FLUMAZENIL
FLUMAZENIL is indicated for the treatment of Benzodiazepine Overdose; Sedation.
Details
- Status
- Prescription
- First Approved
- 2004-10-12
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
FLUMAZENIL Approval History
What FLUMAZENIL Treats
2 indicationsFLUMAZENIL is approved for 2 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Benzodiazepine Overdose
- Sedation
FLUMAZENIL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06513923 | LYG2023002 | Ph 4 | completed | Comparison of Remimazolam and Propofol on Emergence in Elderly Orthopedic Patients Under General Anesthesia |
| NCT05681377 | 2022GR0520 | Ph 4 | completed | Impact of Flumazenil on the Emergence Delirium |
| NCT05468671 | IRB-2020-406 | Ph 4 | completed | Clinical Application Value of Remazolam Combined With Sugammadex Sodium in Anesthesia for Endotracheal Surgery Under Bronchoscopy |
| NCT03462641 results posted | HUM00130361 R01NS099535 | Ph 1, Ph 2 | completed | Modulation of GABA-A Receptors in Parkinson Disease-Flumazenil Arm |
| NCT02899156 FLYP results posted | 837421 | Ph 4 | terminated | Flumazenil for Hypoactive Delirium Secondary to Benzodiazepine Exposure |
| NCT02048969 | 1311013071 P30DK034989 | Ph 1, Ph 2 | withdrawn | Treatment of Hepatic Encephalopathy With Flumazenil and Change in Cortical GABA Levels in MRS |
| NCT01183312 results posted | IRB00044836 | Ph 1, Ph 2 | completed | Flumazenil for the Treatment of Primary Hypersomnia |
| NCT01655914 | CRLS002 | Ph 1 | completed | Safety and Pharmacokinetic Study of Sublingual Flumazenil (CRLS035) in Healthy Adults |
| NCT01071889 | 0076-10-RMB | Ph 1, Ph 2 | completed | Safety and the Efficacy of a Sublingual Administration of Flumazenil to Reverse the Effect of Hypnotic Drugs in Healthy Adults |
| NCT00997087 OCD | JGS-001 | Ph 2 | terminated | A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FLUMAZENIL FDA Label Details
Indications & Usage
FLUMAZENIL is indicated for the treatment of Benzodiazepine Overdose; Sedation.
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ROMAZICON
Full clinical data, patents, trials, and competitive landscape for flumazenil.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.