BARHEMSYS

Peak

amisulpride

Acacia Pharma
NDAINTRAVENOUSSOLUTION
Approved
Feb 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
8

Mechanism of Action

Dopamine D2 Antagonists

Pharmacologic Class:

Dopamine-2 Receptor Antagonist

Indications (3)

vomiting (PONV)either alonecombination with an antiemetic of a different class

Clinical Trials (5)

NCT05546359Phase 2/3Completed

Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients

Started Jan 2024
NCT05822713Phase 3Unknown

A Comparison of the Efficacy of Amisulpride and Placebo in the Prevention of PONV in Patients at Moderate-to-high Risk of PONV.

Started Apr 2023
NCT05347199Phase 1Completed

Effects of a Single Dose of Amisulpride on Functional Brain Changes

Started May 2022
127 enrolled
Major Depressive Disorder
NCT01795183Phase 4Completed

Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia

Started Nov 2012
316 enrolled
Schizophrenia
NCT00436371Phase 4Completed

Amisulpride in Schizophrenic Acute Phase Patients

Started May 2005
50 enrolled
Schizophrenia

Loss of Exclusivity

LOE Date
Feb 9, 2038
145 months away
Patent Expiry
Feb 9, 2038

Patent Records (5)

Patent #ExpiryTypeUse Code
10525033
Mar 10, 2031
Product
—
12194022
Mar 10, 2031
U-3467
9545426
Mar 10, 2031
U-1744
9889118
Mar 10, 2031
U-1744
9084765
Feb 26, 2034
U-3467
Company
Acacia Pharma
Acacia Pharma
UK - Cambridge
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers