Quetiapine

also known as Seroquel · Quetiapine Fumarate · quetiapine XR · Seroquel-XR · SEROQUEL SR · FK949E · Seroquel SRTM · Quetiapine Fumarate Extended-Release · +12 more

Small molecule

Developed for: schizophrenia · major depressive disorder · bipolar disorder · schizoaffective disorder · bipolar depression · generalized anxiety disorder · depressive disorder · delirium
+46 more
· manic bipolar affective disorder · post-traumatic stress disorder · psychotic disorder · alcohol dependence · bipolar I disorder · insomnia · social phobia · substance-related disorder · Alzheimer disease · anxiety · obsessive-compulsive disorder · bipolar II disorder · dementia · postpartum depression · alcohol abuse · anorexia nervosa · anxiety disorder · attention deficit-hyperactivity disorder · borderline personality disorder · cannabis dependence · fibromyalgia · mood disorder · bowel dysfunction · chronic kidney disease · cocaine dependence · cognitive impairment with or without cerebellar ataxia · drug-induced dyskinesia · dysthymic disorder · methamphetamine dependence · multiple sclerosis · neurotic disorder · obstructive sleep apnea syndrome · panic disorder · Parkinson disease · schizophreniform disorder · sleep disorder, initiating and maintaining sleep · specific phobia · substance abuse · substance dependence · traumatic brain injury · vascular dementia · alcohol-related disorders · COVID-19 · drug-induced akathisia · Lewy body dementia · viral pneumonia
Investigated by: AstraZeneca · Massachusetts General Hospital · National Institute of Mental Health (NIMH) · National Institute on Drug Abuse (NIDA) · University of Cincinnati · Astellas Pharma Inc
+185 more
· H. Lundbeck A/S · Shanghai Mental Health Center · Duke University · Janssen Research & Development, LLC · Janssen, LP · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · New York State Psychiatric Institute · Shanghai Jiao Tong University School of Medicine · US Department of Veterans Affairs · University of California, San Diego · University of Sao Paulo · Centre for Addiction and Mental Health · Conselho Nacional de Desenvolvimento Científico e Tecnológico · Copenhagen Trial Unit, Center for Clinical Intervention Research · Dr Alexander McIntyre Inc. · Dr. Inge Winter · Emory University · Hannover Medical School · Hospital de Clinicas de Porto Alegre · Indiana University · Inje University · National Alliance for Research on Schizophrenia and Depression · National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Region Capital Denmark · Seattle Institute for Biomedical and Clinical Research · Seoul National University Bundang Hospital · Technical University of Munich · The University of Hong Kong · The University of Texas Health Science Center at San Antonio · University of Minnesota · University of Montreal · University of Münster · University of Pennsylvania · University of South Florida · Weill Medical College of Cornell University · AP Moeller Foundation · Abbott · Agency for Healthcare Research and Quality (AHRQ) · Ain Shams University · Air Force Military Medical University, China · Albert Einstein College of Medicine · Alexandria University · Allocated inheritance from Elizabeth Stevn and Niels Rindom, Denmark · Anne Katrine Pagsberg · Arthur P. Noyes Research Foundation · Assiut University · Augusta University · Avon and Wiltshire Mental Health Partnership NHS Trust · BC Women's Hospital & Health Centre · Bayside Health · Beth Israel Medical Center · Biomedical Research Institute of New Mexico · Birte Glenthoj · Boston Medical Center · Cambridge Health Alliance · Canadian Psychiatric Research Foundation · Central Institute of Mental Health, Mannheim · Centro de Investigación Biomédica en Red de Salud Mental · Chiang Mai University · Copenhagen Hospital Corporation · Copenhagen University Hospital, Hvidovre · Corporation de Recherche en Neuropsycho Pharmacologie de Quebec · Creighton University · Dalian Seventh People's Hospital · Danish Center for Sleep Medicine · Dartmouth-Hitchcock Medical Center · Dr Rabia Arshad · Eli Lilly and Company · Ewha Womans University · Federal Stare Budgetary Scientific Institution, Mental Health Research Center · Federal State Budgetary Institution V.M. Bekhterev National Research Medical Center for Psychiatry and Neurology, Saint-Petersburg, Russia · Federal University of Rio Grande do Sul · First Affiliated Hospital of Jinan University · First Affiliated Hospital of Zhejiang University · all 191 on the full record

Regulatory milestones approvals, filings & regulatory actions · 8 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed bipolar disorder 1 milestone
Filed	Japan (PMDA)	—	bipolar disorder	2016-08-09	“it submitted a new drug application to the Ministry of Health, Labour and Welfare in Japan for extended-release tablets of quetiapine fumarate” astellas.com ↗
Approved Indication not stated 3 milestones
Label expansions (5)	US (FDA)	SEROQUEL	—	2004-01-12 – 2013-04-30	fda.gov ↗
Label expansion	US (FDA)	SEROQUEL XR	—	2008-10-08	fda.gov ↗
Approved	US (FDA)	SEROQUEL	—	1997-09-26	fda.gov ↗

Trials 236 · started per year

today

US approved 1997

19971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 03 trials
Phase 0	NCT04280965	Feb 2019 → Apr 2022	post-traumatic stress disorder	The University of Texas Health Science Center at San Antonio	Completed	No outcome recorded
Phase 0	NCT00606541	Jan 2008 → Dec 2011	social phobia	Duke University	Terminated	No outcome recorded
Phase 0	NCT00567866	Jan 2008 → Sep 2009	methamphetamine dependence	University of Arkansas	Terminated	No outcome recorded Stop: Business
Phase 116 trials · 1 met primary
Phase 1	NCT05240261	May 2022 → May 2024	chronic kidney disease	Assiut University	Unknown	No outcome recorded
Phase 1	NCT04950868	Mar 2022 → Jun 2025 overdue	postpartum depression	Verinder Sharma	Active not recruiting	No outcome recorded
Phase 1	NCT03872596	Mar → Oct 2019	bipolar disorder, schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 1	NCT02901587	Sep 2016 → Apr 2018	schizoaffective disorder, schizophrenia	H. Lundbeck A/S	Completed	No outcome recorded
Phase 1	NCT02131545	Jun 2014 → Jul 2016	delirium, dementia	Mayo Clinic	Completed	No outcome recorded
Phase 1	NCT02087579	Feb → Oct 2014	bipolar disorder, depressive disorder, schizophrenia	Janssen Research & Development, LLC	Completed	No outcome recorded
Phase 1	NCT02051387	Jan 2013 → Aug 2017	schizophrenia	Central Institute of Mental Health, Mannheim	Completed	No outcome recorded
Phase 1	NCT01871701	Nov 2012 → May 2014	—	Seoul National University Hospital	Completed	No outcome recorded
Phase 1	NCT01607762	Feb → Apr 2012	—	Janssen Research & Development, LLC	Completed	No outcome recorded
Phase 1	NCT01908296	Jul → Aug 2011	—	Astellas Pharma Inc	Completed	No outcome recorded
Phase 1	NCT01903200	Feb 2010 → Sep 2011	major depressive disorder	Astellas Pharma Inc	Completed	No outcome recorded
Phase 1	NCT00919607	Jun 2009 → Mar 2010	schizophrenia	AstraZeneca	Completed	No outcome recorded
Phase 1	NCT01871974	May 2009 → Mar 2010	major depressive disorder	Astellas Pharma Inc	Completed	No outcome recorded
Phase 1	NCT00702676	Jul → Aug 2008	—	AstraZeneca	Completed	Met primary
Phase 1	NCT00087750	Oct 2003 → ?	substance-related disorder	National Institute on Drug Abuse (NIDA)	Unknown	No outcome recorded
Phase 1	NCT00255879	Jan 1999 → Aug 2004	drug-induced dyskinesia	University of California, San Diego	Completed	No outcome recorded

Phase 1/23 trials
Phase 1/2	NCT02056171	Mar 2015 → Dec 2016	delirium	Weill Medical College of Cornell University	Terminated	No outcome recorded Stop: Enrollment
Phase 1/2	NCT02087631	Dec 2014 → Jul 2019	multiple sclerosis	University of Calgary	Completed	No outcome recorded
Phase 1/2	NCT02650102	Jan 2013 → Dec 2016	schizophrenia	Shanxi Medical University	Unknown	No outcome recorded
Phase 220 trials · 2 met primary · 2 missed
Phase 2	NCT07152184	Oct 2026 → Feb 2032 expected	schizophrenia	University Hospital, Strasbourg, France	Not yet recruiting	No outcome recorded
Phase 2	NCT05793632	Mar → Apr 2023	delirium	Ain Shams University	Completed	No outcome recorded
Phase 2	NCT05303935	May 2022 → Apr 2023	obstructive sleep apnea syndrome	Flinders University	Completed	Met primary
Phase 2	NCT02462473	May 2015 → Jan 2016	schizoaffective disorder, schizophrenia	Janssen Research & Development, LLC	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT01697709	Oct 2012 → Apr 2017	cannabis dependence	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 2	NCT01189318	Mar 2012 → Feb 2014	major depressive disorder	Ewha Womans University	Withdrawn	No outcome recorded
Phase 2	NCT01725282	Dec 2011 → Aug 2013	major depressive disorder	Astellas Pharma Inc	Completed	No outcome recorded
Phase 2	NCT00954681	Aug 2009 → Aug 2010	cannabis dependence	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 2	NCT00872716	Apr 2009 → Mar 2011	specific phobia	University Hospital Muenster	Completed	No outcome recorded
Phase 2	NCT00743366	Aug 2008 → Mar 2009	—	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 2	NCT00674765	Jan 2008 → Jan 2013	alcohol dependence	University of Pennsylvania	Completed	Missed primary
Phase 2	NCT00622245	Jan 2008 → Jan 2009	bipolar depression	H. Lundbeck A/S	Terminated	No outcome recorded
Phase 2	NCT00498628	Dec 2007 → Aug 2009	alcohol abuse, alcohol dependence	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Completed	Missed primary
Phase 2	NCT00681668	Aug 2007 → Oct 2008	postpartum depression	AstraZeneca	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00584688	Feb 2007 → Jun 2009	anorexia nervosa	University of South Florida	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00733668	Mar 2006 → Nov 2007	major depressive disorder	AstraZeneca	Completed	No outcome recorded
Phase 2	NCT00254787	Jun 2005 → Jan 2006	schizophrenia	AstraZeneca	Completed	No outcome recorded
Phase 2	NCT00254748	Jun 2004 → Jun 2007	borderline personality disorder	AstraZeneca	Completed	No outcome recorded
Phase 2	NCT00550147	Feb 2004 → Nov 2005	attention deficit-hyperactivity disorder	Indiana University	Completed	Met primary
Phase 2	NCT00318539	Dec 2003 → Aug 2006	obsessive-compulsive disorder	AstraZeneca	Completed	No outcome recorded

Phase 2/35 trials
Phase 2/3	NCT06062953	Sep 2023 → Feb 2029 expected	insomnia, psychiatric disorder	Lone Baandrup	Recruiting	No outcome recorded
Phase 2/3	NCT03572257	Apr 2019 → Feb 2020	delirium	Medical College of Wisconsin	Withdrawn	No outcome recorded Stop: Enrollment
Phase 2/3	NCT00411463	Dec 2006 → Sep 2010	bipolar II disorder	University of Pittsburgh	Completed	No outcome recorded
Phase 2/3	NCT00297947	Dec 2004 → Oct 2014	schizoaffective disorder, schizophrenia	Manhattan Psychiatric Center	Completed	No outcome recorded
Phase 2/3	NCT00215254	Mar 2004 → Feb 2006	social phobia	Duke University	Completed	No outcome recorded
Phase 388 trials · 23 met primary · 6 missed
Phase 3	NCT05603104	Apr 2025 → Jun 2028 expected	bipolar depression, major depressive disorder, schizophrenia	Dr. Inge Winter	Recruiting	No outcome recorded
Phase 3	NCT05973786	Feb 2025 → Jun 2028 expected	bipolar depression	Dr. Inge Winter	Recruiting	No outcome recorded
Phase 3	NCT06333990	Jul 2024 → Jun 2028 expected	traumatic brain injury	Foundation for Advancing Veterans' Health Research	Recruiting	No outcome recorded
Phase 3	NCT05690698	Apr → Jul 2023	delirium	Alexandria University	Completed	No outcome recorded
Phase 3	NCT03739476	Feb 2019 → Apr 2020	delirium	Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT02374567	Jan 2015 → Jun 2017	anxiety disorder, dementia, depressive disorder, schizophrenia +1	Hannover Medical School	Terminated	No outcome recorded
Phase 3	NCT01858948	Jul 2013 → Apr 2018	—	University of Cincinnati	Completed	No outcome recorded
Phase 3	NCT01810380	Mar 2013 → Dec 2014	schizophrenia	H. Lundbeck A/S	Completed	Missed primary
Phase 3	NCT01811459	Feb 2013 → Sep 2016	delirium	University of Montreal Hospital Centre (CHUM)	Completed	No outcome recorded
Phase 3	NCT01765829	Nov 2012 → Nov 2015	psychotic disorder	Fundación Pública Andaluza Progreso y Salud	Unknown	No outcome recorded
Phase 3	NCT01256177	Dec 2010 → Nov 2012	bipolar depression	AstraZeneca	Completed	Met primary
Phase 3	NCT01197846	Sep 2010 → Feb 2012	bipolar disorder	Centro de Investigación Biomédica en Red de Salud Mental	Completed	No outcome recorded
Phase 3	NCT00953108	Sep 2009 → Feb 2012	major depressive disorder	Ludwig-Maximilians - University of Munich	Completed	No outcome recorded
Phase 3	NCT01071135	Sep 2009 → Aug 2010	schizophrenia	Hannover Medical School	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00954603	Jun 2009 → Apr 2011	delirium	Chiang Mai University	Terminated	Missed primary Stop: Enrollment
Phase 3	NCT00857584	May 2009 → Feb 2011	bipolar depression	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00882518	Apr 2009 → Jul 2010	schizophrenia	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00883493	Apr 2009 → Mar 2011	bipolar depression	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00879307	Mar 2009 → Sep 2011	bipolar disorder	Hospital de Clinicas de Porto Alegre	Unknown	No outcome recorded
Phase 3	NCT00852631	Feb 2009 → May 2010	schizophrenia	AstraZeneca	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00811473	Jan 2009 → Nov 2010	bipolar depression	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT01672554	Dec 2008 → Apr 2012	anxiety, schizophrenia	Corporation de Recherche en Neuropsycho Pharmacologie de Quebec	Unknown	No outcome recorded
Phase 3	NCT02142556	Nov 2008 → Mar 2012	schizophrenia	Tri-Service General Hospital (TSGH)	Completed	No outcome recorded
Phase 3	NCT00782405	Oct 2008 → Apr 2011	—	Technical University of Munich	Completed	No outcome recorded
Phase 3	NCT00660595	Sep → Dec 2008	schizophrenia	AstraZeneca	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00751504	Sep 2008 → Jul 2012	psychotic disorder	Ruhr University of Bochum	Completed	No outcome recorded
Phase 3	NCT00868374	Jun 2008 → Oct 2011	generalized anxiety disorder, major depressive disorder	Keming Gao	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00671853	Apr 2008 → Mar 2011	anxiety, bipolar disorder, substance-related disorder	University Hospitals Cleveland Medical Center	Completed	Missed primary
Phase 3	NCT00640601	Mar 2008 → Jul 2010	schizophrenia	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00640562	Feb 2008 → Feb 2010	depressive disorder, schizophrenia	AstraZeneca	Completed	Met primary
Phase 3	NCT00434876	Aug 2007 → Nov 2009	alcohol dependence, sleep disorder, initiating and maintaining sleep	Subhajit Chakravorty	Completed	Missed primary
Phase 3	NCT00534599	Aug 2007 → Sep 2008	anxiety, neurotic disorder	AstraZeneca	Completed	Missed primary
Phase 3	NCT00457899	Jul → Sep 2007	schizoaffective disorder, schizophrenia	AstraZeneca	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00486798	May → Aug 2007	bipolar disorder, schizophrenia	AstraZeneca	Terminated	No outcome recorded
Phase 3	NCT00422123	Jan → Jul 2007	manic bipolar affective disorder	AstraZeneca	Completed	Met primary
Phase 3	NCT00422214	Dec 2006 → Jun 2007	bipolar depression, manic bipolar affective disorder	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00347425	Dec 2006 → Feb 2008	schizophrenia	Solvay Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00388973	Sep 2006 → Dec 2007	major depressive disorder	AstraZeneca	Completed	Met primary
Phase 3	NCT00389064	Sep 2006 → Apr 2008	generalized anxiety disorder	AstraZeneca	Completed	Met primary
Phase 3	NCT00302770	Jun → Dec 2006	social phobia	AstraZeneca	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00351910	May 2006 → Apr 2007	major depressive disorder	AstraZeneca	Completed	Met primary
Phase 3	NCT00322595	May 2006 → May 2007	generalized anxiety disorder	AstraZeneca	Completed	Met primary
Phase 3	NCT00351169	May 2006 → Jun 2007	major depressive disorder	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00329264	Apr 2006 → Aug 2007	generalized anxiety disorder	AstraZeneca	Completed	Met primary
Phase 3	NCT00321490	Apr 2006 → May 2007	major depressive disorder	AstraZeneca	Completed	Met primary
Phase 3	NCT00329446	Apr 2006 → Sep 2007	generalized anxiety disorder	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00320268	Apr 2006 → May 2007	major depressive disorder	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00326144	Apr 2006 → May 2007	major depressive disorder	AstraZeneca	Completed	Met primary
Phase 3	NCT00334126	Apr 2006 → Sep 2007	schizophrenia	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Completed	No outcome recorded
Phase 3	NCT00326105	Apr 2006 → Jul 2007	major depressive disorder	AstraZeneca	Completed	Met primary
Phase 3	NCT00314210	Mar 2006 → Aug 2007	anxiety disorder	AstraZeneca	Completed	Met primary
Phase 3	NCT00114686	Jan 2006 → Apr 2007	alcohol dependence, bipolar I disorder	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00278941	Dec 2005 → Aug 2007	major depressive disorder	AstraZeneca	Completed	Met primary
Phase 3	NCT00232414	Oct 2005 → Dec 2007	bipolar I disorder	University of Cincinnati	Completed	No outcome recorded
Phase 3	NCT00448578	Aug 2005 → Jun 2006	manic bipolar affective disorder	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00174603	Aug 2005 → Jan 2007	major depressive disorder	Rush University Medical Center	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00206141	Aug 2005 → May 2007	bipolar depression	AstraZeneca	Completed	Met primary
Phase 3	NCT00119652	May 2005 → May 2007	bipolar depression	AstraZeneca	Completed	Met primary
Phase 3	NCT00122070	May 2005 → Sep 2007	borderline personality disorder	University of Medicine and Dentistry of New Jersey	Completed	No outcome recorded
Phase 3	NCT00314184	Mar 2005 → Jul 2007	bipolar disorder	AstraZeneca	Completed	Met primary
Phase 3	NCT00228462	Mar 2005 → Apr 2006	schizophrenia	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00306540	Dec 2004 → Sep 2007	post-traumatic stress disorder	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00206115	Nov 2004 → Dec 2005	schizophrenia	AstraZeneca	Completed	Met primary
Phase 3	NCT00206128	Nov 2004 → Feb 2006	schizophrenia	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00234377	Nov 2004 → May 2006	schizophrenia	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00254813	Oct 2004 → Sep 2005	psychotic disorder	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00097032	Oct 2004 → May 2005	bipolar disorder	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Completed	Met primary
Phase 3	NCT00090324	Sep 2004 → Jun 2007	schizophrenia	AstraZeneca	Completed	Met primary
Phase 3	NCT00227305	Aug 2004 → Dec 2007	bipolar I disorder, schizophrenia	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00304473	Aug 2004 → Apr 2006	schizophrenia	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00090311	Jul 2004 → Jul 2006	bipolar disorder	AstraZeneca	Completed	Met primary
Phase 3	NCT00085891	Jun 2004 → Sep 2005	schizophrenia	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00083954	Jun 2004 → Aug 2005	bipolar disorder	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00252226	Jun 2004 → Dec 2007	bipolar disorder	Mood Disorders Center of Ottawa	Completed	No outcome recorded
Phase 3	NCT00107731	Apr 2004 → Oct 2006	bipolar I disorder	AstraZeneca	Completed	Met primary
Phase 3	NCT00081380	Mar 2004 → Sep 2006	bipolar disorder	AstraZeneca	Completed	Met primary
Phase 3	NCT00277667	Feb 2004 → Dec 2007	bipolar disorder	Lindner Center of HOPE	Completed	Missed primary
Phase 3	NCT00161018	Nov 2003 → Nov 2004	schizophrenia	University of Maryland, Baltimore	Completed	No outcome recorded
Phase 3	NCT00328978	Oct 2003 → Sep 2005	schizoaffective disorder, schizophrenia	AstraZeneca	Completed	Met primary
Phase 3	NCT00449397	Jul 2003 → Jan 2006	psychotic disorder	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00221468	Jun 2003 → Apr 2006	mood disorder	University of Cincinnati	Completed	No outcome recorded
Phase 3	NCT00124059	Mar 2003 → Sep 2005	alcohol dependence	University of Pennsylvania	Completed	No outcome recorded
Phase 3	NCT00060489	Sep 2002 → Sep 2003	bipolar depression	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00621647	Sep 2002 → Nov 2003	Alzheimer disease, vascular dementia	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00254735	Apr 2002 → Mar 2006	obsessive-compulsive disorder	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00254774	Jan 2002 → Mar 2006	bipolar disorder	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00159770	Nov 2001 → Sep 2004	schizoaffective disorder, schizophrenia	Viatris Inc.	Completed	No outcome recorded
Phase 3	NCT00305422	Nov 2001 → Jan 2003	schizophrenia	AstraZeneca	Completed	No outcome recorded

Phase 476 trials · 6 met primary · 4 missed
Phase 4	NCT06433635	Oct 2024 → Feb 2030 expected	bipolar I disorder, depressive disorder	Massachusetts General Hospital	Active not recruiting	No outcome recorded
Phase 4	NCT04446234	May 2021 → Dec 2022	schizophrenia	Shanghai Mental Health Center	Unknown	No outcome recorded
Phase 4	NCT02845453	Jan 2017 → Apr 2021	bipolar disorder, substance-related disorder	Boston Medical Center	Completed	No outcome recorded
Phase 4	NCT03004521	Nov 2016 → Apr 2021	mood disorder	King's College London	Unknown	No outcome recorded
Phase 4	NCT02307396	Feb 2015 → Jun 2016	schizoaffective disorder, schizophrenia	Technical University of Munich	Completed	No outcome recorded
Phase 4	NCT01893229	Sep 2013 → Dec 2015	bipolar disorder	Guiyun Xu	Unknown	No outcome recorded
Phase 4	NCT01938859	Jun 2012 → Dec 2017	bipolar disorder	Shanghai Mental Health Center	Unknown	No outcome recorded
Phase 4	NCT01357967	May 2011 → Dec 2012	major depressive disorder	Inje University	Unknown	No outcome recorded
Phase 4	NCT01254721	Dec 2010 → Oct 2012	manic bipolar affective disorder	AstraZeneca	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01250847	Nov 2010 → Oct 2011	schizophrenia	Severance Hospital	Unknown	No outcome recorded
Phase 4	NCT01331304	Sep 2010 → Apr 2013	bipolar disorder	Massachusetts General Hospital	Completed	Missed primary
Phase 4	NCT01213121	Sep 2010 → Oct 2014	bipolar depression	Seoul National University Bundang Hospital	Unknown	No outcome recorded
Phase 4	NCT01133821	Aug 2010 → Oct 2015	bipolar II disorder, depressive disorder	Holly Swartz	Completed	Met primary
Phase 4	NCT01128114	Jun 2010 → Mar 2011	manic bipolar affective disorder	AstraZeneca	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01119014	May 2010 → Jul 2015	psychotic disorder	Anne Katrine Pagsberg	Completed	Missed primary
Phase 4	NCT01164059	Feb 2010 → Aug 2013	schizophrenia	University of Bremen	Completed	Mixed
Phase 4	NCT00746421	Jan 2010 → Apr 2012	bipolar disorder, cognitive impairment with or without cerebellar ataxia	Emory University	Terminated	No outcome recorded Stop: Business
Phase 4	NCT00986167	Oct 2009 → Oct 2010	schizophrenia	Bayside Health	Unknown	No outcome recorded
Phase 4	NCT00954122	Sep 2009 → Mar 2010	schizophrenia	AstraZeneca	Completed	No outcome recorded
Phase 4	NCT00951483	Jul 2009 → Oct 2011	anxiety, depressive disorder	Loyola University	Completed	No outcome recorded
Phase 4	NCT00892463	May 2009 → Dec 2010	major depressive disorder	Sunnybrook Health Sciences Centre	Completed	No outcome recorded
Phase 4	NCT01016145	Apr 2009 → Jun 2010	psychotic disorder	University of Sao Paulo	Unknown	No outcome recorded
Phase 4	NCT00982345	Mar 2009 → Mar 2012	major depressive disorder	Indiana University	Completed	No outcome recorded
Phase 4	NCT00817648	Dec 2008 → May 2010	schizophrenia	Shanghai Mental Health Center	Completed	No outcome recorded
Phase 4	NCT00837343	Dec 2008 → Oct 2010	bipolar disorder	Guangzhou Mental Hospital	Unknown	No outcome recorded
Phase 4	NCT00766350	Nov 2008 → Mar 2010	fibromyalgia	University of Granada	Completed	No outcome recorded
Phase 4	NCT00779506	Nov 2008 → Jul 2009	schizophrenia	AstraZeneca	Completed	No outcome recorded
Phase 4	NCT01200901	Sep 2008 → Sep 2012	depressive disorder	University of Cincinnati	Completed	No outcome recorded
Phase 4	NCT00955474	Sep 2008 → Jan 2013	major depressive disorder	Massachusetts General Hospital	Terminated	No outcome recorded Stop: Business
Phase 4	NCT01244711	Sep 2008 → Sep 2011	generalized anxiety disorder, major depressive disorder	Weill Medical College of Cornell University	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT00838032	Aug 2008 → May 2010	schizophrenia	Sichuan University	Unknown	No outcome recorded
Phase 4	NCT00186043	Aug 2008 → Aug 2011	bipolar II disorder	Stanford University	Completed	No outcome recorded
Phase 4	NCT00521365	May 2008 → Aug 2009	manic bipolar affective disorder	AstraZeneca	Completed	No outcome recorded
Phase 4	NCT00253266	Apr 2008 → Apr 2014	depressive disorder	Max-Planck-Institute of Psychiatry	Completed	No outcome recorded
Phase 4	NCT00983320	Apr 2008 → Oct 2011	fibromyalgia	University of Sherbrooke	Completed	No outcome recorded
Phase 4	NCT00672490	Apr 2008 → Jul 2009	manic bipolar affective disorder	AstraZeneca	Completed	No outcome recorded
Phase 4	NCT01000402	Feb 2008 → Oct 2012	attention deficit-hyperactivity disorder, bipolar disorder	Federal University of Rio Grande do Sul	Unknown	No outcome recorded
Phase 4	NCT00668265	Jan 2008 → Aug 2011	generalized anxiety disorder, opiate dependence	Beth Israel Medical Center	Terminated	No outcome recorded Stop: Business
Phase 4	NCT00511277	Aug 2007 → Oct 2010	schizophrenia	Institute of Application-oriented Research and Clinical Trials GmbH	Completed	No outcome recorded
Phase 4	NCT00498004	Aug 2007 → Sep 2008	schizophrenia	Inje University	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT00723970	Jun 2007 → May 2009	insomnia, major depressive disorder	McMaster University	Completed	No outcome recorded
Phase 4	NCT00466609	May 2007 → Mar 2010	obsessive-compulsive disorder	University of Sao Paulo	Completed	Missed primary
Phase 4	NCT00370500	Apr 2007 → Jul 2008	schizophrenia	University of Erlangen-Nürnberg Medical School	Completed	No outcome recorded
Phase 4	NCT00675896	Apr 2007 → Jun 2011	major depressive disorder	Dr Alexander McIntyre Inc.	Completed	Met primary
Phase 4	NCT00797927	Jan 2007 → Mar 2009	schizophrenia	National Taiwan University Hospital	Completed	No outcome recorded
Phase 4	NCT00428350	Dec 2006 → Sep 2007	schizophrenia	AstraZeneca	Completed	No outcome recorded
Phase 4	NCT00407199	Dec 2006 → Sep 2007	social phobia	University of Minnesota	Completed	Missed primary
Phase 4	NCT03207438	Apr 2006 → Jul 2007	major depressive disorder	University of Saskatchewan	Completed	Mixed
Phase 4	NCT00854919	Jan 2006 → Dec 2007	—	Osaka City University	Completed	No outcome recorded
Phase 4	NCT00292370	Jan 2006 → Dec 2008	combat disorder, post-traumatic stress disorder	VA Office of Research and Development	Completed	Met primary
Phase 4	NCT00564564	Jan 2006 → Dec 2007	obsessive-compulsive disorder	University of Sao Paulo	Completed	No outcome recorded
Phase 4	NCT00255515	Sep 2005 → Dec 2007	schizophrenia	AstraZeneca	Completed	No outcome recorded
Phase 4	NCT00139074	Jul 2005 → Jun 2006	bipolar disorder	AstraZeneca	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT00181883	Feb 2005 → Apr 2009	manic bipolar affective disorder	Massachusetts General Hospital	Completed	No outcome recorded
Phase 4	NCT00090012	Jul 2004 → Mar 2006	schizoaffective disorder, schizophrenia	Eli Lilly and Company	Completed	No outcome recorded
Phase 4	NCT00214578	Apr 2004 → Oct 2005	schizophrenia	AstraZeneca	Completed	Met primary
Phase 4	NCT00156715	Mar 2004 → Sep 2006	alcohol abuse, schizoaffective disorder, schizophrenia	Dartmouth-Hitchcock Medical Center	Completed	No outcome recorded
Phase 4	NCT00113295	Feb 2004 → Feb 2007	generalized anxiety disorder	Massachusetts General Hospital	Completed	Met primary
Phase 4	NCT00229645	Nov 2003 → Apr 2005	major depressive disorder	Dr Alexander McIntyre Inc.	Completed	No outcome recorded
Phase 4	NCT00208143	Nov 2003 → Dec 2005	schizoaffective disorder, schizophrenia, substance abuse, substance dependence	Creighton University	Completed	No outcome recorded
Phase 4	NCT00232336	Oct 2003 → Jan 2006	substance-related disorder	Seattle Institute for Biomedical and Clinical Research	Completed	No outcome recorded
Phase 4	NCT00182442	Oct 2003 → Mar 2006	schizophrenia	Hamilton Health Sciences Corporation	Completed	No outcome recorded
Phase 4	NCT00208819	Sep 2003 → Jul 2007	Alzheimer disease	Emory University	Completed	No outcome recorded
Phase 4	NCT00206102	Sep 2003 → Oct 2008	schizoaffective disorder, schizophrenia	AstraZeneca	Completed	No outcome recorded
Phase 4	NCT00334035	Aug 2003 → Jun 2007	schizophrenia	The University of Hong Kong	Completed	Met primary
Phase 4	NCT00237393	Aug 2003 → Dec 2007	post-traumatic stress disorder	Ralph H. Johnson VA Medical Center	Completed	No outcome recorded
Phase 4	NCT00061802	Jun 2003 → Feb 2004	schizoaffective disorder, schizophrenia	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Completed	No outcome recorded
Phase 4	NCT00048802	Aug 2002 → Aug 2006	bipolar disorder	Northwell Health	Completed	No outcome recorded
Phase 4	NCT00043849	Jul 2002 → Jun 2005	Parkinson disease, dementia	National Institute on Aging (NIA)	Completed	No outcome recorded
Phase 4	NCT00254241	May 2002 → Jun 2006	schizophrenia	AstraZeneca	Completed	No outcome recorded
Phase 4	NCT00034905	Jul 2001 → Sep 2002	schizophrenia	AstraZeneca	Completed	No outcome recorded
Phase 4	NCT00182013	Jun 2001 → Feb 2004	bipolar disorder	Massachusetts General Hospital	Completed	No outcome recorded
Phase 4	NCT00014001	Dec 2000 → Dec 2004	schizophrenia	National Institute of Mental Health (NIMH)	Completed	Mixed
Phase 4	NCT00018668	Oct 2000 → Sep 2004	schizophrenia	US Department of Veterans Affairs	Completed	No outcome recorded
Phase 4	NCT00237861	? → Dec 2002	schizophrenia	Yale University	Completed	No outcome recorded
Phase 4	NCT00295412	—	schizophrenia, substance-related disorder	University of Montreal	Completed	No outcome recorded

Phase not applicable25 trials · 1 met primary · 3 missed
—	NCT04728581	Jan 2024 → May 2026 overdue	insomnia, osteoarthritis, knee	St. Anna Ziekenhuis, Geldrop, Netherlands	Not yet recruiting	No outcome recorded
—	NCT05480150	Nov 2021 → Dec 2026 expected	bipolar disorder, major depressive disorder	First Affiliated Hospital of Zhejiang University	Recruiting	No outcome recorded
—	NCT05098353	Apr → Nov 2021	bipolar disorder	Federal Stare Budgetary Scientific Institution, Mental Health Research Center	Unknown	No outcome recorded
—	NCT06200584	Jan → Jun 2021	poisoning	Dr Rabia Arshad	Completed	No outcome recorded
—	NCT04209166	Aug 2019 → Oct 2022	major depressive disorder	Shanghai Mental Health Center	Unknown	No outcome recorded
—	NCT02451306	Jun 2015 → May 2017	bipolar disorder, depressive disorder	RWTH Aachen University	Unknown	No outcome recorded
—	NCT03019887	Apr 2011 → Jan 2017	schizophrenia	Juntendo University	Completed	No outcome recorded
—	NCT01066156	Feb 2010 → Mar 2015	post-traumatic stress disorder	Cambridge Health Alliance	Completed	No outcome recorded
—	NCT01971203	Sep 2009 → Jun 2013	generalized anxiety disorder, major depressive disorder	Icahn School of Medicine at Mount Sinai	Completed	No outcome recorded
—	NCT00688818	Jun 2008 → Jun 2013	dysthymic disorder, generalized anxiety disorder, major depressive disorder, panic disorder +2	Centre for Addiction and Mental Health	Completed	Met primary
—	NCT01527448	Apr 2008 → Jul 2010	postpartum depression	BC Women's Hospital & Health Centre	Completed	No outcome recorded
—	NCT00742638	Mar 2008 → May 2010	bipolar disorder	Shanghai Jiao Tong University School of Medicine	Unknown	No outcome recorded
—	NCT00642369	Mar 2008 → Jul 2009	schizophrenia	Guang Dong Provincial Mental Health Institute	Completed	No outcome recorded
—	NCT00631748	Feb 2008 → Jul 2010	cocaine abuse, cocaine dependence	Seattle Institute for Biomedical and Clinical Research	Completed	No outcome recorded
—	NCT00617396	Feb 2008 → Jan 2012	bowel dysfunction	University of North Carolina, Chapel Hill	Completed	No outcome recorded
—	NCT00631722	May 2007 → Jan 2008	schizophrenia	Peking University	Completed	No outcome recorded
—	NCT00328822	Dec 2006 → Aug 2007	insomnia	Khon Kaen University	Completed	Missed primary
—	NCT00493233	Nov 2006 → Dec 2008	schizophrenia	Centre for Addiction and Mental Health	Completed	No outcome recorded
—	NCT00518973	Jul 2006 → May 2010	anorexia nervosa	University of California, San Diego	Completed	Missed primary
—	NCT00232570	Nov 2005 → Dec 2009	Alzheimer disease, insomnia	University of Vermont	Unknown	No outcome recorded
—	NCT00207064	Apr 2004 → Sep 2008	schizophrenia	Birte Glenthoj	Completed	No outcome recorded
—	NCT00231101	Jan 2004 → Jun 2006	—	Arthur P. Noyes Research Foundation	Unknown	No outcome recorded
—	NCT00222495	Aug 2002 → Aug 2006	schizoaffective disorder, schizophrenia, schizophreniform disorder	University of Minnesota	Completed	No outcome recorded
—	NCT00015548	Mar 2001 → Oct 2004	Alzheimer disease	National Institute of Mental Health (NIMH)	Completed	Missed primary
—	NCT00018642	Apr 1997 → Mar 2002	schizoaffective disorder, schizophrenia	US Department of Veterans Affairs	Completed	No outcome recorded

Comparator or background therapy116 trials
Phase 0	NCT06546358 Comparator	Sep 2024 → Sep 2025 overdue	postpartum depression	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	Not yet recruiting	No outcome recorded
Phase 1	NCT05542264 Comparator	Nov 2022 → Feb 2024	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 1	NCT05402111 Comparator	Jun 2022 → Sep 2023	schizophrenia	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 1	NCT04310579 Comparator	Jun 2020 → May 2021	respiratory underresponsiveness to hypoxia and hypercapnia	Food and Drug Administration (FDA)	Completed	No outcome recorded
Phase 1	NCT03565068 Background	Jun 2018 → Apr 2020	schizophrenia	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Show all 116 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 24

Date	Issuer	Release
2025-09-22	Janssen Research & Development, LLC	Results Johnson & Johnson’s investigational seltorexant shows numerically higher response in patients with depression with insomnia symptoms, with fewer side effects compared to quetiapine XR jnj.com ↗ Seltorexant and quetiapine XR showed large and clinically meaningful improvements in depressive symptoms (-23.0 and -22.7, respectively), as measured by change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from baseline.
2025-09-15	Janssen Research & Development, LLC	Results Johnson & Johnson to showcase industry-leading neuropsychiatry innovations at the 2025 Psych Congress Annual Meeting jnj.com ↗
2023-10-04	Janssen Research & Development, LLC	Results SPRAVATO® (esketamine) Demonstrates Superior Efficacy Compared to Quetiapine Extended-Release in Treatment-Resistant Major Depressive Disorder jnj.com ↗ SPRAVATO®-treated patients were also 1.55 times as likely to stay relapse-free up to 32 weeks after achieving remission at Week 8, without treatment discontinuation, in comparison to those treated with quetiapine XR (21.7% vs. 14.1%, respectively).
2017-05-18	Lupin Limited	Regulatory Lupin receives FDA approval for generic Seroquel XR® Tablets lupin.com ↗ Lupin Limited (Lupin) announced today that it has received final approval for its Quetiapine Fumarate Extended-Release Tablets
2016-08-09	Astellas Pharma Inc	Regulatory Astellas Submits New Drug Application for Extended-Release Tablets of Quetiapine Fumarate in Japan astellas.com ↗ Astellas Submits New Drug Application for Extended-Release Tablets of Quetiapine Fumarate in Japan
2012-03-28	Sun Pharmaceutical Industries, Inc.	Regulatory Sun Pharma announces USFDA approval for generic Seroquel® tablets sunpharma.com ↗ Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) for generic version of Seroquel®, Quetiapine Fumarate Tablets, in multiple strengths.
2012-03-09	AstraZeneca	Regulatory FDA responds to AstraZeneca Citizen Petitions on quetiapine product labelling astrazeneca.com ↗ Friday, 9 March 2012 AstraZeneca today announced that on 7 March 2012, the FDA denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labelling that omits certain hyperglycaemia warning language that the FDA required AstraZeneca to include in the labelling for SEROQUEL® (quetiapine fumarate) and SEROQUEL XR® (quetiapine fumarate).
2010-09-02	AstraZeneca	Regulatory European Commission Issues Positive Decision for Approval of Seroquel XR as an Add-On Treatment of Major Depressive Disorder astrazeneca.com ↗ AstraZeneca today announced that the European Commission (EC) has issued a positive decision for the approval of once-daily SEROQUEL XR (quetiapine fumarate) Extended Release Tablets as an add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy.
2010-04-23	AstraZeneca	Regulatory Seroquel XR Recommended For Approval In EU as an Add-On Treatment Of Major Depressive Disorder astrazeneca.com ↗ The EMA will now forward the opinion of the CHMP to the European Commission (EC) for their final decision, which will then be implemented in the individual Member States affected.
2009-12-04	AstraZeneca	Regulatory US FDA Approves Seroquel XR For Add-On Treatment Of Major Depressive Disorder astrazeneca.com ↗ AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR (quetiapine fumarate) Extended Release Tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder (MDD).
2009-12-04	AstraZeneca	Regulatory US FDA Approves Seroquel For The Paediatric Treatment Of Schizophrenia And Bipolar Mania astrazeneca.com ↗ AstraZeneca today announced that the US Food and Drug Administration (FDA) approved SEROQUEL (quetiapine fumarate) Tablets
2009-09-29	AstraZeneca	Regulatory Seroquel XR and Seroquel Approved in Europe for Prevention of Recurrence of Bipolar Disorder astrazeneca.com ↗ SEROQUEL XR (quetiapine fumarate extended-release tablets) and SEROQUEL (quetiapine fumarate) have been approved under the European Mutual Recognition Procedure
2009-06-10	AstraZeneca	Regulatory Favourable Vote from FDA Advisory Committee on Seroquel Paediatric Supplemental New Drug Applications astrazeneca.com ↗ We are pleased that the committee found SEROQUEL to be effective and acceptably safe for treating adolescents with schizophrenia and children and adolescents with bipolar mania, and we look forward to having further discussions with the FDA regarding the sNDAs.
2009-05-29	AstraZeneca	Regulatory AstraZeneca Regulatory Update on Seroquel XR for the Treatment of Major Depressive Disorder astrazeneca.com ↗ This follows notification to AstraZeneca by the Netherlands Health Authority (MEB), acting as the Reference Member State for the Mutual Recognition Process (MRP), that the SEROQUEL XR application for MDD has been refused.
2009-04-09	AstraZeneca	Regulatory FDA Advisory Committee Recommendation on Seroquel XR Supplemental New Drug Applications astrazeneca.com ↗ The Advisory Committee concluded: SEROQUEL XR was shown to be effective in MDD as both monotherapy and adjunctive therapy, and shown to be effective in GAD as monotherapy.
2009-03-30	AstraZeneca	Regulatory AstraZeneca to Participate in Tentative FDA Psychopharmacologic Drugs Advisory Committee in June astrazeneca.com ↗ AstraZeneca has been informed that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) has been tentatively scheduled to meet on 9 and 10 June 2009.
2009-02-27	AstraZeneca	Regulatory AstraZeneca Receives FDA Complete Response Letter On Seroquel XR For Generalised Anxiety Disorder astrazeneca.com ↗ AstraZeneca today announced the company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA)
2009-02-25	AstraZeneca	Regulatory AstraZeneca To Participate In Tentative FDA Psychopharmacologic Drugs Advisory Committee astrazeneca.com ↗ AstraZeneca has been informed that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) has been tentatively scheduled to meet on 8 April 2009.
2008-12-23	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Teva Announces Tentative Approval of Generic Seroquel® Tablets tevapharm.com ↗ the U.S. Food and Drug Administration has granted tentative approval
2006-12-01	Eli Lilly and Company	Results Lilly Responds to the Cost-Effectiveness Analysis of the CATIE Schizophrenia Trial lilly.com ↗ Zyprexa was less costly by about $2,700 per year than quetiapine, $1,212 per year less than risperidone, and $3,564 per year less than ziprasidone.
2006-04-01	Eli Lilly and Company	Results CATIE Phase 2 Data Confirm Patients Stay on Treatment Longer Because of Symptom Improvement More So Than Tolerability lilly.com ↗ Zyprexa patients also had the lowest rate of hospitalizations (11 percent) among the other atypicals studied (risperidone (15 percent), ziprasidone (16 percent), and quetiapine (20 percent)(iii)).
2005-09-19	Eli Lilly and Company	Results According to CATIE, Zyprexa(R) More Effective on Discontinuation Rate than Other Antipsychotics Studied lilly.com ↗ CATIE found that for Zyprexa the average time to discontinuation was 9.2 months as compared with 4.6 months for quetiapine, 4.8 months for risperidone, 3.5 months for ziprasidone and 5.6 months for perphenazine.
2005-05-23	Eli Lilly and Company	Results New Study Showed Efficacy was Most Important Factor in Decision to Stay on Antipsychotic Treatment for Schizophrenia lilly.com ↗ People taking atypical antipsychotics for schizophrenia were most likely to discontinue therapy due to continued presence of psychiatric symptoms, according to data presented today at the 158th annual meeting of the American Psychiatric Association (APA).
2005-04-06	Eli Lilly and Company	Results Studies Show Schizophrenia Patients Taking Atypicals Stayed on Treatment Longer Than Patients Taking Older, Typical Antipsychotics lilly.com ↗ One of the studies revealed that patients taking olanzapine or clozapine remained on treatment longer than other atypicals (risperidone, quetiapine, ziprasidone) or the typical perphenazine.

All press releases naming this drug 47 releases

Date	Issuer	Release
2025-09-22	Janssen Research & Development, LLC	Johnson & Johnson’s investigational seltorexant shows numerically higher response in patients with depression with insomnia symptoms, with fewer side effects compared to quetiapine XR jnj.com ↗
2025-09-15	Janssen Research & Development, LLC	Johnson & Johnson to showcase industry-leading neuropsychiatry innovations at the 2025 Psych Congress Annual Meeting jnj.com ↗
2023-10-04	Janssen Research & Development, LLC	SPRAVATO® (esketamine) Demonstrates Superior Efficacy Compared to Quetiapine Extended-Release in Treatment-Resistant Major Depressive Disorder jnj.com ↗
2020-06-01	Lotus Pharmaceutical	Lotus' Korea subsidiary secures exclusive distribution and marketing rights for Seroquel® and Seroquel XR® to strengthen their positions in the CNS field lotuspharm.com ↗
2019-12-16	AstraZeneca	Agreement with Cheplapharm for rights to Seroquel and Seroquel XR in Europe and Russia completed astrazeneca.com ↗
2019-12-03	AstraZeneca	AstraZeneca divests rights to Seroquel and Seroquel XR in the US and Canada astrazeneca.com ↗
2019-10-30	AstraZeneca	AstraZeneca divests rights to Seroquel and Seroquel XR in Europe and Russia astrazeneca.com ↗
2018-05-07	AstraZeneca	AstraZeneca and Luye Pharma Group enter agreement for rights to Seroquel and Seroquel XR in the UK, China and other international markets astrazeneca.com ↗
2017-12-21	Minerva Neurosciences	Minerva Neurosciences Announces Enrollment of First Patient in Phase 2b Trial Comparing Seltorexant (MIN-202) Versus Quetiapine as Adjunctive Therapy to Antidepressants in Patients With Major Depressive Disorder minervaneurosciences.com ↗
2017-08-23	Lupin Limited	Lupin launches generic Seroquel XR® tablets in the US lupin.com ↗
2017-05-18	Lupin Limited	Lupin receives FDA approval for generic Seroquel XR® Tablets lupin.com ↗
2017-02-27	Astellas Pharma Inc	Kyowa and Astellas enter into an Agreement for Exclusive Distribution and Promotion of Extended-Release Tablets of Quetiapine Fumarate in Japan astellas.com ↗
2016-08-09	Astellas Pharma Inc	Astellas Submits New Drug Application for Extended-Release Tablets of Quetiapine Fumarate in Japan astellas.com ↗
2015-01-29	Hutchison Medipharma Limited	Hutchison Sinopharm and AstraZeneca China signed an exclusive distribution agreement on Seroquel® in China hutch-med.com ↗
2013-02-15	AstraZeneca	US Court of Appeals affirms decision finding SEROQUEL XR formulation patent valid and infringed astrazeneca.com ↗
2012-11-13	AstraZeneca	Court in Germany finds SEROQUEL XR® formulation patent invalid astrazeneca.com ↗
2012-03-30	AstraZeneca	US District Court finds SEROQUEL XR® formulation patent valid and infringed astrazeneca.com ↗
2012-03-28	Sun Pharmaceutical Industries, Inc.	Sun Pharma announces USFDA approval for generic Seroquel® tablets sunpharma.com ↗
2012-03-28	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Launch of Generic Seroquel® in the United States tevapharm.com ↗
2012-03-22	AstraZeneca	UK court finds SEROQUEL XR® formulation patent invalid astrazeneca.com ↗
2012-03-13	AstraZeneca	AstraZeneca files lawsuit against the FDA for decision regarding quetiapine product labelling and exclusivity astrazeneca.com ↗
2012-03-09	AstraZeneca	FDA responds to AstraZeneca Citizen Petitions on quetiapine product labelling astrazeneca.com ↗
2011-10-05	AstraZeneca	AstraZeneca enters into a settlement agreement with Accord Healthcare, Inc. and Intas Pharmaceuticals Ltd regarding US SEROQUEL XR® patent litigation astrazeneca.com ↗
2011-09-29	AstraZeneca	AstraZeneca enters into a settlement agreement with Handa Pharmaceuticals regarding US SEROQUEL XR® patent litigation astrazeneca.com ↗
2010-12-20	Astellas Pharma Inc	Astellas and AstraZeneca agreed upon an extension of their existing license for Seroquel,to include SeroquelⓇ extended release Tab in Japan astellas.com ↗
2010-09-02	AstraZeneca	European Commission Issues Positive Decision for Approval of Seroquel XR as an Add-On Treatment of Major Depressive Disorder astrazeneca.com ↗
2010-08-09	AstraZeneca	AstraZeneca Announces Agreements in Principle in Seroquel Product Liability Litigation astrazeneca.com ↗
2010-04-27	AstraZeneca	AstraZeneca Finalises US Agreement On SEROQUEL Marketing astrazeneca.com ↗
2010-04-23	AstraZeneca	Seroquel XR Recommended For Approval In EU as an Add-On Treatment Of Major Depressive Disorder astrazeneca.com ↗
2010-03-18	AstraZeneca	Jury Rules In Favour Of AstraZeneca In First US Seroquel Product Liability Trial astrazeneca.com ↗
2009-12-04	AstraZeneca	US FDA Approves Seroquel XR For Add-On Treatment Of Major Depressive Disorder astrazeneca.com ↗
2009-12-04	AstraZeneca	US FDA Approves Seroquel For The Paediatric Treatment Of Schizophrenia And Bipolar Mania astrazeneca.com ↗
2009-09-29	AstraZeneca	Seroquel XR and Seroquel Approved in Europe for Prevention of Recurrence of Bipolar Disorder astrazeneca.com ↗
2009-09-25	AstraZeneca	US Court of Appeals Affirms Summary Judgment Decision in Seroquel Patent Litigation astrazeneca.com ↗
2009-09-25	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Provides Update on Generic Seroquel® Litigation tevapharm.com ↗
2009-06-10	AstraZeneca	Favourable Vote from FDA Advisory Committee on Seroquel Paediatric Supplemental New Drug Applications astrazeneca.com ↗
2009-05-29	AstraZeneca	AstraZeneca Regulatory Update on Seroquel XR for the Treatment of Major Depressive Disorder astrazeneca.com ↗
2009-04-09	AstraZeneca	FDA Advisory Committee Recommendation on Seroquel XR Supplemental New Drug Applications astrazeneca.com ↗
2009-03-30	AstraZeneca	AstraZeneca to Participate in Tentative FDA Psychopharmacologic Drugs Advisory Committee in June astrazeneca.com ↗
2009-02-27	AstraZeneca	AstraZeneca Receives FDA Complete Response Letter On Seroquel XR For Generalised Anxiety Disorder astrazeneca.com ↗
2009-02-25	AstraZeneca	AstraZeneca To Participate In Tentative FDA Psychopharmacologic Drugs Advisory Committee astrazeneca.com ↗
2008-12-23	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Tentative Approval of Generic Seroquel® Tablets tevapharm.com ↗
2006-12-01	Eli Lilly and Company	Lilly Responds to the Cost-Effectiveness Analysis of the CATIE Schizophrenia Trial lilly.com ↗
2006-04-01	Eli Lilly and Company	CATIE Phase 2 Data Confirm Patients Stay on Treatment Longer Because of Symptom Improvement More So Than Tolerability lilly.com ↗
2005-09-19	Eli Lilly and Company	According to CATIE, Zyprexa(R) More Effective on Discontinuation Rate than Other Antipsychotics Studied lilly.com ↗
2005-05-23	Eli Lilly and Company	New Study Showed Efficacy was Most Important Factor in Decision to Stay on Antipsychotic Treatment for Schizophrenia lilly.com ↗
2005-04-06	Eli Lilly and Company	Studies Show Schizophrenia Patients Taking Atypicals Stayed on Treatment Longer Than Patients Taking Older, Typical Antipsychotics lilly.com ↗

Evidence & citations 24 cited values

Every value below carries the sentence it was read from. 372 sources stand behind the page.

Field	Value	Cited text
Known as	Quetiapine	“Regular antipsychotic medications (Risperidone, Olanzapine, Clozapine, Amisulpride, Quetiapine, Paliperidone, Aripiprazole, Haloperidol, Levomepromazine, Zuclopenthixol...” NCT01323205 ↗ 334 “This study attempts to observe the efficacy (response time) and safety of the second-generation antipsychotic agent-quetiapine versus the first-generation antipsychotic...” NCT00631722 ↗ “Drugs: Aripiprazole, Olanzapine, Zuclopenthixol, Clotiapine, Flupentixol, Risperidone, Sulpiride, Trifluoperazine, Haloperidol, Quetiapine, Paliperidone, Chlorpromazine,...” NCT01765829 ↗ “The objective of the study was to evaluate the safety and plasma concentration changes of quetiapine after multiple oral administration of FK949E (extended-release formulation...” NCT01903200 ↗ “Subjects (N = 44) who failed to respond to SSRIs were randomly assigned to 1 of 3 atypical antipsychotics -- olanzapine, quetiapine, or risperidone -- and were consecutively...” PMID 19422759 ↗ May 2009 “The objective of the study was to evaluate the safety and plasma concentration changes of quetiapine after multiple oral administration of FK949E (extended-release formulation...” NCT01871974 ↗ “All the eligible participants will be randomly assigned to an oral atypical antipsychotic (risperidone, olanzapine, quetiapine, and where commercially available, aripiprazole...” NCT00256997 ↗ “Patients randomized to oral comparator arm will receive oral antipsychotics (haloperidol, paliperidone ER, risperidone, olanzapine, quetiapine or aripiprazole) as per...” NCT01081769 ↗ “For Part 2 only: participants need to be on monotherapy with an atypical antipsychotic medication (eg, Olanzapine, Quetiapine, Paliperidone, Asenapine, Iloperidone,...” NCT02181803 ↗ “Quetiapine is an atypical antipsychotic with a favorable side effect profile, and may be a promising medication for the treatment of alcohol dependence, particularly Type B alcoholism.” PMID 17632217 ↗ Aug 2007 “Oral antipsychotic (new or current treatment) will be administered in which daily dose range permitted will be risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg.” NCT00246259 ↗ Show 324 more sources
Known as	FK949E	“The objective of the study was to evaluate the safety and plasma concentration changes of quetiapine after multiple oral administration of FK949E (extended-release formulation...” NCT01903200 ↗ 2 “The objective of the study was to evaluate the safety and plasma concentration changes of quetiapine after multiple oral administration of FK949E (extended-release formulation...” NCT01871974 ↗ “The objective of the study was to assess the effect of multiple-dose fluvoxamine on the pharmacokinetics of quetiapine (FK949E) in healthy adult male subjects.” NCT01908296 ↗
Known as	QUET	“3. 320 begin double-blind treatment with quetiapine (QUET)” NCT00014001 ↗
Known as	Quetiapine (generic name): Seroquel (brand name)	“Quetiapine (generic name): Seroquel (brand name)” NCT00955474 ↗
Known as	Quetiapine 100 mg (Seroquel, Tablet)	“Quetiapine 100 mg (Seroquel, Tablet)” NCT01871701 ↗
Known as	quetiapine extended release	“The aim of this study was to compare the effect of quetiapine extended release (ER) versus aripiprazole on corrected QT interval (QTc) and QT dispersion (QTd) in youths with...” PMID 29185022 ↗ Nov 2017
Known as	Quetiapine extended-release (Seroquel XR)	“Quetiapine extended-release (Seroquel XR)” NCT00723970 ↗
Known as	Quetiapine Fumarate	“The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in...” NCT00811473 ↗ 50 “This pilot study evaluated the feasibility of extended-release quetiapine fumarate (quetiapine XR) for the treatment of patients with either a primary anxiety disorder or a...” PMID 23020711 ↗ Sep 2012 “This study investigated the efficacy and tolerability of adjunctive extended-release quetiapine fumarate (quetiapine XR) in patients with GAD and an inadequate response to...” PMID 24660224 ↗ Feb 2014 “A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate...” NCT00329446 ↗ “This study evaluated once-daily extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in patients with major depressive disorder (MDD) with inadequate...” PMID 20175941 ↗ Feb 2010 “The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.” NCT00227305 ↗ “BACKGROUND: Evaluate the efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) once-daily monotherapy for patients with major depressive disorder (MDD).” PMID 20691481 ↗ Aug 2010 “This study explores the effects of the medication, sustained-release quetiapine fumarate (Seroquel SR) for the treatment of alcohol dependence and co-morbid anxiety.” NCT00352469 ↗ “This study will investigate quetiapine fumarate XR (SEROQUEL XR®), a dibenzothiazepine derivative, as a potential medication for treating alcohol dependence.” NCT00498628 ↗ “This study evaluated once-daily, extended-release quetiapine fumarate (quetiapine XR) monotherapy in generalized anxiety disorder (GAD).” PMID 21694613 ↗ Aug 2011 “Quetiapine Fumarate Immediate Release (SEROQUEL®) With Quetiapine Fumarate Extended Release (SEROQUEL XR®) in Healthy Male Volunteers” NCT00832221 ↗ Show 40 more sources
Known as	Quetiapine Fumarate Extended-Release	“A Multicentre, Open-label, Prospective Long-term Study Evaluating the Clinical Benefit and Effectiveness of SEROQUEL XR® (Quetiapine Fumarate Extended-Release Tablets) in...” NCT00640601 ↗ 1 “Quetiapine fumarate extended-release for the treatment of major depression with comorbid fibromyalgia syndrome: a double-blind, randomized, placebo-controlled study.” PMID 24504819 ↗ Feb 2014
Known as	Quetiapine Fumarate Sustained Release	“Quetiapine Fumarate Sustained Release(Seroquel SR)50 mg/day for the first 2 days and then up to 150mg/day.” NCT00675896 ↗
Known as	quetiapine SR	“A Study of Quetiapine SR (Seroquel SR) to Treat SSRI-Resistant, Comorbid Panic Disorder Patients” NCT00619892 ↗ 1 “Quetiapine SR (Quetiapine Sustained Release)” NCT00579280 ↗
Known as	Quetiapine Sustained Release	“Quetiapine SR (Quetiapine Sustained Release)” NCT00579280 ↗
Known as	quetiapine XR	“The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in...” NCT00811473 ↗ 28 “This pilot study evaluated the feasibility of extended-release quetiapine fumarate (quetiapine XR) for the treatment of patients with either a primary anxiety disorder or a...” PMID 23020711 ↗ Sep 2012 “This study investigated the efficacy and tolerability of adjunctive extended-release quetiapine fumarate (quetiapine XR) in patients with GAD and an inadequate response to...” PMID 24660224 ↗ Feb 2014 “This study evaluated once-daily extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in patients with major depressive disorder (MDD) with inadequate...” PMID 20175941 ↗ Feb 2010 “The aim of this post-hoc analysis was to determine whether early symptom improvement with extended release quetiapine (quetiapine XR) may predict treatment outcome in patients...” PMID 26474010 ↗ Dec 2015 “All patients will receive Quetiapine XR at an initial dose of 50mg/day to be increased incrementally (dose of 50mg/day 2 and 150mg/day 3) to achieve a target dose of 300 mg/day...” NCT00517387 ↗ “Effects of once-daily extended-release quetiapine fumarate (quetiapine XR) monotherapy on sleep quality and disturbance in patients with major depressive disorder (MDD) were evaluated.” PMID 23673347 ↗ May 2013 “This study is a pooled, post-hoc analysis evaluating once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalized anxiety disorder (GAD).” PMID 24394383 ↗ Sep 2014 “BACKGROUND: Evaluate the efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) once-daily monotherapy for patients with major depressive disorder (MDD).” PMID 20691481 ↗ Aug 2010 “Quetiapine fumarate extended-release (quetiapine XR) has demonstrated efficacy in the treatment of MDD and has been shown to have analgesic properties in patients with depression.” PMID 24504819 ↗ Feb 2014 “Quetiapine XR 50 mg tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily, in the evening for a 9-week treatment period.” NCT00389064 ↗ Show 18 more sources
Known as	Seroquel	“The effect of quetiapine alone or adjunctive with mood stabilizers in the treatment of acute mania in patients with bipolar disorder has been confirmed through 4 phase III...” NCT00742638 ↗ 59 “Participants who continue to have anxiety symptoms will enter the 8-week Phase II, in which they continue taking Paxil CR and they will also be randomly assigned (by chance,...” NCT00113295 ↗ “A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate...” NCT00329446 ↗ “Subjects will receive 20 weeks of an experimental psychotherapy called interpersonal and social rhythm therapy (IPSRT) plus the FDA approved medication quetiapine (Seroquel).” NCT01133821 ↗ “The medication quetiapine also known as seroquel works by activating certain systems in the brain, such as ones known as dopamine and serotonin chemical systems in the brain.” NCT00584688 ↗ “Seroquel (Quetiapine) Therapy for Schizophrenia and Schizoaffective Disorders and Comorbid Cocaine and/or Amphetamine Abuse/Dependence: A Comparative Study With Risperidone” NCT00208143 ↗ “whether Quetiapine (Seroquel) is significantly more effective than Olanzapine (Zyprexa) in improving neurocognitive deficits, community functioning and quality of life” NCT00182442 ↗ “The purpose of this study is to examine the efficacy of quetiapine (Seroquel) in reducing substance use in persons diagnosed with schizophrenia.” NCT00156715 ↗ “The primary aim of this study is to determine the safety and efficacy of quetiapine (Seroquel) for the treatment of psychosis and/or agitation” NCT00043849 ↗ “Quetiapine (marketed under the brand name Seroquel) has been approved by the FDA since 1997 to help adults who suffer from schizophrenia” NCT00393978 ↗ “Quetiapine Fumarate Immediate Release (SEROQUEL®) With Quetiapine Fumarate Extended Release (SEROQUEL XR®) in Healthy Male Volunteers” NCT00832221 ↗ Show 49 more sources
Known as	SEROQUEL IR	“Seroquel IR - quetiapine fumarate” NCT01213836 ↗ 1 “SEROQUEL IR (quetiapine)” NCT00832221 ↗
Known as	Seroquel Prolong	“Quetiapine XR (Seroquel Prolong®) extended-release tablets à 50 mg und 200 mg.” NCT01071135 ↗
Known as	SEROQUEL SR	“The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients...” NCT00107731 ↗ 9 “The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and safe in the acute treatment of patients with Generalized Anxiety Disorder. PLEASE...” NCT00329446 ↗ “The primary purpose of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine fumarate sustained-release (SR) compared to placebo in the treatment of anxiety...” NCT00322595 ↗ “This study explores the effects of the medication, sustained-release quetiapine fumarate (Seroquel SR) for the treatment of alcohol dependence and co-morbid anxiety.” NCT00352469 ↗ “Quetiapine Fumarate (Seroquel SR®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Depression” NCT00422214 ↗ “Quetiapine Fumarate Sustained Release(Seroquel SR)50 mg/day for the first 2 days and then up to 150mg/day.” NCT00675896 ↗ “treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo” NCT00388973 ↗ “PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation.” NCT00326105 ↗ “Quetiapine Fumarate Sustained Release (SEROQUEL SR™)” NCT00278941 ↗ “Quetiapine fumarate (Seroquel) SR” NCT00422123 ↗
Known as	Seroquel SRTM	“A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo- Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM)...” NCT00326105 ↗ 2 “Quetiapine Fumarate Sustained Release (Seroquel SRTM) as Mono- Therapy in the Treatment of Adult Patients With Major Depressive Disorder” NCT00351169 ↗ “Quetiapine Fumarate Sustained Release (Seroquel SRTM)” NCT00351910 ↗
Known as	Seroquel-XR	“The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients...” NCT00107731 ↗ 11 “The purpose of this study is to determine safety \& efficacy of SEROQUEL SR™ in the treatment of major depressive disorder compared to placebo \& to evaluate quality of sleep,...” NCT00278941 ↗ “The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in...” NCT00811473 ↗ “The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and safe in the acute treatment of patients with Generalized Anxiety Disorder. PLEASE...” NCT00329446 ↗ “Quetiapine Fumarate Immediate Release (SEROQUEL®) With Quetiapine Fumarate Extended Release (SEROQUEL XR®) in Healthy Male Volunteers” NCT00832221 ↗ “PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation.” NCT00326105 ↗ “Seroquel XR- quetiapine fumarate extended release” NCT01213836 ↗ “Extended-release Quetiapine (Seroquel XR)” NCT01971203 ↗ “Quetiapine(Seroquel-XR) 50~800mg a day” NCT01250847 ↗ “Quetiapine (Seroquel XR® 800 mg/day)” NCT02901587 ↗ “Quetiapine fumarate (Seroquel XR)” NCT01128114 ↗ Show 1 more source
Known as	Seroquel_XR (Quetiapine Fumarate XR)	“Seroquel_XR (Quetiapine Fumarate XR)” NCT00882518 ↗
Known as	SeroquelXL	“This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) /...” NCT00534599 ↗
Action	Inhibit	“weak Dopamine2 (D2) receptor blocking ability” NCT00156715 ↗
Modality	Small molecule	“a dibenzothiazepine derivative” NCT00498628 ↗
Route	Oral	“oral variable dose” NCT00139074 ↗