fluoxetine

Trade name: prozac

Small moleculeapproved

Approved

Dec 29, 1987

Fluoxetine hydrochloride is the first agent of the class of antidepressants known as selective serotonin-reuptake inhibitors (SSRIs). Fluoxetine is a racemic mixture of the R- and S- enantiomers and are of equivalent pharmacologic activity. Despite distinct structural differences between compounds in this class, SSRIs possess similar pharmacological activity. As with other antidepressant agents, several weeks of therapy may be required before a clinical effect is seen. SSRIs are potent inhibitors of neuronal serotonin reuptake. They have little to no effect on norepinephrine or dopamine reuptake and do not antagonize α- or β-adrenergic, dopamine D2 or histamine H1 receptors. During acute use, SSRIs block serotonin reuptake and increase serotonin stimulation of somatodendritic 5-HT1A and terminal autoreceptors. Fluoxetine is marketed under the trade names Prozac and Sarafem among others. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride). PROZAC is a selective serotonin reuptake inhibitor indicated for: • Acute and maintenance treatment of Major Depressive Disorder (MDD) in adult and pediatric patients aged 8 to 18 years • Acute and maintenance treatment of Obsessive Compulsive Disorder (OCD) in adult and pediatric patients aged 7 to 17 years • Acute and maintenance treatment of Bulimia Nervosa in adult patients • Acute treatment of Panic Disorder, with or without agoraphobia, in adult patients. Studies at clinically relevant doses in man have demonstrated that fluoxetine blocks the uptake of serotonin into human platelets. Studies in animals also suggest that fluoxetine is a much more potent uptake inhibitor of serotonin than of norepinephrine. Antagonism of muscarinic, histaminergic, and α1-adrenergic receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular effects of classical tricyclic antidepressant (TCA) drugs. Fluoxetine binds to these and other membrane receptors from brain tissue much less potently in vitro than do the tricyclic drugs. — NCATS

Clinical trial activity

276 trials · 273 clinical orgs · 56 marketing orgs

Phase 1

Phase 2

101

Phase 3

Phase 4

Earliest trial started Apr 1, 1990 (NCT00000213)

Timeline

1970s

Jun 1, 1977
Eli Lilly — IND Organization
Jun 1, 1977
Eli Lilly — IND Organization

1980s

Dec 29, 1987
Eli Lilly — Earliest FDA Approval
Dec 29, 1987
Eli Lilly — NDA Organization

1990s

Jan 1, 1990
Earliest Phase 2 Sponsor(trial)
Jan 1, 1996
Sandoz — Earliest Phase 1 Sponsor(trial)
Jan 1, 1997
Earliest Phase 3 Sponsor(trial)

2000s

Aug 2, 2001
Barr Laboratories — Marketing Organization
Aug 2, 2001
Mylan — Marketing Organization
Aug 2, 2001
Sandoz — Marketing Organization
Aug 2, 2001
Rising Pharmaceuticals — Marketing Organization
Aug 2, 2001
Apnar Pharma — Marketing Organization
Jan 29, 2002
Beximco — Marketing Organization
Jan 29, 2002
Fosun — Marketing Organization
Jan 29, 2002
Marksans Pharma — Marketing Organization
Jan 29, 2002
Specgx Llc — Marketing Organization
Jan 29, 2002
Watson Pharmaceuticals — Marketing Organization
Jan 30, 2002
Ionis Pharmaceuticals, Inc. — Marketing Organization
Jan 30, 2002
Dr. Reddy's Laboratories — Marketing Organization
Jan 30, 2002
Landela Pharmaceutical — Marketing Organization
Jan 30, 2002
Pharmaceutical Associates — Marketing Organization
Jan 31, 2002
Actavis — Marketing Organization
Jan 31, 2002
Teva — Marketing Organization
Feb 1, 2002
Cr Double Crane — Marketing Organization
Feb 7, 2002
Apotex — Marketing Organization
Feb 7, 2002
Nostrum Laboratories — Marketing Organization
Jun 27, 2002
Hi Tech Pharmaceuticals — Marketing Organization
Jun 27, 2002
Akorn, Inc. — Marketing Organization
Aug 29, 2002
Wockhardt — Marketing Organization
Aug 29, 2002
Xttrium Laboratories — Marketing Organization
May 14, 2004
Lannett Company, Inc. — Marketing Organization
May 14, 2004
Chartwell Pharmaceuticals — Marketing Organization
Dec 13, 2004
Sun Pharmaceuticals — Marketing Organization
Dec 16, 2004
Strides Pharma Science — Marketing Organization
May 19, 2006
Allergan — NDA Secondary Org
May 19, 2006
GlaxoSmithKline — NDA Secondary Org
Jan 16, 2008
Celltrion — Marketing Organization
Jan 16, 2008
Granules India — Marketing Organization
Jan 31, 2008
Aurobindo Pharma — Marketing Organization
May 20, 2008
Ani Pharmaceuticals — Marketing Organization
Nov 17, 2008
Novartis — Marketing Organization
Mar 19, 2009
Alembic — Marketing Organization

2010s

Oct 6, 2011
Alvogen — NDA Secondary Org
Oct 6, 2011
Alvogen — Marketing Organization
Oct 1, 2012
Heritage Pharma — Marketing Organization
Oct 1, 2012
Emcure — Marketing Organization
Nov 16, 2012
Epic Pharma Llc — Marketing Organization
Mar 16, 2015
Sciegen Pharmaceticals — Marketing Organization
Aug 19, 2016
Par Pharmaceuticals — Marketing Organization
Aug 19, 2016
Bristol-Myers Squibb — Marketing Organization
Oct 21, 2016
Torrent Pharmaceuticals Limited — Marketing Organization
Nov 20, 2017
Inventia Hlthcare — Marketing Organization
Nov 21, 2018
Appco Pharma — Marketing Organization
Nov 21, 2018
Taro Pharmaceuticals — Marketing Organization
Jan 30, 2019
Upsher-Smith Laboratories — Marketing Organization
Feb 8, 2019
Lupin — Marketing Organization
May 23, 2019
Cadila Healthcare — Marketing Organization
Jul 5, 2019
G & W Laboratories Inc. — Marketing Organization

2020s

Aug 27, 2020
Accord Research — Marketing Organization
Mar 29, 2022
Micro Labs Ltd India — Marketing Organization
Sep 13, 2022
Piramal — Marketing Organization
Nov 9, 2022
Novitium Pharma — Marketing Organization
Nov 15, 2022
Aptapharma Inc — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Serotonin transporterINHIBITOR
SLC6A4 inhibitor
reuptake inhibitor
- Sodium-dependent serotonin transporter (SLC6A4) ↗

Combination products

symbyax
with olanzapine

Approval history

approvedPriority reviewDec 29, 1987

Chemistry & pharmacology

Loading structure…

SMILES

CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1

Mol. weight: 309.33 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Racemic Mixture
Inorganic: No
Polymer: No
Delivery: Oral
Availability: Prescription Only

Oral

Yes

Parenteral

Topical

Black box warning

Sources

Also known as

felicium
felicium
fluoxetin
fluoxetin
fluoxetin
fluoxetin
fluoxetina
fluoxetina
fluoxetine
fluoxetine
fluoxetine
fluoxetine
fluoxetine
fluoxetine
fluoxetine
fluoxetine
fluoxétine
fluoxétine
fluoxetine hcl
fluoxetine hcl
fluoxetine hcl
fluoxetine hydrochloride
fluoxetine hydrochloride
fluoxetine hydrochloride
fluoxetine hydrochloride
fluoxetine hydrochloride
fluoxetinum
fluoxetinum
fluval
fluval
ly110140
ly110140
ly-110140
ly-110140
(+-)-n-methyl-3-phenyl-3-((alpha,alpha,alpha-trifluoro-p-tolyl)oxy)propylamine
(+-)-n-methyl-3-phenyl-3-((alpha,alpha,alpha-trifluoro-p-tolyl)oxy)propylamine
(+-)-n-methyl-gamma-(4-(trifluoromethyl)phenoxy)benzenepropanamine
(+-)-n-methyl-gamma-(4-(trifluoromethyl)phenoxy)benzenepropanamine
olanzapine-fluoxetine combination
olanzapine-fluoxetine hydrochloride combination
olena
oxactin
prozac
prozac
prozac
prozac
prozac
prozac
prozac
prozac
prozac 60
prozac weekly
prozac weekly
prozep
prozit
ranflutin
sarafem
sarafem
sarafem
symbyax
symbyax
symbyax

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07007221	Phase 2	Jan 1, 2026	University of Minnesota
NCT07239011	Phase 1/Phase 2 (Phase 2)	Nov 1, 2025	Tanta University
NCT07174947	Phase 2	Oct 1, 2025	Wenzhou Medical University
NCT07110831	Phase 4	Aug 14, 2025	National Institute of Mental Health (NIMH), National Institutes of Health (NIH), State University of New York, Buffalo, University of Ibadan
NCT06957223	N/A	May 6, 2025	CMH Nowshera, Pakistan Army
NCT06957210	N/A	May 6, 2025	CMH Nowshera, Pakistan Army
NCT06796946	Early Phase 1 (Phase 1)	Apr 30, 2025	University of Huelva
NCT07025590	N/A	Apr 22, 2025	Shantou University
NCT06860958	Phase 3	Mar 20, 2025	Tanta University
NCT06225011	Phase 1	Dec 1, 2024	University of California, Los Angeles
NCT06898606	Phase 1/Phase 2 (Phase 2)	Sep 5, 2024	Federal University of Latin American Integration
NCT06506136	Phase 1/Phase 2 (Phase 2)	Sep 1, 2024	People's Liberation Army of China
NCT06384209	N/A	Jul 1, 2024	Swiss National Science Foundation, University of Bern, University of Zimbabwe
NCT05944926	Phase 3	Mar 1, 2024	All India Institute of Medical Sciences, Harvard University, National Institute of Mental Health (NIMH), Sangath, University of Toronto, Vanderbilt University
NCT05976347	Phase 4	Feb 29, 2024	Wake Forest University
NCT06341127	N/A	Jan 17, 2024	University of Toronto
NCT07115472	N/A	Jan 1, 2024	People's Liberation Army of China
NCT05948553	Phase 2	Nov 2, 2023	Berry Consultants, Cambridge Cognition Ltd, Citeline, Idorsia Pharmaceuticals Ltd., PPD, United States Army
NCT06046859	Early Phase 1 (Phase 1)	Nov 1, 2023	University of Florida
NCT05792540	Phase 2	Jun 6, 2023	Menoufia University, Tanta University

Showing 20 of 276 trials

Page 1 / 14

Organizations

Research & Development (273)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
National Institute of Mental Health (NIMH)	Government	37	4	5	1992
Eli Lilly	For profit	16	13	4	1997
Columbia University	Academic/Hospital	14	9	4	1990
Harvard University	Academic/Hospital	14	11	5	1995
Omninvest Ltd	For profit	8	8	3	2007
Jiao Tong University	Academic/Hospital	7	7	3	2012
People's Liberation Army of China	Government	7	5	3	2015
The University of Texas, Dallas	Academic/Hospital	7	6	3	1998
University of Pittsburgh	Academic/Hospital	7	6	4	1995
Department of Veteran Affairs	Government	6	4	4	1998
University of Minnesota	Academic/Hospital	6	5	2	2000
University of Pennsylvania	Academic/Hospital	6	5	3	1998
University of Toronto	Academic/Hospital	6	3	4	2000
Zhejiang University	Academic/Hospital	6	5	2	2017
National Institute on Drug Abuse (NIDA)	Government	5	2	4	1990
Otsuka	For profit	5	5	2	2009
Sungkyunkwan University	Academic/Hospital	5	5	1	1999
University of California, Los Angeles	Academic/Hospital	5	5	4	1994
Cairo University	Academic/Hospital	4	4	2	2015
Capital Medical University	Academic/Hospital	4	3	2	2013

273 organizations

Page 1 / 14

Marketing (73)

Organization	Org type	Relationship	Date
Accord Research	For profit	MKTG	Aug 27, 2020
Actavis	For profit	MKTG	Jan 31, 2002
Akorn, Inc.	For profit	MKTG	Jun 27, 2002
Alembic	For profit	MKTG	Mar 19, 2009
Alembic	For profit	SYN	Apr 5, 2017
Allergan	For profit	NDA2	May 19, 2006
Alvogen	For profit	NDA2	Oct 6, 2011
Alvogen	For profit	MKTG	Oct 6, 2011
Ani Pharmaceuticals	For profit	MKTG	May 20, 2008
Ani Pharmaceuticals	For profit	SYN	May 20, 2008
Apnar Pharma	For profit	MKTG	Aug 2, 2001
Apotex	For profit	MKTG	Feb 7, 2002
Appco Pharma	For profit	MKTG	Nov 21, 2018
Aptapharma Inc	For profit	MKTG	Nov 15, 2022
Aurobindo Pharma	For profit	MKTG	Jan 31, 2008
Aurobindo Pharma	For profit	SYN	Mar 19, 2009
Barr Laboratories	For profit	MKTG	Aug 2, 2001
Beximco	For profit	MKTG	Jan 29, 2002
Bristol-Myers Squibb	For profit	MKTG	Aug 19, 2016
Cadila Healthcare	For profit	MKTG	May 23, 2019
Celltrion	For profit	MKTG	Jan 16, 2008
Chartwell Pharmaceuticals	For profit	MKTG	May 14, 2004
Cr Double Crane	For profit	MKTG	Feb 1, 2002
Dr. Reddy's Laboratories	For profit	MKTG	Jan 30, 2002
Dr. Reddy's Laboratories	For profit	SYN	Jan 30, 2002
Eli Lilly	For profit	SYN	Apr 24, 1991
Eli Lilly	For profit	IND	Jun 1, 1977
Eli Lilly	For profit	NDA	Dec 29, 1987
Emcure	For profit	MKTG	Oct 1, 2012
Epic Pharma Llc	For profit	MKTG	Nov 16, 2012
Fosun	For profit	MKTG	Jan 29, 2002
G & W Laboratories Inc.	For profit	MKTG	Jul 5, 2019
GlaxoSmithKline	For profit	NDA2	May 19, 2006
Granules India	For profit	MKTG	Jan 16, 2008
Heritage Pharma	For profit	MKTG	Oct 1, 2012
Heritage Pharma	For profit	SYN	Oct 1, 2012
Hi Tech Pharmaceuticals	For profit	MKTG	Jun 27, 2002
Inventia Hlthcare	For profit	MKTG	Nov 20, 2017
Ionis Pharmaceuticals, Inc.	For profit	MKTG	Jan 30, 2002
Landela Pharmaceutical	For profit	MKTG	Jan 30, 2002
Lannett Company, Inc.	For profit	MKTG	May 14, 2004
Lupin	For profit	MKTG	Feb 8, 2019
Marksans Pharma	For profit	MKTG	Jan 29, 2002
Micro Labs Ltd India	For profit	MKTG	Mar 29, 2022
Mylan	For profit	MKTG	Aug 2, 2001
Mylan	For profit	SYN	Jan 29, 2002
Nostrum Laboratories	For profit	MKTG	Feb 7, 2002
Novartis	For profit	MKTG	Nov 17, 2008
Novitium Pharma	For profit	MKTG	Nov 9, 2022
Par Pharmaceuticals	For profit	MKTG	Aug 19, 2016
Par Pharmaceuticals	For profit	SYN	Dec 16, 2004
Par Pharmaceuticals	For profit	SYN	Nov 16, 2017
Pharmaceutical Associates	For profit	MKTG	Jan 30, 2002
Piramal	For profit	MKTG	Sep 13, 2022
Rising Pharmaceuticals	For profit	MKTG	Aug 2, 2001
Rising Pharmaceuticals	For profit	SYN	Aug 2, 2001
Sandoz	For profit	MKTG	Aug 2, 2001
Sciegen Pharmaceticals	For profit	MKTG	Mar 16, 2015
Specgx Llc	For profit	MKTG	Jan 29, 2002
Strides Pharma Science	For profit	MKTG	Dec 16, 2004
Sun Pharmaceuticals	For profit	MKTG	Dec 13, 2004
Sun Pharmaceuticals	For profit	SYN	Jan 29, 2002
Taro Pharmaceuticals	For profit	MKTG	Nov 21, 2018
Teva	For profit	MKTG	Jan 31, 2002
Teva	For profit	SYN	Aug 2, 2001
Teva	For profit	SYN	Jun 19, 2012
Teva	For profit	SYN	Jan 29, 2002
Torrent Pharmaceuticals Limited	For profit	MKTG	Oct 21, 2016
Upsher-Smith Laboratories	For profit	MKTG	Jan 30, 2019
Watson Pharmaceuticals	For profit	MKTG	Jan 29, 2002
Wockhardt	For profit	MKTG	Aug 29, 2002
Wockhardt	For profit	SYN	Jan 16, 2008
Xttrium Laboratories	For profit	MKTG	Aug 29, 2002