Clinical Trials

Numerous clinical trials have evaluated the therapeutic potential of oral and intravenous amisulpride across diverse neuropsychiatric and perioperative conditions, including schizophrenia, major depressive disorder, and postoperative nausea and vomiting. Spanning early Phase 1 through Phase 4, these studies report recruitment statuses ranging from completed and recruiting to terminated or not yet recruiting. Research is sponsored by both academic centers, such as Stanford University and McLean Hospital, and pharmaceutical companies, including Acacia Pharma Ltd and Sanofi.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07348172 NOT_YET_RECRUITING
Drug Liking
Stanford University
 2026-03-01 EARLY_PHASE1
NCT06887621 RECRUITING
Post Operative Nausea and Vomiting (PONV)
Instituto do Cancer do Estado de São Paulo
 2025-04-10 PHASE2
NCT07631910 NOT_YET_RECRUITING
Nausea and Vomiting, Postoperative
Sir Run Run Shaw Hospital
 2026-07-01
NCT06581302 RECRUITING
Psychotic Disorders
Shanghai Jiao Tong University School of Medicine
 2024-09-01
NCT05956600 WITHDRAWN
Schizophrenia, Treatment-Resistant
University of California, Los Angeles
 2023-11
NCT06585540 RECRUITING
Post Operative Nausea and Vomiting
Benaroya Research Institute
 2024-09-13 PHASE3
NCT05546359 COMPLETED
Nausea and Vomiting, Postoperative
Acacia Pharma Ltd
 2024-01-18 PHASE2; PHASE3
NCT04529226 UNKNOWN
Psychosis; Intellectual Disability
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
 2020-11-26 PHASE2
NCT04341467 UNKNOWN
BPSD; Amisulpride; Olanzapine; Dementia of the Alzheimer Type
Tianjin Anding Hospital
 2019-12-01
NCT06066112 UNKNOWN
Bioequivalence; Schizophrenia
The Affiliated Hospital of Qingdao University
 2023-09-20 PHASE1
NCT03510325 COMPLETED
Schizophrenia
Shanghai Mental Health Center
 2019-02-12 PHASE3
NCT05347199 COMPLETED
Major Depressive Disorder
Simone Grimm
 2022-05-17 PHASE1
NCT04128683 COMPLETED
Anorexia Nervosa
University of California, San Diego
 2020-10-20 EARLY_PHASE1
NCT05822713 UNKNOWN
PONV
Qilu Pharmaceutical (Hainan) Co., Ltd.
 2023-04-29 PHASE3
NCT04674670 COMPLETED
Fibromyalgia; Pain, Chronic; Chronic Pain, Widespread
susanne becker
 2021-11-01
NCT04446234 UNKNOWN
Schizophrenia
Shanghai Mental Health Center
 2021-05 PHASE4
NCT04533724 UNKNOWN
Negative Symptom; Schizophrenia; Amisulpride; Gut Microbiomes
Shanghai Mental Health Center
 2020-10-01 EARLY_PHASE1
NCT04849650 COMPLETED
Renal Disease, End Stage
Acacia Pharma Ltd
 2021-06-03 PHASE1
NCT03652974 COMPLETED
Schizophrenia
Shanghai Mental Health Center
 2018-09-06 PHASE4
NCT04876521 COMPLETED
Post-Schizophrenic Depression
All India Institute of Medical Sciences, Bhubaneswar
 2019-10-14 PHASE4
NCT04849650 Completed
Renal Disease End Stage
Acacia Pharma Ltd
 2021-06-03 Phase 1
NCT03863691 COMPLETED
Healthy Participants
Philipps University Marburg
 2019-04-15
NCT02880995 UNKNOWN
Schizophrenia
Seoul National University Hospital
 2017-11-01
NCT03802838 UNKNOWN
Schizophrenia
Shanghai Mental Health Center
 2017-10-01 PHASE4
NCT01609153 COMPLETED
Schizophrenia; Schizoaffective Disorder
Heinrich-Heine University, Duesseldorf
 2012-06 PHASE4
NCT01446328 COMPLETED
Schizophrenia; Psychotic Disorders
Haukeland University Hospital
 2011-10 PHASE4
NCT02051387 COMPLETED
Schizophrenia
Central Institute of Mental Health, Mannheim
 2013-01 PHASE1
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
 2015-01 PHASE3
NCT01701258 COMPLETED
Major Depressive Disorder (MDD); History of Childhood Sexual Abuse (CSA)
Mclean Hospital
 2013-08 PHASE1
NCT02646566 COMPLETED
Postoperative Nausea and Vomiting
Acacia Pharma Ltd
 2016-03 PHASE3
NCT02449291 COMPLETED
Postoperative Nausea and Vomiting
Acacia Pharma Ltd
 2015-09 PHASE3
NCT01555814 COMPLETED
Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder
Birte Glenthoj
 2011-05
NCT02307396 COMPLETED
Schizophrenia; Schizophrenia and Disorders With Psychotic Features; Schizoaffective Disorders
Technical University of Munich
 2015-02-01 PHASE4
NCT01253421 COMPLETED
Major Depressive Disorder (MDD)
Mclean Hospital
 2012-02 PHASE1
NCT01248195 COMPLETED
Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder
Rene Kahn
 2011-05 PHASE4
NCT02095938 UNKNOWN
Schizophrenia; Schizophreniform Disorder
CHA University
 2014-01 PHASE4
NCT02337062 COMPLETED
PONV
Acacia Pharma Ltd
 2015-02 PHASE3
NCT01972711 COMPLETED
Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.
 2014-03 PHASE1
NCT01246232 COMPLETED
Schizophrenia
Imperial College London
 2011-09 PHASE4
NCT01154829 COMPLETED
Schizophrenia
University of Copenhagen
 2008-12
NCT02557984 COMPLETED
Addiction
University of Zurich
 2014-02
NCT01029769 COMPLETED
Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
Technical University of Munich
 2009-12
NCT01991860 COMPLETED
PONV
Acacia Pharma Ltd
 2013-08 PHASE3
NCT01991821 COMPLETED
PONV
Acacia Pharma Ltd
 2013-07 PHASE3
NCT01795183 COMPLETED
Schizophrenia
Sanofi
 2012-11 PHASE4
NCT01448499 WITHDRAWN
Schizophrenia; Treatment Resistant Disorders
Geha Mental Health Center
 2011-10
NCT00956189 COMPLETED
Metabolic Syndrome X
National Taiwan University Hospital
 2009-11
NCT01615185 TERMINATED
Schizophrenia
Kaohsiung Kai-Suan Psychiatric Hospital
 2008-01 PHASE4
NCT00761670 COMPLETED
Schizophrenia
Sanofi
 2008-09 PHASE4
NCT00534573 COMPLETED
Clozapine-induced Hypersalivation
Beersheva Mental Health Center
 2008-11 PHASE3
NCT01105481 COMPLETED
Treatment-resistant Schizophrenia
National Health Research Institutes, Taiwan
 2006-05 PHASE4
NCT00926965 COMPLETED
Tardive Dyskinesia; Neurocognitive Function
Taipei Veterans General Hospital, Taiwan
 2003-01 PHASE4
NCT00471588 COMPLETED
Obsessive-Compulsive Disorder
GlaxoSmithKline
 2006-08 PHASE1
NCT00419653 TERMINATED
Schizophrenia
University of Jena
 2003-01 PHASE4
NCT00436371 COMPLETED
Schizophrenia
Sanofi
 2005-05 PHASE4
NCT01160991 COMPLETED
Schizophrenia; Diabetes; Insulin Resistance
Central Institute of Mental Health, Mannheim
 2004-05
NCT00245674 Completed
Schizophrenia
Sanofi
 2005-06 Phase 4
NCT00204061 COMPLETED
Schizophrenia; Psychoses
University of Cologne
 2001-01 PHASE4
NCT00628290 COMPLETED
Schizophrenia
University of Cologne
 2002-10 PHASE2
NCT00245674 COMPLETED
Schizophrenia
Sanofi
 2005-06 PHASE4
NCT00331981 COMPLETED
Schizophrenia
Sanofi
 2004-02 PHASE4
NCT00126009 COMPLETED
Bipolar Disorder
Sanofi
 2004-05 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-01-16)

Check the Amisulpride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Amisulpride selectively binds to dopamine D2 and D3 receptors with high affinity, exhibiting dissociation constants of 2.8 nM and 3.2 nM, respectively, to block downstream dopaminergic receptor-mediated signaling pathways. By dampening hyperdopaminergic neurotransmission in mesolimbic regions and inhibiting emetic signaling at the chemoreceptor trigger zone, it effectively alleviates psychotic symptoms in schizophrenia and reduces postoperative nausea and vomiting.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.