Tasimelteon

Drug Profile

Tasimelteon

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

Latest Information Update: 03 Feb 2017

Price : $50

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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Circadian rhythm sleep disorders
  • No development reported Insomnia
  • Discontinued Major depressive disorder

Most Recent Events

  • 01 Sep 2016 Phase-I clinical trials in Circadian rhythm sleep disorders (In children, In adolescents) in USA, United Kingdom, Germany (PO) (EudraCT2015-003394-15) (NCT02776215)
  • 01 Aug 2016 Vanda Pharmaceuticals initiates enrolment in a phase II trial for Circadian rhythm sleep disorders (jet lag disorder) in United Kingdom (PO, Capsule) (EudraCT2016-002213-21)
  • 01 Aug 2016 Launched for Circadian rhythm sleep disorders in Germany (PO)
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