Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IHL-42X: dronabinol+ acetazolamide · 1 trial · 1 indication
To assess the change in efficacy at the end of each dosing period compared with baseline.
| 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 |
| 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 |
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 combination of dronabinol and acetazolamide 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.
IHL-42X combines dronabinol and acetazolamide. Dronabinol is a cannabinoid receptor agonist, and acetazolamide is a carbonic anhydrase inhibitor. The combination is being studied for its potential to treat Obstructive Sleep Apnea.
IHL-42X is being developed by Incannex Healthcare Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol IXHL.
IHL-42X is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The FDA has granted it Fast Track designation for the treatment of Obstructive Sleep Apnea.
IHL-42X is being studied in a Phase 2 clinical trial with the identifier NCT07635563, titled 'DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.' The trial is recruiting participants in the United States.
Yes, IHL-42X is a combination of 2.5 mg dronabinol and 125 mg acetazolamide. It is being investigated for the treatment of Obstructive Sleep Apnea.