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: 14 Nov 2017

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At a glance

  • Originator Sepracor
  • Developer Sepracor; 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

  • 10 Nov 2017 US FDA accepts NDA for dasotraline for Attention-deficit hyperactivity disorder (In adolescents, In adults, In children) for review
  • 31 Aug 2017 Preregistration for Attention-deficit hyperactivity disorder (In adults, In adolescents, In children) in USA (PO)
  • 02 Aug 2017 Sunovion plans a phase III trial for Attention deficit hyperactivity disorder (In children) (NCT03231800)
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