Drugs / Amisulpride
Amisulpride
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | BARHEMSYS | — | 2020-02-26 | fda.gov ↗ |
Trials 55
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT07348172 | Mar 2026 → Mar 2027 expected | — | Stanford University | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT04128683 | Oct 2020 → Sep 2023 | anorexia nervosa | University of California, San Diego | Completed | No outcome recorded |
| Phase 0 | NCT04533724 | Oct 2020 → Sep 2022 | schizophrenia | Shanghai Mental Health Center | Unknown | No outcome recorded |
| Phase 17 trials | ||||||
| Phase 1 | NCT05347199 | May 2022 → Sep 2023 | major depressive disorder | Simone Grimm | Completed | No outcome recorded |
| Phase 1 | NCT04849650 | Jun → Oct 2021 | end stage renal failure | Acacia Pharma Ltd | Completed | No outcome recorded |
| Phase 1 | NCT03583489 | Jul → Aug 2018 | — | Acacia Pharma Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02881840 | Aug 2016 | — | Acacia Pharma Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02661594 | Nov 2013 → Mar 2014 | — | Acacia Pharma Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02051387 | Jan 2013 → Aug 2017 | schizophrenia | Central Institute of Mental Health, Mannheim | Completed | No outcome recorded |
| Phase 1 | NCT00471588 | Aug 2006 → Dec 2007 | obsessive-compulsive disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 25 trials · 2 met primary | ||||||
| Phase 2 | NCT06887621 | Apr 2025 → Mar 2027 expected | — | Cancer Institute of the State of São Paulo | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01857232 | Oct 2013 → Feb 2015 | — | Acacia Pharma Ltd | Completed | Met primary |
| Phase 2 | NCT01510704 | Jan → Apr 2012 | — | Acacia Pharma Ltd | Completed | Met primary |
| Phase 2 | NCT01303978 | Feb 2011 → Jul 2012 | chemotherapy-induced toxicity | Acacia Pharma Ltd | Completed | No outcome recorded |
| Phase 2 | NCT00126009 | May 2004 → ? | bipolar disorder | Sanofi | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05546359 | Jan 2024 → Jun 2025 | — | Acacia Pharma Ltd | Completed | No outcome recorded |
| Phase 311 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT06585540 | Sep 2024 → Sep 2025 overdue | — | Benaroya Research Institute | Recruiting | No outcome recorded |
| Phase 3 | NCT05822713 | Apr → Aug 2023 | — | Qilu Pharmaceutical (Hainan) Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT04528095 | Dec 2020 → Dec 2022 | schizophrenia | Shanghai Mental Health Center | Unknown | No outcome recorded |
| Phase 3 | NCT03510325 | Feb 2019 → Sep 2023 | schizophrenia | Shanghai Mental Health Center | Completed | No outcome recorded |
| Phase 3 | NCT02646566 | Mar 2016 → Jan 2017 | — | Acacia Pharma Ltd | Completed | No outcome recorded |
| Phase 3 | NCT02449291 | Sep 2015 → Jul 2016 | — | Acacia Pharma Ltd | Completed | Met primary |
| Phase 3 | NCT02337062 | Feb → Sep 2015 | — | Acacia Pharma Ltd | Completed | Met primary |
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT01991860 | Aug 2013 → Jan 2014 | — | Acacia Pharma Ltd | Completed | No outcome recorded |
| Phase 3 | NCT01991821 | Jul 2013 → Jan 2014 | — | Acacia Pharma Ltd | Completed | Missed primary |
| Phase 3 | NCT01765829 | Nov 2012 → Nov 2015 | psychotic disorder | Fundación Pública Andaluza Progreso y Salud | Unknown | No outcome recorded |
| Phase 418 trials · 1 missed | ||||||
| Phase 4 | NCT04446234 | May 2021 → Dec 2022 | schizophrenia | Shanghai Mental Health Center | Unknown | No outcome recorded |
| Phase 4 | NCT04876521 | Oct 2019 → Jun 2021 | schizophrenia | All India Institute of Medical Sciences, Bhubaneswar | Completed | No outcome recorded |
| Phase 4 | NCT03652974 | Sep 2018 → Aug 2021 | schizophrenia | Shanghai Mental Health Center | Completed | No outcome recorded |
| Phase 4 | NCT03802838 | Oct 2017 → Apr 2019 | schizophrenia | Shanghai Mental Health Center | Unknown | No outcome recorded |
| Phase 4 | NCT02307396 | Feb 2015 → Jun 2016 | schizoaffective disorder, schizophrenia | Technical University of Munich | Completed | No outcome recorded |
| Phase 4 | NCT02095938 | Jan 2014 → Dec 2015 | schizophrenia, schizophreniform disorder | CHA University | Unknown | No outcome recorded |
| Phase 4 | NCT01795183 | Nov 2012 → Dec 2013 | schizophrenia | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT01454453 | May 2012 → Jul 2015 | Alzheimer disease, schizophrenia | Institute of Psychiatry, London | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01246232 | Sep 2011 → Mar 2015 | schizophrenia | Imperial College London | Completed | No outcome recorded |
| Phase 4 | NCT01248195 | May 2011 → Apr 2016 | schizoaffective disorder, schizophrenia, schizophreniform disorder | Rene Kahn | Completed | Missed primary |
| Phase 4 | NCT01615185 | Jan 2008 → Dec 2011 | schizophrenia | Kaohsiung Kai-Suan Psychiatric Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT01105481 | May 2006 → Mar 2008 | treatment-refractory schizophrenia | National Health Research Institutes, Taiwan | Completed | No outcome recorded |
| Phase 4 | NCT00245674 | Jun 2005 → ? | schizophrenia | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00436371 | May 2005 → Nov 2006 | schizophrenia | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00331981 | Feb 2004 → ? | schizophrenia | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00926965 | Jan 2003 → Dec 2007 | cognitive disorder, tardive dyskinesia | Taipei Veterans General Hospital, Taiwan | Completed | No outcome recorded |
| Phase 4 | NCT00419653 | Jan 2003 → Sep 2007 | schizophrenia | University of Jena | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00204061 | Jan 2001 → Jun 2005 | schizophrenia | University of Cologne | Completed | No outcome recorded |
| Phase not applicable10 trials | ||||||
| — | NCT07631910 | Jul → Oct 2026 expected | — | Sir Run Run Shaw Hospital | Not yet recruiting | No outcome recorded |
| — | NCT05956600 | Nov 2023 → Nov 2025 | treatment-refractory schizophrenia | University of California, Los Angeles | Withdrawn | No outcome recorded |
| — | NCT04674670 | Nov 2021 → Jul 2023 | fibromyalgia | susanne becker | Completed | No outcome recorded |
| — | NCT04218981 | Jan 2020 → Jun 2023 | mental disorder | Central South University | Completed | No outcome recorded |
| — | NCT04341467 | Dec 2019 → Dec 2023 | Alzheimer disease | Tianjin Anding Hospital | Unknown | No outcome recorded |
| — | NCT02880995 | Nov 2017 → Dec 2019 | schizophrenia | Seoul National University Hospital | Unknown | No outcome recorded |
| — | NCT02557984 | Feb → Apr 2014 | substance dependence | University of Zurich | Completed | No outcome recorded |
| — | NCT01448499 | Oct 2011 → Oct 2013 | treatment-refractory schizophrenia | Geha Mental Health Center | Withdrawn | No outcome recorded |
| — | NCT01555814 | May 2011 → Jul 2016 | schizoaffective disorder, schizophrenia, schizophreniform disorder | Birte Glenthoj | Completed | No outcome recorded |
| — | NCT00956189 | Nov 2009 → Aug 2012 | metabolic syndrome X | National Taiwan University Hospital | Completed | No outcome recorded |
| Comparator or background therapy17 trials | ||||||
| Phase 1 | NCT01972711 Comparator | Mar 2014 → Jul 2015 | schizophrenia | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01701258 Comparator | Aug 2013 → May 2017 | major depressive disorder | Mclean Hospital | Completed | No outcome recorded |
| Phase 1 | NCT01253421 Comparator | Feb 2012 → May 2016 | major depressive disorder | Mclean Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04529226 Comparator | Nov 2020 → Jan 2025 | intellectual disability, psychotic disorder | Andalusian Public Foundation for Health Research in Seville | Unknown | No outcome recorded |
| Phase 2 | NCT01323205 Background | May 2011 → Nov 2012 | schizophrenia | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00628290 Comparator | Oct 2002 → Nov 2004 | schizophrenia | University of Cologne | Completed | No outcome recorded |
| Phase 3 | NCT00534573 Comparator | Nov 2008 → Jan 2009 | — | Beersheva Mental Health Center | Completed | No outcome recorded |
| Phase 4 | NCT01609153 Comparator | Jun 2012 → Apr 2019 | schizoaffective disorder, schizophrenia | Heinrich-Heine University, Duesseldorf | Completed | No outcome recorded |
| Phase 4 | NCT01446328 Comparator | Oct 2011 → Dec 2017 | schizophrenia | Haukeland University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00761670 Comparator | Sep 2008 → Jan 2010 | schizophrenia | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00256997 Comparator | Jan 2006 → Apr 2009 | schizophrenia | Janssen-Ortho Inc., Canada | Terminated | Missed primary Stop: Enrollment |
| Phase 4 | NCT00304616 Background | Oct 2004 → Jun 2006 | schizophrenia | Korea Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| — | NCT06581302 Comparator | Sep 2024 → Dec 2025 overdue | psychotic disorder | Shanghai Jiao Tong University School of Medicine | Recruiting | No outcome recorded |
| — | NCT03863691 Comparator | Apr 2019 → Jul 2020 | — | Philipps University Marburg | Completed | No outcome recorded |
| — | NCT01029769 Comparator | Dec 2009 → Mar 2014 | schizoaffective disorder, schizophrenia, schizophreniform disorder | Technical University of Munich | Completed | No outcome recorded |
| — | NCT01154829 Comparator | Dec 2008 → May 2014 | schizophrenia | University of Copenhagen | Completed | No outcome recorded |
| — | NCT01160991 Comparator | May 2004 → Oct 2006 | diabetes mellitus, schizophrenia | Central Institute of Mental Health, Mannheim | Completed | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 76 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | amisulpride | “Regular antipsychotic medications (Risperidone, Olanzapine, Clozapine, Amisulpride, Quetiapine, Paliperidone, Aripiprazole, Haloperidol, Levomepromazine, Zuclopenthixol...” NCT01323205 ↗67“Drugs: Aripiprazole, Olanzapine, Zuclopenthixol, Clotiapine, Flupentixol, Risperidone, Sulpiride, Trifluoperazine, Haloperidol, Quetiapine, Paliperidone, Chlorpromazine,...” NCT01765829 ↗ “All the eligible participants will be randomly assigned to an oral atypical antipsychotic (risperidone, olanzapine, quetiapine, and where commercially available, aripiprazole...” NCT00256997 ↗ “Randomised, Double-blind, Placebo-controlled Study of APD421 (Amisulpride for IV Injection) as Treatment of Established Post-operative Nausea and Vomiting, in Patients Who Have...” NCT02646566 ↗ “Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting” NCT01991821 ↗ “Amisulpride prevents nausea and vomiting associated with highly emetogenic chemotherapy: a randomised, double-blind, placebo-controlled, dose-ranging trial.” PMID 30488222 ↗ Nov 2018 “I.V. APD421 (amisulpride) prevents postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled, multicentre trial.” PMID 23872464 ↗ Jul 2013 “Drugs such as amisulpride, known as antipsychotic drugs, are used to treat troublesome and distressing symptoms in older people.” NCT01454453 ↗ “Intravenous (IV) amisulpride, a well-studied D2/D3 antagonist, has been shown in trials to prevent PONV.” PMID 31094774 ↗ Jun 2019 “Choose one of these antipsychotics (olanzapine, risperidone; amisulpride) for schizophrenia group” NCT04218981 ↗ “APD421 (Amisulpride for IV Injection)” NCT02337062 ↗ |
| Known as | AMI | “or amisulpride (AMI, up to 800 mg/day) for four weeks” PMID 33995015 ↗ Apr 2021 |
| Known as | APD421 | “Randomised, Double-blind, Placebo-controlled Study of APD421 (Amisulpride for IV Injection) as Treatment of Established Post-operative Nausea and Vomiting, in Patients Who Have...” NCT02449291 ↗8“Randomised, Double-blind, Placebo-controlled Study of APD421 (Amisulpride for IV Injection) as Treatment of Established Post-operative Nausea and Vomiting, in Patients Who Have...” NCT02646566 ↗ “Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting” NCT01991821 ↗ “APD421 ( Amisulpride) at 5mg given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia” NCT01991860 ↗ “APD421 (Amisulpride for IV Injection)” NCT02337062 ↗ |
| Known as | Solian | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00304616 ↗ |
| Action | Inhibit | “The control condition in this parallel design will be an established neuroleptic treatment with amisulpride that is primarely an antidopaminergic drug.” NCT00628290 ↗ |
| Modality | Small molecule | “a substituted benzamide derivative” PMID 15521794 ↗ 2004 |
| Route | Oral | “All the eligible participants will be randomly assigned to an oral atypical antipsychotic (risperidone, olanzapine, quetiapine, and where commercially available, aripiprazole...” NCT00256997 ↗ |