Brilaroxazine (developmental code name RP5063), also known as oxaripiprazole,[1][2] is an investigational atypical antipsychotic which is under development by Reviva Pharmaceuticals for the treatment of neuropsychiatric and inflammatory disorders.

[9][11] It lacks significant affinity for 5-HT1B, α2 adrenergic, and muscarinic acetylcholine receptors, as well as for the norepinephrine and dopamine transporters.

This structural change is within the molecule's secondary pharmacophore, which plays a major role in modulating its binding and intrinsic efficacy at dopamine and serotonin receptors.

In October 2023, Reviva Pharmaceuticals released topline results from their pivotal RECOVER phase III clinical trial (NCT05184335).

Brilaroxazine 50 mg successfully met all primary and secondary endpoints with statistically significant and clinically meaningful improvements over placebo across all major symptom domains.

There was no >=7% mean change in bodyweight, blood glucose, lipids, prolactin, or thyroid hormones compared to placebo.

This is a significant improvement over the currently prescribed third-generation antipsychotics aripiprazole (Abilify), brexpiprazole (Rexulti), and cariprazine (Vraylar).

Reviva also has an ongoing 52-week, single-arm, phase III open-label extension (OLE) study of stable schizophrenia patients to further evaluate the long-term safety and tolerability of brilaroxazine as part of the RECOVER program (NCT05184335).