Abilify Asimtufii aripiprazole APPROVED
Drug Profile
ModalitySmall molecule
RouteIM
Therapy AreaNeurology
Launch2023-04-27
Peak Sales Est$2000M
Formulations[{"id":"asimtufii-im","route":"IM","device":"Pre-filled syringe (720mg, 960mg)","setting":"HCP_ONLY"
Companies
LUN (CO_DEVELOPER)20%
4578 (ORIGINATOR)80%
Mechanism: Serotonin-Dopamine Activity Modulator (SDAM)
Expert: Partial agonist at dopamine D2/D3 and serotonin 5-HT1A receptors with antagonism at 5-HT2A receptors. Stabilizes dopaminergic and serotonergic neurotransmission by acting as a functional agonist in hypodopaminergic states and antagonist in hyperdopaminergic states.
Everyday: Fine-tunes dopamine and serotonin signals in the brain — like a thermostat that adjusts these chemical messengers up or down depending on what the brain needs, rather than simply turning them on or off.
Targets: []
Programs (2)
IndicationStageKey StudyRegional Status
SchizophreniaAPPROVEDNCT03346525[{"stage":"APPROVED","region":"US","approval_date":"2023-04-27"}]
Bipolar I maintenanceAPPROVEDNCT03346525[{"stage":"APPROVED","region":"US","approval_date":"2023-04-27"}]
Notes
First-ever once-every-two-months LAI antipsychotic. Replacement for Abilify Maintena. Ready-to-use, no reconstitution.
Data from Supabase · Updated 2026-03-24