Flumazenil
As of the edition of 20 October 2026, Flumazenil is a small molecule: marketed, first approved in 1986 (CH); 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 2022
- Kind
- Small molecule
- Brand name
- Romazicon
- First approved
- 30 December 1986 (CH)
- Approvals on record
- 5 in 4 regions
- Holder of the most recent approval
- BIOPAS BRASIL PRODUTOS FARMACEUTICOS LTDA; 4 holders in all
- Registered trials
- 21, 3 stopped early
- Disease areas
- Mental health; Nervous system; Chemically induced; Digestive system; Cancer; Heart and blood vessels
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 | 7 | 4 | 2 | 0 |
| Phase 1 | 3 | 1 | 0 | 2 |
| Phase 2 | 6 | 5 | 0 | 1 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 4 | 3 | 1 | 0 |
| All trials | 21 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Applicant | 1991 to now |