Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IHL42X · 2 trials · 1 indication
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 |
|---|---|---|
| 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 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: 1. Aged ≥18 years of age 2. Screening polysomnography (PSG) findings confirmed on central over-read: 1. AHI ≥15 2. ≤ 25% central or mixed apneas/hypopneas 3. no Cheyne-Stokes respiration 4. total sleep time ≥ 2 hours 3. Intolerant, non-compliant, or naïve to PAP (No...
IHL42X is an investigational small molecule being developed for the treatment of Obstructive Sleep Apnea (OSA). It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug has received Fast Track designation from the FDA for this indication.
IHL42X is being developed by Incannex Healthcare Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol IXHL. The company is conducting clinical trials for this drug in the United States and Australia.
IHL42X is in Phase 2 clinical development for Obstructive Sleep Apnea. It has completed two clinical trials, including a Phase 1 bioavailability study and a Phase 2 efficacy study. The drug is investigational and has not received FDA approval.
IHL42X has completed two clinical trials. NCT05857384 was a Phase 1 study in Australia evaluating bioavailability, bioequivalence, and tolerability in 125 participants. NCT06146101 was a Phase 2 study in the United States, the RePOSA trial, which enrolled 121 patients with Obstructive Sleep Apnea.
No, IHL42X is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Obstructive Sleep Apnea. The FDA has granted Fast Track designation to IHL42X, which is intended to expedite the development and review of the drug.
Yes, IHL42X and IHL-42X refer to the same investigational drug. The clinical trial records use the name IHL-42X, while the drug is commonly referred to as IHL42X. Both names denote the same small molecule being developed by Incannex Healthcare Inc. for Obstructive Sleep Apnea.