MedPath

Remimazolam

Generic Name
Remimazolam
Brand Names
Byfavo
Drug Type
Small Molecule
Chemical Formula
C21H19BrN4O2
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

Remimazolam Tosilate Sedation and Midazolam Sedation in Dental Patients

Phase 4
Completed
Conditions
Remimazolam
Sedation Complication
Midazolam
Interventions
First Posted Date
2020-10-26
Last Posted Date
2022-03-15
Lead Sponsor
Peking University
Target Recruit Count
81
Registration Number
NCT04602845
Locations
🇨🇳

Peking University Hospital of Stomatology, Beijing, Beijing, China

🇨🇳

Zijian Guo, Haidian, Beijing, China

Effect of Remimazolam Use During Perioperative Period on Brain Waves and Postoperative Cognitive Function

Not Applicable
Completed
Conditions
Benzodiazepine
Interventions
Drug: control group was induced with midazolam 0.05 mg/kg followed by normal saline maintenance of 0.1 ml·kg-1·h-1
First Posted Date
2020-10-23
Last Posted Date
2024-01-16
Lead Sponsor
Yangzhou University
Target Recruit Count
80
Registration Number
NCT04601350
Locations
🇨🇳

the Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, Jiangsu, China

Impact of Remimazolam on Prognosis After Bladder Cancer Surgery

Phase 4
Recruiting
Conditions
Bladder Cancer
Delirium
Benzodiazepines
Cancer Recurrence
Surgery
Interventions
First Posted Date
2020-08-31
Last Posted Date
2023-07-05
Lead Sponsor
Peking University First Hospital
Target Recruit Count
1128
Registration Number
NCT04532606
Locations
🇨🇳

The Sixth Medical Center of PLA General Hospital, Beijing, Beijing, China

🇨🇳

Beijing Tsinghua Chang Gung Hospital, Beijing, Beijing, China

🇨🇳

Guizhou Provincial People's Hospital, Guiyang, Guizhou, China

and more 3 locations

A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy

Phase 3
Completed
Conditions
Sedation
Interventions
First Posted Date
2020-05-22
Last Posted Date
2022-08-22
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Target Recruit Count
330
Registration Number
NCT04400201
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, China

Oral Remimazolam With and Without Alcohol in Healthy Female Subjects

Phase 1
Completed
Conditions
Safety Issues
Interventions
Other: Alcohol
First Posted Date
2019-10-02
Last Posted Date
2019-10-02
Lead Sponsor
Paion UK Ltd.
Target Recruit Count
21
Registration Number
NCT04113343
Locations
🇺🇸

PRA Health Sciences (PRA) - Early Development Services, Salt Lake City, Utah, United States

Absolute Oral Bioavailability of Remimazolam

Phase 1
Completed
Conditions
Bioavailability
Interventions
First Posted Date
2019-10-02
Last Posted Date
2019-10-02
Lead Sponsor
Paion UK Ltd.
Target Recruit Count
14
Registration Number
NCT04113564
Locations
🇺🇸

PRA Health Sciences (PRA) - Early Development Services (EDS), Salt Lake City, Utah, United States

Abuse Potential of Intravenous Remimazolam Compared to Midazolam and Placebo in Recreational CNS Depressant Users

Phase 1
Completed
Conditions
Abuse, Drug
Interventions
First Posted Date
2019-10-01
Last Posted Date
2019-10-01
Lead Sponsor
Paion UK Ltd.
Target Recruit Count
83
Registration Number
NCT04110535
Locations
🇺🇸

PRA Health Sciences Early Development Services, Salt Lake City, Utah, United States

A Clinical Study of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective Surgery

Phase 3
Completed
Conditions
Anesthesia for Elective Surgery Patients
Interventions
First Posted Date
2019-04-19
Last Posted Date
2020-05-15
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Target Recruit Count
330
Registration Number
NCT03921775
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, Beijing, China

Study of Remimazolam Tosilate in Patients Undergoing Colonoscopy

Phase 3
Completed
Conditions
Sedation
Interventions
First Posted Date
2018-12-19
Last Posted Date
2018-12-19
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Target Recruit Count
388
Registration Number
NCT03779061
Locations
🇨🇳

Clinical trial Ethnics Committee of Peking Union Medical College Hospital, Beijing, Beijing, China

Comparative Clinical Study of Efficacy and Safety of Remimazolam and Propofol in Patients Undergoing Elective Surgery Under General Anaesthesia

Phase 3
Completed
Conditions
General Anaesthesia
Interventions
First Posted Date
2018-09-13
Last Posted Date
2018-09-13
Lead Sponsor
R-Pharm
Target Recruit Count
150
Registration Number
NCT03669484
Locations
🇷🇺

SBHI City Clinical Hospital №1 n.a. N.I. Pirogov, Moscow, Russian Federation

🇷🇺

FSBI Central Clinical Hospital and Polyclinic of Adminisatration of the President of the Russian Federation, Moscow, Russian Federation

🇷🇺

SBHI Moscow Clinical Research and Practical center of Department of Healthcare of the city of Moscow, Moscow, Russian Federation

and more 3 locations
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