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Tasimelteon - Vanda Pharmaceuticals

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Drug Profile

Tasimelteon - Vanda Pharmaceuticals

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

Latest Information Update: 05 Aug 2024

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At a glance

  • Originator Bristol-Myers Squibb
  • Developer Vanda Pharmaceuticals
  • Class Amides; Antidepressants; Behavioural disorder therapies; 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
  • Phase III Pervasive child development disorders
  • Clinical Phase Unknown Insomnia
  • Discontinued Major depressive disorder

Most Recent Events

  • 31 Jul 2024 Clinical trials in Insomnia (In children) (PO) before July 2024
  • 31 Jul 2024 Vanda Pharmaceuticals submits Marketing Authorization Application for HETLIOZ® and a Line Extension Application for HETLIOZ LQ® to the European Medicines Agency for Circadian rhythm sleep disorders in Smith-Magenis Syndrome
  • 01 Jul 2024 U.S. District Court for the District of Delaware denies motions for judgment on the pleadings that were filed by Teva Pharmaceuticals USA, Apotex for nimacimab

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