Barhemsys

(Amisulpride)

ApprovedSmall molecule

This medication is an injection used to prevent and treat nausea and vomiting after surgery. It works by blocking dopamine, a chemical in the body that triggers nausea and vomiting.[2] Barhemsys is currently approved and in use across 17 indications[4].[1]

Barhemsys is one of 362 small molecule programs targeting Metabolic Syndrome. It is currently in Approved.

Indications

Total Trials

Active Trials

361

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Metabolic SyndromeActive, not recruiting

Post Operative Nausea and VomitingActive, not recruiting

Mental or Behavioural DisorderActive, not recruiting

Schizoaffective DisorderActive, not recruiting

Chemotherapy-Induced Nausea and VomitingApproved

Chronic PainActive, not recruiting

PsychosisCompleted

Tardive DyskinesiaCompleted

Chronic Kidney DiseaseApproved

Major Depressive DisorderApproved

Metabolic SyndromePreclinical

Active, not recruiting

Post Operative Nausea and VomitingApproved

Active, not recruiting

Mental or Behavioural DisorderPreclinical

Active, not recruiting

Schizoaffective DisorderPreclinical

Active, not recruiting

Chemotherapy-Induced Nausea and VomitingApproved

Approved

Chronic PainPreclinical

Active, not recruiting

PsychosisApproved

Completed

Tardive DyskinesiaApproved

Completed

Chronic Kidney DiseaseApproved

Approved

Major Depressive DisorderApproved

Approved

Showing 10 of 17 indications

Competition

Competitive Landscape

332 competitors in Treatment

#DrugCompanyPhaseTrials

Barhemsys

Tibotec Pharmaceuticals, Ireland

Approved

1 2

Biltricide

Bayer

Preclinical

3 3

Dexilant

Takeda

Preclinical

2 4

Alfenta

Jazz Pharmaceuticals

Preclinical

1 5

Niclocide

Bayer

Preclinical

1 6

Minipress

Pfizer

Preclinical

1 7

Theo-Dur

Pfizer

Preclinical

1 8

Levulan

Sun Pharmaceutical Industries, Inc.

Preclinical

1 9

Lotemax

PPharmos

Preclinical

1 10

Norpramin

VValidus Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2028

PreclinicalNot yet recruiting

PONV

NCT07891312

Phase 1Not yet recruiting

Drug Liking

NCT07348172

Clinical

Trials by Indication[1]

Schizophrenia9 trials

Study on the Gut Microbial Mechanism of Negative Symptoms of Schizophrenia

Unknown status·SShanghai Mental Health Center·Phase 1·NCT04533724·6 enrolled

Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia

Unknown status·SShanghai Mental Health Center·Phase 4·NCT03802838·50 enrolled

Optimization of Treatment and Management of Schizophrenia in Europe (OPTIMISE): Substudy Site Copenhagen

Completed·BBirte Glenthoj·N/A·NCT01555814·56 enrolled

Show 6 more trials

Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy

Completed·SShanghai Mental Health Center·Phase 4·NCT03652974·145 enrolled

Amisulpride Augmentation in Clozapine-unresponsive Schizophrenia

Completed·IImperial College London·Phase 4·NCT01246232·69 enrolled

Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS)

Completed·UUniversity of Copenhagen·N/A·NCT01154829·136 enrolled

Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia

Completed· Sanofi logo

Sanofi·Phase 4·NCT01795183·316 enrolled

Association of Amisulpride Response in Schizophrenia With Brain Image

Unknown status·—·Phase 4·NCT02095938·20 enrolled

Clozapine Versus Amisulpride in Treatment-resistant Schizophrenia Patients

Withdrawn·GGeha Mental Health Center·N/A·NCT01448499

Psychosis3 trials

Evaluation of the Antipsychotic Efficacy of Cannabidiol in Acute Schizophrenic Psychosis

Completed·UUniversity of Cologne·Phase 2·NCT00628290·42 enrolled

Bergen Psychosis Project 2 - The Best Intro Study

Completed·HHaukeland University Hospital·Phase 4·NCT01446328·151 enrolled

Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis

Completed·UUniversity of Cologne·Phase 4·NCT00204061·124 enrolled

Antipsychotics2 trials

Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building

Unknown status·SShanghai Mental Health Center·Phase 4·NCT04446234·350 enrolled

Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients

Completed·TTechnical University of Munich·Phase 4·NCT02307396·21 enrolled

Acute2 trials

Amisulpride in Schizophrenic Acute Phase Patients

Completed· Sanofi logo

Sanofi·Phase 4·NCT00436371·50 enrolled

SOLIACS: Solian Solution in the Acute Setting

Completed· Sanofi logo

Sanofi·Phase 4·NCT00245674·300 enrolled

Depression2 trials

An Investigation of Early Life Stress and Depression

Completed·MMclean Hospital·Phase 1·NCT01701258·153 enrolled

Low Dose Amisulpride Vs Olanzapine-Fluoxetine Combination in Post-Schizophrenic Depression

Completed·—·Phase 4·NCT04876521·60 enrolled

24 more indications

Post Operative Nausea and Vomiting1 trial

Post Operative Nausea and Vomiting (PONV) Rescue Outcomes After Amisulpride Treatment

Withdrawn·AAcacia Pharma Ltd··NCT04954365

Female1 trial

Study Assessing SEP-363856 in Male and Female Volunteers With High or Low Schizotype Characteristics

Completed· Otsuka logo

Otsuka·Phase 1·NCT01972711·105 enrolled

Drug1 trial

An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308)

Completed·OOrganon and Co··NCT01498770·42 enrolled

Metabolism1 trial

Effect of Atypical Antipsychotic Drugs Olanzapine and Amisulpride on Glucose Metabolism

Completed·—·N/A·NCT01160991·10 enrolled

ESS1 trial

The Effects of Dopamine on Reward Processing

Completed·MMclean Hospital·Phase 1·NCT01253421·159 enrolled

Interaction1 trial

Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study

Completed·—·Phase 1·NCT02051387·74 enrolled

Cognitive Function1 trial

Evaluation of Negative Symptoms and Cognitive Function After Administration of Antipsychotics in Healthy Volunteer

Completed·—··NCT01185418·80 enrolled

Monotherapy1 trial

Comparison of Antipsychotic Combination Treatment of Olanzapine and Amisulpride to Monotherapy

Completed·HHeinrich-Heine University, Duesseldorf·Phase 4·NCT01609153·328 enrolled

Metabolic Syndrome1 trial

Identification and Treatment Response Prediction of Antipsychotic-Related Metabolic Syndrome

Completed·NNational Taiwan University Hospital·N/A·NCT00956189·132 enrolled

AIN1 trial

Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

Terminated·UUniversity of Jena·Phase 4·NCT00419653·19 enrolled

Stress Response1 trial

Influence of Dopaminergic Blockade on Stress Responses, Motivation and Emotional Reactivity in Humans.

Completed·PPhilipps University Marburg·N/A·NCT03863691·85 enrolled

Nausea and vomiting1 trial

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

Completed·AAcacia Pharma Ltd·Phase 2/3·NCT05546359·453 enrolled

Chronic pain1 trial

Psychobiological Mechanisms Underlying Chronic Pain

Completed·Ssusanne becker·N/A·NCT04674670·48 enrolled

Renal Impairment1 trial

PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment

Completed·AAcacia Pharma Ltd·Phase 1·NCT04849650·12 enrolled

Schizoaffective Disorder1 trial

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

Withdrawn·UUniversity of California, Los Angeles·N/A·NCT05956600

Prevention1 trial

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

Unknown status·QQilu Pharmaceutical (Hainan) Co., Ltd.·Phase 3·NCT05822713·516 enrolled

MPA1 trial

SOLMANIA - Comparison of Valproate-Amisulpride and Valproate-Haloperidol in Bipolar I Patients

Completed· Sanofi logo

Sanofi·Phase 2·NCT00126009·120 enrolled

Tardive Dyskinesia1 trial

Tardive Dyskinesia and Cognitive Function

Completed·TTaipei Veterans General Hospital, Taiwan·Phase 4·NCT00926965·80 enrolled

Treatment1 trial

Amisulpride Treatment for BPSD in AD Patients

Unknown status·TTianjin Anding Hospital·N/A·NCT04341467·76 enrolled

Opioid1 trial

Dopamine and Opioid Receptor Antagonists Reduce Cue-induced Reward Responding and Reward Impulsivity

Completed·UUniversity of Zurich·N/A·NCT02557984·121 enrolled

Drug Liking1 trial

Characterizing Drug Liking During Drug Administration in Peri-procedural Clinical Settings

Not yet recruiting·SStanford University·Phase 1·NCT07348172·100 enrolled

Anorexia Nervosa1 trial

Dopamine Receptor Contributions to Prediction Error and Reversal Learning in Anorexia Nervosa

Completed·UUniversity of California, San Diego·Phase 1·NCT04128683·31 enrolled

PONV1 trial

An Interventional, Randomized Controlled, Single-blind, Multicenter Clinical Study Evaluating the Efficacy and Safety of Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery.

Not yet recruiting·QQianfoshan Hospital·Preclinical·NCT07891312·718 enrolled

Unspecified2 trials

Amisulpride in Schizophrenic Patients

Completed· Sanofi logo

Sanofi·Phase 4·NCT00331981·138 enrolled

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 26, 2020

BARHEMSYS

NDA NDA209510

Sources

References

[1]
ClinicalTrials.gov — 43 trial records for Amisulpride. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Barhemsys drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Amisulpride compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Amisulpride. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA209510). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Barhemsys. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Tibotec Pharmaceuticals, Ireland company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serotonin (5-HT) Receptor Antagonist; Dopamine Receptors; D2 & D3 Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Tibotec Pharmaceuticals, Ireland

Patent Landscape[6]

Patent Cliff

Mar 10, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9545426Mar 10, 2031

9889118Mar 10, 2031

12194022Mar 10, 2031

10525033Mar 10, 2031

9084765Feb 26, 2034

3 more patents

11357753Feb 9, 2038

12329740Feb 9, 2038

12005042Feb 9, 2038

Barhemsys

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2028

Trials by Indication[1]

Schizophrenia9 trials

Psychosis3 trials

Antipsychotics2 trials

Acute2 trials

Depression2 trials

Post Operative Nausea and Vomiting1 trial

Female1 trial

Drug1 trial

Metabolism1 trial

ESS1 trial

Interaction1 trial

Cognitive Function1 trial

Monotherapy1 trial

Metabolic Syndrome1 trial

AIN1 trial

Stress Response1 trial

Nausea and vomiting1 trial

Chronic pain1 trial

Renal Impairment1 trial

Schizoaffective Disorder1 trial

Prevention1 trial

MPA1 trial

Tardive Dyskinesia1 trial

Treatment1 trial

Opioid1 trial

Drug Liking1 trial

Anorexia Nervosa1 trial

PONV1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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