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Phase 2 Study of the Efficacy and Safety of ORC-13661 for the Prevention of Drug-Induced Hearing Loss in Patients Receiving Intravenous Amikacin for Treatment of Non-Tuberculous Mycobacterium Disease

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Trial Profile

Phase 2 Study of the Efficacy and Safety of ORC-13661 for the Prevention of Drug-Induced Hearing Loss in Patients Receiving Intravenous Amikacin for Treatment of Non-Tuberculous Mycobacterium Disease

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 05 Jul 2025

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At a glance

  • Drugs ORC-13661 (Primary)
  • Indications Sensorineural hearing loss
  • Focus Therapeutic Use

Most Recent Events

  • 14 May 2025 Planned initiation date (estimated date for recruitment of the first subject) changed from 1 Jun 2025 to 1 May 2025.
  • 14 May 2025 Status changed from not yet recruiting to recruiting.
  • 08 May 2025 Planned End Date changed from 1 Jan 2027 to 1 Feb 2028.

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