Agomelatine

Drug Profile

Agomelatine

Alternative Names: AGO-178; AGO178C; Alodil; Melitor; S-20098; S-20098-F55; Thymanax; Valdoxan; Vestin

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator Servier
  • Developer Novartis; Servier
  • Class Acetamides; Antidepressants; Hypnosedatives; Sleep disorder therapies; Small molecules
  • Mechanism of Action Melatonin MT1 receptor agonists; Melatonin MT2 receptor agonists; Serotonin 2C receptor antagonists
  • Orphan Drug Status

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

    No
  • 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 Major depressive disorder
  • Phase III Generalised anxiety disorder
  • No development reported Obsessive-compulsive disorders
  • Discontinued Sleep disorders

Most Recent Events

  • 06 Mar 2015 Agomelatine is still in phase III trials for Generalised anxiety disorder in Canada, Poland and Russia (capsule formulation)
  • 06 Mar 2015 Launched for Major depressive disorder in India (PO) before March 2015
  • 06 Mar 2015 No recent reports on development identified - Phase-II for Generalised anxiety disorder in South Africa (PO)
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