BARHEMSYS (amisulpride)
Barhemsys helps adult patients manage nausea and vomiting that occurs after surgical procedures. It is used both to prevent these symptoms from starting and to treat them if they occur, even in patients who have already received other types of preventive medications. This medication can be used on its own or alongside different classes of anti-nausea drugs to improve patient comfort during recovery.
How BARHEMSYS Works
This drug works by blocking specific dopamine-2 and dopamine-3 receptors in the brain's chemoreceptor trigger zone and area postrema. By binding to these receptors, it prevents dopamine from triggering the signals that lead to the vomiting reflex. This action helps suppress the physical urge to vomit and the sensation of nausea.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-02-26
- Patent Cliff
- 2038
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
BARHEMSYS Approval History
What BARHEMSYS Treats
1 indicationsBARHEMSYS is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Postoperative Nausea and Vomiting
BARHEMSYS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to BARHEMSYS
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01701258 results posted | 2012P002593 5R01MH095809 | Ph 1 | completed | An Investigation of Early Life Stress and Depression |
| NCT04876521 PSD-AOFC results posted | AIIMS BBSR/PGThesis/2019-21 | Ph 4 | completed | Low Dose Amisulpride Vs Olanzapine-Fluoxetine Combination in Post-Schizophrenic Depression |
| NCT01972711 | SEP361-104 | Ph 1 | completed | Study Assessing SEP-363856 in Male and Female Volunteers With High or Low Schizotype Characteristics |
| NCT01446328 BP2 | 2010/3387 11/01070, 2010-022307-22 | Ph 4 | completed | Bergen Psychosis Project 2 - The Best Intro Study |
| NCT01609153 COMBINE | COMBINE | Ph 4 | completed | Comparison of Antipsychotic Combination Treatment of Olanzapine and Amisulpride to Monotherapy |
| NCT02307396 | 1723/1-1 2013-000338-37, DO 1723/1-1 | Ph 4 | completed | Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients |
| NCT01253421 results posted | 2010-P001568 R01MH068376 | Ph 1 | completed | The Effects of Dopamine on Reward Processing |
| NCT02051387 CBD-IS | CBD-IS 2008-008245-38 | Ph 1 | completed | Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT01246232 AMICUS | CRO1498 HTA 08/116/12, 2010-018963-40 | Ph 4 | completed | Amisulpride Augmentation in Clozapine-unresponsive Schizophrenia |
| NCT01795183 ESCAPE | AMISUL06155 U1111-1131-0692 | Ph 4 | completed | Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BARHEMSYS FDA Label Details
Indications & Usage
FDA Label (PDF)BARHEMSYS is indicated for the treatment of Postoperative Nausea and Vomiting.
BARHEMSYS Patents & Exclusivity
Patents (8 active)
Pro Intelligence Preview
Deep insights for BARHEMSYS
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 64 active patents
Trial Analysis
- • 11 total trials
- • Stage: Mature
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment