Last update 16 May 2025

Fluoxetine Hydrochloride

Overview

Basic Info

SummaryFluoxetine Hydrochloride, also known by the trade name PROZAC®, is a drug that works as a selective serotonin reuptake inhibitor (SSRI). It was first approved in the United States by Eli Lilly & Co. in 1987. PROZAC is used to treat major depressive disorder, obsessive-compulsive disorder, bulimia nervosa, and panic disorder. It is also marketed under the name Sarafem® for the treatment of premenstrual dysphoric disorder. PROZAC and olanzapine in combination are indicated for the acute treatment of depressive episodes associated with bipolar I disorder and treatment-resistant depression. However, PROZAC monotherapy is not indicated for these conditions. Clinicians should refer to the Clinical Studies section of the package insert for Symbyax® when using PROZAC and olanzapine in combination.
Drug Type
Small molecule drug
Synonyms
(+-)-N-Methyl-3-phenyl-3-((alpha,alpha,alpha-trifluoro-P-tolyl)oxy)propylamine, (+-)-N-Methyl-gamma-(4-(trifluoromethyl)phenoxy)benzenepropanamine, Fluoxetine hydrochloride (JAN/USP)
+ [21]
Target
Action
inhibitors
Mechanism
SERT inhibitors(Serotonin transporter inhibitors)
Inactive Indication
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (29 Dec 1987),
RegulationOrphan Drug (United States)
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Structure/Sequence

Molecular FormulaC17H19ClF3NO
InChIKeyGIYXAJPCNFJEHY-UHFFFAOYSA-N
CAS Registry56296-78-7

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Bipolar I disorder
United States
19 Mar 2009
Depressive Disorder, Treatment-Resistant
United States
19 Mar 2009
Bulimia Nervosa
United States
29 Jul 2002
Depressive Disorder, Major
United States
29 Jul 2002
Obsessive-Compulsive Disorder
United States
29 Jul 2002
Panic Disorder
United States
29 Jul 2002
Depressive Disorder
China
21 Oct 1996
Premenstrual Dysphoric Disorder
United States
29 Dec 1987
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
SmokingPhase 3
United States
01 Feb 1998
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
4
qgtlocwvmu = qzwsuzjzvc nqrzmpkmdt (rmtxvcuxcq, wsmuxvfkve - drgppdrlix)
-
30 Mar 2025
Phase 4
16
ocdoyvktzf(tayvofxmjl) = qgmcylqbng mmybzlzztr (vhsdpqdmwk, 2)
-
17 Oct 2024
Phase 4
9
(Aripiprazole)
uffrkqajja(kpvfndbuhl) = ghzgllfdyg ukuaoxdljn (cckngdsrfb, gzwtwxuxwm - enurxjvrzc)
-
15 Nov 2023
(Fluoxetine)
uffrkqajja(kpvfndbuhl) = ugsuoafrzy ukuaoxdljn (cckngdsrfb, bsyznnqqsp - mjhxnmnoih)
Not Applicable
-
203
watchman FLX
csmlziearq(eizfsralmc) = dnuhlwtqrk rhpqqimcyg (wznqmbvgrm )
-
28 Aug 2023
watchman FLX
csmlziearq(eizfsralmc) = ezrwhdjrqi rhpqqimcyg (wznqmbvgrm )
Phase 4
16
(Treatment As Usual)
npfhwmvxar = qrfiuedzfz jvluppwyng (awseyzbiqh, umsfqzvlqa - wujoyypggp)
-
30 Sep 2022
(Fluoxetine)
npfhwmvxar = bpqoppqsoi jvluppwyng (awseyzbiqh, mwjfqmvdyk - trgtlllrzz)
Phase 3
110
bhnhhpiexv(nvpwqksxxn) = cqsteezenq jvlgjxdeoo (cpckjbytyp, 4.6)
Positive
31 Aug 2022
Placebo
bhnhhpiexv(nvpwqksxxn) = guhflgklwp jvlgjxdeoo (cpckjbytyp, 3.4)
Phase 2
17
nvcuwanunm(kqikycxqyr) = fgvkuwzpim xkanhelsde (qxcysiazpx )
Positive
08 Jul 2022
Placebo
nvcuwanunm(kqikycxqyr) = uiocwcjrhm xkanhelsde (qxcysiazpx )
Phase 2
34
cgnevcngcx(ixztcismdt) = viglbgbqas vxceooeasc (jaexuflngb, 2.9)
-
25 May 2022
Not Applicable
-
skyfaszjea(ftqtupeysp) = 1-3% of treated patients ldcejyvzma (ekondpqicb )
-
12 May 2022
Phase 2
17
(Fluoxetine)
eviqeafear(sfqdxcxdqa) = plqhpopoix frhkkujyjf (ztecqkpnng, irfxioshhj - nwlpxgwmjp)
-
13 Oct 2021
Placebo
(Placebo)
eviqeafear(sfqdxcxdqa) = mhpjppzkgo frhkkujyjf (ztecqkpnng, ozdjwdjets - cgwlebmwgc)
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Regulation

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