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Esketamine - Auris Medical/INSERM/University of Montpellier

Drug Profile

Esketamine - Auris Medical/INSERM/University of Montpellier

Alternative Names: (s)-ketamine; AM-101; Esketamine otic gel; Keyzilen

Latest Information Update: 17 Sep 2019

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At a glance

  • Originator Auris Medical; INSERM; University of Montpellier I
  • Developer Auris Medical
  • Class Analgesics; Antidepressants; Chlorobenzenes; Cyclohexanones; General anaesthetics; Small molecules
  • Mechanism of Action NMDA receptor antagonists
  • Orphan Drug Status

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

  • New Molecular Entity No

Highest Development Phases

  • Phase III Tinnitus

Most Recent Events

  • 13 Sep 2019 Auris Medical receives advice from the US FDA and the EMA for esketamine in Tinnitus
  • 31 Jul 2019 Phase III development is ongoing United Kingdom, Austria, Hungary, Germany, Belgium, Poland, Spain, Canada, USA, Czech Republic and South Korea (Intratympanic)
  • 25 Apr 2019 Auris Medical plans regulatory filing for marketing authorisation of esketamine in Tinnitus
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