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Dasotraline - Sumitomo Dainippon Pharma

Drug Profile

Dasotraline - Sumitomo Dainippon Pharma

Alternative Names: DSP-225289; SEP 225289; SEP-0225289; SEP-225289-HCI; SEP-289

Latest Information Update: 04 Nov 2018

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At a glance

  • Originator Sepracor
  • Developer Sepracor; Sumitomo Dainippon Pharma; Sunovion Pharmaceuticals
  • Class Amines; Antidepressants; Cyclobutanes; Naphthalenes; Small molecules; Tetrahydronaphthalenes
  • Mechanism of Action Adrenergic uptake inhibitors; Dopamine uptake inhibitors; Serotonin uptake inhibitors
  • Orphan Drug Status

    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 III Eating disorders
  • Discontinued Major depressive disorder

Most Recent Events

  • 25 Jul 2018 Planned Prescription Drug User Fee Act (PDUFA) date for Attention-deficit hyperactivity disorder (In adolescents, In children, In adults) in USA (PO) is 2018-08-30
  • 25 Jul 2018 Top-line safety data from the phase III SEP360-321 trial in Eating disorder released by Sunovion Pharmaceuticals
  • 16 May 2018 Sunovion competes enrolment in a phase III trial for Eating disorder in USA (NCT03107026)
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