Feb 12: Results from PIII study in pts with acute mania associated with biopolar I disorder (n=497). Pts were treated with either cariprazine 3-6mg/day (n=167), cariprazine 6-12mg/day (n=169) or placebo (n=161), for up to 3 weeks. The primary endpoint was change from baseline to week 3 on the Young Mania Rating Scale (YMRS); statistically significant improvement was noted in both cariprazine groups (3-6mg/day, -6.1 points, p<0.001; and 6-12mg, -5.9 points, p<0.001), vs. placebo. Early discontinuation rates were 23% and 30% for cariprazine 3-6mg and 6-12mg/day and 24% for placebo. The most common adverse events (≥10% and 2xrate of placebo) seen in the study were akathisia (both cariprazine groups) and constipation (cariprazine 6-12mg/day).  Oct 11: Top-line results reported from a PIII study of cariprazine monotherapy in 312 in-patients with acute mania associated with bipolar I disorder. Patients were randomized to cariprazine, 3-12mg/day (N=158) or placebo (N=154) for up to 3 weeks and followed up for a further 2 weeks. There was a statistically significant improvement from baseline to Week 3 on the Young Mania Rating Scale (primary endpoint) in the active treatment group (-19.6 cariprazine vs. -15.3 placebo, p<0.001) by MMRM analysis. Premature discontinuation rates were 32% vs 31%; the most common AEs were akathisia, extrapyramidal disorder, tremor, dyspepsia, and vomiting . NCT01059539 is a PIII long-term open-label 16 week study of the safety and tolerability of cariprazine in patients with bipolar I disorder. Starting in Jan 10, and completing Jun 11, the study will enroll 400 patients . NCT01058668 is a PIII a double-blind, placebo-controlled, evaluation of the safety and efficacy of two doses of cariprazine (high and low) in patients with acute mania or mixed episodes associated with bipolar I disorder. Starting Jan 10 and completing Jun 11, the study will enroll 500 patients. The primary outcome is based on the Young Mania Rating Scale score at 3 weeks . · . Sep 15: The US FDA approved Vraylar (cariprazine) to treat schizophrenia and bipolar disorder in adults . 06. Mar 16: Vraylar is approved in the US for acute treatment of adults with manic or mixed episodes associated with bipolar I disorder, with a recommended dose range of 3 to 6 mg/day and for the treatment of schizophrenia in adults, with a recommended dose range of 1.5 to 6 mg/day ..