Sertraline

also known as Zoloft · sertraline hydrochloride · Sertraline, "Zoloft" · Sertralin · Sertraline HCl · SRT · Aremis · Besitron · +9 more

Small molecule targets SLC6A4 via inhibition

Developed for: major depressive disorder · depressive disorder · post-traumatic stress disorder · alcohol dependence · obsessive-compulsive disorder · bipolar disorder · schizophrenia · anxiety disorder
+53 more
· dysthymic disorder · coronary artery disorder · dementia · generalized anxiety disorder · panic disorder · social phobia · Alzheimer disease · anxiety · bipolar depression · cocaine dependence · hepatitis C virus infection · obesity disorder · postpartum depression · premenstrual dysphoric disorder · premenstrual tension · stereotypic movement disorder · traumatic brain injury · acute myeloid leukemia · acute stress disorder · agoraphobia · autism · bipolar II disorder · cardiac rhythm disease · chronic pain syndrome · cirrhosis of liver · coccidioidomycosis · Cryptococcal meningitis · cryptococcosis · fragile X syndrome · gastroesophageal reflux disease · glioblastoma · Huntington disease · hypertensive disorder · impulse control disorder · mental disorder · migraine disorder · mixed anxiety and depressive disorder · myelodysplastic syndrome · Parkinson disease · phobic disorder · premature menopause · uremia · alcohol abuse · autism spectrum disorder · burning mouth syndrome · chronic kidney disease · conversion disorder · melancholia · mood disorder · pathological gambling · psychotic disorder · separation anxiety disorder · sexual disorder
Investigated by: National Institute of Mental Health (NIMH) · Pfizer · Duke University · Massachusetts General Hospital · National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Samsung Medical Center
+193 more
· Centre for Addiction and Mental Health · University of Pennsylvania · University of Sao Paulo · Vanderbilt University · Viatris Inc. · Yale University · Columbia University · Emory University · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · First Affiliated Hospital of Chongqing Medical University · University of Minnesota · Eli Lilly and Company · Federal University of Rio Grande do Sul · Indiana University · Johns Hopkins University · Mclean Hospital · National Heart, Lung, and Blood Institute (NHLBI) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institute of Neurological Disorders and Stroke (NINDS) · New York State Psychiatric Institute · Otsuka Pharmaceutical Development & Commercialization, Inc. · University of California, San Francisco · University of Pittsburgh · Actavis Inc. · Baylor College of Medicine · Dr. Inge Winter · Hamilton Health Sciences Corporation · MaineHealth · Mayo Clinic · Mbarara University of Science and Technology · McMaster University · Medical Research Council · Mylan Pharmaceuticals Inc · National Institute on Drug Abuse (NIDA) · National Institutes of Health (NIH) · Nova Scotia Health Authority · Ontario Mental Health Foundation · Second Affiliated Hospital, School of Medicine, Zhejiang University · Stanford University · São Paulo Research Foundation · Teva Pharmaceuticals USA · University Health Network, Toronto · University of California, Los Angeles · University of Florida · University of Münster · Zhejiang University · 59th Medical Wing · Action Research Group · Ajay Wasan, MD, Msc · Alexandria University · Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Alto Neuroscience · Amsterdam UMC, location VUmc · Anticancer Fund, Belgium · Assistance Publique - Hôpitaux de Paris · Beijing HuiLongGuan Hospital · Boston University Charles River Campus · Bristol-Myers Squibb · Brown University · Caecilie Buhmann · Capital Medical University · Central Hospital, Nancy, France · Centre Hospitalier Universitaire Dijon · Centre Hospitalier Universitaire Vaudois · Children's Hospital of Chongqing Medical University · Dalian Seventh People's Hospital · Demensforbundet, Norway · Dow University of Health Sciences · Dr. Nazanin Alavi · Duke Kunshan University · First Hospital of China Medical University · Forest Laboratories · GlaxoSmithKline · Guang Dong Provincial Mental Health Institute · all 199 on the full record

Regulatory milestones approvals, filings & regulatory actions · 13 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed post-traumatic stress disorder 1 milestone
Filed	US (FDA)	—	post-traumatic stress disorder	2024-06-25	“sNDA for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) has been accepted and filed by the FDA.” lundbeck.com ↗ “brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) has been accepted and filed by the FDA.” lundbeck.com ↗
Approved Indication not stated 2 milestones
Label expansions (11)	US (FDA)	ZOLOFT	—	1996-10-25 – 2004-08-19	fda.gov ↗
Approved	US (FDA)	ZOLOFT	—	1991-12-30	fda.gov ↗

Trials 186 · started per year

today

US approved 1991

19911992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 02 trials
Phase 0	NCT06796946	Jun → Dec 2026 expected	—	University of Huelva	Not yet recruiting	No outcome recorded
Phase 0	NCT02269540	Oct 2014 → Jun 2018	major depressive disorder	Centre for Addiction and Mental Health	Completed	No outcome recorded
Phase 120 trials
Phase 1	NCT07139834	Jun 2026 → Jun 2027 expected	major depressive disorder	Jeffrey Miller	Recruiting	No outcome recorded
Phase 1	NCT04071639	Mar 2020 → Dec 2024	Huntington disease	Second Affiliated Hospital, School of Medicine, Zhejiang University	Unknown	No outcome recorded
Phase 1	NCT02891278	Aug 2016 → Nov 2020	acute myeloid leukemia	Columbia University	Completed	No outcome recorded
Phase 1	NCT02651623	Jan → Sep 2016	—	Viatris Inc.	Completed	No outcome recorded
Phase 1	NCT02452983	May 2015 → Nov 2020	myelodysplastic syndrome	Gustavo Rivero	Terminated	No outcome recorded Stop: Enrollment
Phase 1	NCT02175602	Jun → Aug 2014	hepatitis C virus infection	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 1	NCT01669304	Aug 2012 → Oct 2014	migraine disorder	Mayo Clinic	Completed	No outcome recorded
Phase 1	NCT01250873	Nov 2010 → Jan 2011	major depressive disorder	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT01155531	May → Aug 2010	obesity disorder	Theracos	Completed	No outcome recorded
Phase 1	NCT01113164	Sep 2008 → Feb 2012	alcohol dependence	Brown University	Completed	Mixed
Phase 1	NCT00787501	Jun 2008 → Jul 2011	major depressive disorder	University of Pittsburgh	Completed	No outcome recorded
Phase 1	NCT00270959	Jun 2006 → Sep 2010	post-traumatic stress disorder	University of Washington	Completed	No outcome recorded
Phase 1	NCT00864344	Aug 2004	—	Actavis Inc.	Completed	No outcome recorded
Phase 1	NCT00864019	Aug 2004	—	Actavis Inc.	Completed	No outcome recorded
Phase 1	NCT00648856	Dec 2002	—	Mylan Pharmaceuticals Inc	Completed	No outcome recorded
Phase 1	NCT00650325	Nov → Dec 2002	—	Mylan Pharmaceuticals Inc	Completed	No outcome recorded
Phase 1	NCT00836667	Mar → Apr 2002	—	Teva Pharmaceuticals USA	Completed	No outcome recorded
Phase 1	NCT00836849	Mar → Apr 2002	—	Teva Pharmaceuticals USA	Completed	No outcome recorded
Phase 1	NCT00745017	Jul 2001 → Jul 2006	major depressive disorder	Centre for Addiction and Mental Health	Completed	No outcome recorded
Phase 1	NCT00001777	Dec 1997 → May 2000	dementia	National Institute of Neurological Disorders and Stroke (NINDS)	Completed	No outcome recorded

Phase 1/28 trials · 1 met primary · 2 missed
Phase 1/2	NCT05814640	Feb 2023 → Dec 2026 expected	major depressive disorder, splenic sequestration	First Affiliated Hospital of Chongqing Medical University	Recruiting	No outcome recorded
Phase 1/2	NCT02770378	Nov 2016 → Oct 2018	glioblastoma	University of Ulm	Completed	No outcome recorded
Phase 1/2	NCT02797808	Aug 2013 → Jan 2017	obsessive-compulsive disorder	University of Minnesota	Completed	No outcome recorded
Phase 1/2	NCT01032018	Jan 2010 → Jan 2012	acute coronary syndrome, depressive disorder	Columbia University	Completed	Met primary
Phase 1/2	NCT00133822	Apr 2004 → Sep 2006	post-traumatic stress disorder	Emory University	Completed	Missed primary
Phase 1/2	NCT00048854	Sep 2001 → Jun 2007	premenstrual tension	Yale University	Completed	No outcome recorded
Phase 1/2	NCT00581009	May 2001 → Dec 2011	bipolar disorder, major depressive disorder	University of California, Irvine	Completed	No outcome recorded
Phase 1/2	NCT00262470	Apr 1997 → Dec 2029 expected	cardiac rhythm disease	Satish R. Raj	Active not recruiting	Missed primary
Phase 227 trials · 1 met primary · 7 missed
Phase 2	NCT07645157	Oct 2026 → Oct 2028 expected	major depressive disorder	First Affiliated Hospital of Chongqing Medical University	Recruiting	No outcome recorded
Phase 2	NCT05341843	May → Sep 2022	uremia	Alexandria University	Completed	No outcome recorded
Phase 2	NCT05002309	Dec 2021 → Jun 2028 expected	major depressive disorder	Nova Scotia Health Authority	Recruiting	No outcome recorded
Phase 2	NCT04437485	Oct 2020 → Aug 2022	dysthymic disorder, major depressive disorder, prediabetes syndrome, type 2 diabetes mellitus	Indiana University	Completed	Missed primary
Phase 2	NCT04171193	Dec 2019 → Sep 2020	major depressive disorder	University of Sao Paulo	Unknown	No outcome recorded
Phase 2	NCT03222570	Feb 2018 → Apr 2024	depressive disorder	University of Minnesota	Completed	Missed primary
Phase 2	NCT03033069	Jan 2017 → Nov 2018	post-traumatic stress disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Met primary
Phase 2	NCT02908334	Nov 2016 → Jan 2019	coccidioidomycosis	University of California, San Francisco	Withdrawn	No outcome recorded Stop: Enrollment
Phase 2	NCT02458690	Jul 2015 → Aug 2019	coronary artery disorder, dysthymic disorder, major depressive disorder, stroke disorder	Indiana University	Completed	Missed primary
Phase 2	NCT01977729	Oct 2013 → Sep 2014	anxiety disorder	Yale University	Terminated	No outcome recorded Stop: Business
Phase 2	NCT01474746	Jan 2012 → Aug 2015	fragile X syndrome	Randi J. Hagerman, MD	Completed	No outcome recorded
Phase 2	NCT02473783	Oct 2011 → Nov 2012	major depressive disorder	Tri-Service General Hospital (TSGH)	Completed	No outcome recorded
Phase 2	NCT00742573	Aug 2008 → Jan 2014	major depressive disorder	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 2	NCT00654953	Jan 2006 → May 2009	cocaine dependence, depressive disorder	University of Arkansas	Completed	Missed primary
Phase 2	NCT00275197	Dec 2005 → Jul 2007	major depressive disorder	Pfizer	Completed	No outcome recorded
Phase 2	NCT00143091	Apr 2005 → Apr 2006	major depressive disorder	Pfizer	Terminated	Missed primary
Phase 2	NCT00215150	Nov 2004 → Dec 2008	social phobia	Duke University	Completed	Missed primary
Phase 2	NCT00744406	Jul 2003 → Sep 2006	major depressive disorder	Centre for Addiction and Mental Health	Completed	No outcome recorded
Phase 2	NCT00233103	Jun 2003 → Sep 2008	major depressive disorder	Icahn School of Medicine at Mount Sinai	Completed	Missed primary
Phase 2	NCT00058903	Apr 2003 → Mar 2005	cirrhosis of liver, hepatitis C virus infection	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Completed	No outcome recorded
Phase 2	NCT00000451	Jan 2003 → Aug 2005	alcohol dependence	Yale University	Completed	No outcome recorded
Phase 2	NCT00015132	Mar 1999 → Sep 2000	cocaine dependence	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 2	NCT00001483	Jun 1995 → May 2002	bipolar disorder, depressive disorder	National Institute of Mental Health (NIMH)	Completed	No outcome recorded
Phase 2	NCT00000446	? → Dec 2000	alcohol dependence, post-traumatic stress disorder	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Completed	No outcome recorded
Phase 2	NCT00000458	? → Jan 2002	alcohol dependence, depressive disorder	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Completed	No outcome recorded
Phase 2	NCT00004300	—	stereotypic movement disorder	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Suspended	No outcome recorded
Phase 2	NCT00000440	? → Sep 2002	alcohol dependence	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Completed	No outcome recorded

Phase 2/38 trials · 2 met primary · 2 missed
Phase 2/3	NCT04747314	Mar 2021 → Nov 2024	anxiety, chronic pain syndrome	Ajay Wasan, MD, Msc	Completed	No outcome recorded
Phase 2/3	NCT01033084	Dec 2009 → Dec 2011	major depressive disorder	University of Sao Paulo	Completed	Met primary
Phase 2/3	NCT00767624	Dec 2008 → Jun 2015	major depressive disorder, sleep disorder, initiating and maintaining sleep	Stanford University	Completed	Mixed
Phase 2/3	NCT00704379	Jun 2008 → Apr 2014	traumatic brain injury	Baylor College of Medicine	Completed	Met primary
Phase 2/3	NCT00086138	Jul 2004 → Jul 2008	Alzheimer disease, depressive disorder	Johns Hopkins University	Completed	Missed primary
Phase 2/3	NCT00080158	Mar 2004 → Jun 2007	depressive disorder	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 2/3	NCT00078286	Nov 2003 → Mar 2008	congestive heart failure, depressive disorder	Duke University	Completed	Missed primary
Phase 2/3	NCT00118417	Mar 1999 → Oct 2007	panic disorder	Massachusetts General Hospital	Completed	No outcome recorded
Phase 320 trials · 1 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	NCT05950061	Jun → Oct 2022	major depressive disorder	KRL Hospital, Islamabad	Completed	No outcome recorded
Phase 3	NCT04174170	Oct 2019 → Jul 2023	post-traumatic stress disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Missed primary
Phase 3	NCT04124614	Oct 2019 → Jul 2023	post-traumatic stress disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Met primary
Phase 3	NCT03002012	Nov 2017 → Mar 2018	cryptococcosis	University of Minnesota	Terminated	No outcome recorded
Phase 3	NCT01802385	Mar 2015 → Sep 2017	Cryptococcal meningitis	University of Minnesota	Completed	Missed primary
Phase 3	NCT02374567	Jan 2015 → Jun 2017	anxiety disorder, dementia, depressive disorder, schizophrenia +1	Hannover Medical School	Terminated	No outcome recorded
Phase 3	NCT01214382	Oct 2010 → Aug 2014	—	North Dakota State University	Completed	No outcome recorded
Phase 3	NCT00276965	Sep 2006 → Mar 2012	bipolar II disorder, depressive disorder	Lindner Center of HOPE	Completed	No outcome recorded
Phase 3	NCT00179257	Jun 2004 → Mar 2005	major depressive disorder	Vanderbilt University	Completed	No outcome recorded
Phase 3	NCT00276900	Dec 2003 → Aug 2006	depressive disorder	University of Pittsburgh	Completed	No outcome recorded
Phase 3	NCT00150306	Nov 2002 → Jul 2007	post-traumatic stress disorder	Viatris Inc.	Terminated	Missed primary
Phase 3	NCT00179283	Apr 2002 → Apr 2003	major depressive disorder	Vanderbilt University	Completed	Missed primary
Phase 3	NCT00043550	Nov 2001 → Jun 2009	major depressive disorder	University of Pennsylvania	Completed	Missed primary
Phase 3	NCT00078767	Apr 2001 → Mar 2006	post-traumatic stress disorder	Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	Completed	No outcome recorded
Phase 3	NCT00331305	Aug 1999 → May 2007	depressive disorder	Duke University	Completed	Missed primary
Phase 3	NCT00655174	Jun 1999 → Sep 2006	autism	The Hospital for Sick Children	Completed	No outcome recorded
Phase 3	NCT00000384	May 1997 → Apr 2002	obsessive-compulsive disorder	University of Pennsylvania	Completed	No outcome recorded
Phase 3	NCT00491478	Sep 1992 → ?	stereotypic movement disorder	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Unknown	No outcome recorded

Phase 459 trials · 3 met primary · 4 missed
Phase 4	NCT07552246	Apr 2026 → Mar 2027 expected	mixed anxiety and depressive disorder	Duke Kunshan University	Not yet recruiting	No outcome recorded
Phase 4	NCT07011693	Jun 2025 → Jun 2027 expected	major depressive disorder	Xinyu Zhou	Not yet recruiting	No outcome recorded
Phase 4	NCT06357104	Feb → Mar 2024	—	Pachankis, Yang I., M.D.	Completed	No outcome recorded
Phase 4	NCT05892744	Sep 2023 → Jul 2027 expected	major depressive disorder	University of Texas at Austin	Recruiting	No outcome recorded
Phase 4	NCT05537584	Sep 2022 → Aug 2025	major depressive disorder	Mclean Hospital	Completed	No outcome recorded
Phase 4	NCT06124417	Jan 2022 → Aug 2023	drug allergy	First Affiliated Hospital of Chongqing Medical University	Completed	No outcome recorded
Phase 4	NCT04388202	Oct 2020 → May 2023	major depressive disorder	Alto Neuroscience	Withdrawn	No outcome recorded Stop: Enrollment
Phase 4	NCT04221997	Nov 2019 → Sep 2026 overdue	anxiety disorder	University of Cincinnati	Recruiting	No outcome recorded
Phase 4	NCT03711708	Nov 2018 → Feb 2019	—	Viatris Inc.	Completed	No outcome recorded
Phase 4	NCT03993535	Oct 2018 → Apr 2023	obsessive-compulsive disorder	University of Sao Paulo	Completed	No outcome recorded
Phase 4	NCT03068429	Dec 2016 → Dec 2019	obsessive-compulsive disorder	University of Sao Paulo	Completed	No outcome recorded
Phase 4	NCT02752542	Oct 2016 → Jun 2026 overdue	dysthymic disorder, major depressive disorder	Nova Scotia Health Authority	Recruiting	No outcome recorded
Phase 4	NCT03978286	Jun 2016 → Jun 2017	depressive disorder, type 2 diabetes mellitus	Universidad Juárez Autónoma de Tabasco	Completed	No outcome recorded
Phase 4	NCT02777372	Apr 2016 → Dec 2021	premenstrual dysphoric disorder	Johns Hopkins University	Completed	Missed primary
Phase 4	NCT02185547	Feb 2016 → Nov 2019	depressive disorder, pregnancy disorder	Katarina Wide	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT02463110	Jul 2015 → Feb 2016	coronary artery disorder, depressive disorder	Assistance Publique - Hôpitaux de Paris	Terminated	No outcome recorded
Phase 4	NCT02228005	Jul 2014 → Jul 2016	depressive disorder	University Health Network, Toronto	Completed	No outcome recorded
Phase 4	NCT02268487	Jan 2014 → Jan 2017	major depressive disorder	University of Sao Paulo	Unknown	No outcome recorded
Phase 4	NCT02042573	Nov 2013 → Jun 2018	depressive disorder	Centre Hospitalier Universitaire Dijon	Terminated	No outcome recorded
Phase 4	NCT02520726	Sep 2013 → Sep 2016	post-traumatic stress disorder	University of Utah	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01916824	Aug 2013 → Dec 2015	major depressive disorder	Emory University	Completed	No outcome recorded
Phase 4	NCT01896934	Jul 2013 → Jun 2016	major depressive disorder	Vanderbilt University	Completed	No outcome recorded
Phase 4	NCT01794455	May 2013 → Mar 2015	depressive disorder, hypertensive disorder	Vanderbilt University	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01796132	Aug 2012 → Dec 2016	depressive disorder, lactation disease	Centre Hospitalier Universitaire Vaudois	Unknown	No outcome recorded
Phase 4	NCT02237937	Sep 2011 → Dec 2014	major depressive disorder	HolsboerMaschmeyer NeuroChemie GmbH	Unknown	No outcome recorded
Phase 4	NCT02504931	Apr 2011 → Aug 2016	alcohol dependence, post-traumatic stress disorder	The University of Texas Health Science Center at San Antonio	Completed	No outcome recorded
Phase 4	NCT01287494	Aug 2010 → Feb 2014	depressive disorder	Zhejiang University	Unknown	No outcome recorded
Phase 4	NCT01178671	Jul 2010 → May 2014	post-traumatic stress disorder	Research Foundation for Mental Hygiene, Inc.	Completed	Missed primary
Phase 4	NCT02901249	May 2010 → Nov 2014	major depressive disorder	Federal University of Rio Grande do Sul	Completed	No outcome recorded
Phase 4	NCT02918097	May 2010 → Nov 2014	bipolar disorder	Federal University of Rio Grande do Sul	Completed	No outcome recorded
Phase 4	NCT00969852	Jul → Aug 2009	—	Seoul National University Hospital	Completed	No outcome recorded
Phase 4	NCT00917397	Jun 2009 → Apr 2014	post-traumatic stress disorder	Caecilie Buhmann	Completed	No outcome recorded
Phase 4	NCT00382291	Feb 2009 → Feb 2011	obsessive-compulsive disorder	University of Florida	Completed	Missed primary
Phase 4	NCT00677352	May 2008 → Jan 2010	panic disorder	Viatris Inc.	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	NCT00536198	Nov 2007 → Feb 2012	premenstrual dysphoric disorder	Yale University	Completed	Mixed
Phase 4	NCT01477268	Jun 2007 → Apr 2009	depressive disorder	Unity Health Toronto	Completed	No outcome recorded
Phase 4	NCT00433121	Sep 2006 → Aug 2007	dementia	Innlandet Hospital Trust	Completed	No outcome recorded
Phase 4	NCT00009191	Nov 2005 → Nov 2006	Alzheimer disease, major depressive disorder	Johns Hopkins University	Completed	No outcome recorded
Phase 4	NCT00701675	Oct 2005 → Jul 2009	generalized anxiety disorder	VA Office of Research and Development	Completed	No outcome recorded
Phase 4	NCT00234312	Sep 2005 → Oct 2006	depressive disorder, dysthymic disorder	Oregon Health and Science University	Completed	No outcome recorded
Phase 4	NCT00118430	Sep 2004 → Jul 2008	depressive disorder	Indiana University	Completed	Met primary
Phase 4	NCT00368550	Feb 2004 → Jun 2009	alcohol dependence	UConn Health	Completed	No outcome recorded
Phase 4	NCT00229476	Dec 2003 → Mar 2006	major depressive disorder	University of California, Los Angeles	Completed	No outcome recorded
Phase 4	NCT00485862	Jun 2003 → Jan 2005	depressive disorder	Eli Lilly and Company	Completed	No outcome recorded
Phase 4	NCT00157547	Apr 2003 → Aug 2006	major depressive disorder	Massachusetts General Hospital	Completed	No outcome recorded
Phase 4	NCT00050804	Dec 2002 → Feb 2004	acute stress disorder, post-traumatic stress disorder	National Institute of Mental Health (NIMH)	Completed	No outcome recorded
Phase 4	NCT00182078	Nov 2002 → Jul 2006	depressive disorder, post-traumatic stress disorder	Massachusetts General Hospital	Completed	Mixed
Phase 4	NCT00644982	Oct 2002 → Sep 2003	major depressive disorder	Viatris Inc.	Completed	No outcome recorded
Phase 4	NCT00178828	Oct 2002 → Apr 2013	depressive disorder	Vanderbilt University Medical Center	Completed	No outcome recorded
Phase 4	NCT00182533	Jul 2002 → Jan 2018	agoraphobia, major depressive disorder, obsessive-compulsive disorder, panic disorder +1	Hamilton Health Sciences Corporation	Terminated	No outcome recorded
Phase 4	NCT00318773	Feb 2002 → Dec 2007	premenstrual tension	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Completed	Met primary
Phase 4	NCT00021528	Jul 2001 → Sep 2006	major depressive disorder	National Institute of Mental Health (NIMH)	Completed	No outcome recorded
Phase 4	NCT00004554	Jan 2000 → Aug 2005	alcohol dependence, depressive disorder	University of Pennsylvania	Completed	No outcome recorded
Phase 4	NCT00118014	Jan 2000 → Apr 2004	impulse control disorder	Massachusetts General Hospital	Completed	No outcome recorded
Phase 4	NCT00374426	Mar 1998 → Oct 2004	diabetes mellitus, major depressive disorder	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Completed	No outcome recorded
Phase 4	NCT00508859	Jul 1997 → ?	major depressive disorder	Sunnybrook Health Sciences Centre	Completed	No outcome recorded
Phase 4	NCT00208702	Sep 1996 → Jul 2003	major depressive disorder	Emory University	Completed	Missed primary
Phase 4	NCT00226642	—	depressive disorder	Ludwig-Maximilians - University of Munich	Unknown	Met primary

Phase not applicable42 trials · 2 met primary · 4 missed
—	NCT07654179	Jun 2026 → Jun 2027 expected	depressive disorder, obesity disorder	Riphah International University	Recruiting	No outcome recorded
—	NCT06384209	Jun 2025 → Dec 2027 expected	major depressive disorder	University of Bern	Recruiting	No outcome recorded
—	NCT07015944	Jun 2025 → Dec 2028 expected	breast cancer, major depressive disorder	Pakistan Institute of Living and Learning	Recruiting	No outcome recorded
—	NCT06840379	Oct 2024 → Apr 2025 overdue	end stage renal failure	Nishtar Medical University	Active not recruiting	No outcome recorded
—	NCT06778824	Apr 2024 → Dec 2026 expected	gastroesophageal reflux disease	Hualien Tzu Chi General Hospital	Recruiting	No outcome recorded
—	NCT06001021	Aug → Sep 2023	mental disorder	Sameera Shafiq	Completed	Met primary
—	NCT05683223	May 2023 → Apr 2027 expected	social phobia	Boston University Charles River Campus	Recruiting	No outcome recorded
—	NCT06725771	Sep 2022 → Oct 2024	generalized anxiety disorder	Lin Xiaoqian	Completed	No outcome recorded
—	NCT03841474	Mar → Jun 2021	coronary artery disorder, depressive disorder	University Hospital Centre Zagreb	Unknown	No outcome recorded
—	NCT04478526	Apr 2020 → May 2021	generalized anxiety disorder	Dr. Nazanin Alavi	Completed	No outcome recorded
—	NCT04977544	Sep 2019 → Sep 2022	phobic disorder	Second Affiliated Hospital, School of Medicine, Zhejiang University	Unknown	No outcome recorded
—	NCT04430556	Jul 2018 → Dec 2020	anxiety disorder, major depressive disorder	Hospital Universitario Dr. Jose E. Gonzalez	Unknown	No outcome recorded
—	NCT02955719	Mar 2016 → Jul 2020	anxiety, cognitive impairment with or without cerebellar ataxia, depressive disorder	Centre for Addiction and Mental Health	Completed	No outcome recorded
—	NCT02285699	Nov 2014 → Mar 2016	obsessive-compulsive disorder	McMaster University	Completed	No outcome recorded
—	NCT02235064	Jul 2014 → Jul 2015	postpartum depression	The Cooper Health System	Terminated	No outcome recorded Stop: Enrollment
—	NCT02023567	Nov 2013 → Dec 2016	major depressive disorder	Peking University	Unknown	No outcome recorded
—	NCT01993017	Nov 2013 → Jul 2018	acute coronary syndrome, depressive disorder	Columbia University	Completed	Missed primary
—	NCT02431845	Jan 2013 → Dec 2030 expected	obsessive-compulsive disorder	Severance Hospital	Recruiting	No outcome recorded
—	NCT01751828	Dec 2012 → Aug 2013	depressive disorder	Vanderbilt University	Withdrawn	No outcome recorded Stop: Business
—	NCT04076371	Jan 2012 → Dec 2018	schizophrenia	Beijing HuiLongGuan Hospital	Completed	No outcome recorded
—	NCT01437189	Aug 2011 → Aug 2013	Parkinson disease, depressive disorder	Zhejiang University	Completed	No outcome recorded
—	NCT01305889	Mar 2011 → Feb 2018	major depressive disorder	University of California, San Francisco	Completed	No outcome recorded
—	NCT01032434	Dec 2009 → May 2012	depressive disorder	Guang Dong Provincial Mental Health Institute	Completed	No outcome recorded
—	NCT01454635	Jun 2008 → Mar 2010	major depressive disorder	Showa University	Completed	No outcome recorded
—	NCT01028482	Mar 2008 → Nov 2010	postpartum depression	Tel-Aviv Sourasky Medical Center	Completed	Missed primary
—	NCT00531518	Oct 2007 → May 2013	bipolar disorder, depressive disorder, schizophrenia	MaineHealth	Completed	Met primary
—	NCT00406952	Nov 2006 → Aug 2007	major depressive disorder	Pfizer	Completed	No outcome recorded
—	NCT00817011	Apr 2006 → Dec 2016	depressive disorder	Samsung Medical Center	Unknown	No outcome recorded
—	NCT00284791	Jan 2006 → Feb 2007	—	MaineHealth	Terminated	No outcome recorded
—	NCT00263133	Dec 2005 → Jan 2006	depressive disorder	University Hospital Freiburg	Completed	No outcome recorded
—	NCT00245557	Nov 2004 → Aug 2008	major depressive disorder	Mclean Hospital	Completed	No outcome recorded
—	NCT00169988	Mar 2004 → Apr 2007	schizophrenia	Northwell Health	Completed	No outcome recorded
—	NCT00283192	Jul 2003 → Jan 2006	premature menopause	University of California, San Francisco	Completed	Missed primary
—	NCT00817375	Feb 2003 → Dec 2018	depressive disorder	Samsung Medical Center	Unknown	No outcome recorded
—	NCT01228357	Feb 2003 → Dec 2018	depressive disorder	Samsung Medical Center	Unknown	No outcome recorded
—	NCT00057642	Sep 2002 → Aug 2006	depressive disorder	New York State Psychiatric Institute	Completed	No outcome recorded
—	NCT01352572	Jan 2002 → Dec 2018	depressive disorder	Samsung Medical Center	Unknown	No outcome recorded
—	NCT01352559	Nov 2001 → Mar 2007	depressive disorder	Samsung Medical Center	Unknown	No outcome recorded
—	NCT00339066	Aug 2001 → Mar 2006	depressive disorder	Duke University	Completed	No outcome recorded
—	NCT00208585	Feb 2000 → Dec 2007	traumatic brain injury	Walter Reed Army Medical Center	Unknown	No outcome recorded
—	NCT01237275	Oct 1999 → Dec 2003	antidepressant type abuse, major depressive disorder	Samsung Medical Center	Unknown	No outcome recorded
—	NCT00005013	Dec 1998 → Jul 2001	major depressive disorder	National Institute of Mental Health (NIMH)	Completed	Missed primary

Comparator or background therapy154 trials
Phase 1	NCT06965569 Background	Apr → Dec 2025	—	Alar Pharmaceuticals Inc.	Completed	No outcome recorded
Phase 1	NCT03514810 Background	Jan → Sep 2017	major depressive disorder	Kufa University	Completed	No outcome recorded
Phase 1	NCT03469128 Comparator	Jan 2016 → Jan 2020	—	British University In Egypt	Completed	No outcome recorded
Phase 1	NCT01347541 Background	Jan → Nov 2011	post-traumatic stress disorder	University of Washington	Terminated	No outcome recorded Stop: Enrollment
Phase 1	NCT01235195 Comparator	Nov → Dec 2010	—	Viatris Inc.	Completed	No outcome recorded
Show all 154 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 26

Date	Issuer	Release
2025-09-20	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck Receive Complete Response Letter from U.S. FDA for sNDA of REXULTI (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD)® otsuka.co.jp ↗ The CRL states that the FDA has completed their review but cannot approve the application in the current form, further stating that the application does not provide substantial evidence of effectiveness to support the approval.
2025-09-20	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck Receive Complete Response Letter from U.S. FDA for sNDA of REXULTI® (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) otsuka-us.com ↗ The CRL states that the FDA has completed their review but cannot approve the application in the current form, further stating that the application does not provide substantial evidence of effectiveness to support the approval.
2025-09-20	H. Lundbeck A/S	Regulatory Otsuka and Lundbeck Receive Complete Response Letter from U.S. FDA for sNDA of REXULTI® (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) lundbeck.com ↗ The CRL states that the FDA has completed their review but cannot approve the application in the current form, further stating that the application does not provide substantial evidence of effectiveness to support the approval.
2025-07-19	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on REXULTI (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD)® otsuka.co.jp ↗ The committee voted 1-10, concluding that the efficacy of brexpiprazole, when initiated concurrently with sertraline, has not been established for the treatment of PTSD based on the available data presented.
2025-07-18	H. Lundbeck A/S	Regulatory Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on REXULTI® (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) lundbeck.com ↗ The committee voted 1-10, concluding that the efficacy of brexpiprazole, when initiated concurrently with sertraline, has not been established for the treatment of PTSD based on the available data presented.
2025-01-10	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka Announces FDA Plans to Host an Advisory Committee Meeting to Discuss the sNDA for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) otsuka.co.jp ↗ The FDA's decision to host a PDAC meeting does not reflect a final decision on the approvability.
2025-01-10	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka Announces FDA Plans to Host an Advisory Committee Meeting to Discuss the sNDA for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) otsuka-us.com ↗ The FDA’s decision to host a PDAC meeting does not reflect a final decision on the approvability.
2024-12-19	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results JAMA Psychiatry Publishes Results of Otsuka and Lundbeck's Phase 3 Trial of Brexpiprazole in Combination with Sertraline in Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults otsuka.co.jp ↗ rexpiprazole in combination with sertraline demonstrated a statistically significant reduction in overall PTSD symptoms compared to sertraline plus placebo, as measured by change in CAPS-5 total score from Week 1 to Week 10B1
2024-12-18	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results JAMA Psychiatry Publishes Results of Otsuka and Lundbeck's Phase 3 Trial of Brexpiprazole in Combination with Sertraline in Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults otsuka-us.com ↗
2024-12-18	H. Lundbeck A/S	Results JAMA Psychiatry Publishes Results of Otsuka and Lundbeck's Phase 3 Trial of Brexpiprazole in Combination with Sertraline in Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults lundbeck.com ↗ Brexpiprazole in combination with sertraline demonstrated a statistically significant reduction in overall PTSD symptoms compared to sertraline plus placebo, as measured by change in CAPS-5 total score from Week 1 to Week 101
2024-06-25	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck announce FDA acceptance of sNDA filing for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) otsuka.co.jp ↗ The supplemental new drug application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) has been accepted and filed by the FDA.
2024-06-25	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck Announce FDA Acceptance of sNDA Filing for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) otsuka-us.com ↗ The supplemental new drug application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) has been accepted and filed by the FDA.
2024-06-25	H. Lundbeck A/S	Regulatory Otsuka and Lundbeck announce FDA acceptance of sNDA filing for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) lundbeck.com ↗ The supplemental new drug application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) has been accepted and filed by the FDA.
2024-05-29	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka and Lundbeck Present Results from Three Clinical Trials of Brexpiprazole in Combination with Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults otsuka.co.jp ↗ In Trial 072, while the primary endpoint was not met, reductions in PTSD symptom severity with brexpiprazole in combination with sertraline were consistent with Trials 061 and 071.
2024-05-28	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka and Lundbeck Present Results from Three Clinical Trials of Brexpiprazole in Combination with Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults otsuka-us.com ↗ These data showed that brexpiprazole in combination with sertraline improved symptoms of PTSD in two out of the three studies, based on the primary endpoint of change in CAPS-5 total scores from Week 1 to Week 10 compared to sertraline plus placebo.
2024-05-28	H. Lundbeck A/S	Results Otsuka and Lundbeck Present Results from Three Clinical Trials of Brexpiprazole in Combination with Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults lundbeck.com ↗ These data showed that brexpiprazole in combination with sertraline improved symptoms of PTSD in two out of the three studies, based on the primary endpoint of change in CAPS-5 total scores from Week 1 to Week 10 compared to sertraline plus placebo.
2024-04-10	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck submit sNDA for FDA review of brexpiprazole and sertraline combination as potential treatment for PTSD otsuka-us.com ↗ Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) have submitted a supplemental New Drug Application (sNDA) for U.S. Food and Drug Administration (FDA) review of brexpiprazole as combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD) in adults.
2024-04-09	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka and Lundbeck submit sNDA for FDA review of brexpiprazole and sertraline combination as potential treatment for PTSD otsuka.co.jp ↗ have submitted a supplemental New Drug Application (sNDA) for U.S. Food and Drug Administration (FDA) review of brexpiprazole as combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD) in adults.
2023-09-07	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka Pharmaceutical and Lundbeck Announce Topline Results from Two Phase 3 Trials of Brexpiprazole as Combination Therapy with Sertraline for the Treatment of Post-Traumatic Stress Disorder in Adults otsuka.co.jp ↗ The flexible dose phase 3 trial met its primary endpoint, while the fixed dose phase 3 trial missed its primary endpoint
2023-09-07	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka Pharmaceutical and Lundbeck Announce Topline Results from Two Phase 3 Trials of Brexpiprazole as Combination Therapy with Sertraline for the Treatment of Post-Traumatic Stress Disorder in Adults otsuka-us.com ↗ The first trial met its primary endpoint by demonstrating improvements from baseline on the primary endpoint of CAPS-5 for patients receiving brexpiprazole 2-3 mg/day + sertraline combination therapy being statistically significantly greater than for those receiving sertraline + placebo (p<0.05).
2021-08-11	Zentiva, k.s.	Results Zent2U announces completion of bioequivalence trials on Sertraline zentiva.com ↗
2018-11-30	Otsuka Pharmaceutical Development & Commercialization, Inc.	Results Otsuka and Lundbeck report positive phase II data for the combination treatment of brexpiprazole and sertraline for the treatment of Post-Traumatic Stress Disorder (PTSD) otsuka.co.jp ↗ Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced today the achievement of positive clinical results (in intention-to-treat population) as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score change from baseline compared to placebo, when brexpiprazole and sertraline was given as combination treatment (p<0.01).
2018-11-30	H. Lundbeck A/S	Results Lundbeck and Otsuka Report Positive Phase II Data for the Combination Treatment of Brexpiprazole and Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) lundbeck.com ↗ The combination treatment arm of brexpiprazole and sertraline demonstrated improvement in symptoms of PTSD versus placebo (p<0.01) on the primary efficacy endpoint
2017-07-28	Otsuka Pharmaceutical Development & Commercialization, Inc.	Regulatory Otsuka Submits New Drug Application in Japan for Aripiprazole Sertraline Combination Tablets otsuka.co.jp ↗ Otsuka Pharmaceutical Co., Ltd. today announced the submission of an application for the manufacture and marketing approval in Japan of the aripiprazole sertraline combination tablet, development code ASC-01.
2006-06-30	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Teva Receives FDA Approval for Generic Zoloft® Tablets tevapharm.com ↗ has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Pfizer's Zoloft® (Sertraline) Tablets, 25 mg, 50 mg, and 100 mg.
2006-02-22	Perrigo Company	Regulatory Perrigo Company Announces Tentative Approval for Sertraline Hydrochloride Tablets perrigo.com ↗ The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that, through a partnership with InvaGen Pharmaceuticals, it has received tentative approval from the U.S. Food and Drug Administration (FDA) to market Sertraline Hydrochloride Tablets, 25 mg, 50 mg and 100 mg.

All press releases naming this drug 28 releases

Date	Issuer	Release
2025-09-20	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka and Lundbeck Receive Complete Response Letter from U.S. FDA for sNDA of REXULTI (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD)® otsuka.co.jp ↗
2025-09-20	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka and Lundbeck Receive Complete Response Letter from U.S. FDA for sNDA of REXULTI® (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) otsuka-us.com ↗
2025-09-20	H. Lundbeck A/S	Otsuka and Lundbeck Receive Complete Response Letter from U.S. FDA for sNDA of REXULTI® (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) lundbeck.com ↗
2025-07-19	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on REXULTI (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD)® otsuka.co.jp ↗
2025-07-18	H. Lundbeck A/S	Otsuka and Lundbeck Issue Statement on U.S. Food and Drug Administration (FDA) Advisory Committee Meeting on REXULTI® (brexpiprazole) in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) lundbeck.com ↗
2025-01-10	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka Announces FDA Plans to Host an Advisory Committee Meeting to Discuss the sNDA for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) otsuka.co.jp ↗
2025-01-10	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka Announces FDA Plans to Host an Advisory Committee Meeting to Discuss the sNDA for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) otsuka-us.com ↗
2024-12-19	Otsuka Pharmaceutical Development & Commercialization, Inc.	JAMA Psychiatry Publishes Results of Otsuka and Lundbeck's Phase 3 Trial of Brexpiprazole in Combination with Sertraline in Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults otsuka.co.jp ↗
2024-12-18	Otsuka Pharmaceutical Development & Commercialization, Inc.	JAMA Psychiatry Publishes Results of Otsuka and Lundbeck's Phase 3 Trial of Brexpiprazole in Combination with Sertraline in Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults otsuka-us.com ↗
2024-12-18	H. Lundbeck A/S	JAMA Psychiatry Publishes Results of Otsuka and Lundbeck's Phase 3 Trial of Brexpiprazole in Combination with Sertraline in Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults lundbeck.com ↗
2024-06-25	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka and Lundbeck announce FDA acceptance of sNDA filing for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) otsuka.co.jp ↗
2024-06-25	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka and Lundbeck Announce FDA Acceptance of sNDA Filing for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD) otsuka-us.com ↗
2024-06-25	H. Lundbeck A/S	Otsuka and Lundbeck announce FDA acceptance of sNDA filing for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD) lundbeck.com ↗
2024-05-29	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka and Lundbeck Present Results from Three Clinical Trials of Brexpiprazole in Combination with Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults otsuka.co.jp ↗
2024-05-28	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka and Lundbeck Present Results from Three Clinical Trials of Brexpiprazole in Combination with Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults otsuka-us.com ↗
2024-05-28	H. Lundbeck A/S	Otsuka and Lundbeck Present Results from Three Clinical Trials of Brexpiprazole in Combination with Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults lundbeck.com ↗
2024-04-10	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka and Lundbeck submit sNDA for FDA review of brexpiprazole and sertraline combination as potential treatment for PTSD otsuka-us.com ↗
2024-04-09	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka and Lundbeck submit sNDA for FDA review of brexpiprazole and sertraline combination as potential treatment for PTSD otsuka.co.jp ↗
2023-09-07	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka Pharmaceutical and Lundbeck Announce Topline Results from Two Phase 3 Trials of Brexpiprazole as Combination Therapy with Sertraline for the Treatment of Post-Traumatic Stress Disorder in Adults otsuka.co.jp ↗
2023-09-07	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka Pharmaceutical and Lundbeck Announce Topline Results from Two Phase 3 Trials of Brexpiprazole as Combination Therapy with Sertraline for the Treatment of Post-Traumatic Stress Disorder in Adults otsuka-us.com ↗
2021-08-11	Zentiva, k.s.	Zent2U announces completion of bioequivalence trials on Sertraline zentiva.com ↗
2018-11-30	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka and Lundbeck report positive phase II data for the combination treatment of brexpiprazole and sertraline for the treatment of Post-Traumatic Stress Disorder (PTSD) otsuka.co.jp ↗
2018-11-30	H. Lundbeck A/S	Lundbeck and Otsuka Report Positive Phase II Data for the Combination Treatment of Brexpiprazole and Sertraline for the Treatment of Post-Traumatic Stress Disorder (PTSD) lundbeck.com ↗
2017-07-28	Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka Submits New Drug Application in Japan for Aripiprazole Sertraline Combination Tablets otsuka.co.jp ↗
2007-01-24	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Files Patent Infringement Complaints Regarding Sertraline Hydrochloride tevapharm.com ↗
2006-08-14	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Launch of Generic Zoloft® tevapharm.com ↗
2006-06-30	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Receives FDA Approval for Generic Zoloft® Tablets tevapharm.com ↗
2006-02-22	Perrigo Company	Perrigo Company Announces Tentative Approval for Sertraline Hydrochloride Tablets perrigo.com ↗

Evidence & citations 22 cited values

Every value below carries the sentence it was read from. 343 sources stand behind the page.

Field	Value	Cited text
Known as	Sertraline	“we have restricted the IMPACT list of antidepressants to SSRIs (sertraline, escitalopram, paroxetine, fluoxetine, citalopram), duloxetine, bupropion, and mirtazapine. These...” NCT02458690 ↗ 331 “In this study, the investigators use selective serotonin reuptake inhibitors (SSRIs, i.e., sertraline, fluoxetine and fluvoxamine)and tricyclic drugs(i.e., clomipramine)...” NCT06942494 ↗ “Participants receive only clinical routine antidepressant treatment,Which include fluoxetine (Prozac); sertraline (Zoloft); paroxetine (Paxil); citalopram (Celexa)...” NCT01831440 ↗ “Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR),...” NCT00564278 ↗ “Medication group is a control group that can choose to use the serotonin reuptake inhibitors (SSRIs) approved by China food and Drug Administration (SFDA) for the treatment of...” NCT03558256 ↗ “In cases of intolerance or adverse reaction to fluoxetine, the investigator will switch to sertraline (25 to 200mg) or escitalopram (5 to 20mg), the other two antidepressants...” NCT05002309 ↗ “Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline,...” NCT01347541 ↗ “Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine; sertraline;...” NCT00270959 ↗ “ADT such as citalopram, escitalopram, fluoxetine, sertraline, paroxetine, vilazodone, venlafaxine, desvenlafaxine, duloxetine or bupropion prescribed in accordance with its...” NCT01838876 ↗ “Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine,...” NCT02400346 ↗ “SSRI (paxil CR, es-citalopram, fluoxetine, sertraline) start with (paxil CR 12.5mg, es-citalopram 10mg, fluoxetine 20mg, sertraline 50mg) for 1 week up to maximal dosage,...” NCT01357967 ↗ Show 321 more sources
Known as	Aremis	ChEMBL registry synonym — accepted as the source's own label CHEMBL809 ↗
Known as	Besitron	ChEMBL registry synonym — accepted as the source's own label CHEMBL809 ↗
Known as	CP-51,974-1	ChEMBL registry synonym — accepted as the source's own label CHEMBL809 ↗
Known as	Lustral	“Sertraline hydrochloride (trade names Zoloft, Lustral) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class.” NCT01856127 ↗
Known as	NSC-746308	ChEMBL registry synonym — accepted as the source's own label CHEMBL809 ↗
Known as	NSC-758948	ChEMBL registry synonym — accepted as the source's own label CHEMBL809 ↗
Known as	SER	“The purpose of this study is to compare 3 treatments for children with OCD: medication (sertraline, SER) alone vs OCD-specific therapy (Cognitive Behavior Therapy, CBT) vs...” NCT00000384 ↗
Known as	Sertralin	ClinicalTrials.gov intervention name — accepted as the source's own label NCT00226642 ↗ 2 NCT00433121 ↗ NCT03514810 ↗
Known as	Sertralina	ChEMBL registry synonym — accepted as the source's own label CHEMBL809 ↗
Known as	Sertraline (as hydrochloride)	ChEMBL registry synonym — accepted as the source's own label CHEMBL809 ↗
Known as	Sertraline HCl	“Sertraline HCl 100 mg tablets, single dose” NCT00864344 ↗ 1 NCT02473783 ↗
Known as	sertraline hydrochloride	“This study is designed to determine differences in drug exposure in subjects after being administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure...” NCT01235195 ↗ 7 “The objective of this study was to investigate the bioequivalence of Mylan's sertraline hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral...” NCT00648856 ↗ “Sertraline hydrochloride is a selective serotonin reuptake inhibitor which established improvement in itching in patients with cholestatic pruritis.” NCT05341843 ↗ “Sertraline hydrochloride (trade names Zoloft, Lustral) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class.” NCT01856127 ↗ “Sertraline hydrochloride 100 mg tablets (test) versus Zoloft® (reference)” NCT00836667 ↗ “Sertraline hydrochloride 100 mg tablets (test) versus Zoloft® (reference)” NCT00836849 ↗ “Sertraline Hydrochloride Tablets 100 mg” NCT00650325 ↗ NCT00004300 ↗
Known as	Sertraline, "Zoloft"	“Sertraline, "Zoloft"” NCT02358343 ↗ 3 “sertraline (Zoloft)” NCT01460212 ↗ “sertraline, zoloft” NCT01114100 ↗ “Sertraline, Zoloft” NCT01916824 ↗
Known as	SRT	“sertraline (SRT), cognitive behavioral therapy” PMID 22122292 ↗ Dec 2011 1 “sertraline (SRT, n = 133)” PMID 25721183 ↗ Dec 2014
Known as	Zoloft	“Participants receive only clinical routine antidepressant treatment,Which include fluoxetine (Prozac); sertraline (Zoloft); paroxetine (Paxil); citalopram (Celexa)...” NCT01831440 ↗ 37 “Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR),...” NCT00564278 ↗ “The objective of this study was to investigate the bioequivalence of Mylan's sertraline hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral...” NCT00648856 ↗ “The purpose of this study is to document the efficacy of sertraline (Zoloft) in the treatment of depression (major depressive disorder) after TBI, including the impact on...” NCT00233103 ↗ “The purpose of this study is to understand changes in brain chemical signals when people take antidepressants called sertraline (Zoloft®) and bupropion (Wellbutrin SR, Zyban ®).” NCT00178828 ↗ “The purpose of the study is to evaluate the efficacy and safety of flexible doses of escitalopram (Lexapro) compared to sertraline (Zoloft) for treatment of Dysthymic Disorder.” NCT00234312 ↗ “in fluoxetine (Prozac)-resistant adolescents with Major Depressive Disorder (MDD), Lamotrigine plus fluoxetine will be safe and as effective as sertraline (Zoloft).” NCT00284791 ↗ “the efficacy of the serotonergic medication sertraline (Zoloft) in the treatment and prevention of posttraumatic psychiatric sequelae in ASD victims.” NCT00050804 ↗ “Admnistration of 18FAV45 if patient is compliant with one of those treatment: Seroplex, Zoloft, Deroxat, Venlafaxine, Mirtazapine, Moclamine,” NCT01962753 ↗ “Patients are assigned randomly (like tossing a coin) to receive St. John's wort, Sertraline (Zoloft), or a placebo (sugar pill) for 8 weeks.” NCT00005013 ↗ “This study is a control trial of sertraline (Zoloft) in children aged 2 to 5 years old inclusive with Autism Spectrum Disorder.” NCT02385799 ↗ Show 27 more sources
Known as	Zoloft (Registered)	“A Phase 1, Single Center Randomized, Three-way Crossover, Double-blinded, Placebo- And Moxifloxacin-controlled Thorough Qt (Tqt) Study To Determine The Effects Of Sertraline...” NCT02651623 ↗
Known as	Zoloft Oral Solution	“Test Product: 50 mg sertraline administered as 2.5 mL of Zoloft Oral Solution (20 mg/mL) after dilution with 120 mL of water” NCT03711708 ↗
Action	Inhibit	“acts centrally to selectively block serotonin uptake” NCT00001777 ↗ 1 “Serotonin transporter inhibitor” CHEMBL809 ↗
Modality	Small molecule	“Selective Serotonin Reuptake Inhibitor” NCT00043550 ↗
Route	Oral	“FLD patients will undergo a controlled clinical trial of an orally administered serotonergic agent (Sertraline)” NCT00001777 ↗
Target	SLC6A4	“Serotonin transporter inhibitor” CHEMBL809 ↗