Breaking through barriers to better care

Incannex is dedicated to developing and delivering innovative medicines for people living with chronic diseases and significant unmet needs. To ensure the safety, efficacy, and quality of these therapies, we are dedicated to conducting rigorous, large-scale clinical trials that generate the robust data required to support regulatory approvals by the U.S. Food and Drug Administration (FDA) and other global regulatory authorities.

Access to Incannex’s investigational therapies is currently limited to those participating in our clinical trials. This approach allows us to maintain the rigorous oversight necessary to ensure patient safety, while advancing the development of our innovative therapeutics in the most effective and expedient manner possible.

Expanded Access, sometimes referred to as “compassionate use,” is a mechanism that allows patients with serious or life-threatening conditions to access investigational therapies outside of clinical trials. While Incannex recognizes the importance of Expanded Access programs, we currently do not provide investigational therapies through such pathways. We believe that participation in clinical trials remains the most appropriate and equitable means of accessing our investigational therapies at this stage of development.

We are continuously evaluating the feasibility of Expanded Access programs and will adjust our policies, as appropriate, consistent with applicable regulatory guidelines and ethical considerations.

We encourage physicians and patients interested in our investigational therapies to review our ongoing clinical studies by visiting clinicaltrials.gov. Physicians interested in collaborating on clinical trials, or learning more about our investigational therapies may contact us directly.