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Drug Profile

Agomelatine - Servier

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

Latest Information Update: 19 Nov 2024

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At a glance

  • Originator Servier
  • Developer Novartis; Servier
  • Class Acetamides; Antidepressants; Anxiolytics; Behavioural disorder therapies; Hypnosedatives; Sleep disorder therapies; Small molecules
  • Mechanism of Action 5-HT2C serotonin receptor antagonists; 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Major depressive disorder
  • Suspended Generalised anxiety disorder
  • No development reported Obsessive-compulsive disorders
  • Discontinued Sleep disorders

Most Recent Events

  • 19 Nov 2024 No development reported - Phase-III for Major depressive disorder (In adolescents, In children) in Germany, Poland, Hungary, Finland and Bulgaria (PO)
  • 27 Oct 2021 Servier completes a phase III clinical trials of agomelatine in Major depressive disorder (In adolescents, In children) in Germany, Bulgaria, Finland, Hungary and Poland (PO, Tablet) (EudraCT2015-002181-23)
  • 11 Aug 2017 Suspended - Phase-II for Generalised anxiety disorder (In adolescents, In children) in Poland, Romania, Estonia, Hungary, Sweden, Finland (PO,Tablet) (Servier email communication, August 2017)

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