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Centanafadine centanafadine FILED
Drug Profile
ModalitySmall molecule
RouteORAL
Therapy AreaNeurology
Peak Sales Est$3000M
Formulations[{"id":"centanafadine-er","route":"ORAL","device":"Extended-release capsule","setting":"PATIENT_SELF
Companies
4578 (ORIGINATOR)100%
Mechanism: Triple Reuptake Inhibitor (NDSRI)
Expert: Norepinephrine-dopamine-serotonin reuptake inhibitor (NDSRI). Inhibits NET > DAT > SERT transporters, enhancing all three monoamine pathways. First-in-class mechanism for ADHD with balanced catecholamine and serotonergic activity.
Everyday: Boosts three brain chemicals at once — norepinephrine (focus), dopamine (motivation), and serotonin (mood). Like upgrading three lanes of a highway simultaneously instead of just one, which is what most ADHD drugs do.
Targets: []
Programs (2)
IndicationStageKey StudyRegional Status
ADHDFILEDPhase 3 pivotal (4 studies in children, adolescents, adults)[{"stage":"FILED","region":"US","filing_date":"2025-11-24","label_notes":"NDA fo
MDD adjunctPHASE2—[]
Upcoming Catalysts (1)
Centanafadine - ADHD - FDA PDUFA Decision July 24, 2026
Notes
First-in-class NDSRI. NDA filed Nov 2025, FDA Priority Review accepted Jan 2026. PDUFA July 24, 2026.
Data from Supabase · Updated 2026-03-24