Clinical TrialMay 14, 2026, 10:37 AM
Incannex Commences DReAMzz Clinical Study for OSA Treatment IHL-42X
AI Summary
Incannex Healthcare Inc. announced the official commencement of its DReAMzz clinical study for IHL-42X, targeting obstructive sleep apnea (OSA). This study is designed for dose optimization to refine the drug's profile and strengthen the planned Phase III development program, building on positive Phase II results. The company has completed site identification, manufacturing, and secured permits, positioning IHL-42X, which holds FDA Fast Track designation, as a leading oral pharmacotherapy for OSA.
Key Highlights
- Incannex Healthcare commenced its DReAMzz clinical study evaluating IHL-42X for obstructive sleep apnea (OSA).
- The DReAMzz study is a crossover dose optimization study to refine dosing and strengthen the Phase III program.
- IHL-42X previously demonstrated statistically significant reductions in apnea-hypopnea index (AHI) in the Phase II RePOSA trial.
- The U.S. FDA granted IHL-42X Fast Track designation for the treatment of OSA.
- All 14 clinical trial sites have been identified, and site contracting activities are underway.
- Manufacturing of IHL-42X drug product is complete, and a global distribution partner has been onboarded.
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