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

Story Highlights
  • Nexalis Therapeutics has started a Phase 1 trial of IRX-616a, an inhaled cannabidiol therapy for panic disorder, assessing safety, tolerability and pharmacokinetics in healthy volunteers.
  • The study uses a rapid-onset inhalation approach with Safety Review Committee oversight and aims to complete dosing by June 2026, paving the way for a Phase 2 trial in patients.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Nexalis starts first-in-human trial of inhaled CBD therapy for panic disorder

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

Nexalis Therapeutics has begun dosing participants in a first-in-human Phase 1 clinical trial of IRX-616a, an inhaled cannabidiol-based aerosol being developed for the treatment of panic disorder. The randomised, double-blind, placebo-controlled single ascending dose study in healthy volunteers is designed to evaluate the drug’s pharmacokinetics, safety and tolerability, with up to 24 participants enrolled across three cohorts.

The inhalation delivery of IRX-616a via a metered-dose inhaler aims to achieve rapid systemic absorption and fast onset for acute panic and anxiety-related indications, potentially addressing a significant unmet need. The trial is progressing under the oversight of an independent Safety Review Committee, with dose escalation decisions expected from an early April review and completion of dosing targeted before the end of June 2026, positioning Nexalis for a subsequent Phase 2 trial in patients and reinforcing its strategy in rapid-onset neuropsychiatric therapies.

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 (ASX: NX1) is an Australian clinical-stage drug development company focused on rapid-onset therapies for pain management and mental health conditions. 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: 244,173

Technical Sentiment Signal: Strong Sell

Current Market Cap: A$6.33M

Find detailed analytics on NX1 stock on TipRanks’ Stock Analysis page.

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