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Nexalis Advances Phase 1 Trial of Inhaled CBD Therapy for Panic Disorder

Story Highlights
  • Nexalis has completed first-cohort dosing and begun the second cohort in its Phase 1 trial of IRX-616a, an inhaled CBD therapy for rapid treatment of acute panic and anxiety episodes.
  • The 24-subject trial supports Nexalis’s strategy to target the large anxiety-treatment market with fast-acting inhaled drugs, with Phase 2 in patients planned after Phase 1 dosing concludes by June 2026.
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Nexalis Advances Phase 1 Trial of Inhaled CBD Therapy for Panic Disorder

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InhaleRx Limited ( (AU:NX1) ) has issued an announcement.

Nexalis Therapeutics has completed dosing of the first cohort of eight healthy volunteers in its Phase 1 first-in-human trial of IRX-616a, an inhaled cannabidiol formulation for rapid treatment of acute panic and anxiety episodes. Following a positive assessment of safety, tolerability and pharmacokinetics by the Safety Review Committee, dosing of the second cohort has begun at CMAX in Adelaide.

The study, involving up to 24 participants, is designed as a randomised, double-blind, placebo-controlled trial using a pressurised metered-dose inhaler to achieve rapid systemic absorption. With a large addressable market for anxiety and depression therapies and Phase 2 trials in patients planned after completion of Phase 1 dosing by late June 2026, the advancement of IRX-616a strengthens Nexalis’s position in addressing unmet needs in fast-acting treatments for anxiety-related disorders.

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. Its pipeline includes IRX-211 for breakthrough cancer pain, IRX-616a for panic disorder and SRX-25 for treatment-resistant depression, supported by up to $52.3 million in funding and targeting streamlined U.S. FDA approval pathways.

Average Trading Volume: 214,969

Technical Sentiment Signal: Sell

Current Market Cap: A$4.81M

For detailed information about NX1 stock, go to TipRanks’ Stock Analysis page.

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