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cariprazine

Trade name: vraylar

Small moleculeapproved

Approved

Sep 17, 2015

Cariprazine is an antipsychotic approved by FDA for the treatment of schizophrenia and bipolar I disorder. The drug has a unique clinical action which is explained by its ability to act on dopamine D3 receptors. Pharmacology studies revealed that cariprazine is a dual partial agonist of dopamine D2 and D3 receptors as well as serotonin 5HT1a, 2a and 2b receptors. — NCATS

Clinical trial activity

56 trials · 28 clinical orgs · 6 marketing orgs

Phase 1
4
Phase 2
41
Phase 3
31
Phase 4
7

Earliest trial started Jun 1, 2004 (NCT00095823)

Timeline

2000s

  1. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2006

    Forest Laboratories — Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Forest Laboratories — Earliest Phase 1 Sponsor(trial)

  2. Sep 17, 2015

    Forest Laboratories — Earliest FDA Approval

  3. Sep 17, 2015

    Allergan — NDA Secondary Org

  4. Sep 17, 2015

    Forest Laboratories — NDA Organization

  5. Sep 17, 2015

    Allergan — Marketing Organization

  6. Sep 17, 2015

    AbbVie — Marketing Organization

  7. Sep 17, 2015

    AbbVie — NDA Secondary Org

2020s

  1. Mar 9, 2022

    Sun Pharmaceuticals — Marketing Organization

  2. Sep 9, 2022

    Zydus Discovery DMCC — Marketing Organization

  3. Dec 16, 2025

    Aurobindo Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedSep 17, 2015

Chemistry & pharmacology

Loading structure…

SMILES

CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Mol. weight
427.42 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • cariprazine
  • cariprazine
  • cariprazine
  • cariprazine
  • cariprazine
  • cariprazine
  • cariprazine
  • cariprazine
  • cariprazine
  • cariprazine
  • cariprazine hcl
  • cariprazine hcl
  • cariprazine hydrochloride
  • cariprazine hydrochloride
  • cariprazine hydrochloride
  • cariprazine hydrochloride
  • cariprazine hydrochloride
  • mp-214
  • mp-214
  • rgh-188
  • rgh-188
  • rgh-188
  • rgh-188
  • rgh-188
  • rgh-188 hcl
  • rgh-188 hcl
  • trans-4-(2-(4-(2,3-dichlorophenyl)piperazine-1-yl)-ethyl)-n,n-dimethylcarbamoyl-cyclohexyl-amine hydrochloride
  • trans-n-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-n’,n’-dimethylurea hydrochloride
  • trans-n-{4-[2-[4-(2,3-dichlorophenyl)piperazine-1-yl]ethyl]cyclohexyl}-n’,n’-dimethylurea hydrochloride
  • vraylar
  • vraylar
  • vraylar

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07266545Phase 4Dec 31, 2025Mayo Clinic
NCT07185815Phase 1/Phase 2 (Phase 2)Aug 1, 2025Mapi Pharma Ltd.
NCT06589817Phase 3Oct 31, 2024Chengdu Kanghong Biotech Co.,Ltd.
NCT06433635Phase 4Sep 1, 2024Harvard University, Patient-Centered Outcomes Research Institute
NCT05933538Phase 4Aug 31, 2024Sultan Qaboos University
NCT05913947Phase 4Dec 13, 2022Aalborg University, University of Copenhagen
NCT05368558Phase 3Aug 18, 2022AbbVie
NCT05384483Phase 4Jul 15, 2022AbbVie, Omeicos Therapeutics GmbH, The Medical Research Network, LLC
NCT05439616Phase 3Jul 7, 2022AbbVie
NCT05063201Phase 2Dec 31, 2021National Institute on Drug Abuse (NIDA), University of Pennsylvania
NCT05060549Phase 4Dec 1, 2021Columbia University
NCT05168007Phase 3Nov 19, 2021Whanin Pharmaceutical Company
NCT04965272Phase 2Aug 18, 2021Allergan
NCT04771299Phase 3Jul 7, 2021University of British Columbia
NCT04843423Phase 4May 3, 2021START Clinic for Mood and Anxiety Disorders
NCT04777357Phase 3Apr 28, 2021Allergan
NCT04578756Phase 3Dec 11, 2020Allergan
NCT04382885Phase 1Jul 8, 2020Allergan
NCT03817502Phase 3Jun 6, 2019Allergan
NCT03739203Phase 3Nov 10, 2018Allergan
Showing 20 of 56 trials
Page 1 / 3

Organizations

Research & Development (28)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Forest LaboratoriesFor profit222232006
Gedeon Richter Ltd.For profit17132007
AllerganFor profit12732012
Mitsubishi TanabeFor profit6622008
AbbVieFor profit3222022
ShireFor profit3322009
The University of Texas, DallasAcademic/Hospital3022009
Bristol-Myers SquibbFor profit2212004
National Institute on Drug Abuse (NIDA)Government2012018
OtsukaFor profit2012004
University of PennsylvaniaAcademic/Hospital2212018
Aalborg UniversityAcademic/Hospital1112022
ActavisFor profit1012011
Allergan PLC (2015)For profit1012018
Chengdu Kanghong Biotech Co.,Ltd.For profit1112024
Columbia UniversityAcademic/Hospital1112021
Harvard UniversityAcademic/Hospital1112024
Mapi Pharma Ltd.For profit1112025
Mayo ClinicAcademic/Hospital1112025
National Center of Neurology and Psychiatry, JapanGovernment1012008
28 organizations
Page 1 / 2

Marketing (10)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGSep 17, 2015
AbbVieFor profitNDA2Sep 17, 2015
AllerganFor profitNDA2Sep 17, 2015
AllerganFor profitMKTGSep 17, 2015
Aurobindo PharmaFor profitMKTGDec 16, 2025
Forest LaboratoriesFor profitNDASep 17, 2015
Sun PharmaceuticalsFor profitMKTGMar 9, 2022
Sun PharmaceuticalsFor profitSYNSep 30, 2022
Zydus Discovery DMCCFor profitMKTGSep 9, 2022
Zydus Discovery DMCCFor profitSYNSep 9, 2022