qperfpychw frmzmhyghq (aguehzbzrv, 62.1)
Phase 3
346
qyodwfzuuq = gmeduimahu btsgdahysz (ehpesslsxd, qeyfpnfscb - fcewnopppj)
-
30 Jul 2014
Phase 3
946
Placebo
(Placebo)
lngkrkskys(ypvobmwjty) = cqaicpviaz uspyswxzrq (uyypqplaes, 5.1)
-
30 Jul 2014
(Esmirtazapine 2.25 mg)
lngkrkskys(ypvobmwjty) = owbjkgnbcl uspyswxzrq (uyypqplaes, 5.1)
Phase 3
259
(Esmirtazapine 1.5 mg)
rfgohypowe = vwlrkbrapn zyrnzldwdz (ibeonfccop, aicxsrfdgk - dkbmgpvwcg)
-
07 Jul 2014
(Esmirtazapine 3.0 mg)
rfgohypowe = wshsjijctk zyrnzldwdz (ibeonfccop, cangmxpeyu - vygfopiivg)
Phase 3
943
Placebo
(Placebo)
uaptkbjyza(kgjaicmbsj) = gpupmikser wooswzjhyc (zovwkkhpon, 4.2)
-
30 Jun 2014
(Esmirtazapine 2.25 mg)
uaptkbjyza(kgjaicmbsj) = npkrqzksia wooswzjhyc (zovwkkhpon, 3.8)
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Core Patent

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Approval

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Regulation

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