Nexalis Therapeutics, which recently changed its name from InhaleRx, has announced the initiation of a Phase 1 trial of its IRX-616a cannabidiol MDI, which the company is developing for the treatment of panic disorder. In August 2025, InhaleRx announced that it had received approval for the Phase 1 SAD trial, which is expected to enroll up to 24 healthy adults and is expected to be completed by mid-2026.
In addition to IRX-616a, Nexalis’s pipeline also includes IRX211 inhaled dronabinol for the treatment of breakthrough cancer pain. A Phase 1 trial of IRX211 was conducted in 2023. The company says that it intends to pursue the 505(b)(2) pathway for both inhalers.
Nexalis Therapeutics CEO Darryl Davies commented, “Commencing dosing in our Phase 1 IRX-616a study is a major milestone. We look forward to the upcoming SRC assessment as we continue to advance IRX-616a toward addressing the unmet need in acute panic and anxiety-related conditions.”
Read the Nexalis Therapeutics press release
