Danish pharmaceutical company H. Lundbeck A/S (CPH:HLUN-A) and Japan-based Otsuka Pharmaceutical Co Ltd announced on Thursday that the European Commission has approved Rxulti (brexpiprazole) for treating schizophrenia in adolescents aged 13 years and older.

The drug was previously approved in the European Union in 2018 for adult patients with schizophrenia.

The latest approval follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in January 2025. It is based on a six-week, randomised, double-blind, placebo-controlled trial involving 316 adolescent patients, which demonstrated significant symptom reduction compared to placebo.

Brexpiprazole (2-4 mg/day) was associated with improved Positive and Negative Syndrome Scale (PANSS) total scores and showed a safety profile consistent with findings in adult patients. The approval provides a new treatment option for young patients with schizophrenia, a condition often linked to more chronic and severe symptoms when it emerges in adolescence.

Brexpiprazole is an atypical antipsychotic that modulates serotonin and dopamine activity and is co-developed and co-commercialised by Otsuka and Lundbeck under a collaboration and licence agreement.