Drug Profile


Alternative Names: Cariprazine controlled-release; Cariprazine PR; Cariprazine prolonged release; MP-214; Reagila; RGH-188; RGH-188 HCl; Vraylar

Latest Information Update: 25 Sep 2017

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At a glance

  • Originator Gedeon Richter
  • Developer Allergan; Gedeon Richter; Mitsubishi Tanabe Pharma Corporation; Recordati
  • Class Antidepressants; Antipsychotics; Chlorobenzenes; Cyclohexanes; Piperazines; Small molecules; Urea compounds
  • Mechanism of Action Dopamine D2 receptor partial agonists; Dopamine D3 receptor partial agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Bipolar disorders; Schizophrenia
  • Phase III Bipolar depression; Major depressive disorder
  • Phase I Mental disorders; Schizoaffective disorder

Most Recent Events

  • 22 Sep 2017 Allergan receives Refusal to File letter from the US FDA for Cariprazine in Schizophrenia (Maintenance treatment)
  • 19 Jul 2017 Registered for Schizophrenia (In adults) in European Union (PO)
  • 19 May 2017 CHMP recommends approval of Cariprazine for Schizophrenia in the EU
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