Brexpiprazole was approved by the U.S. Food and Drug Administration (FDA) on Jul 10, 2015. It was codeveloped by Otsuka and Lundbeck, then marketed as Rexulti® by Otsuka in US.
Brexpiprazole was mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. It is indicated for the treatment of schizophrenia and as an add-on treatment for major depressive disorder (MDD).
Rexulti® is available as tablet for oral use, containing 0.25 mg/0.5 mg/1 mg/2 mg/3 mg/4 mg of Brexpiprazole. For major depressive disorder, initially take 0.5 mg or 1 mg once daily, and the recommended dose is 2 mg once daily, and maximum dose is 3 mg once daily. For schizophrenia, initially take 1 mg once daily, and the recommended dose is 2 to 4 mg once daily, and maximum dose is 4 mg once daily.
|Approval Date||Approval Type||Trade Name||Indication||Dosage Form||Strength||Company||Review Classification|
|2015-07-10||First approval||Rexulti||Schizophrenia,Major depressive disorder (MDD)||Tablet||0.25 mg/0.5 mg/1 mg/2 mg/3 mg/4 mg||Otsuka|
|CAS No.||913611-97-9 (Brexpiprazole);|
|Brexpiprazole （Free Acid/Base）Parameters：|
|*：Calculated by ACD/Labs software V11.02.|