Numerous clinical trials evaluate flumazenil's therapeutic applications in reversing procedure-related benzodiazepine sedation and managing central nervous system disorders such as alcoholism and Parkinson disease. Spanning Early Phase 1 through Phase 4 alongside unclassified protocols, these studies are sponsored by prominent academic and medical centers, including Yonsei University, the University of Michigan, and Seoul National University Bundang Hospital. Across this landscape, the trials exhibit diverse recruitment statuses, ranging from completed and actively recruiting to not yet recruiting and terminated.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07619092 | RECRUITING | Depression - Major Depressive Disorder; Bipolar Disorder (BD); Functional Magnetic Resonance Imaging (fMRI); Cognition; Autobiographical Memory; Electroconvulsive Therapy; ECT; Treatment Outcome; Inpatients |
Anders Jørgensen |
2026-01-15 | |
| NCT07663877 | NOT_YET_RECRUITING | Hysteroscopy; Ambulatory Surgery; General Anesthesia |
Chung-Ang University Gwangmyeong Hospital |
2026-06 | PHASE4 |
| NCT07265050 | NOT_YET_RECRUITING | Emergence Agitation |
Seoul National University Hospital |
2026-01-01 | |
| NCT07277881 | NOT_YET_RECRUITING | Postoperative Delirium; Sedation; Remimazolam; Hip Arthroplasty, Total |
Medical University of Gdansk |
2026-01 | PHASE4 |
| NCT05939674 | RECRUITING | Flumazenil Adverse Reaction; Remimazolam; Hip Joint; Elderly Patients |
Pusan National University Yangsan Hospital |
2023-09-19 | |
| NCT06531369 | UNKNOWN | Flumazenil to Antagonize Remimazolam; Remimazolam; Renal Transplantation |
Qianfoshan Hospital |
2024-07 | PHASE1 |
| NCT06205719 | UNKNOWN | Remazolam Anesthesia; Postoperative Recovery |
Sichuan Provincial People's Hospital |
2024-06-01 | EARLY_PHASE1 |
| NCT03825601 | COMPLETED | Multiple Sclerosis; Relapsing-Remitting Multiple Sclerosis |
Institut National de la Santé Et de la Recherche Médicale, France |
2019-05-02 | |
| NCT06275594 | Not yet recruiting | Midazolam|Remimazolam |
Yeungnam University Hospital |
2024-03-01 | Phase 2 |
| NCT05774366 | UNKNOWN | Anesthesia |
Daegu Catholic University Medical Center |
2023-03-22 | |
| NCT06563063 | COMPLETED | Stomach Neoplasm |
Yonsei University |
2023-08-23 | |
| NCT06513923 | COMPLETED | Hip Fracture |
Central South University |
2023-02-01 | PHASE4 |
| NCT05939674 | Recruiting | Flumazenil Adverse Reaction|Remimazolam|Hip Joint|Elderly Patients |
Pusan National University Yangsan Hospital |
2023-09-19 | Not Applicable |
| NCT05841667 | Recruiting | Adult|Middle Aged|Elective Surgical Procedures |
Korea University Guro Hospital |
2023-09-06 | -- |
| NCT05681377 | COMPLETED | Anesthesia, General |
Korea University Guro Hospital |
2023-03-05 | PHASE4 |
| NCT05382806 | COMPLETED | Flumazenil Adverse Reaction; Ambulatory Surgery; Postoperative Nausea; Remimazolam |
Konkuk University Medical Center |
2022-08-02 | |
| NCT05397886 | COMPLETED | Recovery |
Seoul National University Hospital |
2022-08-02 | |
| NCT05435911 | COMPLETED | Recovery |
Seoul National University Hospital |
2022-08-02 | |
| NCT05047939 | COMPLETED | Anesthesia, Intravenous |
Seoul National University Hospital |
2021-12-14 | |
| NCT05220462 | Recruiting | Tooth Extraction |
Guy''s and St Thomas'' NHS Foundation Trust |
2022-03-09 | Phase 3 |
| NCT03440112 | COMPLETED | Parkinson Disease |
Nicolaas Bohnen, MD, PhD |
2018-01-29 | PHASE1; PHASE2 |
| NCT05025410 | Completed | Myoma;Uterus|Polyp Endometrium|Unspecified Condition Associated With Female Genital Organs and Menstrual Cycle |
Seoul National University Bundang Hospital |
2021-11-01 | -- |
| NCT05468671 | COMPLETED | Endobronchial Metastases; Bronchoesophageal Fistula; General Anesthetic Drug Adverse Reaction |
Zhejiang Cancer Hospital |
2021-01-04 | PHASE4 |
| NCT03743805 | WITHDRAWN | Brain Death; Anoxic Brain Injury; Cardiac Arrest; Sedative Intoxication; Narcotic Intoxication |
Prisma Health-Midlands |
2019-01-01 | EARLY_PHASE1 |
| NCT03462641 | COMPLETED | Parkinson Disease |
University of Michigan |
2018-03-09 | PHASE1; PHASE2 |
| NCT04329585 | UNKNOWN | Moderate Sedation; Colonoscopy |
National Taiwan University Hospital |
2020-03-25 | |
| NCT01651520 | UNKNOWN | Multiple Sclerosis |
Assistance Publique - Hôpitaux de Paris |
2013-06 | |
| NCT02899156 | TERMINATED | Hypoactive Delirium |
University of California, Davis |
2016-03 | PHASE4 |
| NCT04308954 | TERMINATED | Fragile X Syndrome (FXS); Idiopathic Intellectual Developmental Disorder (IDD) |
Stanford University |
2016-11-01 | PHASE1 |
| NCT02048969 | WITHDRAWN | Hepatic Encephalopathy; Liver Cirrhosis |
Yale University |
2014-06 | PHASE1; PHASE2 |
| NCT01819675 | TERMINATED | Stroke; Hemiplegia |
Seoul National University Bundang Hospital |
2013-03 | |
| NCT02690389 | COMPLETED | Acupuncture; General Anaesthesia; Sedation |
Dr. Yin Liu |
2015-01 | |
| NCT02138500 | COMPLETED | Healthy |
Pfizer |
2014-05 | PHASE1 |
| NCT01904487 | COMPLETED | Alcoholism |
Rajesh Narendran |
2011-04-19 | PHASE1 |
| NCT00997087 | TERMINATED | Obsessive Compulsive Disorder |
Parkway Medical Center |
2009-10 | PHASE2 |
| NCT02157428 | COMPLETED | Adverse Effect of Other General Anesthetics |
University of Sao Paulo |
2011-01 | |
| NCT01071889 | COMPLETED | Healthy |
Coeruleus Ltd. |
2010-05 | PHASE1; PHASE2 |
| NCT01183312 | COMPLETED | Hypersomnia; Primary Hypersomnia; Idiopathic Hypersomnia; Narcolepsy Without Cataplexy |
Lynn Marie Trotti |
2010-09 | PHASE1; PHASE2 |
| NCT01655914 | COMPLETED | Insomnia |
Coeruleus Ltd. |
2010-07 | PHASE1 |
| NCT00681746 | COMPLETED | Anxiety |
AstraZeneca |
2008-02 | PHASE1 |
| NCT00681720 | COMPLETED | Anxiety |
AstraZeneca |
2008-02 | PHASE1 |
| NCT00262639 | COMPLETED | Alcohol Dependence |
Medical University of South Carolina |
2005-12 | PHASE2; PHASE3 |
| NCT00695630 | COMPLETED | Dental Anxiety |
University of Washington |
2006-09 | PHASE1; PHASE2 |
| NCT00000246 | COMPLETED | Substance-Related Disorders |
Yale University |
1993-01 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-06-01)
Check the
Flumazenil
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
Note: Technical data last updated: Sep 1, 2026.