IXHL Incannex Healthcare

IHL-42X · NCT07635563 registry update

countries: {'total_sites': 14, 'us_sites': 14} → {'total_sites': 13, 'us_sites': 13}

Incannex starts DReAMzz Phase 2 dosing of IHL-42X in OSA

First patient dosing has begun in the DReAMzz Phase 2 crossover dose-optimization study of IHL-42X for obstructive sleep apnea. The study is running at 13 U.S. sites and is intended to generate dose-selection data for a subsequent Phase 3 registration program. The protocol incorporates FDA feedback and was reviewed by the Company’s OSA Clinical Advisory Board.

Incannex granted FDA Fast Track for IHL-42X in OSA

FDA granted Fast Track designation to IHL-42X for obstructive sleep apnea. Designation provides more frequent FDA interactions, eligibility for rolling review, and potential access to Accelerated Approval and Priority Review. Company expects written FDA feedback on Phase 2 data and development strategy.