Drugs / Fluvoxamine
Fluvoxamine
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | LUVOX | — | 1997-03-25 – 2000-09-28 | fda.gov ↗ |
| Approved | US (FDA) | LUVOX | — | 1994-12-05 | fda.gov ↗ |
Trials 55
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 122 trials | ||||||
| Phase 1 | NCT06821698 | Feb → May 2025 | — | Kaken Pharmaceutical | Completed | No outcome recorded |
| Phase 1 | NCT07014930 | Dec 2024 → Nov 2025 overdue | — | Caroline Samer | Recruiting | No outcome recorded |
| Phase 1 | NCT06232109 | Feb → Jul 2024 | — | Asceneuron S.A. | Completed | No outcome recorded |
| Phase 1 | NCT05888207 | Jun → Aug 2023 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05712265 | Jan → Feb 2023 | metabolic dysfunction-associated steatohepatitis | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT05532358 | Sep 2022 → Jan 2023 | — | MODAG GmbH | Completed | No outcome recorded |
| Phase 1 | NCT05264142 | Apr 2022 → Mar 2023 | — | University Hospital, Geneva | Unknown | No outcome recorded |
| Phase 1 | NCT05121714 | Dec 2020 → May 2021 | — | Abivax S.A. | Completed | No outcome recorded |
| Phase 1 | NCT04478513 | Jul → Dec 2020 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT03930602 | May 2019 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03634345 | Sep → Dec 2018 | atopic eczema | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03432793 | Feb → Apr 2018 | — | Theravance Biopharma | Completed | No outcome recorded |
| Phase 1 | NCT03340662 | Nov 2017 → Jan 2018 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02853136 | Aug → Oct 2016 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01700270 | May 2013 → Aug 2014 | neoplasm | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01707407 | Sep → Nov 2012 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01665404 | Jul → Sep 2012 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01540500 | Feb → Mar 2012 | — | Vanda Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01908296 | Jul → Aug 2011 | — | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 1 | NCT01704638 | Aug 2008 → Oct 2012 | depressive disorder | Karolinska Institutet | Completed | No outcome recorded |
| Phase 1 | NCT00456560 | Apr → May 2007 | — | Avigen | Completed | No outcome recorded |
| Phase 1 | NCT00175981 | Feb 2003 → Nov 2004 | — | Heidelberg University | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary · 2 missed | ||||||
| Phase 2 | NCT05216614 | Dec 2021 → Feb 2022 | COVID-19, olfactory nerve disorder | Washington University School of Medicine | Withdrawn | No outcome recorded |
| Phase 2 | NCT04711863 | Jan → May 2021 | COVID-19 | Asan Medical Center | Suspended | Missed primary |
| Phase 2 | NCT04718480 | Nov 2020 → Mar 2022 | COVID-19 | SigmaDrugs Research Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04342663 | Apr → Aug 2020 | COVID-19 | Washington University School of Medicine | Completed | Met primary |
| Phase 2 | NCT04160377 | Aug 2019 → Jun 2022 | endogenous depression, melancholia | Lingjiang Li | Unknown | No outcome recorded |
| Phase 2 | NCT03222570 | Feb 2018 → Apr 2024 | depressive disorder | University of Minnesota | Completed | Missed primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05874037 | May 2023 → Mar 2025 | long COVID-19 | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 311 trials · 1 met primary · 4 missed | ||||||
| Phase 3 | NCT07359482 | Jun 2026 → Dec 2027 expected | long COVID-19 | Academic Medical Center - University of Amsterdam | Recruiting | No outcome recorded |
| Phase 3 | NCT06969287 | Apr 2026 → Apr 2027 expected | delirium | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 3 | NCT05894564 | Aug 2022 → Feb 2023 | COVID-19 | Susanna Naggie, MD | Completed | Missed primary |
| Phase 3 | NCT05890586 | Jun 2021 → Jul 2022 | COVID-19 | Susanna Naggie, MD | Completed | Missed primary |
| Phase 3 | NCT04885530 | Jun 2021 → Apr 2024 | COVID-19 | Susanna Naggie, MD | Completed | No outcome recorded |
| Phase 3 | NCT04510194 | Jan 2021 → Dec 2022 | COVID-19 | University of Minnesota | Completed | Missed primary |
| Phase 3 | NCT04668950 | Dec 2020 → Sep 2021 | COVID-19 | Washington University School of Medicine | Completed | Missed primary |
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT01933919 | Aug 2013 → Jun 2015 | obsessive-compulsive disorder | AbbVie | Completed | Met primary |
| Phase 3 | NCT00655174 | Jun 1999 → Sep 2006 | autism | The Hospital for Sick Children | Completed | No outcome recorded |
| Phase 3 | NCT00000389 | Oct 1996 → Nov 1999 | generalized anxiety disorder, obsessive-compulsive disorder, separation anxiety disorder, social phobia | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase 49 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT05087381 | Oct 2021 → Jun 2022 | — | Chulalongkorn University | Completed | Met primary |
| Phase 4 | NCT04963257 | Jan 2020 → Dec 2023 | obsessive-compulsive disorder | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 4 | NCT03993535 | Oct 2018 → Apr 2023 | obsessive-compulsive disorder | University of Sao Paulo | Completed | No outcome recorded |
| Phase 4 | NCT03219008 | Aug 2017 → Dec 2019 | major depressive disorder | Shanghai Mental Health Center | Unknown | Missed primary |
| Phase 4 | NCT02016261 | Dec 2013 → Jul 2015 | major depressive disorder | Moscow Research Institute of Psychiatry | Completed | No outcome recorded |
| Phase 4 | NCT01796132 | Aug 2012 → Dec 2016 | depressive disorder, lactation disease | Centre Hospitalier Universitaire Vaudois | Unknown | No outcome recorded |
| Phase 4 | NCT00353028 | Oct 2006 → Jul 2009 | major depressive disorder | Solvay Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00352768 | Aug 2006 → Apr 2009 | obsessive-compulsive disorder | Solvay Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00157547 | Apr 2003 → Aug 2006 | major depressive disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT02285699 | Nov 2014 → Mar 2016 | obsessive-compulsive disorder | McMaster University | Completed | No outcome recorded |
| — | NCT02442713 | Nov 2014 → Sep 2016 | depressive disorder | Guang Dong Provincial Mental Health Institute | Unknown | No outcome recorded |
| — | NCT02431845 | Jan 2013 → Dec 2030 expected | obsessive-compulsive disorder | Severance Hospital | Recruiting | No outcome recorded |
| — | NCT01832285 | Dec 2012 → Oct 2013 | schizophrenia 1 | Sha'ar Menashe Mental Health Center | Unknown | No outcome recorded |
| — | NCT00645580 | Apr 2008 → Apr 2009 | schizophrenia | Sha'ar Menashe Mental Health Center | Unknown | No outcome recorded |
| — | NCT00012584 | Nov 2000 → May 2002 | attention deficit-hyperactivity disorder, generalized anxiety disorder, separation anxiety disorder, social phobia | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Comparator or background therapy27 trials | ||||||
| Phase 1 | NCT01396720 Comparator | Sep 2011 → Dec 2012 | — | Hadassah Medical Organization | Completed | No outcome recorded |
| Phase 1 | NCT01269333 Comparator | Jan 2011 → Jul 2012 | — | Hadassah Medical Organization | Completed | No outcome recorded |
| Phase 2 | NCT04539951 Comparator | Sep 2020 → Jun 2027 expected | obsessive-compulsive disorder | Shanghai Mental Health Center | Recruiting | No outcome recorded |
| Phase 2 | NCT03321526 Background | Dec 2017 → Jun 2019 | major depressive disorder | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 3 | NCT06128967 Comparator | Oct 2023 → Jul 2025 | long COVID-19, myalgic encephalomeyelitis/chronic fatigue syndrome | Cardresearch | Completed | No outcome recorded |
| Phase 3 | NCT04727424 Comparator | Jan 2021 → Jun 2024 | COVID-19 | Cardresearch | Unknown | Missed primary |
| Phase 3 | NCT00074815 Background | Sep 2003 → Nov 2009 | obsessive-compulsive disorder | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT05148169 Background | Jan 2020 → Dec 2022 | major depressive disorder | Shanghai Mental Health Center | Unknown | No outcome recorded |
| Phase 4 | NCT03779789 Comparator | Feb 2019 → Feb 2023 | major depressive disorder | Azienda Ospedaliera Universitaria Integrata Verona | Completed | Missed primary |
| Phase 4 | NCT02022709 Comparator | Jan 2014 → Nov 2017 | obsessive-compulsive disorder | Shanghai Mental Health Center | Completed | No outcome recorded |
| Phase 4 | NCT02194075 Comparator | Oct 2013 → Oct 2015 | obsessive-compulsive disorder | Guangdong Provincial People's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01764867 Comparator | Jun 2012 → Oct 2014 | major depressive disorder | Shanghai Mental Health Center | Unknown | No outcome recorded |
| Phase 4 | NCT01460212 Comparator | Dec 2011 → Dec 2014 | major depressive disorder | Nanjing Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT01401491 Comparator | Jan 2008 → Dec 2010 | schizophrenia | Taipei Medical University Hospital | Completed | No outcome recorded |
| — | NCT06942494 Comparator | Apr 2025 → Aug 2027 expected | obsessive-compulsive disorder | Shanghai Mental Health Center | Recruiting | No outcome recorded |
| — | NCT07025590 Comparator | Apr 2025 → Dec 2026 expected | cardiovascular disorder, mixed anxiety and depressive disorder | Guangdong Provincial People's Hospital | Recruiting | No outcome recorded |
| — | NCT06659094 Background | Aug 2023 → Aug 2025 | obsessive-compulsive disorder | Shanghai Mental Health Center | Completed | No outcome recorded |
| — | NCT06358014 Background | May 2023 → Dec 2024 | depressive disorder | Xiao Wang | Unknown | No outcome recorded |
| — | NCT05528224 Background | Sep 2022 → Aug 2023 | obsessive-compulsive disorder | Shanghai Mental Health Center | Terminated | No outcome recorded |
| — | NCT05588102 Background | May 2021 → May 2023 | cognitive disorder | Capital Medical University | Completed | No outcome recorded |
| — | NCT03179839 Comparator | Jan 2017 → Nov 2018 | obsessive-compulsive disorder | Shanghai Mental Health Center | Completed | No outcome recorded |
| — | NCT03558256 Background | May 2016 → Dec 2018 | major depressive disorder | Shanghai Mental Health Center | Unknown | No outcome recorded |
| — | NCT02655354 Background | Oct 2015 → Nov 2019 | alcohol-related disorders, brain injury, cognitive impairment with or without cerebellar ataxia, depressive disorder +1 | University of Washington | Completed | No outcome recorded |
| — | NCT02739061 Comparator | Jun 2014 → Mar 2017 | obsessive-compulsive disorder | Shanghai Mental Health Center | Completed | No outcome recorded |
| — | NCT01944657 Comparator | Sep 2013 → Dec 2015 | major depressive disorder | Sheppard Pratt Health System | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT01896349 Background | Apr 2013 → Aug 2014 | — | Hospital de Clinicas de Porto Alegre | Unknown | No outcome recorded |
| — | NCT01831440 Background | Jan 2011 → Jan 2014 | depressive disorder | Nanjing Medical University | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2005-10-12 | Astellas Pharma Inc | Regulatory Luvox® Receives Approval for Social Anxiety Disorder as an Additional Indication astellas.com ↗
Astellas Pharma Inc. (Head Office: Tokyo, President & CEO: Toichi Takenaka, hereafter referred as "Astellas") today announced that the antidepressant "Luvox® Tablet" (generic name: fluvoxamine maleate) was approved for "social anxiety disorder (SAD)" as an additional indication on October 11, 2005. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2011-06-21 | Astellas Pharma Inc | Transfer of Distribution Rights for SSRI "Luvox® Tablets" astellas.com ↗ |
| 2005-10-12 | Astellas Pharma Inc | Luvox® Receives Approval for Social Anxiety Disorder as an Additional Indication astellas.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 83 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fluvoxamine | “In this study, the investigators use selective serotonin reuptake inhibitors (SSRIs, i.e., sertraline, fluoxetine and fluvoxamine)and tricyclic drugs(i.e., clomipramine)...” NCT06942494 ↗79“Participants receive only clinical routine antidepressant treatment,Which include fluoxetine (Prozac); sertraline (Zoloft); paroxetine (Paxil); citalopram (Celexa)...” NCT01831440 ↗ “Medication group is a control group that can choose to use the serotonin reuptake inhibitors (SSRIs) approved by China food and Drug Administration (SFDA) for the treatment of...” NCT03558256 ↗ “The dose is 20-60mg/day for fluoxetine, 20-40mg/day for paroxetine, 100-300mg/day for fluvoxamine, 50-200mg/day for sertraline, 20-40mg/day for citalopram, 10-20mg/day for...” NCT05148169 ↗ “Participants will receive SSRI antidepressant (such as, citalopram, escitalopram, fluvoxamine, fluoxetine, paroxetine, sertraline, vilazodone or vortioxetine) as a part of...” NCT03321526 ↗ “approved by the State Food and Drug Administration (CFDA) for the treatment of OCD (i.e., fluoxetine, paroxetine, sertraline and fluvoxamine) as well as citalopram and escitalopram” NCT05528224 ↗ “quantifying the range of concentration to citalopram, escitalopram, sertraline, fluoxetine, paroxetine, fluvoxamine, duloxetine and venlafaxine in mother plasma and breast milk” NCT01796132 ↗ “This study uses SSRIs class drugs, including fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, and escitalopram, with no specific restrictions on the type of drugs.” NCT06358014 ↗ “Patients were randomly assigned (1:1) to either fluvoxamine (100 mg twice daily for 10 days) or placebo (or other treatment groups not reported here).” PMID 34717820 ↗ Oct 2021 “These include fluoxetine, paroxetine, sertraline, fluvoxamine, and others, with tricyclic drugs like clomipramine and SNRIs such as venlafaxine.” NCT06659094 ↗ “Session 2: Identical to Session 1, but following a 7-day pretreatment with fluvoxamine (CYP2C19 inhibitor, 50 mg once daily).” NCT07014930 ↗ |
| Known as | fluvoxamine (Luvox) | “fluvoxamine (Luvox)” NCT01460212 ↗ |
| Known as | Fluvoxamine Maleate | “Fluvoxamine Maleate 100 mg each pills” NCT06128967 ↗ |
| Known as | FluvoxaMINE Maleate 50 MG | “Drug: FluvoxaMINE Maleate 50 MG” NCT05087381 ↗ |
| Known as | FLV | “A recent study found that fluvoxamine (FLV) can reduce Interleukin-6 (IL-6) production via sigma-1 receptor in inflammation models.” PMID 37304432 ↗ May 2023 |
| Known as | Luvox | “Participants receive only clinical routine antidepressant treatment,Which include fluoxetine (Prozac); sertraline (Zoloft); paroxetine (Paxil); citalopram (Celexa)...” NCT01831440 ↗ |
| Action | Inhibit | “fluvoxamine - is a member in SSRIs family and a potent inhibitor of the CYP2C19.” NCT01269333 ↗ |
| Route | Oral | “the study medication will orally be administered once daily, at bedtime” NCT00352768 ↗ |
| Target | CYP2C19 | “fluvoxamine - is a member in SSRIs family and a potent inhibitor of the CYP2C19.” NCT01269333 ↗ |