Brexpiprazole

Brexpiprazole is a medication approved for the treatment of schizophrenia in adults since 2018. An extension of its indication to include adolescents aged 13 to 17 years was approved in March 2025, following a variation application submitted in October 2025.

Efficacy data from a long-term, multicenter, open-label Phase 3 trial (Trial 331-10-236) involving 295 adolescents demonstrated a change from baseline in PANSS total score of -24 points and -19 points. For subjects under 15 years old, the PANSS Total Score change at Month 24 was -25.22 points, while for subjects 15 years and older, it was -24.17 points. The proportion of responders, defined as a 30% reduction in PANSS total score, was 71.9%. Discontinuation due to lack of efficacy was observed in 2.3% of patients.

Safety findings from the trial, which included 294 subjects exposed to at least one dose of brexpiprazole, indicated a discontinuation rate due to adverse events of 3.1%. The incidence of serious treatment-emergent adverse events (TEAEs) was 3.1% (9 subjects), with no reported mortality. The overall incidence of TEAEs was 60.3% in males and 67.3% in females. The mean daily dose of brexpiprazole was 2.45 mg, with 85.4% of patients receiving treatment for over 6 months and 73.6% for over 12 months.