Romazicon

(Flumazenil)

ApprovedSmall molecule

Flumazenil is used to reverse the effects of benzodiazepine drugs (like valium or similar sedatives) when someone has taken too much or needs to wake up quickly after anesthesia.[2] Romazicon is currently approved and in use across 17 indications[4].[1]

Romazicon is one of 376 small molecule programs targeting Sedation. It is currently in Approved.

Indications

Total Trials

Active Trials

375

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Dental PhobiaApproved

Parkinson DiseaseActive, not recruiting

DeliriumActive, not recruiting

Kidney TransplantActive, not recruiting

InsomniaApproved

Stomach NeoplasmActive, not recruiting

Fragile X SyndromeActive, not recruiting

EncephalopathyActive, not recruiting

Drug DependenceApproved

Alcohol DependenceApproved

Dental PhobiaApproved

Approved

Parkinson DiseasePhase 1

Active, not recruiting

DeliriumApproved

Active, not recruiting

Kidney TransplantPhase 1

Active, not recruiting

InsomniaApproved

Approved

Stomach NeoplasmPreclinical

Active, not recruiting

Fragile X SyndromePhase 1

Active, not recruiting

EncephalopathyPhase 1/Phase 2

Active, not recruiting

Drug DependenceApproved

Approved

Alcohol DependenceApproved

Approved

Showing 10 of 16 indications

Competition

Competitive Landscape

476 competitors in Kidney Transplant

#DrugCompanyPhaseTrials

Romazicon

CConrado Roberto Hoffmann Filho

Approved

1 2

Nulojix

Bristol-Myers Squibb

Preclinical

16 3

Simulect

Novartis

Preclinical

15 4

Medrol

Pfizer

Preclinical

12 5

Zinbryta

Roche

Preclinical

6 6

Cysteine Hydrochloride

Novartis

Preclinical

1 7

Sensipar

Amgen

Preclinical

1 8

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Preclinical

1 9

Radicava

Shionogi

Preclinical

1 10

Jardiance

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2028

ApprovedNot yet recruiting

Hysteroscopy

NCT07663877

Clinical

Trials by Indication[1]

General Anesthesia3 trials

Comparison of Remimazolam and Propofol on Emergence in Elderly Orthopedic Patients Under General Anesthesia

Completed·—·Phase 4·NCT06513923·136 enrolled

Effect of Flumazenil on Recovery From General Anesthesia With Isoflurane

Completed·UUniversity of Sao Paulo·N/A·NCT02157428·36 enrolled

Comparison of Recovery From General Anesthesia in Remimazolam With Flumazenil vs. Propofol

Completed·SSeoul National University Hospital·N/A·NCT05435911·66 enrolled

Anesthesia2 trials

GABA Antagonist to Improve Reversal of Anesthesia With High-density EEG Surveillance

Unknown status·NNational Taiwan University Hospital·N/A·NCT04329585·60 enrolled

Effect of Remazolam on Anesthesia Recovery in Patients Undergoing Fundus Surgery

Not yet recruiting·SSichuan Provincial People's Hospital·Phase 1·NCT06205719·93 enrolled

Remimazolam2 trials

Reversal of Remimazolam by a Single Dose of Flumazenil

Completed·KKonkuk University Medical Center·N/A·NCT05382806·224 enrolled

Finding ED90 of Flumazenil for Selective Improvement of Respiratory Distress by Remimazolam

Completed·YYonsei University·N/A·NCT06563063·60 enrolled

Delirium2 trials

Impact of Flumazenil on the Emergence Delirium

Completed·KKorea University Guro Hospital·Phase 4·NCT05681377·68 enrolled

Flumazenil for Hypoactive Delirium Secondary to Benzodiazepine Exposure

Terminated·UUniversity of California, Davis·Phase 4·NCT02899156·22 enrolled

Parkinson disease2 trials

Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil Arm

Completed·NNicolaas Bohnen, MD, PhD·Phase 1/2·NCT03440112·34 enrolled

Modulation of GABA-A Receptors in Parkinson Disease-Flumazenil Arm

Completed·UUniversity of Michigan·Phase 1/2·NCT03462641·36 enrolled

16 more indications

Efficacy1 trial

Safety and the Efficacy of a Sublingual Administration of Flumazenil to Reverse the Effect of Hypnotic Drugs in Healthy Adults

Completed·CCoeruleus Ltd.·Phase 1/2·NCT01071889·10 enrolled

Hypersomnia1 trial

Flumazenil for the Treatment of Primary Hypersomnia

Completed·LLynn Marie Trotti·Phase 1/2·NCT01183312·10 enrolled

Atrial Fibrillation1 trial

Comparison of Remimazolam With Flumazenil vs. Propofol During RFCA for Atrial Fibrillation

Completed·SSeoul National University Hospital·N/A·NCT05397886·54 enrolled

Total Intravenous Anesthesia1 trial

Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam

Recruiting·PPusan National University Yangsan Hospital·N/A·NCT05939674·24 enrolled

Brain Death1 trial

Rapid Reversal of CNS-Depressant Drug Effect Prior to Brain Death Determination

Withdrawn·PPrisma Health-Midlands·Phase 1·NCT03743805

Encephalopathy1 trial

Treatment of Hepatic Encephalopathy With Flumazenil and Change in Cortical GABA Levels in MRS

Withdrawn·YYale University·Phase 1/2·NCT02048969

ISS1 trial

Positron Emission Tomography (PET) Study With (11C) Flumazenil to Determine Central GABAA Receptor Occupancy of AZD6280

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00681746·8 enrolled

Kidney Transplant1 trial

Flumazenil Antagonism of Remimazolam in Kidney Transplant Patients

Not yet recruiting·QQianfoshan Hospital·Phase 1·NCT06531369·60 enrolled

Fragile X Syndrome1 trial

Neuroimaging GABA Physiology in Fragile X Syndrome

Terminated·SStanford University·Phase 1·NCT04308954·17 enrolled

Sedation1 trial

Electro-acupuncture and Flumazenil's Effect on Sedation

Completed·—·N/A·NCT02690389·80 enrolled

Obsessive-Compulsive Disorder1 trial

A Randomized, Double-Blind, Placebo-Controlled Trial of Flumazenil for the Treatment of Obsessive Compulsive Disorder

Terminated·—·Phase 2·NCT00997087·11 enrolled

Oral1 trial

Flumazenil Reversal of Oral Triazolam

Completed·UUniversity of Washington·Phase 1/2·NCT00695630·14 enrolled

Adult1 trial

Safety and Pharmacokinetic Study of Sublingual Flumazenil (CRLS035) in Healthy Adults

Completed·CCoeruleus Ltd.·Phase 1·NCT01655914·10 enrolled

Bronchoscopy1 trial

Clinical Application Value of Remazolam Combined With Sugammadex Sodium in Anesthesia for Endotracheal Surgery Under Bronchoscopy

Completed·ZZhejiang Cancer Hospital·Phase 4·NCT05468671·34 enrolled

Hysteroscopy1 trial

Remimazolam With Planned Flumazenil Reversal Versus Sevoflurane-based Balanced Anesthesia for Hysteroscopic Day Surgery: A Randomized Controlled Trial

Not yet recruiting·CChung-Ang University Gwangmyeong Hospital·Approved·NCT07663877·124 enrolled

Unspecified1 trial

Rapid Benzodiazepine Detoxification Using Flumazenil - 1

Completed·YYale University·Phase 2·NCT00000246·10 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 20, 1991

ROMAZICON

NDA NDA020073

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for Flumazenil. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Romazicon drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Flumazenil compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Flumazenil. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020073). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Conrado Roberto Hoffmann Filho company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: GABA-a Receptor; Anion Channel Allosteric Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: CConrado Roberto Hoffmann Filho

Romazicon

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2028

Trials by Indication[1]

General Anesthesia3 trials

Anesthesia2 trials

Remimazolam2 trials

Delirium2 trials

Parkinson disease2 trials

Efficacy1 trial

Hypersomnia1 trial

Atrial Fibrillation1 trial

Total Intravenous Anesthesia1 trial

Brain Death1 trial

Encephalopathy1 trial

ISS1 trial

Kidney Transplant1 trial

Fragile X Syndrome1 trial

Sedation1 trial

Obsessive-Compulsive Disorder1 trial

Oral1 trial

Adult1 trial

Bronchoscopy1 trial

Hysteroscopy1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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