InhaleRx Unveils Oral Esketamine Therapy and Rebrands to Nexalis Therapeutics

Expanding Horizons Beyond Inhaled Therapies

InhaleRx Limited (ASX – IRX), a clinical-stage biotech company focused on pain management and mental health, has announced a significant strategic evolution. The company is preparing to rebrand as Nexalis Therapeutics, a move that reflects its transition from a sole focus on inhaled therapies to a broader drug development portfolio. This reclassification is driven by the addition of a promising new oral therapy, SRX-25, designed to treat treatment-resistant depression (TRD).

SRX-25 combines oral esketamine with a CYP-450 inhibitor to enhance drug bioavailability, potentially offering a more convenient and accessible alternative to existing intranasal esketamine treatments like Spravato. This innovation aims to address a substantial unmet need in the TRD market, which is projected to exceed USD 4 billion globally by 2030, with the U.S. representing over half of this market.

Robust Pipeline with Multiple Clinical Milestones

Alongside SRX-25, InhaleRx is advancing two other drug candidates – IRX-211, targeting breakthrough cancer pain (BTcP), currently entering Phase 2 clinical trials, and IRX-616a, aimed at panic disorder, which has received ethics approval to commence Phase 1 trials. Both candidates leverage inhaled delivery systems and have secured regulatory milestones, including FDA feedback and approvals from Human Research Ethics Committees.

The company has completed manufacturing for IRX-211 and IRX-616a, with patient dosing imminent. These programs are fully funded under a $52.3 million agreement with the Linlithgow Family Office, ensuring financial support through critical development phases. The combined addressable markets for these therapies are substantial, with BTcP estimated at USD 11 billion by 2028 and anxiety disorders and depression treatments projected to reach USD 13.3 billion by 2027.

Strategic Positioning and Future Outlook

InhaleRx’s approach leverages existing safety data and regulatory pathways, such as the 505(b)(2) route for SRX-25, to potentially accelerate development timelines and reduce costs. The company is positioning itself for value creation through licensing, co-development, or asset sales as it progresses toward Phase 3 readiness within three years.

Financially, InhaleRx maintains a market capitalization of approximately A$6.2 million with a cash balance of A$0.92 million as of December 2025, supported by committed funding for clinical trials. The leadership team, including CEO Darryl Davies and Non-Executive Chairman Sean Williams, is steering the company through this pivotal growth phase.

With the rebranding to Nexalis Therapeutics and a diversified pipeline addressing significant unmet clinical needs, the company is poised to capture emerging opportunities in both pain management and mental health sectors.