Icannex news
7/25/2025 11:55am
Here is some news about Incannex:
1. **Advancement in Sleep Apnea Treatment**: Incannex Healthcare Inc. has advanced its IHL-42X RePOSA trial to Phase 3 following FDA protocol clearance, with plans to initiate Phase 3 immediately after completing Phase 2. IHL-42X is an oral fixed-dose combination of dronabinol and acetazolamide, aiming to become the first FDA-approved oral therapy for obstructive sleep apnea.
2. **Positive Pharmacokinetic Results**: The company reported positive pharmacokinetic and safety results from a study of IHL-42X, supporting a potential FDA 505(b)(2) new drug application. The bioavailability of IHL-42X was confirmed, indicating effective delivery of the drugs, with no serious adverse events reported.
3. **Upcoming Phase 3 Study**: Incannex is set to initiate the Phase 3 portion of the RePOSA trial, which is expected to enroll over 560 patients worldwide. This builds on the momentum from Phase 2 and aims to gather further data on the safety and efficacy of IHL-42X in treating sleep apnea.
In conclusion, Incannex Healthcare Inc. has made significant progress in the development of its drug IHL-42X for the treatment of obstructive sleep apnea. The company has completed Phase 2 enrollment and is advancing to Phase 3 with FDA authorization. Positive pharmacokinetic results and excellent tolerability have been demonstrated, supporting the potential for FDA approval.