Overview
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.
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/01 | Not Applicable | Not yet recruiting | Qianfoshan Hospital | ||
2025/07/01 | Not Applicable | Recruiting | |||
2025/06/25 | Not Applicable | Recruiting | Harbin Medical University | ||
2025/06/25 | Phase 2 | Not yet recruiting | |||
2025/06/10 | Early Phase 1 | Not yet recruiting | Second Hospital of Shanxi Medical University | ||
2025/05/25 | Not Applicable | Not yet recruiting | Second Hospital of Shanxi Medical University | ||
2025/02/10 | Phase 4 | Not yet recruiting | Second Affiliated Hospital of Wenzhou Medical University | ||
2025/01/16 | Phase 4 | Recruiting | |||
2025/01/15 | Not Applicable | Not yet recruiting | |||
2025/01/01 | Not Applicable | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Acacia Pharma, Ltd. | 71390-011 | INTRAVENOUS | 2.5 mg in 1 mL | 6/29/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/26/2021 | ||
Authorised | 3/26/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Remimazolam Tosilate for Injection | 国药准字H20217078 | 化学药品 | 注射剂 | 9/10/2021 | |
| Remimazolam Tosilate for Injection | 国药准字H20190034 | 化学药品 | 注射剂 | 12/26/2019 | |
| Remimazolam Besylate for Injection | 国药准字H20227087 | 化学药品 | 注射剂 | 6/29/2022 | |
| Remimazolam Besylate for Injection | 国药准字H20200006 | 化学药品 | 注射剂 | 7/16/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||