Overview
Amisulpride is a benzamide derivative and a dopamine receptor antagonist that selectively works on dopamine D2 and D3 receptors. As an antipsychotic agent, amisulpride alleviates both positive and negative symptoms of schizophrenia, and it exhibits antidepressant properties in patients with psychiatric disorders, dysthymia, and major depression. Amisulpride predominantly works in the limbic system, which explains its relatively lower risk of extrapyramidal adverse effects compared to other atypical antipsychotic agents. Oral tablets of amisulpride is used in European countries as a treatment for acute and chronic schizophrenic disorders, as well as secondary negative symptoms in mental health disorders such as affective disorders, depressive mood, and mental retardation. Amisulpride is also used as an antiemetic agent. In the US, the intravenous formulation of amisulpride is used to treat and prevent postoperative nausea and vomiting in adults, either as monotherapy or in combination with another antiemetic agent of a different drug class. It is marketed under the brand name Barhemsys.
Indication
Intravenous amisulpride is indicated in adults for the prevention of postoperative nausea and vomiting, either alone or in combination with an antiemetic of a different class. It is also indicated for the treatment of postoperative nausea and vomiting in patients who have received anti-emetic prophylaxis with an agent of a different class or have not received prophylaxis. Oral amisulpride is indicated for the treatment of acute and chronic schizophrenic disorders, characterized by positive symptoms with delusions, hallucinations, thought disorders, hostility and suspicious behavior; or primarily negative symptoms (deficit syndrome) with blunted affect, emotional and social withdrawal. Amisulpride also controls secondary negative symptoms in productive conditions as well as affective disorders such as depressive mood or retardation.
Associated Conditions
- Acute Schizophrenia
- Chronic Schizophrenia
- Negative Symptoms
- Post Operative Nausea and Vomiting (PONV)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/05 | Phase 3 | Not yet recruiting | |||
2023/10/04 | Phase 1 | Recruiting | |||
2023/07/21 | Not Applicable | Withdrawn | |||
2023/04/21 | Phase 3 | Not yet recruiting | |||
2025/01/14 | Phase 3 | Completed | |||
2022/04/26 | Phase 1 | Completed | Simone Grimm | ||
2021/07/08 | N/A | Withdrawn | |||
2021/05/06 | Phase 4 | UNKNOWN | All India Institute of Medical Sciences, Bhubaneswar | ||
2021/04/19 | Phase 1 | Completed | |||
2020/12/19 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Acacia Pharma Ltd | 71390-125 | INTRAVENOUS | 2.5 mg in 1 mL | 1/20/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SOLIAN TABLET 200 mg | SIN09773P | TABLET | 200 mg | 5/16/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Amisulpride Oral Solution | syri limited | 国药准字HJ20250043 | 化学药品 | 口服溶液剂 | 4/15/2025 |
| Amisulpride Oral Solution | 国药准字H20243190 | 化学药品 | 口服溶液剂 | 2/20/2024 | |
| Amisulpride Oral Solution | 国药准字H20233767 | 化学药品 | 口服溶液剂 | 6/21/2023 | |
| Amisulpride Oral Solution | 国药准字H20244722 | 化学药品 | 口服溶液剂 | 8/27/2024 | |
| Amisulpride Tablets | 国药准字HJ20171121 | 化学药品 | 片剂 | 9/1/2023 | |
| Amisulpride Tablets | 国药准字H20233724 | 化学药品 | 片剂 | 6/14/2023 | |
| Amisulpride Tablets | 国药准字HJ20171122 | 化学药品 | 片剂 | 9/1/2023 | |
| Amisulpride Tablets | 国药准字H20203564 | 化学药品 | 片剂 | 11/10/2020 | |
| Amisulpride Tablets | 国药准字H20113230 | 化学药品 | 片剂 | 4/24/2020 | |
| Amisulpride Tablets | 国药准字H20233831 | 化学药品 | 片剂 | 6/30/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| VICK-AMISULPRIDE TAB 400MG | N/A | N/A | N/A | 1/30/2009 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| SOLIAN 200 amisulpride 200 mg tablet blister pack | 96425 | Medicine | A | 7/23/2004 | |
| AMISULPRIDE-WGR 50 mg tablet blister pack | 178893 | Medicine | A | 11/3/2011 | |
| APO-Amisulpride 200 mg tablet blister pack | 178902 | Medicine | A | 11/3/2011 | |
| SULPRIX amisulpride 100 mg tablets blister pack | 156044 | Medicine | A | 11/26/2009 | |
| AMISULPRIDE SCP amisulpride 400 mg uncoated tablet blister pack | 234698 | Medicine | A | 1/29/2016 | |
| AMISULPRIDE SCP amisulpride 50 mg uncoated tablet blister pack | 234712 | Medicine | A | 1/29/2016 | |
| SOLIAN 100 amisulpride 100 mg tablet blister pack | 96422 | Medicine | A | 7/23/2004 | |
| AMISULPRIDE SCP amisulpride 100 mg uncoated tablet blister pack | 234706 | Medicine | A | 1/29/2016 | |
| SULPRIX amisulpride 400 mg tablets blister pack | 152460 | Medicine | A | 6/10/2009 | |
| APO-Amisulpride 400 mg tablet blister pack | 178898 | Medicine | A | 11/3/2011 |
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