Data updated: May 26, 2026
ROMAZICON (flumazenil)
Trial Activity: Declining
CNS
Approved 1991-12-20
Development Insights
Coeruleus Ltd. conducting 2 trials (20%)
16 indications explored (Broad Platform)
→ hip fracture (1 trials)
→ anesthesia, general (1 trials)
→ endobronchial metastases (1 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
34
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1991-12-20
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ROMAZICON Approval History
1992
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Original
New Indication
New Form
Label Update
30 FDA actions from 1991 to 2007
Nov 2002 SUPPL Priority
Mfg · Manufacturing (CMC)
Jun 2001 SUPPL Priority
Mfg
May 2000 SUPPL
Label
Sep 1998 SUPPL
Label
Nov 1997 SUPPL Priority
Mfg
Oct 1995 SUPPL
Label
May 1995 SUPPL
Label
Dec 1994 SUPPL Priority
Mfg
Nov 1994 SUPPL Priority
Mfg
Jul 1994 SUPPL
Label
Dec 1992 SUPPL
Label
Sep 1992 SUPPL Priority
Mfg
Dec 1991 ORIGINAL Priority
New Drug
What ROMAZICON Treats
1 FDA approvalsOriginally approved for its first indication in 1991 .
- Other (1)
Other
(1 approval)- • Approved indication (Dec 1991) Priority
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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| NCT02048969 | 1311013071 P30DK034989 | Ph 1, Ph 2 | withdrawn | Treatment of Hepatic Encephalopathy With Flumazenil and Change in Cortical GABA Levels in MRS |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 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
ROMAZICON FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment