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B2037 is a long-acting injectable (LAI) formulation of the atypical antipsychotic brexpiprazole, developed by Bostal Pharma using the 505(b)(2) regulatory pathway. It is designed for the treatment of schizophrenia and bipolar I disorder. Brexpiprazole acts as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors and as an antagonist at serotonin 5-HT2A receptors. The LAI formulation is intended to improve patient adherence by providing sustained therapeutic levels through intramuscular injection, with dosing intervals such as once monthly. The program is currently in late-stage development, with the company targeting NDA registration and potential approval in 2027.
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