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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: 07 Aug 2019

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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; Binge-eating disorder
  • Discontinued Major depressive disorder

Most Recent Events

  • 30 Jul 2019 FDA assigns PDUFA action date of (14/04/2020) for dasotraline for Binge-eating disorder
  • 30 Jul 2019 Sunovion Pharmaceuticals announces intention to submit sNDA to US FDA for Eating disorders in fiscal year 2018
  • 30 Jul 2019 The US FDA accepts NDA for Binge-eating disorder for review
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