Cariprazine - Gedeon Richter

Drug Profile

Cariprazine - Gedeon Richter

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

Latest Information Update: 22 Dec 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Bipolar disorders; Schizophrenia
  • Phase III Bipolar depression; Major depressive disorder
  • Phase I Schizoaffective disorder
  • No development reported Mental disorders

Most Recent Events

  • 18 Dec 2017 Allergan plans to submit sNDA to US FDA for Bipolar depression in the second half of 2018
  • 18 Dec 2017 Positive top-line efficacy and adverse events data from a phase III trial in Bipolar depression released by Allergan and Gedeon Richter
  • 13 Nov 2017 Registered for Schizophrenia (Prevention of relapse, maintenance treatment) in USA (PO)
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