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Efficacy and safety of AM-111 in the Treatment of Acute Inner Ear Hearing Loss

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Trial Profile

Efficacy and safety of AM-111 in the Treatment of Acute Inner Ear Hearing Loss

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Aug 2022

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At a glance

  • Drugs Brimapitide (Primary) ; Prednisolone
  • Indications Sensorineural hearing loss
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms HEALOS
  • Sponsors Altamira Therapeutics; Auris Medical

Most Recent Events

  • 11 Mar 2019 According to an Auris Medical media release, results detailing outcomes of this trial have been published in the journal Otology & Neurotology.
  • 07 May 2018 According to an Auris Medical media release, based on the result from this study, the company has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The company is also planning for a Type C meeting with the US FDA.
  • 04 Jan 2018 Pooled results from this and a phase II trial, published in an Auris Medical media release.

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