Paroxetine

also known as Paxil · Paxil CR · Paroxetine hydrochloride · Brisdelle · LDMP (Low-Dose Mesylate salt of Paroxetine) · Paroxetine HCl · BRL29060A · Paroxetine CR · +31 more

Small molecule targets CYP2D6, SLC6A4 via inhibition

Developed for: major depressive disorder · depressive disorder · post-traumatic stress disorder · social phobia · panic disorder · obsessive-compulsive disorder · anxiety disorder · bipolar disorder
+29 more
· coronary artery disorder · fibromyalgia · generalized anxiety disorder · mental disorder · premature ejaculation · premature menopause · tinnitus · agoraphobia · AIDS dementia complex · alcohol abuse · alcohol dependence · bipolar depression · dementia · dysthymic disorder · infectious disease with sepsis · insomnia · irritable bowel syndrome · myocardial infarction · obstructive sleep apnea syndrome · rheumatoid arthritis · sleep disorder · anxiety · burning mouth syndrome · flushing of ears and somnolence · mixed anxiety and depressive disorder · multiple sclerosis · neuropathy, painful · premenstrual dysphoric disorder · type 2 diabetes mellitus
Investigated by: GlaxoSmithKline · National Institute of Mental Health (NIMH) · Samsung Medical Center · Emory University · US Department of Veterans Affairs · Duke University
+108 more
· Massachusetts General Hospital · Mylan Pharmaceuticals Inc · Noven Therapeutics · University of Pittsburgh · Merck Sharp & Dohme LLC · Wyeth is now a wholly owned subsidiary of Pfizer · AstraZeneca · Beth Israel Medical Center · Capital Medical University · Central South University · Centre for Addiction and Mental Health · Eli Lilly and Company · Indiana University · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Jules Desmeules · Medical University of South Carolina · National Institute on Drug Abuse (NIDA) · New York State Psychiatric Institute · Ontario Mental Health Foundation · Teva Pharmaceuticals USA · Amsterdam UMC, location VUmc · Anna Stanhewicz, PhD · Asceneuron S.A. · Association Francaise pour la Recherche Thermale · Avigen · BioNTech (Shanghai) Pharmaceuticals Co., Ltd. · BioNTech SE · Boehringer Ingelheim · Boston Medical Group · Central Hospital, Nancy, France · Centre Hospitalier Henri Laborit · Centre Hospitalier Universitaire Vaudois · Centre National de la Recherche Scientifique (CeRCA, umr 7295), France · Chang Gung Memorial Hospital · Columbia University · Daewoong Pharmaceutical Co. LTD. · Dalian Seventh People's Hospital · Dong-A ST Co., Ltd. · First Hospital of China Medical University · Food and Drug Administration (FDA) · Forest Laboratories · Foundation for Atlanta Veterans Education and Research, Inc. · French National Agency for Research on AIDS and Viral Hepatitis · H. Lundbeck A/S · HUYABIO International, LLC. · Hamilton Health Sciences Corporation · Hannover Medical School · HolsboerMaschmeyer NeuroChemie GmbH · Hospices Civils de Lyon · Insel Gruppe AG, University Hospital Bern · Istanbul Medipol University Hospital · Janssen, LP · Jing-Ho Mental Hospital, Taiwan · Johns Hopkins University · Leiden University · Les thermes de Saujon · Max-Planck-Institute of Psychiatry · McMaster University · Medtronic - MITG · Ministry of Health & Welfare, Korea · MorePharma Corporation · National Health Research Institutes, Taiwan · National Heart, Lung, and Blood Institute (NHLBI) · National Institute of Mental Health and Neuro Sciences, India · National Institute on Alcohol Abuse and Alcoholism (NIAAA) · National Science and Technology Council, Taiwan · NeuShen Therapeutics · Otolaryngology Medical Clinic,University of California, Irvine · Otsuka Pharmaceutical Development & Commercialization, Inc. · Peking Union Medical College Hospital · Peking University · Pfizer · Poitiers University Hospital · Portland VA Medical Center · all 114 on the full record

Regulatory milestones approvals, filings & regulatory actions · 10 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansion	US (FDA)	PEXEVA	—	2006-12-09	fda.gov ↗
Label expansions (3)	US (FDA)	PAXIL CR	—	2003-08-28 – 2004-01-27	fda.gov ↗
Label expansions (5)	US (FDA)	PAXIL	—	1996-05-07 – 2002-10-02	fda.gov ↗
Approved	US (FDA)	PAXIL	—	1992-12-29	fda.gov ↗

Trials 144 · started per year

today

US approved 1992

1992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 03 trials
Phase 0	NCT07715669	Aug 2026 → Mar 2027 expected	preeclampsia	Anna Stanhewicz, PhD	Recruiting	No outcome recorded
Phase 0	NCT06796946	Jun → Dec 2026 expected	—	University of Huelva	Not yet recruiting	No outcome recorded
Phase 0	NCT00648193	Dec 2006	—	Mylan Pharmaceuticals Inc	Completed	No outcome recorded
Phase 129 trials · 2 met primary
Phase 1	NCT07669571	Jul 2026 → Feb 2027 expected	—	NeuShen Therapeutics	Recruiting	No outcome recorded
Phase 1	NCT06232109	Feb → Jul 2024	—	Asceneuron S.A.	Completed	No outcome recorded
Phase 1	NCT06065735	Oct 2023 → Jan 2024	anxiety disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT05992428	Aug → Nov 2023	—	Dong-A ST Co., Ltd.	Completed	No outcome recorded
Phase 1	NCT05470465	Sep 2022 → Sep 2023	respiratory underresponsiveness to hypoxia and hypercapnia	Food and Drug Administration (FDA)	Completed	Met primary
Phase 1	NCT04888728	Jun → Jul 2021	idiopathic pulmonary fibrosis	Daewoong Pharmaceutical Co. LTD.	Completed	No outcome recorded
Phase 1	NCT04981704	Apr → Jun 2021	—	Spectrum Pharmaceuticals, Inc	Completed	No outcome recorded
Phase 1	NCT04650542	Feb → Aug 2021	—	HUYABIO International, LLC.	Completed	No outcome recorded
Phase 1	NCT02681198	Jan → Mar 2016	—	USWM, LLC (dba US WorldMeds)	Completed	No outcome recorded
Phase 1	NCT02174822	Jan → Mar 2014	—	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 1	NCT01829919	Jul → Aug 2011	—	Noven Therapeutics	Completed	No outcome recorded
Phase 1	NCT01386593	May 2011 → Jan 2012	—	University Hospital, Basel, Switzerland	Completed	No outcome recorded
Phase 1	NCT01318031	Mar → Jun 2011	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT01159821	Aug → Oct 2010	—	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Completed	No outcome recorded
Phase 1	NCT01289756	Dec 2009 → Nov 2014	anovulation	Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)	Completed	No outcome recorded
Phase 1	NCT01000857	Nov 2009 → Feb 2010	depressive disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00938184	Jul → Sep 2009	depressive disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT02264184	Sep → Dec 2008	—	Boehringer Ingelheim	Completed	No outcome recorded
Phase 1	NCT00456560	Apr → May 2007	—	Avigen	Completed	No outcome recorded
Phase 1	NCT00456898	Jan → Mar 2007	diabetic neuropathy, fibromyalgia, major depressive disorder	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 1	NCT00650403	Dec 2006	—	Mylan Pharmaceuticals Inc	Completed	No outcome recorded
Phase 1	NCT00270959	Jun 2006 → Sep 2010	post-traumatic stress disorder	University of Washington	Completed	No outcome recorded
Phase 1	NCT00406432	May → Jun 2006	depressive disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00406003	Mar → Apr 2006	depressive disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00647881	Apr → May 2005	—	Mylan Pharmaceuticals Inc	Completed	No outcome recorded
Phase 1	NCT00648427	Apr 2005	—	Mylan Pharmaceuticals Inc	Completed	No outcome recorded
Phase 1	NCT00841698	Oct 2002	—	Teva Pharmaceuticals USA	Completed	Met primary
Phase 1	NCT00841659	Aug 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 1/24 trials · 1 missed
Phase 1/2	NCT07070232	Aug 2025 → Mar 2028 expected	neoplasm	BioNTech SE	Recruiting	No outcome recorded
Phase 1/2	NCT04757571	Feb 2021 → Dec 2024	rheumatoid arthritis	Sadat City University	Withdrawn	No outcome recorded Stop: Business
Phase 1/2	NCT01354314	Nov 2010 → Mar 2016	AIDS dementia complex	Johns Hopkins University	Completed	Missed primary
Phase 1/2	NCT00121888	Dec 2002 → Jun 2007	post-traumatic stress disorder	Massachusetts General Hospital	Completed	No outcome recorded
Phase 221 trials · 4 missed
Phase 2	NCT06763484	Jan → Jul 2025	premature menopause	Universidad Nacional Autonoma de Honduras	Completed	No outcome recorded
Phase 2	NCT05725837	Jun 2023 → Mar 2025 overdue	infectious disease with sepsis	Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude	Recruiting	No outcome recorded
Phase 2	NCT03274752	Oct 2017 → Jan 2021	myocardial infarction	Insel Gruppe AG, University Hospital Bern	Completed	Missed primary
Phase 2	NCT02458690	Jul 2015 → Aug 2019	coronary artery disorder, dysthymic disorder, major depressive disorder, stroke disorder	Indiana University	Completed	Missed primary
Phase 2	NCT01841502	May 2013 → Sep 2014	depressive disorder, hepatitis C virus infection	Radboud University Medical Center	Terminated	No outcome recorded
Phase 2	NCT00786188	Nov 2008 → Jun 2009	—	Noven Therapeutics	Completed	Mixed
Phase 2	NCT00742573	Aug 2008 → Jan 2014	major depressive disorder	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 2	NCT00557622	Jan → Dec 2008	post-traumatic stress disorder	GlaxoSmithKline	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00420641	Dec 2006 → Jun 2008	major depressive disorder	GlaxoSmithKline	Completed	Missed primary
Phase 2	NCT00394056	Dec 2006 → Aug 2009	tinnitus	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00397722	Nov 2006 → Sep 2007	social phobia	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00273039	Aug 2005 → Sep 2006	social phobia	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00191022	Dec 2004 → Jan 2007	social phobia	Eli Lilly and Company	Completed	Missed primary
Phase 2	NCT00403962	Nov 2004 → Aug 2005	social phobia	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00343707	Nov 2004 → Nov 2005	anxiety disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00744406	Jul 2003 → Sep 2006	major depressive disorder	Centre for Addiction and Mental Health	Completed	No outcome recorded
Phase 2	NCT00062738	Jun 2003 → Jan 2009	Parkinson disease, depressive disorder	Rutgers, The State University of New Jersey	Completed	Mixed
Phase 2	NCT00135525	May 2003 → Oct 2005	anxiety disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00206765	Jan 2003 → Jul 2005	major depressive disorder, panic disorder	Beth Israel Medical Center	Terminated	No outcome recorded
Phase 2	NCT00048204	Nov 2002 → Sep 2003	major depressive disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00073203	? → May 2004	major depressive disorder	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Completed	No outcome recorded

Phase 2/32 trials · 1 missed
Phase 2/3	NCT00136383	Mar 2005 → Jun 2007	depressive disorder	Duke University	Completed	No outcome recorded
Phase 2/3	NCT00215163	Dec 2002 → Jun 2006	post-traumatic stress disorder	Duke University	Completed	Missed primary
Phase 323 trials · 4 met primary · 2 missed
Phase 3	NCT02374567	Jan 2015 → Jun 2017	anxiety disorder, dementia, depressive disorder, schizophrenia +1	Hannover Medical School	Terminated	No outcome recorded
Phase 3	NCT02279966	Oct 2014 → Feb 2016	major depressive disorder	H. Lundbeck A/S	Completed	No outcome recorded
Phase 3	NCT01361308	May → Dec 2011	—	Noven Therapeutics	Completed	Mixed
Phase 3	NCT01101841	Mar 2010 → Sep 2011	—	Noven Therapeutics	Completed	Met primary
Phase 3	NCT00866294	Apr 2009 → Feb 2010	depressive disorder	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01024491	Aug 2008 → Mar 2009	premature ejaculation	MorePharma Corporation	Completed	No outcome recorded
Phase 3	NCT00368303	Dec 2006 → ?	major depressive disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00403455	Oct 2006 → Jul 2011	post-traumatic stress disorder	VA Office of Research and Development	Completed	No outcome recorded
Phase 3	NCT00322595	May 2006 → May 2007	generalized anxiety disorder	AstraZeneca	Completed	Met primary
Phase 3	NCT00329147	May → Jun 2006	depressive disorder	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 3	NCT00318669	Dec 2005 → Nov 2006	social phobia	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00196664	Oct 2005 → Feb 2009	chronic hepatitis C virus infection	French National Agency for Research on AIDS and Viral Hepatitis	Completed	No outcome recorded
Phase 3	NCT00264654	Oct → Nov 2005	social phobia	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00119652	May 2005 → May 2007	bipolar depression	AstraZeneca	Completed	Met primary
Phase 3	NCT00195598	Jan 2005 → Apr 2006	panic disorder	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 3	NCT00489775	Jan 2004 → Jun 2005	major depressive disorder	Eli Lilly and Company	Completed	No outcome recorded
Phase 3	NCT00074802	Dec 2003 → May 2008	social phobia	Temple University	Completed	Missed primary
Phase 3	NCT00067444	Jun 2003 → Jan 2005	major depressive disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00048607	Jul 2002 → Dec 2003	major depressive disorder	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 3	NCT00839397	May 2002 → Nov 2004	post-traumatic stress disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT00034983	Oct 2001 → Dec 2003	major depressive disorder	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 3	NCT00035009	Sep 2001 → Dec 2003	major depressive disorder	Merck Sharp & Dohme LLC	Completed	Missed primary
Phase 3	NCT00000368	Feb 1999 → Jul 2004	agoraphobia, panic disorder	New York State Psychiatric Institute	Completed	No outcome recorded

Phase 439 trials · 2 met primary · 2 missed
Phase 4	NCT04404439	Sep 2019 → Dec 2023	tinnitus	University of California, Irvine	Completed	No outcome recorded
Phase 4	NCT03993535	Oct 2018 → Apr 2023	obsessive-compulsive disorder	University of Sao Paulo	Completed	No outcome recorded
Phase 4	NCT03277339	Jan 2017 → Jan 2020	generalized anxiety disorder	Centre Hospitalier Henri Laborit	Completed	No outcome recorded
Phase 4	NCT01916200	Jan → Sep 2014	depressive disorder	GlaxoSmithKline	Withdrawn	No outcome recorded
Phase 4	NCT01916824	Aug 2013 → Dec 2015	major depressive disorder	Emory University	Completed	No outcome recorded
Phase 4	NCT01796132	Aug 2012 → Dec 2016	depressive disorder, lactation disease	Centre Hospitalier Universitaire Vaudois	Unknown	No outcome recorded
Phase 4	NCT01608295	Jul 2012 → Sep 2015	major depressive disorder	University of California, Los Angeles	Completed	No outcome recorded
Phase 4	NCT02237937	Sep 2011 → Dec 2014	major depressive disorder	HolsboerMaschmeyer NeuroChemie GmbH	Unknown	No outcome recorded
Phase 4	NCT02191124	Jun 2011 → Nov 2012	major depressive disorder	Capital Medical University	Completed	No outcome recorded
Phase 4	NCT01681849	Jul 2009 → Jul 2015	post-traumatic stress disorder	Emory University	Completed	No outcome recorded
Phase 4	NCT00926835	May 2009 → May 2015	major depressive disorder	Ministry of Health & Welfare, Korea	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT00812812	Mar 2009 → Feb 2011	depressive disorder	GlaxoSmithKline	Terminated	Missed primary
Phase 4	NCT00700999	Oct 2008 → Mar 2012	post-traumatic stress disorder	US Department of Veterans Affairs	Completed	No outcome recorded
Phase 4	NCT00785603	Aug 2008	depressive disorder	University of Southern Denmark	Unknown	No outcome recorded
Phase 4	NCT00665678	Apr 2008 → Mar 2012	post-traumatic stress disorder	Foundation for Atlanta Veterans Education and Research, Inc.	Terminated	No outcome recorded
Phase 4	NCT00767754	Jan → Jun 2007	panic disorder	Samsung Medical Center	Completed	No outcome recorded
Phase 4	NCT00269334	Dec 2005 → Nov 2007	major depressive disorder	National Health Research Institutes, Taiwan	Unknown	No outcome recorded
Phase 4	NCT00259883	Jun 2005 → Feb 2006	mental disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00118430	Sep 2004 → Jul 2008	depressive disorder	Indiana University	Completed	Met primary
Phase 4	NCT00225914	Sep 2004 → Sep 2006	premature menopause	Massachusetts General Hospital	Completed	No outcome recorded
Phase 4	NCT01130103	Mar 2004 → Feb 2010	post-traumatic stress disorder	Research Foundation for Mental Hygiene, Inc.	Completed	Met primary
Phase 4	NCT00229528	Mar 2004 → May 2006	coronary artery disorder	University of Oklahoma	Completed	No outcome recorded
Phase 4	NCT00672776	May 2003 → Sep 2007	post-traumatic stress disorder	Emory University	Completed	No outcome recorded
Phase 4	NCT00157547	Apr 2003 → Aug 2006	major depressive disorder	Massachusetts General Hospital	Completed	No outcome recorded
Phase 4	NCT00330239	Jan 2003 → May 2005	post-traumatic stress disorder	Medical University of South Carolina	Completed	No outcome recorded
Phase 4	NCT00049972	Sep 2002 → Sep 2003	major depressive disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00246441	Mar 2002 → Feb 2008	alcohol abuse, alcohol dependence, social phobia	Medical University of South Carolina	Completed	No outcome recorded
Phase 4	NCT00031317	Feb 2002 → Jun 2005	panic disorder	National Institute of Mental Health (NIMH)	Completed	No outcome recorded
Phase 4	NCT00610610	Jan → Dec 2002	fibromyalgia	Duke University	Completed	No outcome recorded
Phase 4	NCT00610909	Jan → Dec 2002	irritable bowel syndrome	Duke University	Completed	Missed primary
Phase 4	NCT00025740	Oct 2001 → Aug 2004	post-traumatic stress disorder	National Institute of Mental Health (NIMH)	Completed	No outcome recorded
Phase 4	NCT00540098	Sep 2001 → Jun 2005	panic disorder	University of Göttingen	Completed	No outcome recorded
Phase 4	NCT00177567	Jul 2001 → Jan 2004	bipolar disorder	University of Pittsburgh	Completed	No outcome recorded
Phase 4	NCT00018759	Mar 2001 → Oct 2003	depressive disorder, hypertensive disorder	US Department of Veterans Affairs	Completed	No outcome recorded
Phase 4	NCT00100464	Nov 2000 → Dec 2003	obstructive sleep apnea syndrome	US Department of Veterans Affairs	Completed	No outcome recorded
Phase 4	NCT00178035	Dec 1999 → Aug 2003	major depressive disorder	University of Pittsburgh	Completed	No outcome recorded
Phase 4	NCT00178100	Mar 1999 → Aug 2005	major depressive disorder	University of Pittsburgh	Completed	Mixed
Phase 4	NCT00178048	Sep 1998 → Dec 2003	depressive disorder, insomnia	University of Pittsburgh	Completed	No outcome recorded
Phase 4	NCT00357045	—	major depressive disorder	Portland VA Medical Center	Completed	No outcome recorded

Phase not applicable23 trials · 2 met primary
—	NCT04207723	Jul 2020 → Jan 2026	premature ejaculation	Boston Medical Group	Completed	No outcome recorded
—	NCT05188833	May 2020 → Oct 2021	obsessive-compulsive disorder	Istanbul Medipol University Hospital	Unknown	No outcome recorded
—	NCT04218981	Jan 2020 → Jun 2023	mental disorder	Central South University	Completed	No outcome recorded
—	NCT03894085	May 2019 → Dec 2022	obsessive-compulsive disorder	Central South University	Completed	No outcome recorded
—	NCT04188028	Jan → Jul 2019	—	Jules Desmeules	Completed	No outcome recorded
—	NCT03054220	Jul 2016 → Dec 2018	—	Jules Desmeules	Completed	No outcome recorded
—	NCT02285699	Nov 2014 → Mar 2016	obsessive-compulsive disorder	McMaster University	Completed	No outcome recorded
—	NCT02023567	Nov 2013 → Dec 2016	major depressive disorder	Peking University	Unknown	No outcome recorded
—	NCT02431845	Jan 2013 → Dec 2030 expected	obsessive-compulsive disorder	Severance Hospital	Recruiting	No outcome recorded
—	NCT00641173	Sep 2008 → Apr 2011	post-traumatic stress disorder	US Department of Veterans Affairs	Withdrawn	No outcome recorded Stop: Business
—	NCT00817011	Apr 2006 → Dec 2016	depressive disorder	Samsung Medical Center	Unknown	No outcome recorded
—	NCT00249847	Oct 2005 → Jul 2007	—	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Terminated	No outcome recorded Stop: Enrollment
—	NCT00218439	Oct 2005 → Aug 2010	nicotine dependence	University of Minnesota	Completed	Met primary
—	NCT00261729	Jul 2004 → Aug 2007	post-traumatic stress disorder, sleep disorder	US Department of Veterans Affairs	Completed	Met primary
—	NCT01228357	Feb 2003 → Dec 2018	depressive disorder	Samsung Medical Center	Unknown	No outcome recorded
—	NCT00817375	Feb 2003 → Dec 2018	depressive disorder	Samsung Medical Center	Unknown	No outcome recorded
—	NCT00457106	Jun 2002 → Jun 2003	major depressive disorder, panic disorder	Beth Israel Medical Center	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
—	NCT01237275	Oct 1999 → Dec 2003	antidepressant type abuse, major depressive disorder	Samsung Medical Center	Unknown	No outcome recorded
—	NCT00012558	Sep 1998 → Sep 2005	bipolar disorder	National Institute of Mental Health (NIMH)	Completed	Mixed
—	NCT00018733	Sep 1996 → Dec 2001	depressive disorder	US Department of Veterans Affairs	Completed	No outcome recorded
—	NCT00209118	? → Jul 2005	chronic hepatitis C virus infection, interferon antiviral depressor, major depressive disorder	Emory University	Completed	Mixed

Comparator or background therapy96 trials
Phase 1	NCT05175430 Comparator	Oct 2022 → Feb 2024	—	University Hospital, Basel, Switzerland	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	NCT02097147 Comparator	Mar → Sep 2014	—	Forest Laboratories	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	NCT00879099 Comparator	Apr 2009 → Jan 2010	—	Santen Inc.	Completed	No outcome recorded
Phase 1	NCT00470483 Comparator	Jan 2007 → Jan 2009	social phobia	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01367535 Comparator	Mar → Aug 2006	—	Bausch Health Americas, Inc.	Completed	No outcome recorded
Phase 1/2	NCT02451475 Comparator	Feb 2013 → Sep 2014	fibromyalgia	Mansoura University	Completed	No outcome recorded
Phase 1/2	NCT00612807 Background	Jul 2006 → Jun 2010	major depressive disorder	Duke University	Completed	No outcome recorded
Phase 2	NCT03321526 Background	Dec 2017 → Jun 2019	major depressive disorder	Janssen Research & Development, LLC	Completed	Missed primary
Phase 2	NCT01254305 Comparator	Apr 2011 → Jul 2012	major depressive disorder	Forest Laboratories	Completed	No outcome recorded
Phase 2	NCT00797966 Background	May 2009 → Jun 2010	major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Met primary
Phase 2	NCT00374166 Comparator	Aug 2006 → Feb 2008	anxiety disorder	Sanofi	Completed	Missed primary
Phase 3	NCT06231745 Comparator	Jan 2024 → Jul 2025	rheumatoid arthritis	Mostafa Bahaa	Completed	No outcome recorded
Phase 3	NCT06203275 Comparator	Jan 2024 → Jan 2025	type 2 diabetes mellitus	aya ramadan ashmawy sarhan	Unknown	No outcome recorded
Phase 3	NCT06025474 Comparator	Jan → Oct 2023	burning mouth syndrome	Federico II University	Unknown	No outcome recorded
Phase 3	NCT05637671 Comparator	Feb 2022 → Dec 2023	—	Cairo University	Unknown	No outcome recorded
Phase 3	NCT03879746 Comparator	Apr 2019 → Apr 2020	premature ejaculation	Assiut University	Unknown	No outcome recorded
Phase 3	NCT03538691 Background	Jul 2018 → Jul 2022	major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	Missed primary
Phase 3	NCT02400346 Background	Mar 2015 → Jun 2016	major depressive disorder	H. Lundbeck A/S	Completed	No outcome recorded
Phase 3	NCT01838681 Background	Jun 2013 → Jun 2016	major depressive disorder	H. Lundbeck A/S	Completed	Missed primary
Phase 3	NCT01838876 Background	Apr 2013 → Jul 2015	major depressive disorder	Forest Laboratories	Completed	No outcome recorded
Phase 3	NCT01715805 Background	Nov 2012 → Jun 2016	major depressive disorder	Forest Laboratories	Completed	Missed primary
Phase 3	NCT01360866 Background	Oct 2011 → Apr 2017	major depressive disorder	Otsuka Pharmaceutical Development & Commercialization, Inc.	Completed	No outcome recorded
Phase 3	NCT00836069 Comparator	Oct 2008 → Feb 2009	anxiety disorder	Cedars-Sinai Medical Center	Terminated	No outcome recorded
Phase 3	NCT00658762 Comparator	May 2008 → Apr 2009	generalized anxiety disorder	Pfizer	Terminated	No outcome recorded
Phase 3	NCT00658372 Comparator	May 2008 → Mar 2009	generalized anxiety disorder	Pfizer	Terminated	No outcome recorded
Phase 3	NCT00658008 Comparator	Apr 2008 → Mar 2009	generalized anxiety disorder	Pfizer	Terminated	No outcome recorded
Phase 3	NCT00629551 Background	Feb 2008 → Feb 2009	major depressive disorder	Sanofi	Completed	No outcome recorded
Phase 3	NCT00445679 Comparator	Jul 2007 → Feb 2009	major depressive disorder	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 3	NCT00400088 Comparator	Jun 2007 → Jan 2013	major depressive disorder	Nova Scotia Health Authority	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00463242 Comparator	Mar 2007 → Jun 2008	major depressive disorder	Novartis	Completed	No outcome recorded
Phase 3	NCT00351910 Background	May 2006 → Apr 2007	major depressive disorder	AstraZeneca	Completed	Met primary
Phase 3	NCT00291148 Comparator	Mar 2006 → Jul 2012	multiple sclerosis, neuropathy, painful	University of Manitoba	Completed	No outcome recorded
Phase 3	NCT00086190 Comparator	Jun 2005 → Nov 2009	Parkinson disease, major depressive disorder	University of Rochester	Completed	No outcome recorded
Phase 3	NCT00825058 Comparator	Nov 2003 → May 2004	major depressive disorder	Sanofi	Completed	No outcome recorded
Phase 3	NCT00825019 Comparator	Sep 2003 → Oct 2004	major depressive disorder	Sanofi	Completed	No outcome recorded
Phase 3	NCT00074815 Background	Sep 2003 → Nov 2009	obsessive-compulsive disorder	Duke University	Completed	No outcome recorded
Phase 3	NCT00338962 Comparator	Oct 2001 → Jul 2015	alcohol dependence, depressive disorder, post-traumatic stress disorder	Yale University	Completed	No outcome recorded
Phase 3	NCT01049347 Comparator	Oct 1997 → May 2000	major depressive disorder	Central Institute of Mental Health, Mannheim	Completed	No outcome recorded
Phase 3	NCT00620581 Comparator	—	premenstrual dysphoric disorder	Hamilton Health Sciences Corporation	Completed	No outcome recorded
Phase 4	NCT06799169 Comparator	Jun 2025 → Dec 2026 expected	tinnitus	University of California, Irvine	Active not recruiting	No outcome recorded
Phase 4	NCT04961190 Comparator	May 2022 → Nov 2026 expected	post-traumatic stress disorder	University of Pennsylvania	Active not recruiting	No outcome recorded
Phase 4	NCT04597190 Comparator	Jun 2020 → Aug 2024	post-traumatic stress disorder	University of Washington	Completed	No outcome recorded
Phase 4	NCT05148169 Background	Jan 2020 → Dec 2022	major depressive disorder	Shanghai Mental Health Center	Unknown	No outcome recorded
Phase 4	NCT03779789 Comparator	Feb 2019 → Feb 2023	major depressive disorder	Azienda Ospedaliera Universitaria Integrata Verona	Completed	Missed primary
Phase 4	NCT02932904 Comparator	Nov 2016 → May 2017	—	Takeda	Completed	Mixed
Phase 4	NCT03149419 Comparator	Mar 2016 → Sep 2017	flushing of ears and somnolence	Rio de Janeiro State University	Completed	No outcome recorded
Phase 4	NCT02273154 Background	Aug 2014 → Dec 2015	major depressive disorder	Si Tianmei	Unknown	No outcome recorded
Phase 4	NCT02022709 Comparator	Jan 2014 → Nov 2017	obsessive-compulsive disorder	Shanghai Mental Health Center	Completed	No outcome recorded
Phase 4	NCT01903447 Comparator	Dec 2013 → Feb 2018	anxiety	University of Illinois at Chicago	Completed	No outcome recorded
Phase 4	NCT01458626 Comparator	Nov 2012 → Aug 2016	major depressive disorder	Capital Medical University	Completed	No outcome recorded
Phase 4	NCT01764867 Comparator	Jun 2012 → Oct 2014	major depressive disorder	Shanghai Mental Health Center	Unknown	No outcome recorded
Phase 4	NCT01460212 Comparator	Dec 2011 → Dec 2014	major depressive disorder	Nanjing Medical University	Unknown	No outcome recorded
Phase 4	NCT01416220 Comparator	Sep 2011 → Feb 2013	major depressive disorder	Nova Scotia Health Authority	Withdrawn	No outcome recorded Stop: Enrollment
Phase 4	NCT01357967 Comparator	May 2011 → Dec 2012	major depressive disorder	Inje University	Unknown	No outcome recorded
Phase 4	NCT02178696 Background	Jan 2011 → Oct 2015	depressive disorder	University of Michigan	Completed	Met primary
Phase 4	NCT01748955 Comparator	Jun 2010 → Mar 2015	depressive disorder	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 4	NCT01305707 Comparator	Jul 2009 → Jul 2014	major depressive disorder	Hospital Universitari de Bellvitge	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT00594269 Comparator	Aug 2008 → Dec 2010	dementia	Innlandet Hospital Trust	Completed	No outcome recorded
Phase 4	NCT00666757 Comparator	May 2008 → Feb 2009	depressive disorder	Eli Lilly and Company	Completed	Missed primary
Phase 4	NCT00677352 Comparator	May 2008 → Jan 2010	panic disorder	Viatris Inc.	Completed	No outcome recorded
Phase 4	NCT00519012 Comparator	Aug 2007 → Dec 2010	depressive disorder	Oizumi Hospital	Unknown	No outcome recorded
Phase 4	NCT00292370 Background	Jan 2006 → Dec 2008	combat disorder, post-traumatic stress disorder	VA Office of Research and Development	Completed	Met primary
Phase 4	NCT00560612 Comparator	Jan 2006 → Jul 2008	post-traumatic stress disorder	Durham VA Medical Center	Completed	No outcome recorded
Phase 4	NCT00680602 Comparator	Jan 2006 → Sep 2008	obsessive-compulsive disorder	University of Sao Paulo	Completed	No outcome recorded
Phase 4	NCT00184106 Comparator	Oct 2004 → Dec 2009	social phobia	Norwegian University of Science and Technology	Completed	No outcome recorded
Phase 4	NCT00429169 Comparator	Jun 2004 → Jan 2010	major depressive disorder	New York State Psychiatric Institute	Terminated	No outcome recorded
Phase 4	NCT00113295 Background	Feb 2004 → Feb 2007	generalized anxiety disorder	Massachusetts General Hospital	Completed	Met primary
Phase 4	NCT00516113 Comparator	Oct 2000 → Nov 2002	premenstrual dysphoric disorder	Karolinska Institutet	Completed	No outcome recorded
Phase 4	NCT02852577 Comparator	Jan 2000 → Aug 2012	agoraphobia, panic disorder	Federal University of Rio de Janeiro	Completed	No outcome recorded
—	NCT07392645 Background	Feb 2026 → Oct 2027 expected	generalized anxiety disorder	Lishu Gao	Not yet recruiting	No outcome recorded
—	NCT07318181 Comparator	Jan 2026 → Nov 2027 expected	post-traumatic stress disorder	University of Luxembourg	Recruiting	No outcome recorded
—	NCT07057011 Comparator	Jul 2025 → Feb 2026 overdue	premature ejaculation	South Valley University	Not yet recruiting	No outcome recorded
—	NCT07025590 Comparator	Apr 2025 → Dec 2026 expected	cardiovascular disorder, mixed anxiety and depressive disorder	Guangdong Provincial People's Hospital	Recruiting	No outcome recorded
—	NCT06659094 Background	Aug 2023 → Aug 2025	obsessive-compulsive disorder	Shanghai Mental Health Center	Completed	No outcome recorded
—	NCT06358014 Background	May 2023 → Dec 2024	depressive disorder	Xiao Wang	Unknown	No outcome recorded
—	NCT05832619 Background	Nov 2022 → Dec 2025	major depressive disorder	Xiaomei Shao	Unknown	No outcome recorded
—	NCT05720637 Background	Nov 2022 → Jan 2024	major depressive disorder	Xiaomei Shao	Completed	No outcome recorded
—	NCT05528224 Background	Sep 2022 → Aug 2023	obsessive-compulsive disorder	Shanghai Mental Health Center	Terminated	No outcome recorded
—	NCT05605002 Background	Jan 2022 → Dec 2025	major depressive disorder	Xiaomei Shao	Unknown	No outcome recorded
—	NCT05588102 Background	May 2021 → May 2023	cognitive disorder	Capital Medical University	Completed	No outcome recorded
—	NCT03558256 Background	May 2016 → Dec 2018	major depressive disorder	Shanghai Mental Health Center	Unknown	No outcome recorded
—	NCT02655354 Background	Oct 2015 → Nov 2019	alcohol-related disorders, brain injury, cognitive impairment with or without cerebellar ataxia, depressive disorder +1	University of Washington	Completed	No outcome recorded
—	NCT01944657 Comparator	Sep 2013 → Dec 2015	major depressive disorder	Sheppard Pratt Health System	Withdrawn	No outcome recorded Stop: Enrollment
—	NCT01896349 Background	Apr 2013 → Aug 2014	—	Hospital de Clinicas de Porto Alegre	Unknown	No outcome recorded
—	NCT01962753 Background	May 2012 → Jan 2020	major depressive disorder	University Hospital, Tours	Completed	No outcome recorded
—	NCT01488266 Comparator	Nov 2011 → Jan 2013	major depressive disorder	Korea University	Unknown	No outcome recorded
—	NCT02300051 Background	Feb 2011 → Apr 2015	sexual disorder	University of Sao Paulo General Hospital	Completed	No outcome recorded
—	NCT01831440 Background	Jan 2011 → Jan 2014	depressive disorder	Nanjing Medical University	Unknown	No outcome recorded
—	NCT00944996 Comparator	Jun 2009 → Jun 2010	major depressive disorder	Tirat Carmel Mental Health Center	Completed	No outcome recorded
—	NCT00564278 Background	Feb 2008 → Aug 2013	depressive disorder	New York State Psychiatric Institute	Completed	No outcome recorded
—	NCT00736346 Comparator	Oct 2005 → Dec 2009	panic disorder	Université du Québec a Montréal	Unknown	No outcome recorded
—	NCT00202449 Comparator	Jul 2004 → Feb 2008	post-traumatic stress disorder, sleep disorder	Seattle Institute for Biomedical and Clinical Research	Terminated	No outcome recorded Stop: Enrollment
—	NCT00901407 Background	Dec 2003 → Jul 2006	major depressive disorder	Louisiana State University Health Sciences Center in New Orleans	Completed	Missed primary
—	NCT00715039 Comparator	Oct 2003 → May 2004	anxiety disorder	Pfizer	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 18

Date	Issuer	Release
2026-03-01	Alembic Pharmaceuticals Ltd.	Regulatory 27th March, 2026 Vadodara, India alembicpharmaceuticals.com ↗ Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) Paroxetine Extended-Release Tablets USP, 12.5 mg.
2025-09-01	Alembic Pharmaceuticals Ltd.	Regulatory 25th September, 2025 Vadodara, India alembicpharmaceuticals.com ↗ Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Paroxetine Extended -Release Tablets USP, 25 mg and 37.5 mg.
2017-01-23	Lupin Limited	Regulatory Lupin Receives FDA Approval for Generic Paxil CR® Tablets lupin.com ↗
2016-08-26	Lupin Limited	Regulatory Lupin Receives Tentative Approval for Generic Paxil CR® Tablets lupin.com ↗ Mumbai, Baltimore: Pharma Major Lupin Limited (Lupin) announced today that it has received tentative approval for its Paroxetine Extended-Release Tablets USP, 12.5 mg, 25 mg and 37.5 mg from the United States Food and Drug Administration (FDA) to market a generic version of Apotex Technologies, Inc.’s Paxil CR® Tablets, 12.5 mg, 25 mg and 37.5 mg.
2016-07-11	Lannett Company, Inc.	Regulatory Lannett Announces Approval And Launch Of Paroxetine Extended Release Tablets USP, 12.5 Mg, 25 Mg, 37.5 Mg investorroom.com ↗
2014-10-14	Noven Therapeutics	Results Noven Announces Publication of Exploratory Analyses from Pooled Phase 3 Results of the Effects of Brisdelle® (Paroxetine) Capsules on Weight and Sexual Function During Treatment of Vasomotor Symptoms Associated with Menopause noven.com ↗ The analyses showed that the frequency of treatment-emergent sexual dysfunction and weight change from baseline were similar between Brisdelle and placebo.
2013-09-19	Hisamitsu Pharmaceutical Co., Inc.	Results Noven Pharmaceuticals,Inc.プレスリリ－ス:閉経に伴う血管運動症状に対するFDA承認の非ホルモン療法薬であるBrisdelle™(パロキセチン) カプセルに関する主要試験結果をメノポーズ誌にて公表 hisamitsu.co.jp ↗
2013-09-18	Noven Therapeutics	Results Menopause Publishes Pivotal Trial Results for Brisdelle™ (Paroxetine) Capsules, an FDA-Approved Non-Hormonal Therapy for Vasomotor Symptoms Associated with Menopause noven.com ↗ Noven Pharmaceuticals, Inc., today announced the publication of results from its two Phase 3 clinical studies in Menopause, the peer-reviewed, scientific journal of The North American Menopause Society.
2013-07-01	Hisamitsu Pharmaceutical Co., Inc.	Regulatory Noven Pharmaceuticals,Inc.プレスリリ－ス:ノーベン社は閉経に伴う血管運動症状に対する初の非ホルモン療法剤Brisdelle™（パロキセチン）カプセルについて米国食品医薬品局から承認を取得 hisamitsu.co.jp ↗ Noven Receives FDA Approval for BrisdelleTM (Paroxetine) Capsules, the First Nonhormonal Therapy for Vasomotor Symptoms Associated with Menopause
2013-06-28	Noven Therapeutics	Regulatory Noven Receives FDA Approval for Brisdelle™ (Paroxetine) Capsules, the First Non-hormonal Therapy for Vasomotor Symptoms Associated with Menopause noven.com ↗
2013-03-04	Noven Therapeutics	Regulatory Noven Announces FDA Advisory Committee Vote on Investigational Low-Dose Mesylate Salt of Paroxetine (ldmp) for Vasomotor Symptoms Associated With Menopause noven.com ↗ Noven Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) Reproductive Health Drugs Advisory Committee voted 10 to 4 that the overall risk/benefit profile of low-dose mesylate salt of paroxetine (LDMP; 7.5 mg/day) is not acceptable to support approval.
2012-11-12	Noven Therapeutics	Regulatory FDA Accepts Noven’s NDA For An Investigational Nonhormonal Therapy For Menopausal Vasomotor Symptoms noven.com ↗
2012-10-03	Noven Therapeutics	Results Noven Announces Positive Phase 3 Data Results For Investigational Low-dose Nonhormonal Therapy For The Treatment of Vasomotor Symptoms Associated With Menopause noven.com ↗ today announced positive results from two multicenter, double-blind, randomized, placebo-controlled Phase 3 clinical studies evaluating low-dose mesylate salt of paroxetine (LDMP; 7.5 mg/day) for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.
2012-08-29	Noven Therapeutics	Regulatory Noven Submits New Drug Application For Investigational Non-hormonal Therapy For Menopausal Vasomotor Symptoms noven.com ↗
2012-03-20	Noven Therapeutics	Results Noven Completes Phase 3 Clinical Program For Investigational Non-Hormonal Therapy For Menopausal Vasomotor Symptoms noven.com ↗ The second Phase 3 study, which received a Special Protocol Assessment (SPA) by the U.S. Food & Drug Administration (FDA), was completed in February 2012.
2011-12-22	Noven Therapeutics	Results Noven Announces Phase 3 Results For Investigational Non-hormonal Therapy For Vasomotor Symptoms noven.com ↗
2007-03-12	Zydus Lifesciences Limited	Regulatory Zydus Cadila receives USFDA approval for Paroxetine Tablets zyduslife.com ↗ Zydus Cadila has received approval from th e US FDA to market Paroxetine Tablets in different strengths of 10 mg, 20 mg, 30 mg and 40 mg.
2005-08-16	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Teva Announces Approval of Paroxetine HCL Tablets tevapharm.com ↗ Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Paroxetine Hydrochloride Tablets, 10 mg, 20 mg, 30 mg and 40 mg.

All press releases naming this drug 26 releases

Date	Issuer	Release
2026-03-01	Alembic Pharmaceuticals Ltd.	27th March, 2026 Vadodara, India alembicpharmaceuticals.com ↗
2025-09-01	Alembic Pharmaceuticals Ltd.	25th September, 2025 Vadodara, India alembicpharmaceuticals.com ↗
2017-03-07	Lupin Limited	Lupin launches Generic Paxil CR® tablets in the US lupin.com ↗
2017-01-23	Lupin Limited	Lupin Receives FDA Approval for Generic Paxil CR® Tablets lupin.com ↗
2016-08-26	Lupin Limited	Lupin Receives Tentative Approval for Generic Paxil CR® Tablets lupin.com ↗
2016-07-26	Hisamitsu Pharmaceutical Co., Inc.	米国子会社Noven Pharmaceuticals, Inc.の閉経に伴う中等度から高度の血管運動症状（VMS）に対する非ホルモン経口製剤「Brisdelle®」および抗うつ経口製剤「Pexeva®」の権利譲渡に関するお知らせ hisamitsu.co.jp ↗
2016-07-11	Lannett Company, Inc.	Lannett Announces Approval And Launch Of Paroxetine Extended Release Tablets USP, 12.5 Mg, 25 Mg, 37.5 Mg investorroom.com ↗
2014-10-20	Sumitomo Pharma America, Inc.	Announcement of termination of co-promotion of anti-depressant, Paxil CR Tablets sumitomo-pharma.com ↗
2014-10-14	Noven Therapeutics	Noven Announces Publication of Exploratory Analyses from Pooled Phase 3 Results of the Effects of Brisdelle® (Paroxetine) Capsules on Weight and Sexual Function During Treatment of Vasomotor Symptoms Associated with Menopause noven.com ↗
2014-03-25	Noven Therapeutics	Noven Pharmaceuticals Announces Issuance of New U.S. Patent, an Important Addition to its Intellectual Property Portfolio for Brisdelle® (Paroxetine) Capsules, 7.5 mg noven.com ↗
2014-01-13	Noven Therapeutics	Noven Enters Co-Promotion Agreement with Shionogi for Brisdelle™ (Paroxetine) Capsules noven.com ↗
2013-09-19	Hisamitsu Pharmaceutical Co., Inc.	Noven Pharmaceuticals,Inc.プレスリリ－ス:閉経に伴う血管運動症状に対するFDA承認の非ホルモン療法薬であるBrisdelle™(パロキセチン) カプセルに関する主要試験結果をメノポーズ誌にて公表 hisamitsu.co.jp ↗
2013-09-18	Noven Therapeutics	Menopause Publishes Pivotal Trial Results for Brisdelle™ (Paroxetine) Capsules, an FDA-Approved Non-Hormonal Therapy for Vasomotor Symptoms Associated with Menopause noven.com ↗
2013-07-01	Hisamitsu Pharmaceutical Co., Inc.	Noven Pharmaceuticals,Inc.プレスリリ－ス:ノーベン社は閉経に伴う血管運動症状に対する初の非ホルモン療法剤Brisdelle™（パロキセチン）カプセルについて米国食品医薬品局から承認を取得 hisamitsu.co.jp ↗
2013-06-28	Noven Therapeutics	Noven Receives FDA Approval for Brisdelle™ (Paroxetine) Capsules, the First Non-hormonal Therapy for Vasomotor Symptoms Associated with Menopause noven.com ↗
2013-03-04	Noven Therapeutics	Noven Announces FDA Advisory Committee Vote on Investigational Low-Dose Mesylate Salt of Paroxetine (ldmp) for Vasomotor Symptoms Associated With Menopause noven.com ↗
2012-11-12	Noven Therapeutics	FDA Accepts Noven’s NDA For An Investigational Nonhormonal Therapy For Menopausal Vasomotor Symptoms noven.com ↗
2012-10-03	Noven Therapeutics	Noven Announces Positive Phase 3 Data Results For Investigational Low-dose Nonhormonal Therapy For The Treatment of Vasomotor Symptoms Associated With Menopause noven.com ↗
2012-08-29	Noven Therapeutics	Noven Submits New Drug Application For Investigational Non-hormonal Therapy For Menopausal Vasomotor Symptoms noven.com ↗
2012-06-22	Sumitomo Pharma America, Inc.	Anti-depressant Paxil CR Tablets newly launched sumitomo-pharma.com ↗
2012-03-30	Sumitomo Pharma America, Inc.	GlaxoSmithKline and Dainippon Sumitomo Pharma commence the co-promotion of anti-depressant Paxil CR Tablets sumitomo-pharma.com ↗
2012-03-20	Noven Therapeutics	Noven Completes Phase 3 Clinical Program For Investigational Non-Hormonal Therapy For Menopausal Vasomotor Symptoms noven.com ↗
2012-01-19	Sumitomo Pharma America, Inc.	Announcement of basic agreement concerning co-promotion of anti-depressant Paxil® CR Tablets sumitomo-pharma.com ↗
2011-12-22	Noven Therapeutics	Noven Announces Phase 3 Results For Investigational Non-hormonal Therapy For Vasomotor Symptoms noven.com ↗
2007-03-12	Zydus Lifesciences Limited	Zydus Cadila receives USFDA approval for Paroxetine Tablets zyduslife.com ↗
2005-08-16	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Approval of Paroxetine HCL Tablets tevapharm.com ↗

Evidence & citations 45 cited values

Every value below carries the sentence it was read from. 241 sources stand behind the page.

Field	Value	Cited text
Known as	Paroxetine	“we have restricted the IMPACT list of antidepressants to SSRIs (sertraline, escitalopram, paroxetine, fluoxetine, citalopram), duloxetine, bupropion, and mirtazapine. These...” NCT02458690 ↗ 232 “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 ↗ “Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine; sertraline;...” NCT00270959 ↗ “Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline,...” NCT01347541 ↗ “ADT such as citalopram, escitalopram, fluoxetine, sertraline, paroxetine, vilazodone, venlafaxine, desvenlafaxine, duloxetine or bupropion prescribed in accordance with its...” NCT01838876 ↗ “A chemical in the body called serotonin maybe responsible for COAT-platelet production. Paroxetine causes a significant reduction in platelet serotonin and therefore may have...” NCT00229528 ↗ “The dose is 20-60mg/day for fluoxetine, 20-40mg/day for paroxetine, 100-300mg/day for fluvoxamine, 50-200mg/day for sertraline, 20-40mg/day for citalopram, 10-20mg/day for...” NCT05148169 ↗ “Participants will receive SSRI antidepressant (such as, citalopram, escitalopram, fluvoxamine, fluoxetine, paroxetine, sertraline, vilazodone or vortioxetine) as a part of...” NCT03321526 ↗ “Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.” NCT00742573 ↗ Show 222 more sources
Known as	(-)3s,4r-paroxetine	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	[3H]-Paroxetine	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	Arketis	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	Aropax	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	Arotin	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	Besitram	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	Brisdelle	“The purpose of this study is to assess the pharmacokinetics (absorption, breakdown and elimination from the body), safety and tolerability of Brisdelle (paroxetine mesylate)...” NCT01829919 ↗ 3 “This is 12-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mg and placebo capsules in subjects with...” NCT01361308 ↗ “Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause” NCT01101841 ↗ “Brisdelle (paroxetine mesylate) Capsules 7.5 mg” NCT00786188 ↗
Known as	BRL 29060	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	BRL29060A	“Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) -A Double-blind, Placebo-controlled Study- <Phase III Study>” NCT00318669 ↗ 2 “BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder” NCT00839397 ↗ “BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine)” NCT00557622 ↗
Known as	Casbol	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	Daparox	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	Deroxat	“Admnistration of 18FAV45 if patient is compliant with one of those treatment: Seroplex, Zoloft, Deroxat, Venlafaxine, Mirtazapine, Moclamine,” NCT01962753 ↗ 1 “Paroxetine (Deroxat®) Posology : 20 mg per day for 3 weeks.” NCT03277339 ↗
Known as	Fg-7051	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	Frosinor	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	LDMP (Low-Dose Mesylate salt of Paroxetine)	“LDMP (Low-Dose Mesylate salt of Paroxetine)” NCT01829919 ↗ 3 “LDMP (Low-Dose Mesylate salt of Paroxetine)” NCT01101841 ↗ “LDMP (Low-Dose Mesylate salt of Paroxetine)” NCT00786188 ↗ “LDMP (Low-Dose Mesylate salt of Paroxetine)” NCT01361308 ↗
Known as	Mesafem	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	Motivan	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	NSC-758654	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	Parogen	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	Paroxetina	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	Paroxetine CR	“Trial of Paroxetine-CR for the Treatment of Patients With Post Traumatic Stress Disorder Remaining Symptomatic After Initial Exposure Therapy” NCT00121888 ↗ 2 “the other group will receive 12.5 mg of paroxetine CR orally once daily for 12 weeks.” NCT05637671 ↗ “Paroxetine CR (Paxil CR)” NCT00797966 ↗
Known as	Paroxetine HCl	“Paroxetine HCl is an orally administered psychotropic drug indicated in the treatment of major depressive, obsessive compulsive, panic, social anxiety, and generalized anxiety...” NCT02681198 ↗ 3 “Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period” NCT00841698 ↗ “Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period” NCT00841659 ↗ “Comparator: paroxetine HCL” NCT00034983 ↗
Known as	Paroxetine hydrochloride	“Randomized, 2-Way Crossover, Bioequivalence Study of Paroxetine Hydrochloride 40 mg Film-Coated Tablets and Paxil® 40 mg Film-Coated Tablets Administered as 1 x 40 mg...” NCT00841659 ↗ 5 “Paroxetine hydrochloride 40 mg tablet” NCT00648193 ↗ “Paroxetine hydrochloride 40 mg tablet” NCT00650403 ↗ NCT07715669 ↗ NCT03879746 ↗ NCT00648427 ↗
Known as	Paroxetine hydrochloride anhydrous	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	paroxetine hydrochloride controlled-release tablets	“We now propose to perform a placebo controlled study with Paxil CR (paroxetine hydrochloride controlled-release tablets), which is thought as paroxetine with less side-effects.” NCT00672776 ↗
Known as	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	paroxetine hydrochloride hydrate	“Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Social Phobia/Social Anxiety Disorder (SAD) -A Double-blind, Placebo-controlled Study- <Phase III Study>” NCT00318669 ↗ 2 “BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder” NCT00839397 ↗ “BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine)” NCT00557622 ↗
Known as	Paroxetine mesilate	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	paroxetine mesylate	“This is 12-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mg and placebo capsules in subjects with...” NCT01361308 ↗ 2 “Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause” NCT01101841 ↗ NCT00786188 ↗
Known as	Paroxetine methanesulfonate	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	Paroxetine methanesulphonate	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	Paroxetine, Paxil	“paroxetine (Paxil)” NCT01460212 ↗ 1 “Paroxetine, Paxil” NCT01916824 ↗
Known as	Paxil	“Participants receive only clinical routine antidepressant treatment,Which include fluoxetine (Prozac); sertraline (Zoloft); paroxetine (Paxil); citalopram (Celexa)...” NCT01831440 ↗ 8 “We have previously shown that serotonin reuptake inhibitor medications (paroxetine; Paxil) can change memory function and hippocampal structure in PTSD.” NCT00672776 ↗ “Comparatively assess the effectiveness and safety profile of pregabalin (Lyrica) and paroxetine (Paxil) in managing MS-induced neuropathic pain.” NCT00291148 ↗ “Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period” NCT00841698 ↗ “paroxetine (Paxil, Pexeva, and others)” NCT01944657 ↗ “paroxetine_Paxil, Seroxat” NCT00817011 ↗ “Paroxetine (Paxil)10-50;” NCT00074815 ↗ “Paxil® 40 mg Tablet” NCT00650403 ↗ “Paxil® 40 mg Table” NCT00648193 ↗
Known as	Paxil CR	“Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR),...” NCT00564278 ↗ 8 “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 ↗ “Patients on active drug (Paroxetine CR) who were successful responders during the double-blind phase will be eligible to continue on open label Paxil CR for an additional...” NCT00610909 ↗ “We now propose to perform a placebo controlled study with Paxil CR (paroxetine hydrochloride controlled-release tablets), which is thought as paroxetine with less side-effects.” NCT00672776 ↗ “In Phase II subjects will receive 5 more sessions of PE therapy and be randomly assigned (by chance, like a flip of a coin) to receive paroxetine-cr (Paxil-CR) or placebo.” NCT00121888 ↗ “The type of paroxetine used in this trial will be Paxil CR®, which is a sustained release formulation of paroxetine, which has fewer side effects and greater tolerability.” NCT00330239 ↗ “In phase I, all participants receive paroxetine CR (Paxil CR) for 10 weeks.” NCT00113295 ↗ “paroxetine (Paxil CR®) controlled-release tablets” NCT03538691 ↗ “Paroxetine CR (Paxil CR)” NCT00797966 ↗
Known as	Paxpar	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	Pexeva	“paroxetine (Paxil, Pexeva, and others)” NCT01944657 ↗
Known as	PO-T.MES	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Known as	Seroxat	“paroxetine_Paxil, Seroxat” NCT00817011 ↗ 1 NCT00184106 ↗
Known as	Xetanor	ChEMBL registry synonym — accepted as the source's own label CHEMBL490 ↗
Action	Inhibit	“a SSRI (selective serotonin reuptake inhibitor) antidepressant, paroxetine, a tricyclic antidepressant, nortriptyline, and placebo in a placebo-controlled trial.” NCT00062738 ↗ 1 “Serotonin transporter inhibitor” CHEMBL490 ↗
Modality	Small molecule	“the SSRI, paroxetine-CR” NCT00121888 ↗
Route	Oral	“was orally administered once daily for 8 weeks” NCT00135525 ↗
Target	CYP2D6	“Paroxetine is a very potent inhibitor of the enzyme CYP2D6” NCT00785603 ↗
Target	SLC6A4	“Serotonin transporter inhibitor” CHEMBL490 ↗