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Drug ReportsFluoxetine
Fluoxetine
Fluoxetine, Prozac, Symbyax (fluoxetine) is a small molecule pharmaceutical. Fluoxetine was first approved as Prozac on 1987-12-29. It is used to treat bulimia, major depressive disorder, obsessive-compulsive disorder, and panic disorder in the USA. The pharmaceutical is active against sodium-dependent serotonin transporter. In addition, it is known to target anoctamin-1, voltage-gated potassium channel KCNC1, G protein-activated inward rectifier potassium channel 2, 5-hydroxytryptamine receptor 6, 5-hydroxytryptamine receptor 2B, equilibrative nucleoside transporter 4, 5-hydroxytryptamine receptor 2A, and 5-hydroxytryptamine receptor 2C.
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Events Timeline
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YTD
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2Y
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EMA approval date
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Last update post date
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Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
mental disordersD001523
Trade Name
FDA
EMA
Fluoxetine, Sarafem (discontinued: Fluoxetine, Prozac, Sarafem, Selfemra)
Combinations
Olanzapine fluoxetine, Symbyax
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fluoxetine hydrochloride
Tradename
Company
Number
Date
Products
PROZACEli LillyN-018936 RX1987-12-29
3 products, RLD
FLUOXETINE HYDROCHLORIDETWi PharmaceuticalsN-202133 RX2011-10-06
1 products, RLD, RS
Show 6 discontinued
Fluoxetine hydrochloride
+
Olanzapine
Tradename
Company
Number
Date
Products
SYMBYAXEli LillyN-021520 RX2003-12-24
5 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
fluoxetineANDA2025-02-12
fluoxetine hclANDA2025-01-22
fluoxetine hydrochlorideANDA2024-12-30
gaboxetineunapproved drug other2011-08-01
olanzapine and fluoxetineANDA2024-04-19
prozacNew Drug Application2024-11-13
sentraflox am-10unapproved drug other2011-08-17
sentroxatineunapproved drug other2011-08-01
symbyaxNew Drug Application2025-01-22
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bulimia—D002032F50.2
panic disorderEFO_0004262D016584F41.0
major depressive disorderEFO_0003761D003865F22
obsessive-compulsive disorderEFO_0004242D009771F42
schizophreniaEFO_0000692D012559F20
psychotic disorders—D011618F20.81
bipolar disorderEFO_0000289D001714F30.9
schizophrenia spectrum and other psychotic disorders—D019967—
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N06: Psychoanaleptics
— N06A: Antidepressants
— N06AB: Selective serotonin reuptake inhibitors
— N06AB03: Fluoxetine
— N06C: Psycholeptics and psychoanaleptics in combination
— N06CA: Antidepressants in combination with psycholeptics
— N06CA03: Fluoxetine and psycholeptics
HCPCS
No data
Clinical
Clinical Trials
366 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DepressionD003863—F33.93————3
MalnutritionD044342EFO_0008572E40-E461————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFluoxetine
INNfluoxetine
Description
N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine is an aromatic ether consisting of 4-trifluoromethylphenol in which the hydrogen of the phenolic hydroxy group is replaced by a 3-(methylamino)-1-phenylpropyl group. It is a member of (trifluoromethyl)benzenes, an aromatic ether and a secondary amino compound.
Classification
Small molecule
Drug classantidepressants (fluoxetine type)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Identifiers
PDB—
CAS-ID54910-89-3
RxCUI—
ChEMBL IDCHEMBL41
ChEBI ID86990
PubChem CID3386
DrugBankDB00472
UNII ID01K63SUP8D (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
KCNC1
KCNC1
Organism
Homo sapiens
Gene name
KCNC1
Gene synonyms
NCBI Gene ID
3746
Protein name
potassium voltage-gated channel subfamily C member 1
Protein synonyms
NGK2, potassium channel, voltage gated Shaw related subfamily C, member 1, voltage-gated potassium channel protein KV3.1, Voltage-gated potassium channel subunit Kv3.1, Voltage-gated potassium channel subunit Kv4
Uniprot ID
P48547
Mouse ortholog
Kcnc1 (16502)
potassium voltage-gated channel subfamily C member 1 (P15388)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Fluoxetine
Total medical expenditures per year (USD, in millions)
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Fluoxetine
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Olanzapine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 45,082 documents
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Safety
Black-box Warning
Black-box warning for: Fluoxetine, Fluoxetine hcl, Fluoxetine hydrochloride, Gaboxetine, Olanzapine and fluoxetine, Prozac, Sentraflox am-10, Sentroxatine, Symbyax
Adverse Events
Top Adverse Reactions
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47,834 adverse events reported
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