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A Pivotal, Phase II/III trial of Keyzilen for the treatment of Tinnitus

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Trial Profile

A Pivotal, Phase II/III trial of Keyzilen for the treatment of Tinnitus

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 25 Aug 2022

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At a glance

  • Drugs Esketamine (Primary)
  • Indications Tinnitus
  • Focus Registrational; Therapeutic Use
  • Sponsors Altamira Therapeutics

Most Recent Events

  • 16 Apr 2020 According to an Auris Medical media release, the FDA considers the improvement in tinnitus loudness as a co-primary efficacy endpoint, whereas the EMA endorsed it as a secondary efficacy endpoint. In addition, the two agencies endorsed the planned sample size for the trial.
  • 13 Sep 2019 According to an Auris Medical media release, the company has received advice on the development plan and regulatory pathway for its investigational tinnitus treatment Keyzilen (AM-101) from the U.S. Food and Drug Administration and from the European Medicines Agency .
  • 15 Aug 2019 According to an Auris Medical media release, the company has completed the design of the trial. The Company has solicited advice on the development plan and regulatory pathway from the U.S. Food and Drug Administration (FDA) in the context of a Type C meeting and from the European Medicines Agency (EMA) in the context of a Scientific Advice procedure.

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