Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as IHL-42X Low Dose
IHL-42X · 3 trials · 2 indications
To assess the change in efficacy at the end of each dosing period compared with baseline.
Phase 2 - Assess the change in AHI compared to baseline
Assess the proportion of IHL-42X that is taken up and enters the circulation post dose.
Compare the proportion of IHL-42X taken up and enters the circulation to the reference listed drugs for dronabinol and acetazolamide. It will be determined whereby 90% confidence interval for the ratio of averages of measures Cmax and AUC0-inf for IHL-42X and the reference listed drug.
Assess the effect of food on the uptake and absorption of IHL-42X by measuring Cmax (Maximum observed drug concentration)
Assess the effect of food on the uptake and absorption of IHL-42X by measuring Tmax (time of the maximum drug concentration)
Assess the effect of food on the uptake and absorption of IHL-42X by measuring AUC0-last (Area under the drug concentration-time curve, from time zero to time of last measurable concentration)
Assess the effect of food on the uptake and absorption of IHL-42X by measuring AUC0-inf (Area under the drug concentration-time curve from time zero to infinity)
Assess the effect of food on the uptake and absorption of IHL-42X by measuring AUC0-12h (Area under the drug concentration-time curve from time zero to 12 hours)
Assess the effect of food on the uptake and absorption of IHL-42X by measuring AUC0-24h (Area under the drug concentration-time curve from time zero to 24 hours)
Assess the effect of food on the uptake and absorption of IHL-42X by measuring t1/2 (the elimination half-life)
Assess the effect of food on the uptake and absorption of IHL-42X by measuring kel (Terminal elimination rate constant)
Assess the effect of food on the uptake and absorption of IHL-42X by measuring CL/F (Apparent total body clearance)
Assess the effect of food on the uptake and absorption of IHL-42X by measuring Vz/F (Apparent volume of distribution)
| Arm | Type | Description |
|---|---|---|
| IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide | EXPERIMENTAL | IHL-42X (2.5 mg dronabinol + 125 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. |
| IHL-42X: 5 mg dronabinol + 125 mg acetazolamide | EXPERIMENTAL | IHL-42X (5 mg dronabinol + 125 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. |
| IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide | EXPERIMENTAL | IHL-42X (7.5 mg dronabinol + 125 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. |
| IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide | EXPERIMENTAL | IHL-42X (2.5 mg dronabinol + 250 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. |
| IHL-42X: 5 mg dronabinol + 250 mg acetazolamide | EXPERIMENTAL | IHL-42X (5 mg dronabinol + 250 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. |
| IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide | EXPERIMENTAL | IHL-42X (7.5 mg dronabinol + 250 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. |
| IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide | EXPERIMENTAL | IHL-42X (2.5 mg dronabinol + 375 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. |
| IHL-42X: 5 mg dronabinol + 375 mg acetazolamide | EXPERIMENTAL | IHL-42X (5 mg dronabinol + 375 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. |
| IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide | EXPERIMENTAL | IHL-42X (7.5 mg dronabinol + 375 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. |
| Placebo: Negative control | PLACEBO_COMPARATOR | One capsule self-administered once daily every night approximately 1 hour prior to bed for 4 weeks |
| Phase 2 Investigational Product - IHL-42X Low dose | EXPERIMENTAL | IHL-42X (2.5 mg dronabinol + 125 mg acetazolamide), one capsule self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. |
| Phase 2 Investigational Product - IHL-42X High dose | EXPERIMENTAL | IHL-42X (5 mg dronabinol + 250 mg acetazolamide), one capsule self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. |
| Phase 2 Placebo | PLACEBO_COMPARATOR | One capsule self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. |
| Phase 3 Investigational Product - IHL-42X | EXPERIMENTAL | IHL-42X (dose will be identified based on the safety and efficacy results in Phase II), one capsule self-administered once daily every night approximately 1 hour prior to bed for 52 weeks. |
| Phase 3 Comparator - Reference Listed Drug/Dronabinol | ACTIVE_COMPARATOR | One capsule of dronabinol (equivalent dose strength to that in the IHL-42X optimal dose strength) self-administered once daily every night approximately 1 hour prior to bed for 3 months then IHL-42X (optimal dose) one capsule self-administered once daily every night approximately 1 hour prior to bed for the remaining 9 months. |
| Phase 3 Comparator - Reference Listed Drug/Acetazolamide | ACTIVE_COMPARATOR | One capsule of acetazolamide (equivalent dose strength to that in the IHL-42X optimal dose strength) self-administered once daily every night approximately 1 hour prior to bed for 3 months then IHL-42X (optimal dose) one capsule self-administered once daily every night approximately 1 hour prior to bed for the remaining 9 months. |
| Phase 3 Placebo | PLACEBO_COMPARATOR | One capsule self-administered once daily every night approximately 1 hour prior to bed for 52 weeks. |
| Comparator Arm A- Reference Listed Drug/Marinol | ACTIVE_COMPARATOR | dronabinol 5 mg, two capsules of 2.5 mg administered on an empty stomach once only in the study period |
| Comparator Arm B-Reference Listed Drug/Taro Acetazolamide | ACTIVE_COMPARATOR | 250 mg acetazolamide, one tablet administered on an empty stomach once only in the study period |
| Investigational Product Arm C-IHL42X Fasted | EXPERIMENTAL | IHL-42X (5 mg dronabinol, 250 mg acetazolamide), one capsule administered on an empty stomach once only in the study period |
| Investigational Product Arm D-IHL42X Fed | EXPERIMENTAL | IHL-42X (5 mg dronabinol, 250 mg acetazolamide), one capsule administered after food once only in the study period |
| Name | Type | Description |
|---|---|---|
| IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide | DRUG | DReAMzz Phase 2 Investigational Product - IHL-42X Dose 1 |
| IHL-42X: 5 mg dronabinol + 125 mg acetazolamide | DRUG | DReAMzz Phase 2 Investigational Product - IHL-42X Dose 2 |
| IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide | DRUG | DReAMzz Phase 2 Investigational Product - IHL-42X Dose 3 |
| IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide | DRUG | DReAMzz Phase 2 Investigational Product - IHL-42X Dose 4 |
| IHL-42X: 5 mg dronabinol + 250 mg acetazolamide | DRUG | DReAMzz Phase 2 Investigational Product - IHL-42X Dose 5 |
| IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide | DRUG | DReAMzz Phase 2 Investigational Product - IHL-42X Dose 6 |
| IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide | DRUG | DReAMzz Phase 2 Investigational Product - IHL-42X Dose 7 |
| IHL-42X: 5 mg dronabinol + 375 mg acetazolamide | DRUG | DReAMzz Phase 2 Investigational Product - IHL-42X Dose 8 |
| IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide | DRUG | DReAMzz Phase 2 Investigational Product - IHL-42X Dose 9 |
| Placebo: Negative control | DRUG | DReAMzz Phase 2 Placebo |
| IHL-42X Low Dose | DRUG | Softgel capsule |
| IHL-42X High Dose | DRUG | Softgel capsule |
| Placebo | DRUG | Softgel capsule |
| IHL-42X (Optimal Dose) | DRUG | Softgel capsule |
| Dronabinol | DRUG | Softgel capsule |
| Acetazolamide | DRUG | Softgel capsule |
| IHL42X | DRUG | IHL-42X consists of acetazolamide and dronabinol. |
| Acetazolamide 250 MG | DRUG | A solid tablet containing 250 mg acetazolamide |
| Dronabinol 2.5 MG | DRUG | A soft gelatin capsules containing 2.5mg dronabinol |
Inclusion Criteria Participants must satisfy all the following criteria at screening unless otherwise stated: 1. Aged ≥18 and ≤65 years of age at the time of consent. 2. Two screening PSG findings confirmed on central over-read that both must meet the below criteria: 1. AHI4 ≥5 2. ≤25% cent...
IHL-42X is an investigational small molecule therapy being developed for obstructive sleep apnea (OSA). It is a fixed-dose combination of dronabinol and acetazolamide. Incannex Healthcare Inc. (IXHL) is developing it as a potential treatment option for adults with OSA, a respiratory condition in which breathing repeatedly stops and starts during sleep.
IHL-42X combines two small molecule active ingredients, dronabinol and acetazolamide. Dronabinol is a cannabinoid, and acetazolamide is a carbonic anhydrase inhibitor. The combination is designed to act on the mechanisms that contribute to obstructive sleep apnea, though the specific molecular target of the combination has not been publicly characterized in the available trial documentation.
IHL-42X is being developed by Incannex Healthcare Inc., which trades under the ticker IXHL. The company is advancing the drug as a combination of dronabinol and acetazolamide for obstructive sleep apnea and has conducted Phase 1 and Phase 2 clinical trials of the candidate.
IHL-42X is in Phase 2 clinical development for obstructive sleep apnea. It has completed a Phase 1 bioavailability and bioequivalence study and a Phase 2 efficacy study, and a Phase 2 dose confirmation crossover trial is currently recruiting. The drug is investigational and has not been approved by the FDA.
IHL-42X has been studied in three clinical trials. The completed Phase 2 RePOSA trial (NCT06146101) enrolled 121 patients with OSA in the United States. The completed Phase 1 trial (NCT05857384) enrolled 125 healthy volunteers in Australia. The ongoing Phase 2 DReAMzz dose confirmation crossover study (NCT07635563) is recruiting 120 participants in the United States.