Ramelteon

Drug Profile

Ramelteon

Alternative Names: Ramelteon SL; Ramelteon sublingual; Rozerem; TAK-375; TAK-375SL

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator Takeda
  • Developer Sun Pharmaceutical Industries; Takeda
  • Class Anxiolytics; Indenes; 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.

    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 Insomnia
  • Discontinued Alzheimer's disease; Bipolar depression; Bipolar disorders; Circadian rhythm sleep disorders

Most Recent Events

  • 16 Jul 2016 No recent reports of development identified for phase-I development in Insomnia(In adolescents, In children) in USA (PO, Tablet)
  • 11 Sep 2015 Discontinued - Phase-III for Bipolar depression (Adjunctive treatment) in USA, United Kingdom, Poland, Bulgaria, Czech Republic, Germany, Romania, Russia, Serbia, Ukraine, Argentina, Canada, Chile, Colombia, Mexico (Sublingual) before 15 May 2015
  • 11 Sep 2015 Discontinued - Phase-III for Bipolar disorders (Adjunctive treatment) in Mexico, Colombia, Chile, Argentina, USA (Sublingual) before 15 May 2015
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