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Amisulpride

Generic Name
Amisulpride
Brand Names
Barhemsys
Drug Type
Small Molecule
Chemical Formula
C17H27N3O4S
CAS Number
71675-85-9
Unique Ingredient Identifier
8110R61I4U

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.

Background

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

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Title
Posted
Study ID
Phase
Status
Sponsor
2020/09/01
Early Phase 1
UNKNOWN
2020/06/24
Phase 4
UNKNOWN
2020/04/10
Not Applicable
Recruiting
2019/10/16
Early Phase 1
Completed
2019/03/05
Not Applicable
Completed
2019/01/14
Phase 4
UNKNOWN
2018/08/31
Phase 4
Completed
2018/07/11
Phase 1
Completed
2016/01/05
Phase 3
Completed
2015/09/23
Not Applicable
Completed

FDA Drug Approvals

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No FDA approvals found for this drug.

EMA Drug Approvals

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Status
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No EMA approvals found for this drug.

HSA Drug Approvals

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NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Amisulpride Tablets
国药准字H20223053
化学药品
片剂
1/30/2022
Amisulpride Tablets
国药准字H20233774
化学药品
片剂
6/21/2023
Amisulpride Tablets
国药准字H20223052
化学药品
片剂
1/30/2022
Amisulpride Tablets
国药准字H20233830
化学药品
片剂
6/30/2023
Amisulpride Tablets
国药准字H20203565
化学药品
片剂
11/10/2020
Amisulpride Tablets
国药准字H20203734
化学药品
片剂
12/29/2020
Amisulpride Tablets
国药准字H20113231
化学药品
片剂
4/24/2020

PPB Drug Approvals

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