Amisulpride
As of the edition of 20 October 2026, Amisulpride is a small molecule: marketed, first approved in 1986 (FR); acts on DRD2 and DRD3.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Barhemsys
- First approved
- 20 January 1986 (FR)
- Approvals on record
- 6 in 4 regions
- Holder of the most recent approval
- Lxo Ireland Designated Activity; 3 holders in all
- Registered trials
- 52, 6 stopped early
- Disease areas
- Mental health; Nervous system; Bones, joints and muscles; Nutrition and metabolism; Pregnancy and women's health; Urinary and reproductive
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
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 12 | 6 | 1 | 3 |
| Phase 1 | 10 | 8 | 1 | 0 |
| Phase 2 | 3 | 3 | 0 | 0 |
| Phase 3 | 11 | 7 | 1 | 1 |
| Phase 4 | 16 | 11 | 0 | 2 |
| All trials | 52 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant and Lead sponsor of trials | 1998 to now |
| Acacia Pharma | Applicant and Lead sponsor of trials | 2011 to now |
| Lxo Ireland Designated Activity | Acquired holder | 2026 to now |