This section highlights FDA-related milestones and regulatory updates for drugs developed by Incannex Healthcare (IXHL).
Over the past two years, Incannex Healthcare has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CannQuit-N, CannQuit-O, IHL-42X, and PSX-001. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CannQuit-N - FDA Regulatory Timeline and Events
CannQuit-N is a drug developed by Incannex Healthcare for the following indication: for tobacco smoking cessation and control of relapse.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CannQuit-N
- Announced Date:
- May 7, 2024
- Indication:
- for tobacco smoking cessation and control of relapse.
Announcement
Incannex Healthcare Inc. is pleased to announce the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of CannQuit-O for treatment of Opioid Use Disorder (OUD).
AI Summary
Incannex Healthcare Inc. recently announced a successful pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA). This important meeting focused on the company’s development of CannQuit-O, a promising new treatment for Opioid Use Disorder (OUD). The discussion provided valuable feedback from the FDA that will guide Incannex’s next steps in the research and development process.
During the meeting, Incannex Healthcare gained crucial insights into the FDA’s expectations for safety and efficacy. These insights will help the company plan further studies and compile the necessary documentation. The progress made in this meeting marks an important milestone, underlining the potential of CannQuit-O to offer a new therapeutic option for individuals suffering from opioid addiction. Incannex’s proactive collaboration with the FDA reflects its commitment to addressing the opioid crisis with innovative solutions.
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CannQuit-O - FDA Regulatory Timeline and Events
CannQuit-O is a drug developed by Incannex Healthcare for the following indication: for the treatment of opioid use disorder (OUD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CannQuit-O
- Announced Date:
- May 7, 2024
- Indication:
- for the treatment of opioid use disorder (OUD).
Announcement
Incannex Healthcare Inc announced the successful completion of a pre-investigational new drug meeting with the U.S. Food and Drug Administration (FDA) regarding the development of CannQuit-O for the treatment of opioid use disorder (OUD).
AI Summary
Incannex Healthcare Inc recently announced the successful completion of a pre-investigational new drug meeting with the U.S. Food and Drug Administration (FDA). In the meeting, the company discussed its plans for developing CannQuit-O, a new treatment aimed at addressing opioid use disorder (OUD). The discussions helped clarify the regulatory requirements for further development and potential clinical trials. This important milestone indicates that the FDA reviewed and provided guidance on Incannex’s approach, which may streamline the path for the drug's future development. The announcement underscores Incannex’s commitment to offering innovative solutions in the fight against opioid addiction. Working closely with the FDA, the company aims to ensure that CannQuit-O meets safety and efficacy standards as it moves forward in its development process.
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IHL-42X - FDA Regulatory Timeline and Events
IHL-42X is a drug developed by Incannex Healthcare for the following indication: Obstructive Sleep Apnoea (OSA).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IHL-42X
- Announced Date:
- June 18, 2025
- Indication:
- Obstructive Sleep Apnoea (OSA)
Announcement
Incannex Healthcare Inc. is pleased to announce that it has achieved database lock for the RePOSA Phase 2 clinical trial of IHL-42X, its lead drug candidate for obstructive sleep apnoea (OSA), on schedule as of 16 June 2025.
AI Summary
Incannex Healthcare Inc. announced it has reached a major milestone by achieving database lock for its RePOSA Phase 2 clinical trial of IHL-42X, its lead drug candidate for obstructive sleep apnoea (OSA), on schedule as of 16 June 2025. Database lock marks the end of clinical data collection and allows the start of final statistical analysis. This achievement confirms that all necessary patient data has been gathered for the trial, which is testing IHL-42X on patients with moderate to severe OSA who struggle with or refuse continuous positive airway pressure (CPAP) therapy.
The company is on track to share top-line results in July 2025, reinforcing its commitment to advancing a much-needed oral treatment for OSA. The milestone underscores Incannex’s strong clinical capabilities and dedication to tackling a condition that affects millions worldwide and remains underdiagnosed and undertreated.
Read Announcement- Drug:
- IHL-42X
- Announced Date:
- June 3, 2025
- Indication:
- Obstructive Sleep Apnoea (OSA)
Announcement
Incannex Healthcare Inc. announced the recent appointment of four distinguished experts to its IHL-42X Obstructive Sleep Apnea (OSA) Clinical Advisory Board
AI Summary
Incannex Healthcare Inc. recently appointed four top experts to its IHL-42X Obstructive Sleep Apnea (OSA) Clinical Advisory Board. The new members include Dr. Scott A. Sands, Associate Professor at Harvard Medical School and Director at Brigham and Women’s Hospital; Dr. Ali Azarbarzin, also from Harvard Medical School and Brigham and Women’s Hospital; Dr. Lora J. McGill, a board-certified neurologist and clinical researcher from Memphis; and Dr. Nancy Collop, Director of the Emory Sleep Center and Professor of Medicine and Neurology.
These experts bring a wide range of knowledge in sleep medicine and research. According to Incannex’s Chief Medical Officer, Dr. Lou Barbato, their guidance will be invaluable as the company advances IHL-42X, an oral once-daily treatment for OSA. Their experience in both academic and clinical settings is expected to further support the promising development of this treatment.
Read Announcement- Drug:
- IHL-42X
- Announced Date:
- May 29, 2025
- Indication:
- Obstructive Sleep Apnoea (OSA)
Announcement
Incannex Healthcare Inc announced that the Phase 3 component of the RePOSA clinical trial will proceed.
AI Summary
Incannex Healthcare Inc. announced that the Phase 3 component of its RePOSA clinical trial will soon begin. This important development will focus on assessing the safety and effectiveness of IHL-42X, the company’s lead asset designed to treat obstructive sleep apnea (OSA). OSA is a common condition that affects millions globally, and IHL-42X aims to become the first oral pharmaceutical treatment available for it.
The Phase 3 trial is set to start immediately after the successful completion of Phase 2, using a common protocol and a U.S.-based infrastructure to improve speed and efficiency. By running the trial solely in the United States, Incannex hopes to streamline site operations, reduce administrative complexity, and quickly bring valuable treatment options to patients in need.
Read Announcement- Drug:
- IHL-42X
- Announced Date:
- May 14, 2025
- Indication:
- Obstructive Sleep Apnoea (OSA)
Announcement
Incannex Healthcare Inc. today provided an update on its obstructive sleep apnea (OSA) clinical program and outlined key upcoming catalysts in the development of IHL-42X.
AI Summary
Incannex Healthcare recently provided an update on its obstructive sleep apnea (OSA) clinical program, focusing on the development of IHL-42X. The company announced that patient dosing in the Phase 2 portion of the Phase 2/3 RePOSA study is now complete. End-of-study follow-up assessments are expected to finish by May 17, 2025, with topline results anticipated in July 2025. These milestones set the stage for an upcoming end-of-Phase 2 meeting with the FDA to discuss the results and further steps, paving the way toward a potential 505(b)(2) NDA submission.
In addition, Incannex is planning the Phase 3 trial exclusively in the United States, a decision driven by positive feedback from U.S. clinical sites and trial participants. This strategic move, along with promising pharmacokinetic and safety data, supports IHL-42X as a potential breakthrough oral treatment for millions of patients with OSA.
Read Announcement- Drug:
- IHL-42X
- Announced Date:
- May 14, 2025
- Estimated Event Date Range:
- July 1, 2025 - July 31, 2025
- Target Action Date:
- July 1, 2025
- Indication:
- Obstructive Sleep Apnoea (OSA)
Announcement
Incannex Healthcare announced that Topline results expected in July 2025.
AI Summary
Incannex Healthcare announced that it expects topline results from the Phase 2 portion of its Phase 2/3 RePOSA study in July 2025. The study is evaluating IHL-42X, an oral treatment for obstructive sleep apnea (OSA). Patient dosing was completed recently, and end-of-study follow-up assessments will finish by May 17, 2025. With these key milestones met, the company is moving quickly toward data analysis. IHL-42X is designed to target two main pathways related to OSA, potentially offering a new oral treatment option that could benefit millions of patients worldwide. The upcoming topline results are seen as an important step for Incannex Healthcare, as positive data could lead to further regulatory discussions and help promote a shift from traditional mechanical therapies like CPAP devices to a more convenient oral medication.
Read Announcement- Drug:
- IHL-42X
- Announced Date:
- April 3, 2025
- Indication:
- Obstructive Sleep Apnoea (OSA)
Announcement
Incannex Healthcare Inc announced that the Company has completed Phase 2 patient enrollment in the global Phase 2/3 RePOSA study of IHL-42X for the treatment of Obstructive Sleep Apnea (OSA).
AI Summary
Incannex Healthcare Inc recently announced a key milestone in its global Phase 2/3 RePOSA study for IHL-42X, an innovative oral medication designed to treat Obstructive Sleep Apnea (OSA). The company successfully completed Phase 2 patient enrollment, enrolling over 120 participants in a four‐week dose-finding study. IHL-42X is a fixed-dose combination aimed at reducing breathing interruptions during sleep and improving overall sleep quality by targeting the physiological pathways involved in airway obstruction and CO2 buildup.
This fast enrollment reflects strong interest from both clinicians and the sleep apnea patient community in a new treatment option for OSA. The results from the Phase 2 segment will help determine the optimal dose strength to be used in the upcoming larger Phase 3 trial, moving one step closer to providing a potential new pharmaceutical option for managing this serious condition.
Read Announcement- Drug:
- IHL-42X
- Announced Date:
- January 23, 2025
- Indication:
- Obstructive Sleep Apnoea (OSA)
Announcement
Incannex Healthcare Inc. announced positive topline results from a completed pharmacokinetics (PK) and safety study of IHL-42X, a novel, oral fixed-dose combination of acetazolamide and dronabinol for the treatment of Obstructive Sleep Apnea (OSA).
AI Summary
Incannex Healthcare Inc. announced positive topline results from a pharmacokinetics (PK) and safety study of IHL-42X, a novel oral fixed-dose combination of acetazolamide and dronabinol intended for obstructive sleep apnea (OSA). The study confirmed that IHL-42X delivers both drugs effectively, showing bioavailability and PK profiles similar to the reference listed drugs. This finding builds a scientific bridge to established safety and toxicology data, supporting the potential for a future FDA 505(b)(2) new drug application if future Phase 2/3 trials continue to show positive results.
The trial, conducted in both fed and fasted conditions, revealed no significant food impact on acetazolamide exposure, although dronabinol levels increased when taken with food. Safety outcomes were positive, with no serious adverse events reported and most treatment-emergent adverse events being mild to moderate. These encouraging results lay the groundwork for further clinical studies in OSA patients.
Read Announcement- Drug:
- IHL-42X
- Announced Date:
- May 30, 2024
- Indication:
- Obstructive Sleep Apnoea (OSA)
Announcement
Incannex Healthcare Inc is pleased to announce that patient dosing has commenced in the Company's Phase 2/3 clinical trial to assess safety and efficacy of IHL-42X in patients with obstructive sleep apnea (‘OSA').
AI Summary
Incannex Healthcare Inc. has started patient dosing in its Phase 2/3 clinical trial for IHL-42X, a new fixed dose combination drug for treating obstructive sleep apnea (OSA). This trial aims to assess both the safety and the efficacy of IHL-42X in patients who are intolerant, non-compliant, or new to positive airway pressure treatments. The commencement of dosing marks an important milestone as it moves forward in addressing OSA, a condition that affects a large number of adults and has few effective, non-device-based treatments. Incannex hopes that IHL-42X will offer an alternative to traditional therapies, potentially reducing the impact of OSA on patients’ health and quality of life. The trial will further evaluate whether IHL-42X can provide a significant improvement in reducing sleep apnea symptoms and related complications.
Read Announcement- Drug:
- IHL-42X
- Announced Date:
- April 16, 2024
- Indication:
- Obstructive Sleep Apnoea (OSA)
Announcement
Incannex Healthcare Inc announced the quarterly activities update
AI Summary
Incannex Healthcare Inc. recently announced its quarterly activities update for the period ending 31 March 2024. The company highlighted progress in its FDA research and development programs for cannabinoid pharmaceutical products and psychedelic medicine therapies. Incannex is advancing several clinical trials, including a Phase 2/3 study of its IHL-42X drug candidate for Obstructive Sleep Apnea and Phase 2b studies for its IHL-675A candidate aimed at treating Rheumatoid Arthritis. Additionally, the company is preparing to initiate Phase 2b clinical trials for its Psi-GAD psilocybin treatment for generalized anxiety disorder. Incannex also unveiled the launch of its first Clarion Clinic, which will provide psychedelic-assisted psychotherapies in regulatory permissible locations. This update underscores the company's commitment to developing novel treatments in areas with significant unmet medical needs.
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PSX-001 - FDA Regulatory Timeline and Events
PSX-001 is a drug developed by Incannex Healthcare for the following indication: In Patients with Generalised Anxiety Disorder to Proceed.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PSX-001
- Announced Date:
- August 5, 2024
- Indication:
- In Patients with Generalised Anxiety Disorder to Proceed
Announcement
Incannex Healthcare Inc. announce that it has received approval from the US Food and Drug Administration (‘FDA') to conduct the Company's Investigational New Drug (‘IND') opening Phase 2 clinical trial.
AI Summary
Incannex Healthcare Inc. announced that it has received approval from the US Food and Drug Administration (FDA) to conduct its Phase 2 clinical trial under an Investigational New Drug (IND) application. The trial, known as PsiGAD2, will evaluate the company’s new psilocybin formulation, PSX-001, alongside psychotherapy for patients with generalized anxiety disorder. The IND dossier included detailed information on the clinical trial protocol, the safety and quality of the drug product, and the credentials of the lead trial investigator. Following the FDA’s 30-day review period, the study has been confirmed as safe to proceed. Approximately 94 patients in the United States and the United Kingdom will be enrolled, with dosing conducted under double-blind conditions. The trial will measure changes in anxiety levels using the Hamilton Anxiety Rating Scale, aiming to demonstrate improvements in patient outcomes.
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