NDAINTRAVENOUSSOLUTION
Approved
Feb 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
13
Data completeness
5/8 — Partial
BARHEMSYS (amisulpride) by Acacia Pharma is dopamine d2 antagonists [moa]. First approved in 2020.
Drug data last refreshed 4h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BARHEMSYS (amisulpride) is an intravenous dopamine D2 receptor antagonist approved in February 2020 for the treatment of postoperative nausea and vomiting (PONV). It works by blocking dopamine signaling in the chemoreceptor trigger zone, making it a non-serotonergic alternative in the antiemetic space. The IV formulation allows rapid onset in acute clinical settings.
Peak11.4 years to LOE
BARHEMSYS is in its peak commercial phase with established market presence and no direct competitors, suggesting mature team structures and stable commercial operations.
Mechanism of Action
Dopamine D2 Antagonists
Pharmacologic Class:
Dopamine-2 Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (13)
Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients
Started Jan 2024
453 enrolled
Nausea and Vomiting, Postoperative
An Open-Label, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of Amisulpride in Treating Patients With Schizophrenia and Schizoaffective Disorder Who Have Treatment-Resistant Positive Symptoms
Started Nov 2023
0Schizophrenia, Treatment-Resistant
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
516 enrolled
PONV
Post Operative Nausea and Vomiting (PONV) Rescue Outcomes After Amisulpride Treatment
Started Nov 2022
0Nausea and Vomiting, Postoperative
Effects of a Single Dose of Amisulpride on Functional Brain Changes
Started May 2022
127 enrolled
Major Depressive Disorder
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.