fluvoxamine

Trade name: luvox

Small moleculeapproved

Approved

Dec 5, 1994

Fluvoxamine is an antidepressant which functions pharmacologically as a selective serotonin reuptake inhibitor. Though it is in the same class as other SSRI drugs, it is most often used to treat obsessive-compulsive disorder. Fluvoxamine has been in use in clinical practice since 1983 and has a clinical trial database comprised of approximately 35,000 patients. It was launched in the US in December 1994 and in Japan in June 1999. As of the end of 1995, more than 10 million patients worldwide have been treated with fluvoxamine. The exact mechanism of action of fluvoxamine has not been fully determined, but appears to be linked to its inhibition of CNS neuronal uptake of serotonin. Fluvoxamine blocks the reuptake of serotonin at the serotonin reuptake pump of the neuronal membrane, enhancing the actions of serotonin on 5HT1A autoreceptors. In-vitro studies suggest that fluvoxamine is more potent than clomipramine, fluoxetine, and desipramine as a serotonin-reuptake inhibitor. Studies have also demonstrated that fluvoxamine has virtually no affinity for α1- or α2-adrenergic, β-adrenergic, muscarinic, dopamine D2, histamine H1, GABA-benzodiazepine, opiate, 5-HT1, or 5-HT2 receptors. Fluvoxamine is used for management of depression and for Obsessive Compulsive Disorder (OCD). Has also been used in the management of bulimia nervosa. Fluvoxamine is known under the brand names: Faverin, Fevarin, Floxyfral, Dumyrox and Luvox. — NCATS

Clinical trial activity

82 trials · 119 clinical orgs · 25 marketing orgs

Phase 1
22
Phase 2
19
Phase 3
13
Phase 4
17

Earliest trial started Oct 1, 1996 (NCT00000389)

Timeline

1990s

  1. Dec 5, 1994

    Solvay — Earliest FDA Approval

  2. Dec 5, 1994

    Solvay — NDA Secondary Org

  3. Dec 5, 1994

    Solvay — NDA Organization

  4. Jan 1, 1996

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Nov 29, 2000

    Mylan — Marketing Organization

  2. Nov 29, 2000

    Upsher-Smith Laboratories — Marketing Organization

  3. Nov 29, 2000

    AiPing Pharm Inc — Marketing Organization

  4. Nov 29, 2000

    Quagen Pharma — Marketing Organization

  5. Dec 28, 2000

    Actavis — Marketing Organization

  6. Jan 17, 2001

    Byondis — Marketing Organization

  7. Jan 25, 2001

    Ani Pharmaceuticals — Marketing Organization

  8. Apr 18, 2001

    Watson Pharmaceuticals — Marketing Organization

  9. Apr 18, 2001

    Heritage Pharma — Marketing Organization

  10. May 7, 2001

    Apotex — Marketing Organization

  11. Apr 29, 2002

    Sun Pharmaceuticals — Marketing Organization

  12. Sep 10, 2002

    Teva — Marketing Organization

  13. Jan 1, 2003

    Earliest Phase 1 Sponsor(trial)

  14. Feb 23, 2006

    Pharma Life Sciences LLC — Marketing Organization

  15. Feb 23, 2006

    Eci Pharmaceuticals Llc — Marketing Organization

  16. Feb 23, 2006

    Chartwell Pharmaceuticals — Marketing Organization

  17. Dec 20, 2007

    Ani Pharmaceuticals — NDA Secondary Org

  18. Apr 14, 2008

    Jazz Pharmaceuticals — NDA Secondary Org

2010s

  1. Mar 13, 2013

    Anchen Pharmaceuticals, Inc — Marketing Organization

  2. Mar 13, 2013

    Par Pharmaceuticals — Marketing Organization

  3. Mar 13, 2013

    PH HEALTH — Marketing Organization

  4. Oct 31, 2014

    Torrent Pharmaceuticals Limited — Marketing Organization

  5. Jan 1, 2018

    Earliest Phase 2 Sponsor(trial)

2020s

  1. Feb 14, 2020

    Bionpharma Inc — Marketing Organization

  2. Oct 17, 2024

    Ajanta Pharma Ltd — Marketing Organization

  3. Jul 30, 2025

    Annora Pharma — Marketing Organization

  4. Apr 30, 2026

    Appco Pharma — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedDec 5, 1994

Chemistry & pharmacology

Loading structure…

SMILES

COCCCC/C(=N\OCCN)c1ccc(C(F)(F)F)cc1
Mol. weight
318.34 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • depromel
  • du-23000
  • du-23000
  • faverin 100
  • faverin 50
  • floxyfral
  • floxyfral
  • fluvoxamina
  • fluvoxamina
  • fluvoxamine
  • fluvoxamine
  • fluvoxamine
  • fluvoxamine
  • fluvoxamine
  • fluvoxamine
  • fluvoxamine
  • fluvoxamine
  • fluvoxamine
  • fluvoxamine
  • fluvoxamine maleate
  • fluvoxamine maleate
  • fluvoxamine maleate
  • fluvoxamine maleate
  • fluvoxamine maleate
  • fluvoxaminum
  • fluvoxaminum
  • luvox
  • luvox
  • luvox
  • luvox
  • luvox cr
  • luvox cr

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06969287Phase 3Oct 1, 2025National Institute on Aging (NIA), Washington University in St. Louis
NCT06957223N/AMay 6, 2025CMH Nowshera, Pakistan Army
NCT06957210N/AMay 6, 2025CMH Nowshera, Pakistan Army
NCT07025590N/AApr 22, 2025Shantou University
NCT06821698Phase 1Feb 10, 2025Kaken Pharmaceutical Co.,Ltd.
NCT06232109Phase 1Feb 22, 2024Asceneuron S.A., QPS
NCT06128967Phase 3Oct 18, 2023Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA
NCT05888207Phase 1Jun 2, 2023AstraZeneca, Parexel
NCT05874037Phase 2/Phase 3 (Phase 3)May 15, 2023Washington University in St. Louis
NCT06358014N/AMay 12, 2023Capital Medical University
NCT05712265Phase 1Jan 24, 2023Corcept Therapeutics
NCT05532358Phase 1Sep 12, 2022Aptuit Inc., MODAG GmbH, Quotient, Teva
NCT05894564Phase 3Aug 25, 2022Duke University, National Center for Advancing Translational Science (NCATS), Vanderbilt University
NCT05353543N/AMay 1, 2022Hangzhou First People Hospital, Zhejiang University
NCT05352113N/AMay 1, 2022Hangzhou First People Hospital, Zhejiang University
NCT05264142Phase 1Apr 1, 2022University of Geneva
NCT05524519N/AJan 1, 2022First People's Hospital of Hangzhou, Zhejiang University
NCT05605002N/AJan 1, 2022First People's Hospital of Hangzhou, Zhejiang Chinese Medical University, Zhejiang University
NCT05216614Phase 2Dec 14, 2021Washington University in St. Louis
NCT05087381Phase 4Oct 1, 2021Chulalongkorn University, Government of Thailand, Mae Fah Luang University Hospital, Mahidol University, Rajavithi Hospital, Bangkok, University of Queensland, University of Western Australia, Washington University in St. Louis, Yamagata Prefectural Central Hospital
Showing 20 of 82 trials
Page 1 / 5

Organizations

Research & Development (119)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Jiao Tong UniversityAcademic/Hospital7732012
Washington University in St. LouisAcademic/Hospital6532020
Zhejiang UniversityAcademic/Hospital6522017
Duke UniversityAcademic/Hospital4412003
Nanjing Medical UniversityAcademic/Hospital4332011
Capital Medical UniversityAcademic/Hospital3212013
National Center for Advancing Translational Science (NCATS)Government3012021
National Institute of Mental Health (NIMH)Government3221996
Vanderbilt UniversityAcademic/Hospital3012021
AstraZenecaFor profit2212020
Cardresearch - Cardiologia Assistencial e de Pesquisa LTDAAcademic/Hospital2212021
CelgeneFor profit2212012
Central South UniversityAcademic/Hospital2122017
CMH NowsheraAcademic/Hospital2012025
First People's Hospital of HangzhouAcademic/Hospital2012022
Hangzhou First People HospitalAcademic/Hospital2012022
Hangzhou Seventh People's HospitalAcademic/Hospital2022017
Hebrew UniversityAcademic/Hospital2212011
Kunming Medical UniversityAcademic/Hospital2022017
McMaster UniversityAcademic/Hospital2122014
119 organizations
Page 1 / 6

Marketing (29)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGDec 28, 2000
AiPing Pharm IncFor profitMKTGNov 29, 2000
Ajanta Pharma LtdFor profitMKTGOct 17, 2024
Anchen Pharmaceuticals, IncFor profitMKTGMar 13, 2013
Ani PharmaceuticalsFor profitNDA2Dec 20, 2007
Ani PharmaceuticalsFor profitMKTGJan 25, 2001
Annora PharmaFor profitMKTGJul 30, 2025
ApotexFor profitMKTGMay 7, 2001
Appco PharmaFor profitMKTGApr 30, 2026
Bionpharma IncFor profitMKTGFeb 14, 2020
Bionpharma IncFor profitSYNMay 11, 2020
ByondisFor profitMKTGJan 17, 2001
Chartwell PharmaceuticalsFor profitMKTGFeb 23, 2006
Eci Pharmaceuticals LlcFor profitMKTGFeb 23, 2006
Heritage PharmaFor profitMKTGApr 18, 2001
Jazz PharmaceuticalsFor profitNDA2Apr 14, 2008
Jazz PharmaceuticalsFor profitSYNFeb 28, 2008
MylanFor profitMKTGNov 29, 2000
PH HEALTHFor profitMKTGMar 13, 2013
Par PharmaceuticalsFor profitMKTGMar 13, 2013
Pharma Life Sciences LLCFor profitMKTGFeb 23, 2006
Quagen PharmaFor profitMKTGNov 29, 2000
SolvayFor profitNDA2Dec 5, 1994
SolvayFor profitNDADec 5, 1994
Sun PharmaceuticalsFor profitMKTGApr 29, 2002
TevaFor profitMKTGSep 10, 2002
Torrent Pharmaceuticals LimitedFor profitMKTGOct 31, 2014
Upsher-Smith LaboratoriesFor profitMKTGNov 29, 2000
Watson PharmaceuticalsFor profitMKTGApr 18, 2001