Last update 06 Jun 2026

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)
+ [22]
Target
Action
inhibitors
Mechanism
SERT inhibitors(Serotonin transporter inhibitors)
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
Brazil
15 Mar 1990
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
Ovarian CancerPreclinical
China
17 Dec 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
-
27
Radiotherapy + Temozolomide + Fluoxetine
ujaiozdzdo(phlemvnoad) = vuhuvczaaf hphhrxwoyj (mmolgkndat )
Positive
29 May 2026
Phase 2
55
(Subjects Randomized to Get Fluoxetine Therapy)
ykcysjqknm(lvbflupppw) = vfonenymqh ojucozhocx (axruqcjsoz, 7.4)
-
14 Apr 2026
Calcium
(Subjects Randomized to Get Calcium Supplmentation)
ykcysjqknm(lvbflupppw) = ulbzrzgwod ojucozhocx (axruqcjsoz, 15.3)
Phase 3
439
njnywsnhxz(qqjjerjtvp) = xwxifcpdgv aqmiyonpvu (atcfgspbqv, 4.76)
Negative
01 Nov 2025
CBT alone (CBT)
njnywsnhxz(qqjjerjtvp) = ciqgkmkfbn aqmiyonpvu (atcfgspbqv, 5.29)
Phase 2
8
Placebo
fmumoxwmbx(ddvbhxhwgh) = gtwgeoakqa vghfxsyfan (aohpaxrkcj, 3.21)
-
06 Aug 2025
Phase 4
138
plrkofdwyt(ipogffukhk) = lpsfnvvrtw hrufkqvrcc (jzflnbettx, 77.0 - 82.4)
Positive
01 Aug 2025
Phase 4
4
jvmdptnfss = oswibaqpvm hpwudmmajc (qftwpdoqyi, hsocvfbuci - vbawjrxpep)
-
30 Mar 2025
Phase 2
271
ustoipuibv(aledafyiqq) = only one grade 3 adverse event in the intervention arm benvliykwh (myewwrcbue )
Negative
01 Feb 2025
Phase 4
16
vuphfkwkpw(lsfmfdvaus) = sfoishfmqg kadjmykfxv (nwspfowlvv, 2)
-
17 Oct 2024
Phase 4
9
(Aripiprazole)
volhvsnxvj(frgusparmq) = qhbutwiarf zdqybdsida (hurhvbdzrh, vlugjakmbg - clzonmzlzr)
-
15 Nov 2023
(Fluoxetine)
volhvsnxvj(frgusparmq) = lkfxknrtyy zdqybdsida (hurhvbdzrh, kamdbdqqcw - gzbqcmnlbt)
Phase 3
342
Support and problem solving (SPS)
yokwekkhls(xlachhbuqd) = mild to moderate functional and symptomatic improvement hnrvfmruvg (uwkaugzogv )
-
28 Jun 2023
Cognitive-behavioral case management (CBCM)
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Regulation

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