drug
as of 2026-07-01Amisulpride
amisulpridePhase 1: AmisulpridePhase 2: Amisulpride6 weeks of treatment with amisulprideAmisulpride 50 MGfull-dose amisulprideAMISULPRIDEAmisulpride open label
MeSH D000077582RxCUI 46303OrangeBook_Appl N209510
at a glance
small molecule
Pre-approval / investigational in the US
Developed by Sanofi
Orange Book protection to 2038
28 trials in the graph
Synthesized from structured facts only — each point cited above.
Mechanism & identity
Modality
small molecule
RxCUI
46303
Indications
Investigational (via trials)
SchizophreniaDepressionPsychosomatic DisordersTreatment-resistant SchizophreniaGut MicrobiomesDiabetes MellitusSchizophrenia Spectrum and Other Psychotic DisordersPsychosesAmisulprideDiabetesSchizophreniform DisorderTreatment Resistant DisordersSchizophreniaSchizophrenia, Treatment-ResistantAnxiety DisordersNegative Symptom
Patents & exclusivity
Orange Book
patent 11357753 · U-27542038-02-09
patent 12329740 · U-27542038-02-09
patent 12005042 · U-17442038-02-09
patent 9084765 · U-17442034-02-26
patent 105250332031-03-10
patent 9889118 · U-27542031-03-10
patent 12194022 · U-17442031-03-10
patent 9545426 · U-17442031-03-10
Trials
28
Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments(SMART-CAT)
NCT03510325Phase 3Completed
Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building
NCT04446234Phase 4Unknown
Study on the Gut Microbial Mechanism of Negative Symptoms of Schizophrenia
NCT04533724Early Phase 1Unknown
[18 Fluorine(F)]DOPA Determinants and Predictors of Treatment Response in Psychosis
NCT02880995—Unknown
Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia
NCT03802838Phase 4Unknown
Comparison of Antipsychotic Combination Treatment of Olanzapine and Amisulpride to Monotherapy
NCT01609153Phase 4Completed
Bergen Psychosis Project 2 - The Best Intro Study
NCT01446328Phase 4Completed
Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study
NCT02051387Phase 1Completed
Pharmacovigilance in Gerontopsychiatric Patients
NCT02374567Phase 3Terminated
Optimization of Treatment and Management of Schizophrenia in Europe (OPTIMISE): Substudy Site Copenhagen
NCT01555814—Completed
Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients
NCT02307396Phase 4Completed
Optimization of Treatment and Management of Schizophrenia in Europe
NCT01248195Phase 4Completed
Association of Amisulpride Response in Schizophrenia With Brain Image
NCT02095938Phase 4Unknown
Study Assessing SEP-363856 in Male and Female Volunteers With High or Low Schizotype Characteristics
NCT01972711Phase 1Completed
Amisulpride Augmentation in Clozapine-unresponsive Schizophrenia
NCT01246232Phase 4Completed
Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS)
NCT01154829—Completed
Effectiveness and Safety of Amisulpride in Chinese Patients With Schizophrenia
NCT01795183Phase 4Completed
Clozapine Versus Amisulpride in Treatment-resistant Schizophrenia Patients
NCT01448499—Withdrawn
A Randomized, Double-blind, Comparison of the Efficacy and Safety of Amisulpride Versus Low-dose Amisulpride Plus Low-dose Sulpiride in the Treatment of Schizophrenia
NCT01615185Phase 4Terminated
Amisulpride Augmentation Therapy for Clozapine-resistant Schizophrenic Patients
NCT01105481Phase 4Completed
Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy
NCT00419653Phase 4Terminated
Amisulpride in Schizophrenic Acute Phase Patients
NCT00436371Phase 4Completed
KOLs & investigators
12
Stefan Leucht, ProfessorKOL score 87
René Kahn, Prof. Dr.KOL score 11
Zhenghui YiKOL score 10
Daniel H. Mathalon, Ph.D., M.D.KOL score 5
Ching-Hua Lin, MD, PhDKOL score 5
Birte Glenthoj, MD, DMSc.KOL score 5
Helge Frieling, Prof., MDKOL score 5
Christian Schmidt-Kraepelin, Dr.KOL score 4
Qinyu LvKOL score 2
Birte Y Glenthoj, professorKOL score 0
Publications & congress
30
Risperidone-Induced Priapism: A Systematic Review of Risk Factors, Comprehensive Assessment, and Management Recommendations.
Journal of clinical psychopharmacology · 2026 Jul-Aug 01 · high-value
Comparative efficacy and tolerability of antidopaminergic and muscarinic antipsychotics for acute schizophrenia: a network meta-analysis of randomised controlled trials indexed in international English and Chinese databases.
Lancet (London, England) · 2026 · high-value
Molecular and topographic mapping of antipsychotic effects: a meta-analysis of postsynaptic density proteins in animal models with translational implications.
Molecular psychiatry · 2026 · high-value
Levels of and changes in psychosis symptoms and clinical insight: Exploring the impact of differential antipsychotic mechanisms.
Psychiatry research · 2026 · high-value
Clozapine After 1 Failed Antipsychotic Drug Trial in First-Episode Psychosis: A Randomized Clinical Trial.
JAMA psychiatry · 2026 · high-value
Symptom Network Dynamics during Antipsychotic Treatment in First-Episode Psychosis.
Schizophrenia bulletin · 2026 · high-value
Clinical Practice Guideline on the Choice of First Antipsychotic Medicine for Females Experiencing a First-Episode of Psychosis.
Schizophrenia bulletin · 2026 · high-value
Antipsychotics cause reversible structural brain changes within one week.
Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2025 · high-value
Effects of antipsychotics on human cognitive function: causal evidence from healthy volunteers following sustained D2/D3 antagonism, D2/D3 partial agonism and placebo.
Molecular psychiatry · 2025 · high-value
The use of antipsychotics in the treatment of catatonia: a systematic review.
European psychiatry : the journal of the Association of European Psychiatrists · 2025 · high-value
Bidirectional modulation of reward-guided decision making by dopamine.
Psychopharmacology · 2025 · high-value
QT Interval, Antipsychotics and Correlates Among Patients with Schizophrenia: Cross-Sectional Data from the Multicentric Real-World FACE-SZ.
Drug safety · 2025 · high-value
Bioequivalence and Safety of Two Amisulpride Formulations in Healthy Chinese Subjects Under Fasting and Fed Conditions: A Randomized, Open‑Label, Single‑Dose, Crossover Study.
Drugs in R&D · 2025 · high-value
Efficacy of antipsychotics in delusional infestation.
Journal of the European Academy of Dermatology and Venereology : JEADV · 2025 · high-value
Determinants of real-world functioning in first-episode psychosis patients receiving 4 weeks of amisulpride treatment: findings from the multinational OPTiMiSE study.
Journal of psychiatric research · 2025 · high-value
Generic Intravenous Amisulpride (QLG2069) for the Prevention of Postoperative Nausea and Vomiting in Adults: A Phase III, Multicenter, Randomized, Placebo-Controlled Study.
Drug design, development and therapy · 2025 · high-value
Facts & assertions
9 sourced
Anda Generic Count
0
Available Strengths
amisulpride 50 MG Oral Tablet, amisulpride 200 MG Oral Tablet, 2 ML amisulpride 2.5 MG/ML Injection, 4 ML amisulpride 2.5 MG/ML Injection, amisulpride 100 MG/ML Oral Solution, amisulpride 400 MG Oral Tablet, amisulpride 100 MG Oral Tablet
Dose Forms
Injection, Oral Solution, Oral Tablet
Has Generic Competition
no
Latest Patent Expiry
2038-02-09
Latest Protection Date
2038-02-09
Oral Strengths In Vocab Not Us Approved
amisulpride 50 MG Oral Tablet, amisulpride 200 MG Oral Tablet, amisulpride 100 MG/ML Oral Solution, amisulpride 400 MG Oral Tablet, amisulpride 100 MG Oral Tablet
Rxcui
46303
Us Brand Is Injectable Only
yes
relationships
The graph out of here
developer
company
trial
indication
indication
indication
indication
indication
KOL
Stefan Leucht, Professor
personKOL score 87
René Kahn, Prof. Dr.
personKOL score 11
Zhenghui Yi
personKOL score 10
Daniel H. Mathalon, Ph.D., M.D.
personKOL score 5