FDA Grants Fast Track Designation to Incannex Healthcare for IHL-42X in Obstructive Sleep Apnea
Incannex Healthcare Inc. has received Fast Track designation from the FDA for its product candidate IHL-42X, aimed at treating obstructive sleep apnea. This designation, based on positive clinical trial results, allows for more frequent FDA interactions and potential accelerated approval processes.
Incannex Healthcare Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its oral fixed-dose combination product candidate, IHL-42X, for the treatment of obstructive sleep apnea (OSA). The designation was based on promising results from three clinical trials, including a Phase 2 study that showed significant reductions in Apnea-Hypopnea Index and strong patient-reported outcomes. Fast Track status enables Incannex to benefit from more frequent interactions with the FDA, eligibility for rolling review, and potential access to Accelerated Approval and Priority Review, subject to meeting relevant criteria. No other organizations were mentioned as recipients of this grant or regulatory designation. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Incannex Healthcare Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001213900-25-117571), on December 03, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT) Original Document: here
