Incannex Healthcare Limited engages in the research, development, and sale of medicinal cannabinoid products in Australia. It offers pharmaceutical grade cannabinoid products under the Incannex brand name. The company's products include IHL-42X, which is in Phase II clinical trials for obstructive sleep apnea; IHL-216A for traumatic brain injury; and IHL-675A, a combination of hydroxychloroquine and cannabidiol for the prevention and treatment of inflammatory lung conditions, such as acute respiratory distress syndrome, chronic obstructive pulmonary disease, asthma, and bronchitis, as well as rheumatoid arthritis and inflammatory bowel diseases. It has partnership with The Alfred Hospital and Novotech on IHL-42X clinical program for obstructive sleep apnea; and Monash Trauma Group at the Department of Neuroscience, Monash University to conduct a study on the protective effect of IHL-216A in sports concussion. The company was formerly known as Impression Healthcare Limited and changed its name to Incannex Healthcare Limited in June 2020. Incannex Healthcare Limited was incorporated in 2001 and is based in Sydney, Australia.
IPO Year:
Exchange: NASDAQ
Website: https://www.incannex.com.au
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MELBOURNE, Australia, July 27, 2022 /PRNewswire/ -- Clinical stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL) (NASDAQ:IXHL), ('Incannex' or the 'Company'), is pleased to provide its quarterly activities report and appendix 4C for the period ended 30 June 2022. Incannex is undertaking a multitude of U.S. Food and Drug Administration ('FDA') programs for cannabinoid pharmaceutical products and psychedelic medicine therapies administered by health professionals. Cannabinoid IHL-42X: positive phase 2a clinical trial results in patients with obstructive sleep apnoea In June 2022, Incannex announced positive results from full analysis of its phase 2 clinical trial o
Highlights: Positive phase 2a clinical trial results for IHL-42X with 60% of trial participants experiencing at least a 55% reduction in the Apnoea Hypopnea Index ('AHI') 20% of IHL-42X clinical trial participants experienced a reduction in AHI of greater than 80% completes comprehensive in vivo study on the neuroprotective capability of IHL-216A with results being analysed to be released within 2-3 weeks treatment commences in the phase 2a clinical trial to assess psilocybin and specialised psychotherapy for the treatment of generalised anxiety disorder initiates a second clinical psychedelic therapy program in a leading-edge academic field of virtual reality (VR) exposure response therapy
NEW YORK and MELBOURNE, Australia, April 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ:IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing new oral combination medicines, today 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). IHL-42X is an oral fixed dose combination medicine designed to reduce the incidence of interruptions to breathing during sleep and improve sleep quality. "We are excited to have achieved this milestone and deeply grateful to our investigators, site coordinators, and, especially to the sleep apne
NEW YORK and MELBOURNE, Australia, March 07, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ:IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing oral combination medicines, today announced that it has entered into security purchase agreements with certain institutional investors for the purchase and sale of 11,574,090 shares of the Company's common stock for a purchase price of $1.08 per share of common stock (or common stock equivalents in lieu thereof) and Series A common stock warrants (the "Series A Warrants") to purchase up to 11,574,090 shares of common stock at an initial exercise price of $2.16 per share (the "Offering"). The Offeri
Positive IHL-42X PK findings for the treatment of Obstructive Sleep Apnea (OSA) support future 505(b)(2) New Drug Application (NDA) submissionNew OSA Clinical Advisory Board Announced; Appoints Dr. Alison Wimms, Representing ResMed NEW YORK and MELBOURNE, Australia, Feb. 14, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ:IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing oral combination medicines, today reported fiscal second quarter financial results and provided business highlights for the quarter ended December 31, 2024. "Patients with obstructive sleep apnea need new and convenient therapeutic options to manage this serious, chroni
NEW YORK and MELBOURNE, Australia, Feb. 04, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ:IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing combination medicines today announced the appointment of Alison Wimms, Ph.D. as an advisor to its newly formed IHL-42X Obstructive Sleep Apnea (OSA) Clinical Advisory Board where she will represent ResMed. Dr. Wimms brings two decades of sleep medicine industry and research expertise to her advisory role at Incannex. Dr. Wimms holds a Doctor of Philosophy (Ph.D.) in Medicine, and Master of Medicine (Sleep Medicine) and Bachelor of Science degrees from the University of Sydney. "Incannex's
Demonstrated bioavailability of IHL-42X, Incannex's proprietary combination formulation, confirming delivery of both dronabinol and acetazolamideAchieved similar PK and equivalent total drug exposure levels of IHL-42X and the reference listed drugs (RLD) for dronabinol and acetazolamide, building a scientific bridge to established safety and toxicology data with the potential to support a future FDA 505(b)(2) new drug application (NDA)Pharmacokinetic results for IHL-42X will inform analysis of anticipated Phase 2/3 data assessing IHL-42X in patients with obstructive sleep apneaContinued excellent safety and tolerability findings, with no serious adverse events reported NEW YORK and MELBOURN
NEW YORK and MELBOURNE, Australia, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ:IXHL), (Incannex), a clinical-stage biopharmaceutical company developing innovative medicines for people with chronic diseases and significant unmet medical needs, today reported fiscal first quarter financial results and provided business highlights for the quarter ended September 30, 2024. "The first quarter reflects ongoing progress for Incannex, building on the momentum of a transformative year. Our commitment to pioneering novel oral synthetic cannabinoid combination therapeutics and our oral synthetic psilocybin treatment remains strong, and we look forward to sharing further update
NEW YORK and MELBOURNE, Australia, Oct. 24, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ:IXHL), (Incannex), a clinical-stage biopharmaceutical company developing innovative medicines for people with chronic diseases and significant unmet medical needs, today announced the appointment of Lou Barbato, M.D., as Chief Medical Officer (CMO) effective immediately. Dr. Barbato's drug development experience includes senior clinical development and operational roles at Jazz Pharmaceuticals, AbbVie, Biogen, Novartis, and Solvay. He joins Incannex as the company continues to advance its lead clinical-stage programs in obstructive sleep apnea, generalized anxiety disorder, and rheumatoid
Announced strategic financing with Arena Investors, providing access to up to $59.0 million USD in gross proceeds to Incannex Announced positive top-line results from our Phase 2 proof-of-concept clinical trial of PSX-001, known as the PsiGAD1 study, in which synthetic psilocybin in combination with psychotherapy was observed to significantly reduce anxiety scores and to be well tolerated in patients with generalised anxiety disorder (GAD) Commenced dosing in the RePOSA Phase 2/3 clinical trial of IHL-42X, an oral investigational treatment for patients with obstructive sleep apneaReceived Investigational New Drug (IND) application clearance from the U.S. Food and Drug Administration (FDA) t
NEW YORK and MELBOURNE, Australia, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ:IXHL), (the "Company" or "Incannex"), a clinical-stage biopharmaceutical company developing life-changing medicines for people with chronic diseases and significant unmet medical needs, today announced it has entered into an agreement to issue up to $10 million in secured convertible notes to Arena Investors, LP (Arena) and its affiliates. Under the terms of the agreements, Incannex will also secure a $50 million equity line of credit (ELOC) with Arena affiliate, Arena Business Solutions ("ABS"), which the Company does not anticipate drawing upon at closing. "We are pleased to be partner
Approval from FDA to proceed with 94 patient Phase 2 clinical trial received following review of IND dossier containing information on the clinical trial, as well as safety and quality of the investigational drug product.PsiGAD2, short for Psilocybin for Generalised Anxiety Disorder trial two, follows the PsiGAD1 proof of concept trial, which demonstrated a 12.8 point reduction in the Hamilton Anxiety Rating Sacle (HAM-A) score from baseline in the psilocybin treatment group. NEW YORK and MELBOURNE, Australia, Aug. 05, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ:IXHL), (‘Incannex' or the ‘Company'), a clinical-stage pharmaceutical company developing proprietary medicinal c
Positive IHL-42X PK findings for the treatment of Obstructive Sleep Apnea (OSA) support future 505(b)(2) New Drug Application (NDA) submissionNew OSA Clinical Advisory Board Announced; Appoints Dr. Alison Wimms, Representing ResMed NEW YORK and MELBOURNE, Australia, Feb. 14, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ:IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing oral combination medicines, today reported fiscal second quarter financial results and provided business highlights for the quarter ended December 31, 2024. "Patients with obstructive sleep apnea need new and convenient therapeutic options to manage this serious, chroni
NEW YORK and MELBOURNE, Australia, Feb. 04, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ:IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing combination medicines today announced the appointment of Alison Wimms, Ph.D. as an advisor to its newly formed IHL-42X Obstructive Sleep Apnea (OSA) Clinical Advisory Board where she will represent ResMed. Dr. Wimms brings two decades of sleep medicine industry and research expertise to her advisory role at Incannex. Dr. Wimms holds a Doctor of Philosophy (Ph.D.) in Medicine, and Master of Medicine (Sleep Medicine) and Bachelor of Science degrees from the University of Sydney. "Incannex's
NEW YORK and MELBOURNE, Australia, Oct. 24, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ:IXHL), (Incannex), a clinical-stage biopharmaceutical company developing innovative medicines for people with chronic diseases and significant unmet medical needs, today announced the appointment of Lou Barbato, M.D., as Chief Medical Officer (CMO) effective immediately. Dr. Barbato's drug development experience includes senior clinical development and operational roles at Jazz Pharmaceuticals, AbbVie, Biogen, Novartis, and Solvay. He joins Incannex as the company continues to advance its lead clinical-stage programs in obstructive sleep apnea, generalized anxiety disorder, and rheumatoid
MELBOURNE, Australia, July 28, 2023 (GLOBE NEWSWIRE) -- Clinical stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL) (NASDAQ:IXHL), (‘Incannex' or the ‘Company'), is pleased to provide its quarterly activities report and appendix 4C for the period ended 30 June 2023. Incannex is undertaking a multitude of U.S. Food and Drug Administration (‘FDA') research and development (‘R&D') programs for cannabinoid pharmaceutical products and psychedelic medicine therapies administered by health professionals. Incannex Receives Ethics Approval for Bioequivalence/Bioavailability Clinical Trial for IHL-42X During the quarter, Inc
MELBOURNE, Australia, June 16, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (NASDAQ:IXHL) (ASX: IHL), (‘Incannex' or the ‘Company') a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has recruited two highly experienced lead principal investigators (PIs) for the IND opening Phase 2/3 clinical trial investigating IHL-42X for treatment of obstructive sleep apnoea (‘OSA'). Dr John D Hudson of FutureSearch Trials of Neurology, Austin, Texas and Dr Russell Rosenberg of Neurotrials Research Inc, Atlanta, Georgia. Recruiting the lead PIs is a cri
Highlights: Interim analysis of study data to date indicates that there is a greater than 85% chance (>85%, alpha error probability 0.05) of the study showing a statistically significant benefit for the psilocybin treatment arm versus the placebo treatment arm at the conclusion of the study period.An independent Data Safety Monitoring Board (DSMB) has reviewed data from Incannex's ongoing Phase 2 "PsiGAD" clinical trial and recommends no changes to study design.The trial team and DSMB have identified no safety concerns to date. MELBOURNE, Australia, March 15, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (NASDAQ:IXHL) (ASX: IHL), (‘Incannex' or the ‘Company') a pharmaceutical cann
MELBOURNE, Australia, Oct. 28, 2022 (GLOBE NEWSWIRE) -- Clinical stage pharmaceutical development company, Incannex Healthcare Limited (ASX: IHL) (NASDAQ:IXHL), (‘Incannex' or the ‘Company'), is pleased to provide its quarterly activities report and appendix 4C for the period ended 30 September 2022. Incannex is undertaking a multitude of U.S. Food and Drug Administration (‘FDA') programs for cannabinoid pharmaceutical products and psychedelic medicine therapies administered by health professionals. Positive preliminary results from Phase 1 clinical trial of IHL-675A During the quarter, Incannex received approval from the Bellberry Human Resear
Highlights: Highly experienced pharmaceutical executive with 20+ years at Pfizer and 10+ years at Novo NordiskSecured FDA registration and marketing approval for 12 significant new drugs in the past 10 years at Novo Nordisk in his capacity of Vice President – US Regulatory AffairsPersonal leadership of more than 15 successful US FDA Advisory Committee Meetings on behalf of Novo Nordisk and PfizerNationally recognized expert on FDA/EMA liaison interactions and US pharmaceutical advertising and promotional practicesDocumented success with FDA accelerated approval programs including Fast-Track, Orphan Drug, Breakthrough Therapy Designations, and Priority Reviews. MELBOURNE, Australia, Aug. 1