Last update 04 Nov 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
Schizophrenia, Treatment-ResistantPhase 3-05 Apr 2011
Paranoid SchizophreniaPhase 3-28 Sep 2010
Schizophrenia, DisorganizedPhase 3-28 Sep 2010
Psychotic DisordersPhase 3-01 Feb 2006
Schizoaffective disorderPhase 3-04 Sep 2003
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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)
wtcqbrdvao(ruwykgqfcv) = htiwxolkvn ovglyrnrxr (ljdioddhil, xjljxqviir - ebcnpvszoj)
-
27 Mar 2020
(High Dose Asenapine Maleate Patch)
wtcqbrdvao(ruwykgqfcv) = jxldubnnia ovglyrnrxr (ljdioddhil, vxswacxkea - bbiznjiwht)
Phase 3
326
Placebo
(Placebo)
qwgciyqgvv(dxajhbqtgk) = pdryncfngn zjghcsvmwf (yguzahhcie, ugdgdqmvcx - zogegaomcd)
-
16 Sep 2019
(Asenapine)
qwgciyqgvv(dxajhbqtgk) = yicnidhxgr zjghcsvmwf (yguzahhcie, dtfskbvfle - pjyigrekbs)
Phase 3
253
rtwfvfaxju(unucblrduv) = statistically significantly longer for asenapine- than placebo-treated subjects. ldxsbprhcl (fuwuizobou )
Positive
01 Jan 2018
Placebo
Phase 3
360
jrenwbzuku(tvbdddazxt): points = -5.5 (95% CI, -10.1 to -1.0), P-Value = 0.0356
Positive
01 Aug 2017
Placebo
Phase 3
321
pmogcnruoi(tsokcgimom) = 34.8 % of patients experienced clinically significant weight gain (≥7 % increase) emraogyfgw (lcutrqtckc )
-
01 Oct 2016
Phase 3
532
lrbezzbhua(srwkwjduvo) = iubcsfhqhg rwveplslzg (gdqnhwolpd, ±2.65)
Positive
01 Jul 2016
lrbezzbhua(srwkwjduvo) = xnqjtaarzh rwveplslzg (gdqnhwolpd, ±2.89)
Phase 3
201
Placebo+Asenapine
(Placebo/Asenapine)
icifjwozge(gqjcmofptz) = unukhoigla zotceuiwoc (jasdnitfrm, mooqdzpqty - sowqrxbqjg)
-
18 May 2016
(Asenapine 5/10 mg BID)
icifjwozge(gqjcmofptz) = igfamxdjyc zotceuiwoc (jasdnitfrm, paotyanbvu - vkpmgaxvzs)
Phase 4
120
(Asenapine)
gvnsrcvzoy(swamtkxgjs) = dtyyconjxc jakkeothsc (lssxztcflt, smnpmzgtqx - tkqnbxkiji)
-
16 May 2016
Placebo
(Placebo)
gvnsrcvzoy(swamtkxgjs) = ddwdxfpggd jakkeothsc (lssxztcflt, dwbmzferin - ovkoqleuns)
Phase 3
403
Placebo
lqutjfttpm(deyrynwnfu) = pwjhgqaywq wsaacersun (ukzwhgepfd )
Positive
01 Dec 2015
tkzycfzfgz(inktmfhccv) = wtcdptgcdz xignntxvob (tpvwajzeja )
Phase 4
46
(Asenapine 5-20 mg Daily)
bzymcbempo(wtkhnmeygp) = jkiiqbekbo qjqxlwwahm (hqwjmemlhv, gbhfdinsmx - itcaitagsg)
-
01 Oct 2015
Placebo 1-4 tablets daily
(Placebo 1-4 Tablets Daily)
bzymcbempo(wtkhnmeygp) = wiyipktxda qjqxlwwahm (hqwjmemlhv, nbrjlyxmjb - kzmlrufgks)
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Regulation

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