IHL - 42X - OSA | Incannex

IHL-42X Obstructive Sleep Apnoea (OSA)

IHL-42X is a novel cannabinoid combination product for treatment of Obstructive Sleep Apnoea (OSA).

People suffering from OSA have multiple interruptions in their breathing while asleep, which decreases oxygen uptake and has a detrimental effect on sleep quality. In turn this leads to daytime sleepiness and other consequences associated with poor sleep.
Current treatment options such as CPAP and dental devices have poor patient compliance due to discomfort and inconvenience. There are no FDA approved pharmacotherapies for OSA.
The two active pharmaceutical ingredients in IHL-42X, dronabinol (synthetic THC) and acetazolamide, each target a different component of the OSA pathology. Dual mechanisms of action mean there is the potential for a synergistic therapeutic effect. This could also lead to the benefit being achieved at lower dose levels, minimising potential side effects.
An effective pharmacotherapy for OSA will not only improve sleep and alertness but is also predicted to decrease the health risks associated with OSA including cardiovascular disease, depression, and cognitive deficits.

A proof-of-concept clinical trial has been completed.
- IHL-42X reduced AHI relative to baseline and improved patient reported sleep quality.
- IHL-42X was well tolerated.
- Low dose IHL-42X had the greatest reduction in AHI, 50.7% relative to baseline, and the THC levels were within legal limits for driving the morning after dosing.
- Click here for a presentation of the clinical trial results.
Multi-site, international Phase 2 and Phase 3 clinical trials performed under an FDA IND will follow in coming years.
Approval will be sought under the FDA505(b)2 pathway and then expanded globally.