Amisulpride
Barhemsys (amisulpride) is a small molecule pharmaceutical. Amisulpride was first approved as Barhemsys on 2020-02-26. The pharmaceutical is active against D(2) dopamine receptor. In addition, it is known to target D(3) dopamine receptor.
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Commercial
Therapeutic Areas
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Trade Name
FDA
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Barhemsys
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Amisulpride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BARHEMSYS | Acacia Pharma | N-209510 RX | 2020-02-26 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| barhemsys | New Drug Application | 2026-06-17 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
AMISULPRIDE, BARHEMSYS, ACACIA | |||
| 2025-02-26 | NCE | ||
HCPCS
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Clinical
Clinical Trials
85 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | D012559 | EFO_0000692 | F20 | 6 | 3 | 3 | 21 | 11 | 44 |
| Psychotic disorders | D011618 | — | F20.81 | — | 1 | 1 | 6 | 6 | 14 |
| Depression | D003863 | — | F33.9 | 3 | — | 1 | 1 | — | 5 |
| Mental disorders | D001523 | EFO_0000677 | F91.9 | — | 1 | 1 | 1 | 1 | 4 |
| Treatment-resistant schizophrenia | D000090663 | — | — | — | — | 1 | 2 | 1 | 4 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 3 | — | — | 1 | — | 4 |
| Schizophrenia spectrum and other psychotic disorders | D019967 | — | — | — | — | — | 1 | 1 | 2 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | — | — | 1 | 1 | 2 |
| Tardive dyskinesia | D000071057 | — | G24.01 | — | — | — | 1 | — | 1 |
| Dyskinesias | D020820 | — | G24 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | 2 | 3 | 8 | — | 3 | 15 |
| Vomiting | D014839 | — | R11.1 | 2 | 4 | 3 | — | 1 | 10 |
| Nausea | D009325 | — | R11.0 | — | 2 | 3 | — | 1 | 6 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | 1 | — | 1 | 2 |
| Psychophysiologic disorders | D011602 | — | F45.9 | — | — | 1 | — | — | 1 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | — | 1 | — | — | 1 |
| Somatoform disorders | D013001 | — | F45 | — | — | 1 | — | — | 1 |
| Sialorrhea | D012798 | — | K11.7 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 2 | — | — | 1 | 3 |
| Intellectual disability | D008607 | EFO_0003847 | F73 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 3 | — | — | — | — | 3 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | 1 | 2 |
| Gastrointestinal microbiome | D000069196 | — | — | 1 | — | — | — | — | 1 |
| Anorexia | D000855 | — | R63.0 | 1 | — | — | — | — | 1 |
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | 1 | — | — | — | — | 1 |
| Psychological stress | D013315 | — | — | 1 | — | — | — | — | 1 |
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | 1 | — | — | — | — | 1 |
| Compulsive behavior | D003192 | — | R46.81 | 1 | — | — | — | — | 1 |
| Compulsive personality disorder | D003193 | — | F60.5 | 1 | — | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | — | — | 3 | 3 |
| Hyperprolactinemia | D006966 | — | E22.1 | — | — | — | — | 2 | 2 |
| Syndrome | D013577 | — | — | — | — | — | — | 2 | 2 |
| Chronic pain | D059350 | — | — | — | — | — | — | 1 | 1 |
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | — | — | — | 1 | 1 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | — | — | — | 1 | 1 |
| Addictive behavior | D016739 | EFO_0004347 | — | — | — | — | — | 1 | 1 |
| Treatment-resistant depressive disorder | D061218 | — | — | — | — | — | — | 1 | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Amisulpride |
| INN | amisulpride |
| Description | Amisulpride is a member of the class of benzamides resulting from the formal condensation of the carboxy group of 4-amino-5-(ethylsulfonyl)-2-methoxybenzoic acid with the primary amino group of 2-(aminomethyl)-1-ethylpyrrolidine. It is a potent, selective dopamine D2 and D3 receptor antagonist. It is an atypical antipsychotic/antischizophrenic agent with limited extrapyrimidal side effects. It has a role as a second generation antipsychotic, a xenobiotic and an environmental contaminant. It is a member of pyrrolidines, an aromatic amine, a sulfone, a member of benzamides and an aromatic amide. |
| Classification | Small molecule |
| Drug class | sulpride derivatives and analogs |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCN1CCCC1CNC(=O)c1cc(S(=O)(=O)CC)c(N)cc1OC |
Identifiers
| PDB | — |
| CAS-ID | 71675-85-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL243712 |
| ChEBI ID | 64045 |
| PubChem CID | 2159 |
| DrugBank | DB06288 |
| UNII ID | 8110R61I4U (ChemIDplus, GSRS) |
Target
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Safety
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Adverse Events
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5,052 adverse events reported
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