Incannex Submits IND Application To The FDA For Dronabinol-Based Drug For Obstructive Sleep Apnea

Incannex Healthcare Limited IXHL IHL has successfully submitted an Investigational New Drug (‘IND’) application to the US Food and Drug Administration for IHL-42X for treatment of obstructive sleep apnea.

The IND dossier compiled by the Incannex team includes comprehensive modules on the safety and efficacy of IHL-42X and its component active pharmaceutical ingredients. It also includes detailed information on the development, manufacturing, quality and stability of the IHL-42X drug product, as well as the clinical protocol and investigator information for the phase 2/3 IND opening clinical trial.


The modules of the IND are:

  • Module 1 – Administrative information and prescribing information

  • Module 2 – Nonclinical/clinical overviews and summaries

  • Module 3 – Quality data

  • Module 4 – Nonclinical study reports and key literature rferences

  • Module 5 – Clinical study reports, clinical protocol and investigator information

The IND application details the clinical trial protocol for the IND opening clinical trial, which is a multi-site phase 2/3 clinical trial investigating IHL-42X for the treatment of obstructive sleep apnea (‘OSA’). This pivotal trial will assess IHL-42X at the best performing two doses from the successful phase 2 proof-of-concept clinical trial, in patients with OSA who are intolerant, non-compliant, or naïve to positive airway pressure, over a 52-week treatment period.

Participants will receive one of IHL-42X, dronabinol, acetazolamide or placebo for the entirety of the trial. All participants will complete daily surveys on their sleep quality, attend monthly clinic visits to assess functional outcomes of sleep, cognitive function and other measures of safety and efficacy. Every three months, overnight polysomnography will be conducted to determine the effect of treatment on the patients’ apnea hypopnea index score along with a range of other sleep parameters. All drug treatments will be compared to placebo.

Benzinga Cannabis Capital Conference

The Benzinga Cannabis Capital Conference, the place where deals get done, is returning to Chicago this Sept 27-28 for its 17th edition. Get your tickets today before prices increase and secure a spot at the epicenter of cannabis investment and branding.

Photo: Benzinga edit with photos by Matthias Zomer on Pexels and squarefrog on Pixabay

Related News

Fortrea To Manage Incannex's FDA IND Opening Phase 2/3 Trial Of Its Dronabinol-Based Drug For Obstructive Sleep Apnea

Market News and Data brought to you by Benzinga APIs
Posted In: CannabisNewsPenny StocksMarketspremium
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Cannabis rescheduling seems to be right around the corner

Want to understand what this means for the future of the industry? Hear directly for top executives, investors and policymakers at the 19th Benzinga Cannabis Capital Conference, coming to Chicago this Oct. 8-9. Get your tickets now before prices surge by following this link.