fluvoxamine
Trade name: luvox
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
Earliest trial started Oct 1, 1996 (NCT00000389)
Timeline
1990s
2000s
- Nov 29, 2000
Mylan — Marketing Organization
- Nov 29, 2000
Upsher-Smith Laboratories — Marketing Organization
- Nov 29, 2000
AiPing Pharm Inc — Marketing Organization
- Nov 29, 2000
Quagen Pharma — Marketing Organization
- Dec 28, 2000
Actavis — Marketing Organization
- Jan 17, 2001
Byondis — Marketing Organization
- Jan 25, 2001
Ani Pharmaceuticals — Marketing Organization
- Apr 18, 2001
Watson Pharmaceuticals — Marketing Organization
- Apr 18, 2001
Heritage Pharma — Marketing Organization
- May 7, 2001
Apotex — Marketing Organization
- Apr 29, 2002
Sun Pharmaceuticals — Marketing Organization
- Sep 10, 2002
Teva — Marketing Organization
- Jan 1, 2003
Earliest Phase 1 Sponsor(trial)
- Feb 23, 2006
Pharma Life Sciences LLC — Marketing Organization
- Feb 23, 2006
Eci Pharmaceuticals Llc — Marketing Organization
- Feb 23, 2006
Chartwell Pharmaceuticals — Marketing Organization
- Dec 20, 2007
Ani Pharmaceuticals — NDA Secondary Org
- Apr 14, 2008
Jazz Pharmaceuticals — NDA Secondary Org
2010s
- Mar 13, 2013
Anchen Pharmaceuticals, Inc — Marketing Organization
- Mar 13, 2013
Par Pharmaceuticals — Marketing Organization
- Mar 13, 2013
PH HEALTH — Marketing Organization
- Oct 31, 2014
Torrent Pharmaceuticals Limited — Marketing Organization
- Jan 1, 2018
Earliest Phase 2 Sponsor(trial)
2020s
- Feb 14, 2020
Bionpharma Inc — Marketing Organization
- Oct 17, 2024
Ajanta Pharma Ltd — Marketing Organization
- Jul 30, 2025
Annora Pharma — Marketing Organization
- Apr 30, 2026
Appco Pharma — Marketing Organization
Indications
Approved for
Studied for
- Anxiety Disorders · Phase 4
- Anxiety, Separation · Phase 3
- Autistic Disorder · Phase 3
- Breast Neoplasms · Phase 1
- Coronavirus · Phase 3
- Coronavirus Infections · Phase 2
- COVID-19 · Phase 3
- Delirium · Phase 3
- Dementia · Phase 3
- Depression · Phase 4
- Dermatitis, Atopic · Phase 1
- Drug Interactions · Phase 1
- Fatigue Syndrome, Chronic · Phase 3
- General Surgery · Phase 3
- Healthy Volunteers · Phase 1
- Major Depressive Disorder · Phase 4
- Mental Disorders · Phase 4
- Non-alcoholic Fatty Liver Disease · Phase 1
- Obsessive Behavior · Phase 4
- Obsessive-Compulsive Disorder · Phase 4
- Olfaction Disorders · Phase 2
- Olfactory Nerve Diseases · Phase 2
- Pharmacokinetics · Phase 1
- Pharmacology, Clinical · Phase 1
- Phobia, Social · Phase 3
- Psychophysiologic Disorders · Phase 3
- SARS-CoV-2 · Phase 2
- Schizophrenia · Phase 4
- Severe acute respiratory syndrome-related coronavirus · Phase 3
- Treatment Outcome · Phase 4
- Volunteers · Phase 1
- Weight Gain · Phase 1
Mechanism of action
- Serotonin transporterINHIBITOR
SLC6A4 inhibitor
reuptake inhibitor
Approval history
- approvedDec 5, 1994
Chemistry & pharmacology
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
Sources
- ChEMBLCHEMBL814 ↗
- WikipediaFluvoxamine ↗
- NCATS5LGN83G74V ↗
- ChEMBLCHEMBL1409 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06969287 | Phase 3 | Oct 1, 2025 | National Institute on Aging (NIA), Washington University in St. Louis |
| NCT06957223 | N/A | May 6, 2025 | CMH Nowshera, Pakistan Army |
| NCT06957210 | N/A | May 6, 2025 | CMH Nowshera, Pakistan Army |
| NCT07025590 | N/A | Apr 22, 2025 | Shantou University |
| NCT06821698 | Phase 1 | Feb 10, 2025 | Kaken Pharmaceutical Co.,Ltd. |
| NCT06232109 | Phase 1 | Feb 22, 2024 | Asceneuron S.A., QPS |
| NCT06128967 | Phase 3 | Oct 18, 2023 | Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA |
| NCT05888207 | Phase 1 | Jun 2, 2023 | AstraZeneca, Parexel |
| NCT05874037 | Phase 2/Phase 3 (Phase 3) | May 15, 2023 | Washington University in St. Louis |
| NCT06358014 | N/A | May 12, 2023 | Capital Medical University |
| NCT05712265 | Phase 1 | Jan 24, 2023 | Corcept Therapeutics |
| NCT05532358 | Phase 1 | Sep 12, 2022 | Aptuit Inc., MODAG GmbH, Quotient, Teva |
| NCT05894564 | Phase 3 | Aug 25, 2022 | Duke University, National Center for Advancing Translational Science (NCATS), Vanderbilt University |
| NCT05353543 | N/A | May 1, 2022 | Hangzhou First People Hospital, Zhejiang University |
| NCT05352113 | N/A | May 1, 2022 | Hangzhou First People Hospital, Zhejiang University |
| NCT05264142 | Phase 1 | Apr 1, 2022 | University of Geneva |
| NCT05524519 | N/A | Jan 1, 2022 | First People's Hospital of Hangzhou, Zhejiang University |
| NCT05605002 | N/A | Jan 1, 2022 | First People's Hospital of Hangzhou, Zhejiang Chinese Medical University, Zhejiang University |
| NCT05216614 | Phase 2 | Dec 14, 2021 | Washington University in St. Louis |
| NCT05087381 | Phase 4 | Oct 1, 2021 | Chulalongkorn 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 |
Organizations
Research & Development (119)
Marketing (29)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Actavis | For profit | MKTG | Dec 28, 2000 |
| AiPing Pharm Inc | For profit | MKTG | Nov 29, 2000 |
| Ajanta Pharma Ltd | For profit | MKTG | Oct 17, 2024 |
| Anchen Pharmaceuticals, Inc | For profit | MKTG | Mar 13, 2013 |
| Ani Pharmaceuticals | For profit | NDA2 | Dec 20, 2007 |
| Ani Pharmaceuticals | For profit | MKTG | Jan 25, 2001 |
| Annora Pharma | For profit | MKTG | Jul 30, 2025 |
| Apotex | For profit | MKTG | May 7, 2001 |
| Appco Pharma | For profit | MKTG | Apr 30, 2026 |
| Bionpharma Inc | For profit | MKTG | Feb 14, 2020 |
| Bionpharma Inc | For profit | SYN | May 11, 2020 |
| Byondis | For profit | MKTG | Jan 17, 2001 |
| Chartwell Pharmaceuticals | For profit | MKTG | Feb 23, 2006 |
| Eci Pharmaceuticals Llc | For profit | MKTG | Feb 23, 2006 |
| Heritage Pharma | For profit | MKTG | Apr 18, 2001 |
| Jazz Pharmaceuticals | For profit | NDA2 | Apr 14, 2008 |
| Jazz Pharmaceuticals | For profit | SYN | Feb 28, 2008 |
| Mylan | For profit | MKTG | Nov 29, 2000 |
| PH HEALTH | For profit | MKTG | Mar 13, 2013 |
| Par Pharmaceuticals | For profit | MKTG | Mar 13, 2013 |
| Pharma Life Sciences LLC | For profit | MKTG | Feb 23, 2006 |
| Quagen Pharma | For profit | MKTG | Nov 29, 2000 |
| Solvay | For profit | NDA2 | Dec 5, 1994 |
| Solvay | For profit | NDA | Dec 5, 1994 |
| Sun Pharmaceuticals | For profit | MKTG | Apr 29, 2002 |
| Teva | For profit | MKTG | Sep 10, 2002 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Oct 31, 2014 |
| Upsher-Smith Laboratories | For profit | MKTG | Nov 29, 2000 |
| Watson Pharmaceuticals | For profit | MKTG | Apr 18, 2001 |