InhaleRx
InhaleRx Ltd is an Australian biotechnology company specializing in precision medicine delivered through inhalation. The company is actively pursuing new drug approvals with the U.S. FDA for pain and mental health management, focusing on developing safe, effective, rapid-onset inhaled therapies to address unmet clinical needs in pain and mental health markets. Their long-term goal is to develop first-to-market, medically registered inhaled medical cannabis delivery systems, leveraging FDA pathways and partnerships for clinical trials and device registration.
Industries
Nr. of Employees
small (1-50)
InhaleRx
Level 9, 505 Little Collins Street, Melbourne, VIC, 3000
Products
Medical inhaler device platform with disposable pods
A medical-grade inhaler system designed to deliver proprietary inhalable liquid formulations via single-use pod cartridges, intended to achieve rapid onset and high bioavailability for acute indications.
Clinical asset: inhaled rapid-onset analgesic for breakthrough cancer pain
A clinical-stage inhaled, non-opioid analgesic candidate developed for rapid management of breakthrough cancer pain; completed Phase I safety studies and progressed toward Phase II.
Clinical asset: inhaled therapy candidate for panic disorder
An inhaled therapeutic candidate being developed to treat panic disorder and acute anxiety episodes, with IND submission activity and planned clinical studies.
Medical inhaler device platform with disposable pods
A medical-grade inhaler system designed to deliver proprietary inhalable liquid formulations via single-use pod cartridges, intended to achieve rapid onset and high bioavailability for acute indications.
Clinical asset: inhaled rapid-onset analgesic for breakthrough cancer pain
A clinical-stage inhaled, non-opioid analgesic candidate developed for rapid management of breakthrough cancer pain; completed Phase I safety studies and progressed toward Phase II.
Clinical asset: inhaled therapy candidate for panic disorder
An inhaled therapeutic candidate being developed to treat panic disorder and acute anxiety episodes, with IND submission activity and planned clinical studies.
Services
Design and execution support for early-phase and Phase II clinical trials, including ethics submissions, study orders and CRO partnerships.
Collaborative engineering and design services to develop inhaler hardware suitable for medical device registration and clinical use.
Preparation of Pre‑IND materials, IND and 505(b)(2) pathway planning to support US FDA engagement and downstream regulatory approvals.
Provisioning and coordination of GMP-compliant manufacturing for investigational product and device supply to support clinical study timelines.
Pilot market launches, distribution access via prescriber networks, and partnership arrangements for third-party formulation development for device pods.
Design and execution support for early-phase and Phase II clinical trials, including ethics submissions, study orders and CRO partnerships.
Collaborative engineering and design services to develop inhaler hardware suitable for medical device registration and clinical use.
Preparation of Pre‑IND materials, IND and 505(b)(2) pathway planning to support US FDA engagement and downstream regulatory approvals.
Provisioning and coordination of GMP-compliant manufacturing for investigational product and device supply to support clinical study timelines.
Pilot market launches, distribution access via prescriber networks, and partnership arrangements for third-party formulation development for device pods.
Expertise Areas
- Inhalation therapeutics
- Clinical trial management (early phase and Phase II)
- Medical device development and design
- Regulatory strategy for FDA (505(b)(2), Pre‑IND/IND)
Key Technologies
- Inhalation drug-delivery platforms
- Pod-based aerosolisation systems
- Inhalable liquid formulation development
- Rapid-onset pharmacokinetic formulation strategies
News & Updates
Webinar with Darryl Davies discussing company updates and progress.
Announcement of the company's annual report and governance updates.
Funding announcement to support clinical development of inhaled therapies.
Summary of recent general meeting outcomes.
Phase I trials for IRX-211 have been completed with no significant adverse events, demonstrating safety.
Webinar with Darryl Davies discussing company updates and progress.
Announcement of the company's annual report and governance updates.
Funding announcement to support clinical development of inhaled therapies.
Summary of recent general meeting outcomes.
Phase I trials for IRX-211 have been completed with no significant adverse events, demonstrating safety.