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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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
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 | 2020-09-09 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
AMISULPRIDE, BARHEMSYS, ACACIA | |||
| 2025-02-26 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
62 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 | 3 | 1 | 1 | 19 | 6 | 30 |
| Psychotic disorders | D011618 | F20.81 | — | 1 | — | 6 | 2 | 9 | |
| Schizophrenia spectrum and other psychotic disorders | D019967 | — | — | — | 1 | — | 1 | ||
| Tardive dyskinesia | D000071057 | G24.01 | — | — | — | 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 | — | 1 | — | — | 1 | 2 |
| Vomiting | D014839 | HP_0002013 | R11.1 | 1 | 1 | — | — | — | 2 |
| Intellectual disability | D008607 | 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 nervosa | D000856 | EFO_0004215 | F50.0 | 1 | — | — | — | — | 1 |
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | 1 | — | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic pain | D059350 | HP_0012532 | — | — | — | — | 1 | 1 | |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | EFO_0002614 | — | — | — | — | 1 | 1 | |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | — | — | 1 | 1 |
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
Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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146 adverse events reported
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