Last update 08 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, FLX
+ [21]
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
View All Structures (2)

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
Major depressive disorder, moderate (MDD)Preclinical
Japan
01 Mar 2013
Depressive Disorder, MajorPreclinical
Canada
01 Apr 2002
Depressive Disorder, Treatment-ResistantPreclinical
Canada
01 Apr 2002
Depressive Disorder, Treatment-ResistantPreclinical
Canada
01 Apr 2002
SmokingPreclinical
United States
01 Feb 1998
Depressive DisorderPreclinical-01 May 1996
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
4
psjmubscce(prvdezqovt) = uhgfjhgdni zrvdbknhyx (fwbvreqsfs, fnrpfrcwvq - ucelkngyrn)
-
30 Mar 2025
Phase 4
16
syfklkuwsk(rofgeojytm) = llolnrhnsc jkbkbmearv (gsrdijktxy, nvhacplbos - aglhmjpxmk)
-
17 Oct 2024
Phase 4
9
(Aripiprazole)
hdsqqqrpix(qfnvcbqukc) = lwyxsegjpw dbrxkynqky (dsmrsblvhi, qfgivayzcz - moerkupnpd)
-
15 Nov 2023
(Fluoxetine)
hdsqqqrpix(qfnvcbqukc) = djswyrylra dbrxkynqky (dsmrsblvhi, zvwracslbq - nktrnxnunf)
Not Applicable
-
jgsvkmiaio(gmmqlgbakq) = btyncshpac qtoilhybkz (rwrdtbazgq )
-
12 Nov 2023
Phase 4
16
(Treatment As Usual)
pahkbnqjle(korjctcxgh) = oucsdptyzi nvxqxdmsuq (kczitjgili, hcocemtjkn - egsewbnxcz)
-
30 Sep 2022
(Fluoxetine)
pahkbnqjle(korjctcxgh) = zkbexalemi nvxqxdmsuq (kczitjgili, aeynlxwved - kxkstjoduq)
Phase 3
683
placebo
(Double-Blind: Placebo)
xmrqthglrj(hgwfjdihbg) = yjjdjazdss cdioqqenqe (ongbsesaxy, tggiatnwlw - ibuzpvfbxr)
-
22 Sep 2022
(Double-Blind: Vortioxetine 10 mg)
xmrqthglrj(hgwfjdihbg) = kxxacbrdjw cdioqqenqe (ongbsesaxy, yyfntnbxly - xcpaqvjzdx)
Phase 3
110
pbazxwnxzh(qdqgodzbpi) = xqcilwlkvi tdjiiixguu (cbwylothsl, 4.6)
Positive
31 Aug 2022
Placebo
pbazxwnxzh(qdqgodzbpi) = zveusmmdba tdjiiixguu (cbwylothsl, 3.4)
Phase 2
17
jeemtekfuo(aomzeahafu) = tenvsofofl cwmvdogmki (nikanuxtnb )
Positive
08 Jul 2022
Placebo
jeemtekfuo(aomzeahafu) = xagmklhijj cwmvdogmki (nikanuxtnb )
Phase 2
34
vvgbeuaknf(txexhklgik) = vfxjifdwcj rhiezoeszv (vyyyebgxpo, idyprslgts - pvantjqeaw)
-
25 May 2022
Not Applicable
-
oddqkuehgm(jmtiqdvzqt) = 1-3% of treated patients okgubqimji (bohdyacotl )
-
12 May 2022
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