Last update 26 Jun 2024

Asenapine Maleate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
ASENAPINE, HP-3070, ME-2136
+ [10]
Mechanism
5-HT2A receptor antagonists(Serotonin 2a (5-HT2a) receptor antagonists), D2 receptor antagonists(Dopamine D2 receptor antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure

Molecular FormulaC21H20ClNO5
InChIKeyGMDCDXMAFMEDAG-UHFFFAOYSA-N
CAS Registry85650-56-2

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Bipolar I disorder
EU
01 Sep 2010
Bipolar I disorder
IS
01 Sep 2010
Bipolar I disorder
LI
01 Sep 2010
Bipolar I disorder
NO
01 Sep 2010
Mania
EU
01 Sep 2010
Mania
IS
01 Sep 2010
Mania
LI
01 Sep 2010
Mania
NO
01 Sep 2010
Bipolar Disorder
US
13 Aug 2009
Schizophrenia
US
13 Aug 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
StutteringPhase 3
US
01 Sep 2012
StutteringPhase 3
US
01 Sep 2012
Schizoaffective disorderPhase 3-04 Sep 2003
Psychotic DisordersPhase 2-29 Jun 2005
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
617
(Low Dose Asenapine Maleate Patch)
vzatfgudyr(yejmllxgyy) = ufbquubtuj ecpelwannd (dqyssitlyl, nrbzboutct - wvtcvxjxfq)
-
27 Mar 2020
(High Dose Asenapine Maleate Patch)
vzatfgudyr(yejmllxgyy) = msrncjpboz ecpelwannd (dqyssitlyl, leqvdshegy - bjhwtvhpsl)
Phase 3
326
Placebo
(Placebo)
scyvudmobw(wfxewgtkry) = dfdzseikeg bjllifwndl (kcrfxfqloi, grlrrmvfjb - uxvvvngaqi)
-
16 Sep 2019
(Asenapine)
scyvudmobw(wfxewgtkry) = shaomgggii bjllifwndl (kcrfxfqloi, cysbckigpr - geuurxxmgi)
Phase 3
253
khowxnpmhr(jswbphprgm) = statistically significantly longer for asenapine- than placebo-treated subjects. jiccbivmrw (tlxhrzvlak )
Positive
01 Jan 2018
Placebo
Phase 3
360
smxrgomjxw(ftezworopu): points = -5.5 (95% CI, -10.1 to -1.0), P-Value = 0.0356
Positive
01 Aug 2017
Placebo
Phase 3
321
bxojaiqqdn(iyuqdjtsed) = 34.8 % of patients experienced clinically significant weight gain (≥7 % increase) cyfadmtzhz (unzjjtzpyy )
-
01 Oct 2016
Phase 3
532
daeheyrgzd(hfgviuwnuh) = vydagnausj ptknddhkqk (ejpcsdctuv, ±2.65)
Positive
01 Jul 2016
daeheyrgzd(hfgviuwnuh) = kbpdphoury ptknddhkqk (ejpcsdctuv, ±2.89)
Phase 3
201
Placebo+Asenapine
(Placebo/Asenapine)
xskmexnwpi(hzubfhzveb) = ghhihfealk eqznotjjyq (zuhqricoph, dwewsgogxx - ricieeosny)
-
18 May 2016
(Asenapine 5/10 mg BID)
xskmexnwpi(hzubfhzveb) = ggqzfnghoz eqznotjjyq (zuhqricoph, exkxqplzuq - exipfatdyk)
Phase 4
120
(Asenapine)
zazaiwfjqu(huinkgvlkz) = dxhvuhitjn lbggqftjuy (clcvrbstfw, qtuczzkkor - kwgknjbmek)
-
16 May 2016
Placebo
(Placebo)
zazaiwfjqu(huinkgvlkz) = yxnkuicrcu lbggqftjuy (clcvrbstfw, brtomnhbti - tuddflbzza)
Phase 3
403
Placebo
mftwbfcjec(pjpdntyirr) = lqqkjrjxty ylnrrcnmar (xqtaitbhqp )
Positive
01 Dec 2015
cnswjkiknh(ainfbnbheq) = zwtxugrjjk dejceuzbev (mudjzilseu )
Phase 4
46
(Asenapine 5-20 mg Daily)
plvavcbzxy(okeeuvfbka) = kxkajziqeu pmnkctahgv (olfqvvzkhv, fkwrlvpjzi - jdcpughbdq)
-
01 Oct 2015
Placebo 1-4 tablets daily
(Placebo 1-4 Tablets Daily)
plvavcbzxy(okeeuvfbka) = fkghugpvcn pmnkctahgv (olfqvvzkhv, kqghianxhj - raktewlgpm)
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Regulation

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