Delays and FDA Protocol Changes Test InhaleRx’s Path to Breakthrough Approvals
InhaleRx has secured FDA alignment and ethics approvals to progress clinical trials for its inhaled therapies targeting breakthrough cancer pain and panic disorder, with patient dosing set to begin soon.
- FDA alignment achieved for IRX-211 Phase 2 trial design targeting breakthrough cancer pain
- Ethics approvals secured for Phase 2 IRX-211 and Phase 1 IRX-616a clinical trials
- Manufacturing of trial drugs underway; patient screening for IRX-211 expected in November
- Funding facility of $38.5 million secured to cover clinical development through Phase 2
- Focus on rapid, cost-effective regulatory pathways aiming for FDA New Drug Approvals
Clinical Progress and Regulatory Alignment
InhaleRx Limited (ASX, IRX), an Australian drug development company specialising in novel inhaled medicines, has reported significant progress in its clinical programs for two promising drug candidates, IRX-211 for breakthrough cancer pain (BTcP) and IRX-616a for panic disorder. The company has successfully engaged with the US Food and Drug Administration (FDA) to align its Phase 2 clinical trial design for IRX-211, marking a critical milestone in its regulatory pathway.
Following a truncated Pre-Investigational New Drug (PIND) application submitted in a Written Responses Only format, InhaleRx incorporated FDA feedback into its trial protocol, refining endpoints, inclusion criteria, and safety monitoring. This regulatory alignment has de-risked the BTcP program and paved the way for patient screening and dosing to commence imminently.
Ethics Approvals and Manufacturing Milestones
The company has secured Human Research Ethics Committee (HREC) approvals for both the Phase 2 IRX-211 trial and the Phase 1 IRX-616a trial, enabling clinical operations to move forward. Manufacturing of the trial drugs is well underway, with the pilot, active, and placebo batches for IRX-211 produced by Ab-Initio Pharma in Sydney. Manufacturing for IRX-616a is scheduled for the fourth quarter of 2025.
Clinical trial sites across Australia, including Vitalis, GenisisCare, Braeside Hospital, Liverpool Hospital, and CMAX in Adelaide, have been engaged and are preparing for site activation and staff training. The company is also qualifying additional sites to accelerate patient recruitment and trial execution.
Market Opportunity and Strategic Focus
IRX-211 targets a substantial unmet need in the cancer pain market, where no non-opioid inhaled treatments are currently FDA-approved. The market for breakthrough cancer pain is projected to reach nearly $11 billion USD by 2028. Meanwhile, IRX-616a addresses panic disorder, with the broader anxiety and depression treatment market estimated at $13.3 billion USD by 2027.
InhaleRx’s strategy focuses on rapid onset inhaled cannabinoid therapies, aiming to fill critical gaps in treatment options that currently rely heavily on opioids or lack inhaled delivery methods. The company’s clinical programs are designed to leverage accelerated regulatory pathways, such as the FDA’s 505(b)(2) process, to bring these therapies to market efficiently.
Financial and Operational Discipline
InhaleRx continues to manage its capital prudently, reporting a net cash outflow of $310,000 for the quarter ending 30 September 2025. The company benefits from a $38.5 million funding facility secured through Clendon, now assigned to Linlithgow Family Office Pty Ltd, which covers clinical development costs through Phase 2 trials. This financial backing provides a solid runway for the company’s near-term objectives.
Operational expenditures remain tightly controlled, with clinical development and corporate costs carefully monitored. Payments to directors and key personnel reflect a disciplined approach aligned with shareholder-approved performance rights.
Looking Ahead
With patient screening for the IRX-211 Phase 2 trial expected to begin in November 2025, InhaleRx is poised to advance its clinical programs into critical data-generating phases. The company’s commitment to FDA approval and market entry for both indications underscores its potential to impact significant therapeutic areas with high unmet needs.
Bottom Line?
As InhaleRx prepares to dose its first patients, the coming months will be pivotal in validating its inhaled therapies and advancing toward FDA approval.
Questions in the middle?
- How quickly can InhaleRx recruit and dose patients to meet its trial timelines?
- What additional regulatory feedback might emerge as trials progress?
- Will further funding be required beyond the current facility to complete Phase 3 development?
