Remimazolam

Generic Name: Remimazolam

Brand Names: Byfavo

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₁₉BrN_₄O_₂

CAS Number: 308242-62-8

Unique Ingredient Identifier: 7V4A8U16MB

Background: Remimazolam is an ultra short-acting benzodiazepine used in the induction and maintenance of sedation during short (<30 minute) procedures. Recent trends in anesthesia-related drug development have touted the benefits of so-called "soft drugs" - these agents, such as remifentanil, are designed to be metabolically fragile and thus susceptible to rapid biotransformation and elimination as inactive metabolites. These "soft drugs" are useful in the context of surgical procedures, wherein a rapid onset/offset is desirable, enabling anesthesiologists to manipulate drug concentrations as needed. Remimazolam was the first "soft" benzodiazepine analog to be developed and was approved for use by the FDA in July 2020 under the brand name Byfavo.

Indication: Remimazolam is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.

Associated Conditions: Procedural Sedation

Clinical Trials

A Randomized Single-blind Clinical Trial of the Efficacy and Safety of Remimazolam in Painless Bronchoscopy

Phase 4

Conditions: Bronchoscopy
Sedation

Interventions: Drug: Remimazolam
Drug: Dexmedetomidine

First Posted Date: 2021-06-09

Last Posted Date: 2021-06-09

Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Target Recruit Count: 364

Registration Number: NCT04919174

Locations: 🇨🇳
The Second Affiliated Hospital of Zhejiang University Medical College, Hangzhou, Zhejiang, China

Study on the Safety and Effectiveness of Remimazolam Tosilate for Injection for Short-term Elective Surgery in Adults

Phase 4

Completed

Conditions: Hypotension During Surgery

Interventions: Drug: Remimazolam Tosilate for Injection 0.1mg/kg
Drug: Remimazolam Tosilate for Injection 0.15mg/kg
Drug: Remimazolam Tosilate for Injection 0.2mg/kg

First Posted Date: 2021-06-01

Last Posted Date: 2023-04-12

Lead Sponsor: Tongji Hospital

Target Recruit Count: 650

Registration Number: NCT04908553

Locations: 🇨🇳
TongjiHospital, Wuhan, China

Remimazolam and Postoperative Nausea and Vomiting in High-risk Patients

Phase 4

Completed

Conditions: Postoperative Nausea and Vomiting
High-risk Patients
Benzodiazepine

Interventions: Drug: Placebo
Drug: Remimazolam

First Posted Date: 2021-04-27

Last Posted Date: 2024-01-03

Lead Sponsor: Peking University First Hospital

Target Recruit Count: 552

Registration Number: NCT04861337

Locations: 🇨🇳
Beijing YouAn Hospital, Capital Medical University, Beijing, Beijing, China
🇨🇳
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, Zhejiang, China
🇨🇳
Suzhou Municipal Hospital, Suzhou, Jiangsu, China

and more 7 locations

Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures

Phase 2

Active, not recruiting

Conditions: Pediatric ALL

Interventions: Drug: Remimazolam

First Posted Date: 2021-04-20

Last Posted Date: 2022-12-14

Lead Sponsor: Acacia Pharma Ltd

Target Recruit Count: 100

Registration Number: NCT04851717

Locations: 🇺🇸
Texas Children's Hospital, Houston, Texas, United States
🇩🇰
Odense Universitetshospital, Odense, Denmark
🇺🇸
Stanford University, Palo Alto, California, United States

and more 5 locations

Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation

Phase 4

Conditions: Sedation

Interventions: Drug: Remimazolam
Drug: Dexmedetomidine

First Posted Date: 2021-03-24

Last Posted Date: 2021-03-24

Lead Sponsor: Tianjin Nankai Hospital

Target Recruit Count: 488

Registration Number: NCT04815265

Efficacy and Safety of Remimazolam Tosylate for Sedation in Gastroscopy

Not Applicable

Recruiting

Conditions: Sedation Complication
Hypoxia
Propofol Adverse Reaction
Gastric Cancer

Interventions: Drug: Remimazolam tosylate
Drug: Propofol

First Posted Date: 2021-01-27

Last Posted Date: 2022-10-12

Lead Sponsor: RenJi Hospital

Target Recruit Count: 1800

Registration Number: NCT04727034

Locations: 🇨🇳
Shanghai East Hospital, Shanghai, Shanghai, China, China
🇨🇳
Renji Hospital, Shanghai, Shanghai, China, China
🇨🇳
Affiliated Hospital of Jiaxing University, Jiaxing, China

and more 2 locations