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: 12 Apr 2018

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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 Schizoaffective disorder
  • No development reported Mental disorders

Most Recent Events

  • 03 Apr 2018 Efficacy and adverse events from a phase III RGH-MD-53 trial, which met its primary endpoint, in Bipolar disorders released by Allergan and Richter
  • 18 Jan 2018 Forest Laboratories completes a phase-III trial for Bipolar I depression in USA, Bulgaria, Croatia, Puerto Rico, Romania, Serbia, Slovakia, Ukraine (PO) (NCT02670538)
  • 18 Dec 2017 Allergan plans to submit sNDA to US FDA for Bipolar depression in the second half of 2018
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