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IRX616a is an investigational inhaled drug-device combination developed by Nexalis Therapeutics (formerly InhaleRx) for the acute treatment of panic disorder and anxiety episodes. The product utilizes synthetic cannabidiol (CBD) delivered via a pressurized metered-dose inhaler (pMDI) at a dose of 2.5 mg per actuation. By utilizing the inhalation route, IRX616a is designed to bypass first-pass hepatic metabolism, facilitating rapid systemic absorption and a fast onset of action, which is critical for managing acute psychiatric episodes. The pharmacological profile of CBD involves the modulation of the endocannabinoid system through CB1 and CB2 receptors, as well as partial agonism at the serotonin 5-HT1A receptor. As of 2024, IRX616a has completed Phase 1 single ascending dose clinical trials in healthy volunteers and is being prepared for Phase 2 studies.
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