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Nexalis starts first-in-human trial of inhaled CBD therapy for panic disorder

Story Highlights
  • Nexalis has initiated a Phase 1 trial of IRX-616a, an inhaled CBD aerosol, to assess pharmacokinetics, safety and tolerability in healthy volunteers as a potential rapid-onset treatment for panic disorder.
  • By advancing a first-of-its-kind inhaled therapy in a large anxiety market lacking FDA-approved inhaled options, Nexalis aims to complete Phase 1 dosing by June 2026 and rapidly progress to Phase 2 patient studies.
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Nexalis starts first-in-human trial of inhaled CBD therapy for panic disorder

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InhaleRx Limited ( (AU:NX1) ) has shared an update.

Nexalis Therapeutics has begun a Phase 1 first-in-human clinical trial of IRX-616a, an inhaled cannabidiol aerosol being developed as a rapid-onset treatment for panic disorder. The randomised, double-blind, placebo-controlled, single ascending dose study in up to 24 healthy volunteers at CMAX Adelaide will assess pharmacokinetics, safety and tolerability, with oversight from an independent Safety Review Committee.

The inhalation-based CBD formulation is designed to bypass first-pass metabolism and deliver fast systemic absorption, positioning Nexalis in a niche where no FDA-approved inhaled therapies for panic disorder currently exist. The company expects to complete dosing by the end of June 2026 and then move into a Phase 2 patient trial, targeting a share of the growing multi-billion-dollar global market for anxiety and depression treatments while advancing its broader rapid-onset CNS therapy portfolio.

The most recent analyst rating on (AU:NX1) stock is a Hold with a A$0.02 price target. To see the full list of analyst forecasts on InhaleRx Limited stock, see the AU:NX1 Stock Forecast page.

More about InhaleRx Limited

Nexalis Therapeutics Ltd, listed on the ASX as NX1, is an Australian clinical-stage drug development company focused on rapid-onset therapies for pain management and mental health. Its pipeline includes IRX-211 for breakthrough cancer pain, IRX-616a for panic disorder and SRX-25 for treatment-resistant depression, targeting U.S. FDA approval via accelerated regulatory pathways.

Average Trading Volume: 287,699

Technical Sentiment Signal: Sell

Current Market Cap: A$7.09M

See more insights into NX1 stock on TipRanks’ Stock Analysis page.

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