Remimazolam
As of the edition of 20 October 2026, Remimazolam is a small molecule: marketed, first approved in 2020 (JP); acts on GABRA1, GABRA2 and GABRA3 and 4 more.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Byfavo
- First approved
- 23 January 2020 (JP)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- Mundipharma; 4 holders in all
- Registered trials
- 220, 5 stopped early
- Disease areas
- Nervous system; Mental health; Heart and blood vessels; Digestive system; Cancer; Lungs and airways
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| GABRA1 | Gamma-aminobutyric acid receptor subunit alpha-1 | P14867 |
| GABRG2 | Gamma-aminobutyric acid receptor subunit gamma-2 | P18507 |
| GABRA5 | Gamma-aminobutyric acid receptor subunit alpha-5 | P31644 |
| GABRA3 | Gamma-aminobutyric acid receptor subunit alpha-3 | P34903 |
| GABRA2 | Gamma-aminobutyric acid receptor subunit alpha-2 | P47869 |
| GABRG1 | Gamma-aminobutyric acid receptor subunit gamma-1 | Q8N1C3 |
| GABRG3 | Gamma-aminobutyric acid receptor subunit gamma-3 | Q99928 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 100 | 53 | 24 | 2 |
| Phase 1 | 14 | 10 | 4 | 0 |
| Phase 2 | 16 | 11 | 1 | 0 |
| Phase 3 | 25 | 18 | 3 | 1 |
| Phase 4 | 65 | 22 | 27 | 2 |
| All trials | 220 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Mundipharma | Applicant | 2020 to now |
| Acacia Pharma | Applicant and Lead sponsor of trials | 2020 to now |
| PAION Pharma | Applicant | 2021 to now |