Fluoxetine
Approved · FDAAlso known as (+-)-N-Methyl-gamma-(4-(trifluoromethyl)phenoxy)benzenepropanamine, PROzac, RECONCILE, Rapiflux+10 more
(+-)-N-Methyl-gamma-(4-(trifluoromethyl)phenoxy)benzenepropanamine, PROzac, RECONCILE, Rapiflux, Sarafem, Selfemra, Symbyax, Fluoxetin, Fluoxetina, Fluoxétine, (+-)-N-Methyl-3-phenyl-3-((alpha,alpha,alpha-trifluoro-P-tolyl)oxy)propylamine, FLUoxetine HCl, FLUoxetine Hydrochloride, Fluoxetinum.
Recent clinical, regulatory, research and industry developments relating to this drug.
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Supplemental approval: FLUOXETINE (ANDA210935)
Identifying and Treating Depression in the Orthopaedic Trauma Population
Serotonin modulates excitatory synapse maturation in the developing prefrontal cortex.
Label change: FLUOXETINE (ANDA210935)
Label change: FLUOXETINE (ANDA210935)
Approval: FLUOXETINE (ANDA210935)
Update of EULAR recommendations for the treatment of systemic sclerosis.
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes8
Journals, researchers & institutions
- The Journal of neuroscience : the official journal of the Society for Neuroscience3
- Biological psychiatry2
- The American journal of psychiatry2
- Annals of the rheumatic diseases1
- Drug and alcohol dependence1
- JAMA1
- Castrén E3
- Davidson RJ3
- Heller AS3
- Johnstone T3
- Kalin NH3
- Kolden GG3
- Peterson MJ3
- Ernfors P2
- Neuroscience Center2
- A. I. Virtanen Institute1
- Anhui Provincial Key Laboratory for Brain Bank Construction and Resource Utilization1
- Basel University1
- Center for Investigating Healthy Minds at the Waisman Center1
- Center for Neuroscience1
Related drugs
Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).
Studied across 7 of the same disease areas as Fluoxetine in the shared literature.
Studied across 2 of the same disease areas as Fluoxetine in the shared literature.
Studied across the same disease area as Fluoxetine in the shared literature.
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.