Incannex Healthcare Inc. (NASDAQ: IXHL) has commenced dosing in its DReAMzz Phase 2 clinical study for IHL-42X, an oral fixed-dose combination of dronabinol and acetazolamide being developed to treat obstructive sleep apnea.
The crossover dose-optimization trial is enrolling across 13 clinical sites in the United States, all of which have received Institutional Review Board approval.
The study follows positive results from Incannex’s earlier RePOSA Phase 2 trial, which enrolled 121 subjects at 16 U.S. sites and reported its findings in August 2025. Both low-dose and high-dose cohorts of IHL-42X showed statistically significant reductions in the apnea-hypopnea index and oxygen desaturation index compared with placebo. The U.S. Food and Drug Administration granted IHL-42X Fast Track designation in December 2025.
In other regulatory developments, the U.S. Patent and Trademark Office on June 25, 2026, granted a patent covering the IHL-42X composition and treatment methods. The patent carries a baseline expiry date of July 9, 2040.
Financially, Incannex reported approximately $70 million in cash with no debt as of August 31, 2026. During 2026, the company also received more than A$11.2 million through Australia’s Research and Development Tax Incentive program.
Incannex’s pipeline extends beyond IHL-42X. The company is advancing PSX-001, an oral synthetic psilocybin therapeutic for generalized anxiety disorder. PSX-001 posted positive results from its 73-subject PsiGAD1 Phase 2 study in August 2025, and the company holds an open U.S. Investigational New Drug application for a Phase 2b dose-comparison study.
