Drug Overview
Vraylar (cariprazine; Gedeon Richter/Allergan/Mitsubishi Tanabe) is a novel atypical antipsychotic with partial agonistic activity at D2 and D3 receptors, and selectivity for the D3 receptor. Vraylar is also a partial agonist at 5-HT1A receptors and an antagonist at 5-HT2A receptors. Most atypical antipsychotics have full antagonistic activity at D2 and 5-HT2A receptors, giving cariprazine a unique pharmacology among drugs in the class.
Vraylar was initially developed as a drug for schizophrenia and bipolar disorder, and is now being investigated for the adjunctive treatment of major depressive disorder (MDD) as a line extension. Allergan has so far completed a single Phase III trial in MDD, which yielded negative data. Vraylar was first approved by the US Food and Drug Administration in September 2015.
Vraylar (cariprazine; Gedeon Richter/Allergan/Mitsubishi Tanabe) is a novel atypical antipsychotic with partial agonistic activity at D2 and D3 receptors, and selectivity for the D3 receptor. Vraylar is also a partial agonist at 5-HT1A receptors and an antagonist at 5-HT2A receptors. Most atypical antipsychotics have full antagonistic activity at D2 and 5-HT2A receptors, giving cariprazine a unique pharmacology among drugs in the class.
Vraylar was initially developed as a drug for schizophrenia and bipolar disorder, and is now being investigated for the adjunctive treatment of major depressive disorder (MDD) as a line extension. Allergan has so far completed a single Phase III trial in MDD, which yielded negative data. Vraylar was first approved by the US Food and Drug Administration in September 2015.
Table of Contents
OVERVIEWDrug Overview
Product Profiles
Vraylar: Bipolar disorder
Vraylar: Schizophrenia
Vraylar: Depression
List of Figures
Figure 1: Vraylar for bipolar disorder - SWOT analysis
Figure 2: Drug assessment summary for Vraylar in bipolar disorder
Figure 3: Drug assessment summary for Vraylar in bipolar disorder
Figure 4: Vraylar for schizophrenia - SWOT analysis
Figure 5: Drug assessment summary of Vraylar for schizophrenia
Figure 6: Drug assessment summary of Vraylar for schizophrenia
Figure 7: Vraylar sales for schizophrenia across the US and five major EU markets, by country, 2017-26
Figure 8: Vraylar for depression - SWOT analysis
Figure 9: Drug assessment summary for Vraylar in depression
Figure 10: Drug assessment summary for Vraylar in depression
List of Tables
Table 1: Vraylar bipolar disorder indication approvals
Table 2: Vraylar drug profile
Table 3: Overview of key pivotal trial data for Vraylar in bipolar disorder
Table 4: Key side effects (=5%) reported in clinical trials of Vraylar monotherapy for bipolar mania
Table 5: Vraylar Phase III trials in bipolar depression
Table 6: Vraylar drug profile
Table 7: Vraylar pivotal trial data in schizophrenia
Table 8: Vraylar other late-phase trial data in schizophrenia
Table 9: Vraylar sales for schizophrenia across the US and five major EU markets, by country ($m), 2017-26
Table 10: Vraylar drug profile
Table 11: Vraylar Phase II and III data in depression
