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Barhemsys (AMISULPRIDE)
Barhemsys works by blocking dopamine receptors in the brain.
Amisulpride (Barhemsys), marketed by Acacia, is positioned as a preventive treatment for postoperative nausea and vomiting (PONV) with a key composition patent expiring in 2028. Its mechanism of action, which involves blocking dopamine receptors, provides a targeted approach to managing PONV, distinguishing it from broader-spectrum competitors. The primary risk to Barhemsys is the competitive landscape, including drugs like apomorphine, aripiprazole, cariprazine, and clozapine, all of which are patent-protected and target the same receptor, potentially limiting market share.
At a glance
| Generic name | AMISULPRIDE |
|---|---|
| Sponsor | Acacia |
| Drug class | Dopamine-2 Receptor Antagonist [EPC] |
| Target | D(2) dopamine receptor |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2020 |
Mechanism of action
Amisulpride is selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist. D2 receptors are located in the chemoreceptor trigger zone (CTZ) and respond to the dopamine released from the nerve endings. Activation of CTZ relays stimuli to the vomiting center which is involved in emesis. Studies in multiple species indicate that D3 receptors in the area postrema also play role in emesis. Studies conducted in ferrets have shown that amisulpride inhibits emesis caused by apomorphine, with an estimated ED50 of less than mcg/kg, subcutaneously; and inhibits cisplatin-induced emesis at mg/kg and morphine-induced emesis at to mg/kg, when given intravenously.Amisulpride has no appreciable affinity for any other receptor types apart from low affinities for 5-HT2B and 5-HT7 receptors.
Approved indications
- Prevention of PONV
- Treatment of PONV
Common side effects
- Chills
- Hypokalemia
- Procedural hypotension
- Abdominal distension
- Infusion site pain
- Increased blood prolactin concentrations
- Agranulocytosis
- Bradycardia
- Torsades de pointes
- Ventricular tachycardia
- Prolonged QT by electrocardiogram
- Neuroleptic malignant syndrome
Drug interactions
- High Risk QT Prolonging Agents
Key clinical trials
- Multicenter Study to Assess the Efficacy and Safety of LB-102 in the Treatment of Adult Patients With BP1MDE. (PHASE2)
- Enhancing Recovery in Early Schizophrenia (PHASE2)
- Characterizing Drug Liking During Drug Administration in Peri-procedural Clinical Settings (EARLY_PHASE1)
- Magnetic Seizure Therapy for Psychotic Disorders (NA)
- Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients (PHASE2,PHASE3)
- An Investigation of Early Life Stress and Depression (PHASE1)
- Efficacy of Adding Oral Amisulpride to Dual Prophylaxis for Postoperative Nausea and Vomiting in Patients at High Risk for Nausea and Vomiting Undergoing Gynecological Surgery (PHASE2)
- Dopamine Receptor Contributions to Prediction Error and Reversal Learning in Anorexia Nervosa (EARLY_PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Barhemsys CI brief — competitive landscape report
- Barhemsys updates RSS · CI watch RSS
- Acacia portfolio CI