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A Phase II/III, Randomised, Double-Blind Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnoea Who Are Intolerant, Non-Compliant, or Naïve to Positive Airway Pressure

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Trial Profile

A Phase II/III, Randomised, Double-Blind Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnoea Who Are Intolerant, Non-Compliant, or Naïve to Positive Airway Pressure

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 03 Jun 2025

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At a glance

  • Drugs Acetazolamide/dronabinol (Primary)
  • Indications Sleep apnoea syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms REPOSA
  • Sponsors Incannex Healthcare

Most Recent Events

  • 29 May 2025 According to the Incannex Healthcare media release, With the FDA authorization in place, company will initiate Phase 3 immediately following the completion of Phase 2, leveraging a shared protocol and U.S. based infrastructure to maximize efficiency and speed.
  • 29 May 2025 According to the Incannex Healthcare media release, approximately 20 U.S. sites from Phase 2 are expected to roll over directly into Phase 3, with 10 new U.S. sites to be added following final Phase 2 data review.. A topline readout from the U.S. Phase 2 portion is anticipated in July 2025.
  • 20 Apr 2025 Status changed from recruiting to active, no longer recruiting.

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