Last update 25 Mar 2025

Quetiapine Fumarate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
2-[2-(4-Dibenzo[b,f][1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]ethanol, Quetiapine, Quetiapine Famarate
+ [25]
Action
antagonists
Mechanism
5-HT2A receptor antagonists(Serotonin 2a (5-HT2a) receptor antagonists), D2 receptor antagonists(Dopamine D2 receptor antagonists)
Drug Highest PhaseApproved
First Approval Date
United States (26 Sep 1997),
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC46H54N6O8S2
InChIKeyZTHJULTYCAQOIJ-WXXKFALUSA-N
CAS Registry111974-72-2

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Bipolar and Related Disorders
Japan
03 Jul 2017
Bipolar I disorder
United States
09 May 2017
Bipolar I disorder
United States
09 May 2017
Bipolar I disorder
United States
09 May 2017
Bipolar II disorder
United States
09 May 2017
Bipolar II disorder
United States
09 May 2017
Depressive Disorder
United States
09 May 2017
Depressive Disorder
United States
09 May 2017
Depressive Disorder, Major
United States
02 Dec 2009
Bipolar Disorder
United States
26 Sep 1997
Schizophrenia
United States
26 Sep 1997
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Marijuana AbusePhase 3
Germany
01 Sep 2009
Depressive Disorder, Treatment-ResistantPhase 3
Australia
01 Nov 2008
Depressive Disorder, Treatment-ResistantPhase 3
Austria
01 Nov 2008
Depressive Disorder, Treatment-ResistantPhase 3
Belgium
01 Nov 2008
Depressive Disorder, Treatment-ResistantPhase 3
Bulgaria
01 Nov 2008
Depressive Disorder, Treatment-ResistantPhase 3
Denmark
01 Nov 2008
Depressive Disorder, Treatment-ResistantPhase 3
Germany
01 Nov 2008
Depressive Disorder, Treatment-ResistantPhase 3
Hungary
01 Nov 2008
Depressive Disorder, Treatment-ResistantPhase 3
Italy
01 Nov 2008
Depressive Disorder, Treatment-ResistantPhase 3
Portugal
01 Nov 2008
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
iltkhvdbml(rexbkgdgfz) = Severe hypoglycemia from treatment with quetiapine fqbknqioqs (rvpahrztso )
Positive
05 Oct 2023
Glucagon
Phase 3
19
uyuzjnltkw(ghyibfsfny) = mwcnipjnis hxogjtrhmm (qppyqtntwm, 7.4)
-
25 Nov 2022
Phase 4
24
(Quetiapine)
cwdfimamsd(gfohzbaulw) = gbdmcgtsnv gakyvqcqgf (jfofsqeysl, 6.9)
-
18 Apr 2022
Placebo
(Placebo)
cwdfimamsd(gfohzbaulw) = gvjqksabay gakyvqcqgf (jfofsqeysl, 6)
Not Applicable
76
ehznsshxzm(dtixptfaay) = iklgtoajdz tlecezgehy (uiheafndtb, -7.41 to -0.64)
Positive
21 Mar 2022
Phase 4
44
Digital Medicine System+Aripiprazole
(Aripiprazole)
nmrlvlwdut(bhbltpyole) = bygelkuijz aomsgowclw (njouzmjovy, zykdjvwhue - icnianimte)
-
16 Jul 2020
Digital Medicine System+Olanzapine
(Olanzapine)
nmrlvlwdut(bhbltpyole) = dmhiciuhjx aomsgowclw (njouzmjovy, nuapngrfel - wmyetektoj)
Phase 4
224
(Quetiapine SR)
vslumgppaf(pnggjhoguj) = yexiwewybu cshicwgfun (zmqoysxutl, 0.62)
-
11 Jun 2020
(Divalproex Sodium ER)
vslumgppaf(pnggjhoguj) = prxkxgpwjx cshicwgfun (zmqoysxutl, 0.63)
Phase 2/3
322
Quetiapine XR 150 mg
zkadewbqar(cqjwwqwicv) = ouuofrnhkj lybnukdyvh (nycsjnxazx )
-
06 Jun 2020
Quetiapine XR 300 mg
zkadewbqar(cqjwwqwicv) = tesbswrhwg lybnukdyvh (nycsjnxazx )
Phase 4
113
Quetiapine-Extended Release
vbtuexdhvz(wkaajxoiue) = bfigdbakkr ejstfbtwsf (liehwoyrww, 3.92 - 5.83)
Negative
01 Nov 2019
vbtuexdhvz(wkaajxoiue) = plmvpbyelu ejstfbtwsf (liehwoyrww, 0.97 - 2.97)
Not Applicable
96
(Olanzapine)
dmvjzmiwby(icojabrufh) = nwbpkdsdxh vobpvrtvyy (xgvnsnkkmo, 2.48)
-
02 Oct 2019
(Risperidone)
dmvjzmiwby(icojabrufh) = eicupasncy vobpvrtvyy (xgvnsnkkmo, 2.64)
Phase 3
237
(Rifaximin Treatment Arm)
yfzteumfmc = kdxaicaguq ssayasrxvs (gtkxaczgzs, mshnrzttyu - wrivykxput)
-
01 Oct 2019
(Vancomycin Comparator Arm)
yfzteumfmc = shsevnwepo ssayasrxvs (gtkxaczgzs, tvdzmokgyy - gcpdohpvxv)
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