Nexalis Therapeutics has initiated its Phase 1 trial for IRX-616a, an inhaled cannabidiol treatment aimed at panic disorder, marking a significant step in developing rapid-onset anxiety therapies.
- Phase 1 trial underway with first participant recruited
- Randomised, double-blind, placebo-controlled design in healthy volunteers
- Inhaled CBD delivery for rapid systemic absorption
- Study to assess pharmacokinetics, safety, and tolerability
- Phase 2 trial planned to start mid-2026
Nexalis Therapeutics Advances Panic Disorder Treatment
Australian biotech Nexalis Therapeutics Ltd (ASX: NX1) has commenced its Phase 1 clinical trial for IRX-616a, an innovative inhaled cannabidiol (CBD) therapy targeting panic disorder. This first-in-human study represents a crucial milestone as the company seeks to address a significant unmet need in acute anxiety-related conditions.
The trial is designed as a randomised, double-blind, placebo-controlled, single ascending dose study involving up to 24 healthy adult volunteers. Conducted at CMAX in Adelaide, the study aims to characterise the pharmacokinetics (how the drug is absorbed and processed in the body), safety, and tolerability of IRX-616a. An independent Safety Review Committee will oversee dose escalation to ensure participant safety.
A Novel Delivery Platform for Rapid Onset
IRX-616a utilises a pressurised metered-dose inhaler to deliver 2.5 mg of CBD per actuation directly to the lungs. This inhalation route is designed to bypass first-pass metabolism in the liver, enabling rapid systemic absorption and a fast onset of action; an important feature for treating acute panic attacks where speed of relief is critical.
Currently, there are no FDA-approved inhaled treatments for panic disorder, making Nexalis’ approach a potential world-first. The company’s CEO, Darryl Davies, emphasised the importance of establishing a robust pharmacokinetic and safety profile in this early-stage trial as a foundation for future clinical development.
Market Opportunity and Next Steps
Panic disorder is a debilitating condition characterised by sudden, recurrent panic attacks and ongoing anxiety about future episodes. The broader market for anxiety and depression treatments is projected to reach USD 13.3 billion by 2027, highlighting the commercial potential for effective new therapies.
Nexalis plans to complete dosing in the Phase 1 trial by the end of June 2026, with Phase 2 trials in patients expected to commence shortly thereafter. The company has secured funding of up to $52.3 million to accelerate development of IRX-616a alongside other pipeline candidates targeting breakthrough cancer pain and treatment-resistant depression.
As the trial progresses, Nexalis will provide updates on key milestones, with investors and the market watching closely for safety data and early indications of efficacy.
Bottom Line?
Nexalis’ inhaled CBD therapy could redefine acute panic disorder treatment if early trials confirm safety and rapid action.
Questions in the middle?
- How will IRX-616a’s safety profile compare to existing anxiety treatments?
- What are the timelines and endpoints planned for the upcoming Phase 2 trial?
- Could inhaled CBD expand to other acute anxiety or mental health indications?