Brexpiprazole (brand name Rexulti recks-UL-tee, previously known as OPC-34712) is a novel atypical antipsychotic drug. It is a D2 dopamine partial agonist called serotonin-dopamine activity modulator (SDAM). The drug received FDA approval on July 13, 2015 for the treatment of schizophrenia, and as an adjunctive treatment for depression. Although it failed Phase II clinical trials for ADHD, it has been designed to provide improved efficacy and tolerability (e.g., less akathisia, restlessness and/or insomnia) over established adjunctive treatments for major depressive disorder (MDD).
The drug was developed by Otsuka and Lundbeck, and is considered to be a successor of Otsuka’s top-selling antipsychotic agent aripiprazole (brand names: Abilify, Aripiprex). Otsuka’s US patent on aripiprazole expired on October 20, 2014; however, due to a pediatric extension, a generic will become available in the near future.