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
- Associated Therapies
- -
Comparative Clinical Study of Efficacy and Safety of Remimazolam and Propofol in Patients Undergoing Elective Surgery Under General Anaesthesia
- 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
Efficacy and Safety of Remimazolam (CNS7056) Compared to Propofol for Intravenous Anesthesia During Elective Surgery
- 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 Trial of Intranasal Remimazolam Pharmacokinetics, Pharmacodynamics, Safety and Bioavailability
- 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
Safety and Efficacy of Remimazolam in ASA III and IV Patients Undergoing Colonoscopy
- 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
- 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 Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy
- 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
A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients
- 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
Remimazolam Phase II Cardiac Anesthesia Study
- Conditions
- General Anesthesia
- Interventions
- First Posted Date
- 2013-09-10
- Last Posted Date
- 2020-01-18
- Lead Sponsor
- Paion UK Ltd.
- Target Recruit Count
- 90
- Registration Number
- NCT01937767
- Locations
- 🇩🇪
Herzzentrum Leipzig GmbH, Leipzig, Germany
Drug Development Updates
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