Incannex begins screening patients in Phase 2 sleep apnea trial of IHL-42X

Incannex Healthcare Inc. said on July 23, 2026 that participant screening has begun in its DReAMzz Phase 2 dose confirmation study, which is testing IHL-42X as a treatment for obstructive sleep apnea (OSA).¹

The first group of clinical trial sites has received approval to start screening potential participants, which the company described as another milestone toward Phase III development.¹ More sites are expected to begin screening as they receive approval.¹

Participants will be identified through site patient databases and public outreach before being assessed against the study's inclusion and exclusion criteria.¹ The company said the move into active recruitment follows operational steps including hiring a global CRO, completing drug product manufacturing, finalizing import and export permits, and setting up clinical and distribution infrastructure.¹

The DReAMzz study is described as a randomized, crossover Phase 2 dose confirmation trial designed to further refine the dosing profile of IHL-42X.¹ It builds on earlier Phase 2 results that the company said showed statistically significant reductions in Apnea-Hypopnea Index versus placebo, with reductions of up to 83%.¹ IHL-42X also showed statistically significant gains on several patient-reported outcome measures, including fatigue and sleep-related impairment, while the company said the drug's safety profile remained favorable.¹

IHL-42X previously received FDA Fast Track designation, which the company said reflects the unmet need in OSA and allows for more frequent FDA interactions during development.¹ Incannex's other lead programs include IHL-675A for rheumatoid arthritis and PSX-001 for generalized anxiety disorder.¹