Centanafadine - Otsuka Pharmaceutical
Alternative Names: Centanafadine SR; Centanafadine XR; CTN SR; EB-1020; EB-1020 SRLatest Information Update: 02 Feb 2026
At a glance
- Originator Euthymics Bioscience; Otsuka Pharmaceutical
- Class Analgesics; Antidepressants; Azabicyclo compounds; Behavioural disorder therapies; Cyclohexanes; Naphthalenes; Small molecules; Smoking cessation therapies
- Mechanism of Action Adrenergic uptake inhibitors; Dopamine uptake inhibitors; Serotonin uptake inhibitors
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Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Preregistration Attention-deficit hyperactivity disorder
- Phase II Major depressive disorder; Smoking withdrawal
- Discontinued Binge-eating disorder; Neuropathic pain
Most Recent Events
- 27 Jan 2026 The US FDA sets PDUFA date of 24 July 2026 for NDA review for Centanafadine
- 27 Jan 2026 US FDA accepts priority review for New Drug Application (NDA) for centanafadine for Attention-deficit hyperactivity disorder (ADHD)
- 02 Jan 2026 Otsuka Pharmaceutical Development & Commercialization plans a phase I trial in Attention deficit hyperactivity disorder (In volunteers) in USA (PO, capsule) in February 2026 (NCT07314333)