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A Phase II Trial of SENS-401 for the Treatment of Sudden Sensorineural Hearing Loss (or SSNHL) in Pediatric Population

Trial Profile

A Phase II Trial of SENS-401 for the Treatment of Sudden Sensorineural Hearing Loss (or SSNHL) in Pediatric Population

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 21 Jun 2023

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At a glance

  • Drugs Arazasetron (Primary)
  • Indications Sensorineural hearing loss
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Sensorion
  • Most Recent Events

    • 19 Jun 2023 According to a Sensorion media release, SENS-401 has been granted Orphan Drug Designation by the EMA in Europe for the treatment of sudden sensorineural hearing loss, and by the FDA in the U.S. for the prevention of platinum-induced ototoxicity in pediatric population.
    • 06 Jul 2020 According to a Sensorion media release, data expected in mid-2021.
    • 28 Jun 2019 According to a Sensorion media release, the company intend to continue discussions and propose this phase 2 clinical trial protocol in order to investigate SENS-401 for the treatment of severe hearing loss (SSNHL).
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