IHL-42X - (DReAMzz)

July 23, 2026: Incannex Healthcare Inc. (NASDAQ: IXHL) announced that participant screening has commenced for its DReAMzz Phase 2 dose confirmation study of IHL-42X for obstructive sleep apnea (OSA), with the first tranche of clinical sites approved and actively screening; additional sites are expected to come online as approvals are obtained. The randomized, crossover Phase 2 study is designed to optimize IHL-42X dosing and further assess relationships between objective sleep metrics and patient-reported outcomes, with the goal of informing a planned Phase III program and strengthening the regulatory and commercial package.

The company noted IHL-42X previously received FDA Fast Track designation. The study builds on previously reported positive Phase 2 data showing statistically significant reductions in apnea-hypopnea index (AHI) versus placebo, with reductions up to 83%, plus statistically significant improvements in patient-reported measures (including fatigue and sleep-related impairment) and a favorable safety profile.