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Drug ReportsAmisulpride
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
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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
BARHEMSYSAcacia PharmaN-209510 RX2020-02-26
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
barhemsysNew Drug Application2022-09-26
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
AMISULPRIDE, BARHEMSYS, ACACIA
2025-02-26NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Amisulpride, Barhemsys, Acacia
113577532038-02-09U-2754
90847652034-02-26U-1744, U-2754, U-3467
95454262031-03-10U-1744, U-2754
98891182031-03-10U-1744, U-2754
105250332031-03-10DP
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05A: Antipsychotics
— N05AL: Benzamide antipsychotics
— N05AL05: Amisulpride
HCPCS
No data
Clinical
Clinical Trials
80 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Postoperative nausea and vomitingD020250EFO_0004888—226—110
VomitingD014839—R11.1243—19
NauseaD009325—R11.0—33—16
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1————1
Chronic kidney failureD007676EFO_0003884N18.61————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAmisulpride
INNamisulpride
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 classsulpride derivatives and analogs
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCN1CCCC1CNC(=O)c1cc(S(=O)(=O)CC)c(N)cc1OC
Identifiers
PDB—
CAS-ID71675-85-9
RxCUI—
ChEMBL IDCHEMBL243712
ChEBI ID64045
PubChem CID2159
DrugBankDB06288
UNII ID8110R61I4U (ChemIDplus, GSRS)
Target
Agency Approved
DRD2
DRD2
Organism
Homo sapiens
Gene name
DRD2
Gene synonyms
NCBI Gene ID
Protein name
D(2) dopamine receptor
Protein synonyms
Dopamine D2 receptor, seven transmembrane helix receptor
Uniprot ID
Mouse ortholog
Drd2 (13489)
D(2) dopamine receptor (Q0VGH9)
Alternate
DRD3
DRD3
Organism
Homo sapiens
Gene name
DRD3
Gene synonyms
NCBI Gene ID
Protein name
D(3) dopamine receptor
Protein synonyms
Dopamine D3 receptor, essential tremor 1
Uniprot ID
Mouse ortholog
Drd3 (13490)
D(3) dopamine receptor (P30728)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,032 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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4,398 adverse events reported
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