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IRX-616A

Development stage: Unknown
Lead developer: Nexalis Therapeutics
Modality: Small Molecules
Administration: Inhalation

Overview

IRX-616A is an inhaled formulation of cannabidiol (CBD) delivered via a metered-dose inhaler (MDI). Developed by Nexalis Therapeutics (formerly InhaleRx Ltd), it is designed as a rapid-acting, non-opioid treatment for Panic Disorder. The drug is intended to provide acute relief by utilizing the inhalation route to achieve rapid systemic absorption and a fast onset of action, addressing the need for immediate intervention during panic attacks. IRX-616A is being developed through the FDA's 505(b)(2) regulatory pathway. As of 2025, the program has transitioned into Phase 1 clinical testing following the approval of a Single Ascending Dose (SAD) trial.

Other names: cannabidiol MDIinhaled cannabidiol

Targets

SCN4A (Voltage-gated sodium channel protein type 4 subunit alpha)CNR1 (Cannabinoid receptor 1)

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