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amisulpride

Trade name: BARHEMSYS

Small moleculeapproved

Approved

Feb 26, 2020

Amisulpride, sold under the brand names Socian and Barhemsys, is a medication used in the treatment of schizophrenia, acute psychotic episodes, depression, and nausea and vomiting. It is specifically used at lower doses intravenously to prevent and treat postoperative nausea and vomiting; at low doses by mouth to treat depression; and at higher doses by mouth to treat psychosis. — Wikipedia

Clinical trial activity

69 trials · 74 clinical orgs · 1 marketing orgs

Phase 1
13
Phase 2
18
Phase 3
11
Phase 4
21

Earliest trial started Jan 1, 2001 (NCT00204061)

Timeline

2000s

  1. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2008

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Feb 26, 2020

    Acacia Pharma Ltd — Earliest FDA Approval

  2. Feb 26, 2020

    Acacia Pharma Ltd — Marketing Organization

  3. Feb 26, 2020

    Acacia Pharma Ltd — NDA Secondary Org

  4. Feb 26, 2020

    Acacia Pharma Ltd — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedFeb 26, 2020

Chemistry & pharmacology

Loading structure…

SMILES

CCN1CCCC1CNC(=O)c1cc(S(=O)(=O)CC)c(N)cc1OC
Mol. weight
369.49 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 4-amino-n-((1-ethyl-2-pyrrolidinyl)methyl)-5-(ethylsulfonyl)-2-methoxybenzamide
  • 4-amino-n-((1-ethyl-2-pyrrolidinyl)methyl)-5-(ethylsulfonyl)-2-methoxybenzamide
  • 4-amino-n-((1-ethyl-2-pyrrolidinyl)methyl)-5-(ethylsulfonyl)-o-anisamide
  • 4-amino-n-((1-ethyl-2-pyrrolidinyl)methyl)-5-(ethylsulfonyl)-o-anisamide
  • aminosultopride
  • aminosultopride
  • aminosultopride
  • amisulprida
  • amisulprida
  • amisulpride
  • amisulpride
  • amisulpride
  • amisulpride
  • amisulpride
  • amisulpride
  • amisulpride
  • amisulpride
  • amisulpride
  • amisulpridum
  • amisulpridum
  • apd421
  • barnetil
  • barnetil
  • dan 2163
  • deniban
  • lin 1418
  • n-(ethyl-1-pyrrolidinyl- 2-methyl)methoxy-2-ethylsulfonyl-5-benzamide
  • solian
  • solian
  • solian
  • solian
  • solian
  • solian 100
  • solian 200
  • solian 400
  • solian 50
  • sultopride
  • sultopride
  • sultopride
  • (+/-)-sultopride
  • sultopride hcl
  • sultopride hcl
  • sultopride hcl
  • sultopride hcl
  • sultopride hydrochloride
  • sultopride hydrochloride

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06887621Phase 2Apr 10, 2025Instituto do Cancer do Estado de São Paulo, University of Groningen, University of Sao Paulo
NCT06585540Phase 3Sep 13, 2024Virginia Mason Medical Center
NCT06179108Phase 2Dec 4, 2023LB Pharmaceuticals Inc., The Zucker Hillside Hospital
NCT05956600N/ANov 30, 2023University of California, Los Angeles
NCT06066112Phase 1Sep 20, 2023Qingdao University
NCT05822713Phase 3Apr 29, 2023Peking University, Qilu Pharmaceutical Co., Ltd.
NCT05546359Phase 2/Phase 3 (Phase 3)Dec 19, 2022Acacia Pharma Ltd, Amicus Therapeutics, Premier Research Group
NCT05347199Phase 1May 31, 2022Boehringer Ingelheim, Humboldt University, Medical School Berlin
NCT05039489N/ASep 6, 2021Central South University
NCT04674670N/AAug 16, 2021Balgrist Universitaets
NCT04849650Phase 1Jun 3, 2021Acacia Pharma Ltd, University of California, San Francisco
NCT04446234Phase 4May 31, 2021Jiao Tong University
NCT04876521Phase 4May 4, 2021All India Institute of Medical Sciences
NCT04588129Phase 1Dec 21, 2020LB Pharmaceuticals Inc., Washington University in St. Louis
NCT04533724Early Phase 1 (Phase 1)Oct 1, 2020Jiao Tong University
NCT04529226Phase 2Sep 30, 2020Andalusian Health Service, Fundación Pública Andaluza
NCT04341467N/AMay 31, 2020Tianjin Medical University
NCT04218981N/AJan 31, 2020Central South University
NCT04128683Early Phase 1 (Phase 1)Dec 31, 2019University of California, San Diego
NCT04187560Phase 1Dec 23, 2019LB Pharmaceuticals Inc., Medpace, Inc.
Showing 20 of 69 trials
Page 1 / 4

Organizations

Research & Development (74)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Acacia Pharma LtdFor profit121232011
SanofiFor profit8632003
Jiao Tong UniversityAcademic/Hospital4422017
University of LondonAcademic/Hospital4122008
LB Pharmaceuticals Inc.For profit3322019
Technical University of MunichAcademic/Hospital3222009
University of CologneAcademic/Hospital3232001
Utrecht UniversityAcademic/Hospital3022008
Central South UniversityAcademic/Hospital2212020
Government of TaiwanGovernment2112003
Harvard UniversityAcademic/Hospital2012012
Ludwig Maximilians UniversityAcademic/Hospital2012001
Mclean HospitalAcademic/Hospital2212012
National Institute of Mental Health (NIMH)Government2012012
Technion UniversityAcademic/Hospital2122008
University of CopenhagenAcademic/Hospital2212008
University of DuesseldorfAcademic/Hospital2112001
University of HeidelbergAcademic/Hospital2222004
University of ManchesterAcademic/Hospital2012011
All India Institute of Medical SciencesAcademic/Hospital1112021
74 organizations
Page 1 / 4

Marketing (4)

OrganizationOrg typeRelationshipDate
Acacia Pharma LtdFor profitSYNFeb 26, 2020
Acacia Pharma LtdFor profitMKTGFeb 26, 2020
Acacia Pharma LtdFor profitNDA2Feb 26, 2020
Acacia Pharma LtdFor profitNDAFeb 26, 2020