USA: The US Food and Drug Authority (FDA) has approved Cariprazine as an adjunctive treatment to antidepressants for major depressive disorder in adult patients.
The FDA has also approved the drug for the treatment of adults with manic episodes associated with clinically diagnosed Bipolar disorder as well as Schizophrenia
The registration-enabling study, illustrated a clinically and quantitatively vast difference from the baseline at the beginning of the study, to the eighth week in the MADRS total score for participants treated with Cariprazine. A total of 20 clinical trials have been completed prior to its approval, to ensure its efficacy in the treatment of several psychiatric disorders.