InhaleRx Limited
IRX.AX
Australian Securities Exchange0.03
AUD
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InhaleRx Limited
IRX.AX
(Australian Securities Exchange)
Recent
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0.03
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div
yld
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ROIC.AI
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- InhaleRx Limited (ASX:IRX) is an Australian biotechnology company that develops and commercializes inhaled drug-device combinations targeting unmet needs in pain management and mental health; its lead product candidates include IRX-211, a non-opioid pressurized metered dose inhaler formulation for breakthrough cancer pain (BTcP) that has completed Phase 1 clinical trials with no significant adverse events and is advancing to Phase 2, and IRX-616a, a preclinical-stage inhaled therapy for panic disorder (PD) with an investigational new drug (IND) application submitted to the U.S. Food and Drug Administration (FDA). The company pursues FDA new drug approvals (NDAs) for both programs, with supportive FDA feedback on regulatory pathways and plans for subsequent approvals from the European Medicines Agency (EMA) and Therapeutic Goods Administration (TGA); it targets large addressable markets, including a $9 billion U.S. cancer pain opportunity by 2028 and a $13.3 billion anxiety/depression sector by 2027. Founded in 2016 and headquartered in Sydney, Australia, with operations focused on Australia and global regulatory markets, InhaleRx recently secured a transformative up-to-$38.5 million funding facility from Clendon Biotech Capital in October 2024 to fully fund Phase 1 and 2 clinical development, non-clinical work, and manufacturing for IRX-211 and IRX-616a through to Phase 3 readiness; this partnership addresses FDA feedback on the IRX-616a IND and supports accelerated timelines amid rising demand for rapid-onset, non-opioid alternatives following fentanyl product withdrawals. Formerly known as Lifespot Health Ltd, the company changed its name in October 2021 to reflect its refined inhalation therapeutics strategy after winding up prior German subsidiaries in 2022.