acetazolamide/dronabinol (IHL-42X) / Incannex - LARVOL DELTA

A Randomized Four-Period Cross-Over Phase I Study to Assess Bioavailability, Bioequivalence, and Tolerability of IHL-42X Compared with the Reference Drugs in Healthy Volunteers. (PubMed, Clin Drug Investig) - P1 | "IHL-42X was well tolerated in both fasted and fed states with an increased overall exposure to THC when administered with food. No serious adverse events were reported during the study. The PK profiles IHL-42X were similar to the RLDs for DRN and ACZ, selected analytes, and PK parameters. The data support bioavailability of IHL-42X, confirming oral delivery of both DRN and ACZ from the formulations."

Journal • P1 data • Cardiovascular • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea. (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Incannex Healthcare Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA (clinicaltrials.gov) - P2/3 | N=121 | Completed | Sponsor: Incannex Healthcare Ltd | Active, not recruiting ➔ Completed | N=560 ➔ 121

Enrollment change • Trial completion • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Incannex Commences Participant Screening in DReAMzz Phase 2 Study of IHL-42X for Obstructive Sleep Apnea (GlobeNewswire) - "The first tranche of clinical trial sites have now received approval to commence screening potential participants for the DReAMzz study, marking another important milestone in the advancement of Incannex’s lead clinical program towards Phase III development. Additional clinical sites are expected to commence screening activities as they receive the necessary approvals....The DReAMzz study is a randomized, crossover Phase 2 dose confirmation study designed to further optimize the dosing profile of IHL-42X."

Trial status • Obstructive Sleep Apnea

Incannex Healthcare…announced that the United States Patent and Trademark Office (USPTO) has granted a key patent titled 'Compositions and Methods of Treatment for Obstructive Sleep Apnea' (GlobeNewswire) - "The granted patent includes claims directed to the proprietary IHL-42X composition and its associated therapeutic methods for the treatment of Obstructive Sleep Apnea (OSA). The patent is expected to have a baseline expiry date of 9 July 2040 and the Company is exploring its eligibility for patent term extension following potential U.S. Food and Drug Administration (FDA) approval, with a view to further enhancing the long-term exclusivity of the asset."

Patent • Sleep Apnea

DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea. (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Incannex Healthcare Ltd

New P2 trial • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

On December 3, 2025, Incannex Healthcare Inc. announced that it received Fast Track designation from the U.S. Food and Drug Administration for its IHL-42X product, aimed at treating obstructive sleep apnea. (TipRanks) - "This designation, supported by successful Phase 2 trial results, allows for more frequent FDA interactions and potential expedited review processes, highlighting the significance of IHL-42X in addressing unmet medical needs in sleep apnea treatment."

Fast track • Obstructive Sleep Apnea

Incannex Wrapping Up US Phase 2 Trial for Dual-Mechanism OSA Drug Candidate (Sleep Review) - "Incannex Healthcare Inc has completed data collection for its phase 2 clinical trial of IHL-42X, its lead drug candidate for obstructive sleep apnea (OSA), which remains on schedule for top-line results to be delivered later this month....This marks a major milestone in the development of IHL-42X, confirming the completion of RePOSA phase 2 clinical data collection and enabling final statistical analysis to begin."

Trial completion • Obstructive Sleep Apnea

Incannex Reports Positive Topline Results from RePOSA Phase 2 Trial of IHL-42X (GlobeNewswire) - P2/3 | N=560 | (NCT06146101) | Sponsor: Incannex Healthcare Ltd | "The low-dose and high-dose IHL-42X groups achieved a statistically significant reduction in percent change in AHI from baseline compared to placebo (p<0.05), the primary measure of OSA severity. Maximum reductions in AHI were observed at up to 83% for the high-dose group and up to 79% for the low-dose group...The low-dose IHL-42X group showed statistically significant improvement (p<0.05), reflecting meaningful patient-perceived benefits...Statistically significant improvement in the low-dose group, suggesting enhanced daytime alertness and reduced fatigue...Wake After Sleep Onset (WASO): Reduced by 29.8% in the high-dose arm, meaning patients spent less time awake during the night; AHI During Supine Sleep: Decreased by 30.3% in the high-dose arm....In parallel, Incannex will continue to evaluate all clinical data and complete the full Clinical Study Report in the coming months."

P2 data • Obstructive Sleep Apnea

Incannex Healthcare Expands Clinical Advisory Board to Support Obstructive Sleep Apnea Program with Appointment of Dr. Douglas B. Kirsch (GlobeNewswire) - "Incannex Healthcare Inc...announces the appointment of Douglas B. Kirsch, M.D., FAAN, FAASM to its IHL-42X Obstructive Sleep Apnea (OSA) Clinical Advisory Board."

Clinical • Obstructive Sleep Apnea

Incannex achieves key milestone with database lock for RePOSA Phase 2 trial of IHL-42X (GlobeNewswire) - "Incannex Healthcare Inc...is pleased to announce that it has achieved database lock for the RePOSA Phase 2 clinical trial of IHL-42X, its lead drug candidate for obstructive sleep apnoea (OSA), on schedule as of 16 June 2025...The Company is on track to deliver top-line results in July 2025..."

P2 data • Trial status • Obstructive Sleep Apnea

Incannex Healthcare Inc. Advances IHL-42X RePOSA Trial to Phase 3 Following FDA Protocol Clearance (GlobeNewswire) - "Incannex Healthcare Inc....announced that the Phase 3 component of the RePOSA clinical trial will proceed. The U.S. Food and Drug Administration (FDA) previously reviewed and authorized the protocol to proceed under the Company’s Investigational New Drug (IND) application. The study will evaluate the efficacy and safety of IHL-42X, Incannex’s lead asset for the treatment of obstructive sleep apnea (OSA)—a condition affecting an estimated one billion people globally with no approved oral pharmaceutical therapy...With the FDA authorization in place, Incannex will initiate Phase 3 immediately following the completion of Phase 2, leveraging a shared protocol and U.S. based infrastructure to maximize efficiency and speed....The study will also include a 3-month head-to-head comparison against the monotherapy components of IHL-42X — dronabinol and acetazolamide — to demonstrate the synergistic effect of the combination therapy."

Clinical protocol • FDA event • Trial status • Obstructive Sleep Apnea

Incannex Healthcare Inc. Provides Clinical Program Update on IHL-42X, an Oral Once-Daily Treatment for Obstructive Sleep Apnea (OSA) (GlobeNewswire) - "Patient dosing in the Phase 2 portion of the Phase 2/3 study was completed on May 8, 2025. End-of-study follow-up assessments are expected to conclude by May 17, 2025 and topline data is anticipated in July 2025. Ahead of the data readout, Incannex is preparing for an end-of-Phase 2 meeting with the FDA to discuss results and next steps toward a 505(b)(2) NDA submission; RePOSA Phase 3 planning is underway and will be conducted exclusively at U.S. sites to improve operational efficiency. This decision was supported by U.S. clinical site and patient enthusiasm. The study will recruit 440 patients across sites including those rolled over from the Phase 2 trial portion; As the asset advances in clinical development, Incannex has started to engage in preliminary commercial discussions that reflect growing interest in the IHL-42X program and its position in the OSA treatment market."

Commercial • FDA event • P2 data • Trial status • Obstructive Sleep Apnea

The impact of acetazolamide and dronabinol on the physiological endotypes responsible for obstructive sleep apnea. (PubMed, Sleep Med) - "Mechanistically, our findings suggest that medium and high doses of Aceta-Dro primarily reduce OSA severity by lowering loop gain, while the efficacy of the low dose was due to improved airway collapsibility."

Journal • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA (clinicaltrials.gov) - P2/3 | N=560 | Active, not recruiting | Sponsor: Incannex Healthcare Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Incannex Healthcare Completes Phase 2 Enrollment in RePOSA Phase 2/3 Trial of IHL-42X, an Oral Once-Daily Treatment for Obstructive Sleep Apnea (OSA) (GlobeNewswire) - "Incannex Healthcare Inc...announced that the Company has completed Phase 2 patient enrollment in the global Phase 2/3 RePOSA study of IHL-42X for the treatment of Obstructive Sleep Apnea (OSA). IHL-42X is an oral fixed dose combination medicine designed to reduce the incidence of interruptions to breathing during sleep and improve sleep quality...The RePOSA Phase 2/3 is a randomized, double-blind clinical trial designed to evaluate the safety and efficacy of IHL-42X in patients with mild to severe OSA, who are intolerant, non-compliant, or naïve to positive airway pressure (PAP) therapy. At least 560 patients will be recruited, with a total of 355 patients receiving IHL-42X over the course of the study....A topline readout from the U.S. Phase 2 portion is anticipated in the first half of 2025."

Enrollment status • P2 data • Obstructive Sleep Apnea

Incannex Healthcare Inc. Announces Pricing of $12.5 Million Private Placement Priced at the Market Under Nasdaq Rules (GlobeNewswire) - "Incannex Healthcare Inc...announced that it has entered into security purchase agreements with certain institutional investors for the purchase and sale of 11,574,090 shares of the Company’s common stock for a purchase price of $1.08 per share of common stock (or common stock equivalents in lieu thereof) and Series A common stock warrants (the 'Series A Warrants') to purchase up to 11,574,090 shares of common stock at an initial exercise price of $2.16 per share (the 'Offering'). The Offering is being priced at the market under Nasdaq rules....Incannex intends to use the net proceeds from the private placement to fund ongoing clinical trials, including the completion and topline readout of the U.S. Phase 2 study of IHL-42X, an oral, once-daily treatment for OSA, and its expansion into the Phase 3 portion of the study, with sites in the U.K. and the U.S. The proceeds will also be used for the repayment of outstanding convertible debentures..."

Financing • Obstructive Sleep Apnea

Incannex Healthcare Inc. Reports Fiscal Second Quarter 2025 Financial Results and Business Updates (GlobeNewswire) - "'Looking ahead, we are committed to executing our clinical programs and are energized by the upcoming catalysts, including the top-line readout from the U.S. Phase 2 portion of the IHL-42X trial expected in the first half of 2025.'"

P2 data • Obstructive Sleep Apnea

Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs (clinicaltrials.gov) - P1 | N=125 | Completed | Sponsor: Incannex Healthcare Ltd | Active, not recruiting ➔ Completed | Trial completion date: Apr 2025 ➔ Jul 2024

Trial completion • Trial completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs (clinicaltrials.gov) - P1 | N=116 | Active, not recruiting | Sponsor: Incannex Healthcare Ltd | Trial completion date: Dec 2024 ➔ Apr 2025 | Trial primary completion date: Dec 2024 ➔ Jul 2024

Trial completion date • Trial primary completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

A randomised dose finding study of combination dronabinol and acetazolamide for the treatment of obstructive sleep apnoea. (PubMed, Sleep) - "One week of nightly IHL-42X at low, medium, and high doses was well tolerated, safe and associated with significant reductions in OSA severity."

Journal • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs (clinicaltrials.gov) - P1 | N=116 | Active, not recruiting | Sponsor: Incannex Healthcare Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2024 ➔ Dec 2024 | Trial primary completion date: Jul 2024 ➔ Dec 2024

Enrollment closed • Trial completion date • Trial primary completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs (clinicaltrials.gov) - P1 | N=116 | Recruiting | Sponsor: Incannex Healthcare Ltd | Trial primary completion date: Apr 2024 ➔ Jul 2024

Trial primary completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA (clinicaltrials.gov) - P2/3 | N=560 | Recruiting | Sponsor: Incannex Healthcare Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA (clinicaltrials.gov) - P2/3 | N=560 | Not yet recruiting | Sponsor: Incannex Healthcare Ltd | Initiation date: Jan 2024 ➔ Apr 2024

Trial initiation date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder