Clinical Trials

Fluvoxamine has been evaluated in numerous clinical trials spanning Phase 1 to Phase 4 across psychiatric, neurological, and infectious disease indications, including major depressive disorder, schizophrenia, childhood autism, pharmacokinetic studies, acute COVID-19, and post-COVID conditions. Sponsored by academic institutions, hospital systems, and biotechnology organizations, these studies encompass various recruitment statuses, ranging from actively recruiting to completed, terminated, or unknown. Key completed investigations include trials evaluating symptomatic COVID-19 treatment and selective serotonin reuptake inhibitor efficacy in autism.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07359482 RECRUITING
Post-COVID; POST-Covid 19; Post-COVID Conditions
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
 2026-06-04 PHASE3
NCT04539951 RECRUITING
Obsessive-Compulsive Disorder
Shanghai Mental Health Center
 2020-09-22 PHASE2
NCT06969287 RECRUITING
Delirium; Surgery-Complications
Washington University School of Medicine
 2026-04-06 PHASE3
NCT07025590 RECRUITING
Cardiovascular Diseases (CVD); Depression Anxiety Disorder
Guangdong Provincial People's Hospital
 2025-04-22
NCT06128967 COMPLETED
Long COVID-19 Syndrome; Chronic Fatigue Syndrome
Cardresearch
 2023-10-18 PHASE3
NCT06821698 COMPLETED
Healty Volunteers
Kaken Pharmaceutical
 2025-02-13 PHASE1
NCT05874037 COMPLETED
Long COVID
Washington University School of Medicine
 2023-05-15 PHASE2; PHASE3
NCT06232109 COMPLETED
Drug Drug Interaction
Asceneuron S.A.
 2024-02-22 PHASE1
NCT04727424 UNKNOWN
Covid19; SARS-Associated Coronavirus
Cardresearch
 2021-01-19 PHASE3
NCT04885530 COMPLETED
Covid19
Susanna Naggie, MD
 2021-06-08 PHASE3
NCT04963257 UNKNOWN
OCD
Second Affiliated Hospital, Zhejiang University, School of Medicine
 2020-01-01 PHASE4
NCT05888207 COMPLETED
Healthy Male Subjects
AstraZeneca
 2023-06-02 PHASE1
NCT05588102 COMPLETED
Geriatric Depression; Cognitive Impairment
Capital Medical University
 2021-05-18
NCT05264142 UNKNOWN
Healthy
University Hospital, Geneva
 2022-04-01 PHASE1
NCT03779789 COMPLETED
Major Depressive Disorder
Azienda Ospedaliera Universitaria Integrata Verona
 2019-02-01 PHASE4
NCT05894564 COMPLETED
Covid19
Susanna Naggie, MD
 2022-08-25 PHASE3
NCT05712265 COMPLETED
Antipsychotic Induced Weight Gain; Non-alcoholic Steatohepatitis (NASH)
Corcept Therapeutics
 2023-01-24 PHASE1
NCT05532358 COMPLETED
Healthy Volunteers
MODAG GmbH
 2022-09-12 PHASE1
NCT04510194 COMPLETED
Covid19; SARS-CoV Infection
University of Minnesota
 2021-01-01 PHASE3
NCT05890586 COMPLETED
Covid19
Susanna Naggie, MD
 2021-06-08 PHASE3
NCT04160377 UNKNOWN
Depressive Disorder; Endogenous Depression; Melancholia
Lingjiang Li
 2019-08-01 PHASE2
NCT05087381 COMPLETED
Treatment Efficacy
Chulalongkorn University
 2021-10-01 PHASE4
NCT04718480 COMPLETED
Covid19
SigmaDrugs Research Ltd.
 2020-11-27 PHASE2
NCT05216614 WITHDRAWN
COVID-19; Olfactory Disorder; Parosmia
Washington University School of Medicine
 2021-12-14 PHASE2
NCT04668950 COMPLETED
Covid19; Coronavirus
Washington University School of Medicine
 2020-12-22 PHASE3
NCT04711863 SUSPENDED
Severe Acute Respiratory Syndrome Coronavirus 2; Coronavirus Infection; Mild to Moderate COVID-19
Asan Medical Center
 2021-01-16 PHASE2
NCT05121714 COMPLETED
Healthy
Abivax S.A.
 2020-12-17 PHASE1
NCT04478513 COMPLETED
Healthy Volunteer/DDI Study
AstraZeneca
 2020-07-21 PHASE1
NCT04342663 COMPLETED
COVID 19; Coronavirus
Washington University School of Medicine
 2020-04-10 PHASE2
NCT03219008 UNKNOWN
Depressive Disorder
Shanghai Mental Health Center
 2017-08-01 PHASE4
NCT02655354 COMPLETED
Posttraumatic Stress Disorder; Depression; Alcohol-Related Disorders; Suicidal Ideation; Substance-Related Disorders; Mild Cognitive Impairment; Quality of Life; Pain; Wounds and Injury; Brain Injuries; Chronic Disease
University of Washington
 2015-10
NCT03930602 COMPLETED
Healthy
Bristol-Myers Squibb
 2019-05-01 PHASE1
NCT03634345 COMPLETED
Dermatitis, Atopic
Pfizer
 2018-09-12 PHASE1
NCT03179839 COMPLETED
Obsessive-Compulsive Disorder
Shanghai Mental Health Center
 2017-01-20
NCT03432793 COMPLETED
Drug Drug Interaction (DDI)
Theravance Biopharma
 2018-02-28 PHASE1
NCT03340662 COMPLETED
Healthy Volunteer
Celgene
 2017-11-09 PHASE1
NCT02022709 COMPLETED
Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders
Shanghai Mental Health Center
 2014-01 PHASE4
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
 2015-01 PHASE3
NCT02739061 COMPLETED
Obsessive-Compulsive Disorder
Shanghai Mental Health Center
 2014-06-12
NCT02853136 COMPLETED
Healthy
Boehringer Ingelheim
 2016-08-25 PHASE1
NCT02442713 UNKNOWN
Depression
Guang Dong Provincial Mental Health Institute
 2014-11
NCT02194075 COMPLETED
Obsessive Compulsive Disorder
Guangdong Provincial People's Hospital
 2013-10 PHASE4
NCT02016261 COMPLETED
Recurrent Depressive Disorder
Moscow Research Institute of Psychiatry
 2013-12 PHASE4
NCT01933919 COMPLETED
Obsessive Compulsive Disorder
AbbVie
 2013-08-14 PHASE3
NCT01764867 UNKNOWN
Major Depressive Disorder
Shanghai Mental Health Center
 2012-06 PHASE4
NCT01700270 COMPLETED
Advanced Solid Tumors, Excluding Breast Cancer
Novartis Pharmaceuticals
 2013-05 PHASE1
NCT01896349 UNKNOWN
Treatment Resistant Depression
Hospital de Clinicas de Porto Alegre
 2013-04
NCT01832285 UNKNOWN
SCHIZOPHRENIA 1 (Disorder)
Sha'ar Menashe Mental Health Center
 2012-12
NCT01396720 COMPLETED
Drug Interactions Between Clopidogrel and Serotonin Reuptake Inhibitors
Hadassah Medical Organization
 2011-09 PHASE1
NCT01707407 COMPLETED
Pharmacology, Clinical; Healthy
Celgene
 2012-09-01 PHASE1
NCT01704638 COMPLETED
Depression
Karolinska Institutet
 2008-08 PHASE1
NCT01665404 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2012-07 PHASE1
NCT01269333 COMPLETED
Drug Interaction of Clopidogrel
Hadassah Medical Organization
 2011-01 PHASE1
NCT01540500 COMPLETED
Healthy Volunteers
Vanda Pharmaceuticals
 2012-02 PHASE1
NCT01908296 COMPLETED
Healthy; Pharmacokinetics of Quetiapine
Astellas Pharma Inc
 2011-07 PHASE1
NCT01401491 COMPLETED
Schizophrenia
Taipei Medical University Hospital
 2008-01 PHASE4
NCT01299415 TERMINATED
Solid Tumors
Novartis Pharmaceuticals
 2009-08 PHASE1
NCT00353028 COMPLETED
Major Depressive Disorder
Solvay Pharmaceuticals
 2006-10 PHASE4
NCT00645580 UNKNOWN
Schizophrenia
Sha'ar Menashe Mental Health Center
 2008-04
NCT00352768 TERMINATED
Obsessive Compulsive Disorder
Solvay Pharmaceuticals
 2006-08 PHASE4
NCT00655174 COMPLETED
Autism
The Hospital for Sick Children
 1999-06 PHASE3
NCT00012584 COMPLETED
Attention Deficit Hyperactivity Disorder; Anxiety, Separation; Social Phobia; Generalized Anxiety Disorder
National Institute of Mental Health (NIMH)
 2000-11
NCT00175981 COMPLETED
Healthy
Heidelberg University
 2003-02 PHASE1
NCT00456560 COMPLETED
Healthy
Avigen
 2007-04 PHASE1
NCT00000389 COMPLETED
Obsessive-Compulsive Disorder; Anxiety Disorders; Generalized Anxiety Disorder; Social Phobia; Separation Anxiety
National Institute of Mental Health (NIMH)
 1996-10 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-06-09)

Check the Fluvoxamine (DU-23000) maleate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fluvoxamine functions as a selective serotonin reuptake inhibitor by binding with high affinity to the presynaptic serotonin transporter and acting as a potent agonist at the sigma-1 receptor, thereby blocking extracellular serotonin reuptake and increasing synaptic serotonin availability. This enhanced serotonergic neurotransmission and cellular signaling modulation underlie its therapeutic efficacy in psychiatric conditions such as major depressive disorder and obsessive-compulsive disorder, while also providing a rational basis for its investigation in viral inflammatory conditions including COVID-19.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.