Clobazam
As of the edition of 20 October 2026, Clobazam is a small molecule: marketed, first approved in 1979 (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 2024
- Kind
- Small molecule
- Brand name
- Onfi
- First approved
- 1 May 1979 (CH)
- Approvals on record
- 12 in 5 regions
- Holder of the most recent approval
- PHARLAB INDÚSTRIA FARMACÊUTICA S.A.; 6 holders in all
- Registered trials
- 16, 4 stopped early
- Disease areas
- Nervous system; Mental health; Inherited and neonatal
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 | 2 | 2 | 0 | 0 |
| Phase 2 | 4 | 4 | 0 | 0 |
| Phase 3 | 7 | 3 | 0 | 4 |
| Phase 4 | 3 | 1 | 0 | 0 |
| All trials | 16 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Lundbeck | Applicant and Lead sponsor of trials | 2005 to now |
| Aquestive Therapeutics | Later holder | 2018 to now |
| Cosette Pharmaceuticals | Acquired holder | 2026 to now |