Cariprazine: First Global Approval

Abstract

Cariprazine (Vraylar™) is an oral atypical antipsychotic originated by Gedeon Richter. It is a potent dopamine D 3 and D 2 receptor partial agonist, which preferentially binds to the D 3 receptor. Cariprazine also has partial agonist activity at serotonin 5-HT 1A receptors. In September 2015, cariprazine received its first global approval in the USA for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder. It is also in development in a variety of countries for the treatment of schizophrenia with predominant negative symptoms (phase III), as adjunctive therapy for major depressive disorder (phase II/III) and for the treatment of bipolar depression (phase II). This article summarizes the milestones in the development of cariprazine leading to this first approval for schizophrenia and manic or mixed episodes associated with bipolar I disorder.