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Tasimelteon - Vanda Pharmaceuticals

Drug Profile

Tasimelteon - Vanda Pharmaceuticals

Alternative Names: BMS-214778; HETLIOZ; VEC-162

Latest Information Update: 28 Oct 2019

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At a glance

  • Originator Bristol-Myers Squibb
  • Developer Vanda Pharmaceuticals
  • Class Amides; Antidepressants; Benzofurans; Cyclopropanes; Sleep disorder therapies; Small molecules
  • Mechanism of Action Melatonin MT1 receptor agonists; Melatonin MT2 receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Circadian rhythm sleep disorders
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Circadian rhythm sleep disorders
  • Discontinued Major depressive disorder

Most Recent Events

  • 06 Nov 2019 Vanda Pharmaceuticals announces intention to submit sNDA to the US FDA for Circadian rhythm sleep disorders (Smith-Magenis Syndrome) in the fourth quarter of 2019
  • 06 Nov 2019 Vanda Pharmaceuticals intends to meet the US FDA to confirm the regulatory pathway of tasimelteon for Circadian rhythm sleep disorders (Smith-Magenis Syndrome) in the fourth quarter of 2019
  • 06 Nov 2019 Vanda Pharmaceuticals plans a phase III trial for Circadian rhythm sleep disorders (Delayed sleep phase disorder) by end of 2019
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