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
Clinical Trials
Related News

Efficacy and Safety of Remimazolam (CNS7056) Compared to Propofol for Intravenous Anesthesia During Elective Surgery

Phase 3
Completed
Conditions
Anesthesia, Intravenous
Interventions
First Posted Date
2018-09-07
Last Posted Date
2020-05-28
Lead Sponsor
Paion UK Ltd.
Target Recruit Count
469
Registration Number
NCT03661489
Locations
🇩🇪

University of Erlangen, Erlangen, Bavaria, Germany

A Phase Ⅰb Study of Remimazolam Tosylate in Healthy Volunteers

Phase 1
Completed
Conditions
Anesthesia
Interventions
First Posted Date
2018-02-23
Last Posted Date
2018-02-23
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Target Recruit Count
8
Registration Number
NCT03444480
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, Beijing, China

Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy

Phase 3
Completed
Conditions
Sedation
Interventions
First Posted Date
2018-02-07
Last Posted Date
2018-02-12
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Target Recruit Count
378
Registration Number
NCT03425474
Locations
🇨🇳

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

A Trial of Intranasal Remimazolam Pharmacokinetics, Pharmacodynamics, Safety and Bioavailability

Phase 1
Completed
Conditions
Procedural Sedation
Interventions
Drug: Placebo
First Posted Date
2017-11-01
Last Posted Date
2019-04-04
Lead Sponsor
Paion UK Ltd.
Target Recruit Count
12
Registration Number
NCT03329014
Locations
🇺🇸

PRA Health Sciences, Salt Lake City, Utah, United States

A Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy

Phase 2
Completed
Conditions
Sedation
Interventions
First Posted Date
2016-12-28
Last Posted Date
2017-09-08
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Target Recruit Count
153
Registration Number
NCT03003884
Locations
🇨🇳

Beijing Union Medical College Hospital, Beijing, Beijing, China

Safety and Efficacy of Remimazolam in ASA III and IV Patients Undergoing Colonoscopy

Phase 3
Completed
Conditions
Colonoscopy
Interventions
Drug: Placebo
First Posted Date
2015-08-26
Last Posted Date
2020-09-30
Lead Sponsor
Paion UK Ltd.
Target Recruit Count
79
Registration Number
NCT02532647
Locations
🇺🇸

Jupiter Medical Center, Jupiter, Florida, United States

🇺🇸

Indiana University Division of Gastroenterology/Hepatology, Indianapolis, Indiana, United States

🇺🇸

Delta Research Partners Inc, Monroe, Louisiana, United States

Study of the Efficacy and Safety of Remimazolam in General Anesthesia in Adults Undergoing Cardiac Surgery

Phase 3
Terminated
Conditions
Anesthesia
Interventions
First Posted Date
2015-08-14
Last Posted Date
2023-08-30
Lead Sponsor
Paion UK Ltd.
Target Recruit Count
25
Registration Number
NCT02523859
Locations
🇩🇪

Herzzentrum Leipzig GmbH, Leipzig, Germany

A Study Comparing Remimazolam Tosilate and Propofol for Intravenous General Anaesthesia in Operations

Phase 2
Completed
Conditions
General Anesthesia
Interventions
First Posted Date
2015-04-02
Last Posted Date
2015-12-31
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Target Recruit Count
144
Registration Number
NCT02406872
Locations
🇨🇳

Peking Union Medical College Hospital, Peking, Beijing, China

A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy

Phase 3
Completed
Conditions
Bronchoscopy
Interventions
Drug: Placebo
First Posted Date
2014-11-21
Last Posted Date
2020-03-18
Lead Sponsor
Paion UK Ltd.
Target Recruit Count
446
Registration Number
NCT02296892
Locations
🇺🇸

Washington University School of Medicine/Barnes-Jewish Hospital, Saint Louis, Missouri, United States

🇺🇸

Sun City Office, Sun City Center, Florida, United States

🇺🇸

Pab Clinical Research, Brandon, Florida, United States

and more 11 locations

A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients

Phase 3
Completed
Conditions
Colonoscopy
Interventions
Drug: Placebo
First Posted Date
2014-11-14
Last Posted Date
2020-10-20
Lead Sponsor
Paion UK Ltd.
Target Recruit Count
461
Registration Number
NCT02290873
Locations
🇺🇸

University of South Alabama, Mobile, Alabama, United States

🇺🇸

Borland-Grover Clinic, P.A, Jacksonville, Florida, United States

🇺🇸

Advanced Clinical Research Institute, Anaheim, California, United States

and more 9 locations
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