Top-line results expected July 2025 as development of first-in-class OSA drug advances NEW YORK and MELBOURNE, Australia, June 18, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, is pleased to announce that it has achieved database lock for the RePOSA Phase 2 clinical... Read More

Expanded platform improves access, scales operations, and advances Incannex’s position in next-generation mental health treatment NEW YORK and MELBOURNE, Australia, June 17, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, announces entering into a 50:50 joint venture... Read More

Capital structure streamlined and potential dilution from Series A Warrants eliminated ahead of key Phase 2 clinical milestones NEW YORK and MELBOURNE, Australia, June 12, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, announces it has successfully canceled all... Read More

NEW YORK and MELBOURNE, Australia, June 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company leading the way in developing oral combination medicines, today announced the recent appointment of four distinguished experts to its IHL-42X Obstructive Sleep Apnea (OSA) Clinical Advisory Board: Scott A. Sands, Ph.D., Associate Professor of... Read More

Streamlined U.S.-only study design builds on Phase 2 momentum for IHL-42X in obstructive sleep apnea NEW YORK and MELBOURNE, Australia, May 29, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage pharmaceutical company developing novel combination therapies, today announced that the Phase 3 component of the RePOSA clinical trial will proceed. The U.S. Food and Drug Administration (FDA)... Read More

MELBOURNE, Australia and NEW YORK, May 28, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, today announced that it has entered into a binding agreement to cancel the remaining 172 million Series A Warrants issued under a previous financing arrangement contingent upon Incannex paying the Series A... Read More

Raises $12.5M via ATM to Strengthen Shareholder Position Ahead of IHL-42X Phase 2 Data NEW YORK and MELBOURNE, Australia, May 20, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company pioneering the development of combination drug therapies, today announced the successful completion of a $16.7 million gross proceeds capital raise through its... Read More

NEW YORK and MELBOURNE, Australia, May 16, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (“Incannex”), a clinical-stage biopharmaceutical company leading the way in developing oral combination medicines, announced its entry on May 15, 2025 into agreements with the outstanding holders of its Series A Warrants (the “Letter Agreements”) permitting Incannex to potentially reduce up to 50.4% of the shares of... Read More

NEW YORK and MELBOURNE, Australia, May 15, 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 March 31, 2025. “The third quarter of 2025 represents a pivotal period of progress for Incannex... Read More

Patient dosing completed in Phase 2 portion of Phase 2/3 RePOSA study evaluating IHL-42X oral treatment for OSA. End-of-study follow-up assessments on track for completion by May 17, 2025. Topline results expected in July 2025. NEW YORK and MELBOURNE, Australia, May 14, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company leading the way in developing oral... Read More

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... Read More

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... Read More

Positive IHL-42X PK findings for the treatment of Obstructive Sleep Apnea (OSA) support future 505(b)(2) New Drug Application (NDA) submission New 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... Read More

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... Read More

Demonstrated bioavailability of IHL-42X, Incannex’s proprietary combination formulation, confirming delivery of both dronabinol and acetazolamide Achieved 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... Read More

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... Read More

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... Read More

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... Read More

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)... Read More

A new survey conducted by Quantum Research Group, LLC finds that more than half of patients diagnosed with sleep apnea are not satisfied with their current treatment. Nearly 70 percent of patients express a willingness to switch to a prescribed pill-form treatment. New York, New York--(Newsfile Corp. - September 9, 2024) - Quantum Research Group, LLC just published the results of a new survey entitled "Understanding... Read More

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)... Read More

IHL-42X is a fixed dose combination drug targeting obstructive sleep apnea (OSA), a medical condition with no available registered pharmaceutical treatment for millions of sufferers in the USA alone. bioavailability/bioequivalence (‘BA/BE’) clinical trial assessed the pharmacokinetics and tolerability of IHL-42X consistent with FDA development plan. Analysis of data underway, however, no serious adverse events were reported.... Read More

NEW YORK and MELBOURNE, Australia, May 30, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies 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... Read More

MELBOURNE, Australia and NEW YORK, May 07, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex or the Company), a leading cannabinoid and psychedelic medicine biotechnology company, 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... Read More

MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Clinical stage pharmaceutical development company, Incannex Healthcare Inc. (NASDAQ: IXHL), (‘Incannex’ or the ‘Company’), is pleased to provide quarterly activities update and for the quarter ended 31 March 2024. Incannex is undertaking various U.S. Food and Drug Administration (‘FDA’) research and development (‘R&D’) programs for cannabinoid pharmaceutical products... Read More

Highlights: PsiGAD1 trial achieves primary endpoint; PsiGAD psilocybin-assisted therapy demonstrated a statistically significant HAM-A reduction of 12.8 points from baseline, representing a 9.2-point improvement over psychotherapy with placebo (p <0.0001), exceeding the company’s expectations. 44% of patients in the psilocybin... Read More

MELBOURNE, Australia and NEW YORK, Feb. 16, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex or the Company), a leading cannabinoid and psychedelic medicine biotechnology company, 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-N for tobacco smoking cessation and... Read More

Highlights: Clarion’s Head of Psychiatry, Professor Suresh Sundram, has been approved by the TGA to prescribe MDMA for Post-traumatic Stress Disorder and psilocybin for Treatment-resistant Depression, alongside extensive psychotherapy. Clarion Clinics’ built-for-purpose clinic in Melbourne is now open for treatment, and will begin screening patients immediately. Clarion Clinics represents Australia’s leading track record in... Read More

MELBOURNE, Australia and NEW YORK, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a pharmaceutical company developing novel medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies for unmet medical needs, is pleased to announce that patient dosing has commenced in the Phase 2 clinical trial assessing IHL-675A in patients with rheumatoid arthritis... Read More

Highlights: 72 patients treated at purpose-built facilities within Monash University, Melbourne, Australia. Topline results from the trial anticipated within current Q1 2024. FDA IND application is well-advanced after commencing preparations in August, 2023. Independent documentary covering Monash Clinical Psychedelic Lab and PsiGAD research program to be released by SBS television network following 2 years of filming and... Read More

MELBOURNE, Australia and NEW YORK, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies is pleased to announce that an independent Institutional Review Board (IRB) has approved the protocol for the Company’s Phase 2/3 clinical trial to be conducted in the... Read More

Highlights: Incannex subsidiary, Clarion Clinics, has received Human Research Ethics Committee (HREC) endorsement for administration of psychedelic-assisted therapies for TRD and PTSD. HREC approval is required for the administration of psychedelic drugs in Australia. Clarion Clinics is the only dedicated psychedelic-assisted therapy clinic in Australia, with intentions to open more clinics across the country and... Read More

MELBOURNE, Australia and NEW YORK, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (‘Incannex’ or the ‘Company’), a pharmaceutical company developing unique medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies for unmet medical needs, is pleased to provide the following update on its proprietary IHL-42X drug candidate. Obstructive sleep apnea (OSA) is characterised by a... Read More

MELBOURNE, Australia and NEW YORK, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ: IXHL) is pleased to announce that its previously announced transaction to redomicile Incannex Healthcare from Australia to the United States has been implemented as of yesterday, November 28, 2023 New York time (November 29, 2023 Melbourne time). The shares of common stock of Incannex Healthcare Inc. issued yesterday in... Read More

MELBOURNE, Australia, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (ASX: IHL) (NASDAQ: IXHL) (the “ Company ” or “ Incannex ”) is pleased to announce that the Federal Court of Australia (“ Court ”) has today made orders approving the scheme of arrangement in relation to the Company’s proposed re-domiciliation from Australia to the United States (“ Scheme ”), under which Incannex Healthcare Inc. (“ Holdco ”)... Read More

MELBOURNE, Australia, Sept. 08, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a pharmaceutical company developing cannabinoid pharmaceutical medicines and psychedelic therapies for unmet medical needs, is pleased to announce that it will be featured as a presenting company at the H.C. Wainwright 25th Annual Global Investment Conference - September 11-13, 2023.... Read More

MELBOURNE, Australia, Aug. 24, 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 its subsidiary Psychennex Pty Ltd has commenced preparations of an investigational new drug... Read More

MELBOURNE, Australia, Aug. 22, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic assisted psychotherapies for unmet needs, is pleased to announce that it has received approval from the US Food and Drug Administration (‘FDA’) to conduct the Company’s... Read More

Highlights: Incannex subsidiary, Clarion Clinics Group Pty Ltd (Clarion) begins accepting registrations of interest in its psychedelic-assisted therapy (PAT) treatments ahead of planned Q3 opening. First clinic in Abbotsford, Melbourne, nearing fit-out completion. Clarion’s bespoke protocol involves a thorough pre-treatment assessment process, including psychiatric evaluation/diagnosis, medical assessment, and psychological... Read More

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... Read More

MELBOURNE, Australia, July 26, 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 completed a constructive pre-Investigational New Drug Application (‘pre-IND’) meeting... Read More

MELBOURNE, Australia, July 21, 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 successfully submitted an Investigational New Drug (‘IND’) application to the US Food... Read More

Highlights: Incannex has engaged Fortrea as the contract research organisation (‘CRO’) to manage the IND opening Phase 2/3 clinical trial investigating IHL-42X for treatment of OSA. The Phase 2/3 clinical trial will assess the safety and efficacy of IHL-42X in people with OSA who are intolerant, non-compliant, or naïve to continuous positive airway pressure (‘CPAP’). The extensive trial will be conducted across 45 sites,... Read More

Highlights: Incannex has received approval from HREC for the lead site, Emeritus Research, Camberwell, VIC for the Phase 2, Blinded, Placebo Controlled Clinical Trial to Determine the Effect on Pain and Function of IHL-675A in Patients with Rheumatoid Arthritis. The Phase 2 trial follows a successful Phase 1 trial where IHL-675A was observed to be well tolerated and safe. It follows animal study observations of IHL-675A... Read More

Highlights: Incannex to redomicile to the United States via a Scheme of Arrangement pursuant to Australian law A newly formed Delaware corporation (Incannex Healthcare Inc.) will become the ultimate parent company of the group, following implementation of the Scheme of Arrangement The shares of common stock issued by Incannex Healthcare Inc. in exchange for all outstanding ordinary shares of Incannex, pursuant to the Scheme... Read More

Highlights: Incannex has received approval from Bellberry Human Research Ethics Committee (‘HREC’) to commence the bioavailability/bioequivalence (‘BA/BE’) clinical trial to assess the pharmacokinetics and tolerability of IHL-42X The trial will include 116 participants at CMAX Clinical Research in South Australia and will be managed by Novotech Data from the clinical trial will be a critical component of future marketing... Read More

MELBOURNE, Australia, June 23, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a pharmaceutical company developing medicinal cannabinoid pharmaceutical products and psychedelic therapies for unmet medical needs, is pleased to announce that it will be featured as a presenting company at the H.C. Wainwright 4 th Annual Neuropsychiatry Virtual Conference. The... Read More

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... Read More

Highlights: Three world-leading clinical psychedelics experts join Clarion Clinics Advisory Board. Dr. Bill Richards is among the world’s best known psychedelic researchers and practitioners. He has had a multi-decade career at the forefront of psychedelic research, therapy, and training, and is a mentor and trainer to numerous research groups around the world. He co-founded the psychedelic research group at Johns Hopkins... Read More

MELBOURNE, Australia, May 16, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Ltd (Nasdaq: IXHL) (ASX: IHL) (‘Incannex’ or ‘the Company’) is pleased to announce a company presentation which details activities of its psychedelic therapies subsidiary company, called Psychennex. Incannex Healthcare 5/16 Presentation Incannex Contact Information: Incannex Healthcare Limited Mr Joel Latham Managing Director and Chief Executive... Read More

MELBOURNE, Australia, May 05, 2023 (GLOBE NEWSWIRE) - - Incannex Healthcare Ltd (Nasdaq: IXHL) (ASX: IHL) (‘Incannex’ or ‘the Company’), a medicinal cannabinoid and psychedelic pharmaceutical development company, is delighted to announce that its subsidiary company, Clarion Clinics Group Pty Ltd, has entered a lease for riverfront premises in Abbottsford, Melbourne. The premises will be used to provide psychedelic-assisted... Read More

MELBOURNE, Australia, May 03, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Ltd (Nasdaq: IXHL) (ASX: IHL) (‘Incannex’ or ‘the Company’) is pleased to announce a company presentation containing data and analysis of the results from the Phase 1 clinical trial undertaken to assess safety and pharmacokinetics of IHL-675A as an anti-inflammatory drug candidate. Click here to access the presentation Incannex Contact Information:... Read More

MELBOURNE, Australia, May 02, 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... Read More

MELBOURNE, Australia, April 14, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Ltd (Nasdaq: IXHL) (ASX: IHL) (‘Incannex’ or ‘the Company’) a pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic assisted psychotherapies for unmet medical needs, is pleased to announce that is has appointed Quest Pharmaceutical Services (‘QPS’) to provide regulatory advice and manage clinical trials for the... Read More

Highlights: Incannex plans to open multiple psychedelic-assisted psychotherapy clinics in Australia and overseas. First clinic will open in Melbourne in 2023, followed by rapid expansion based on development of sound operating model. Dr. Paul Liknaitzky, Professor Suresh Sundram and Sean O’Carroll to join the Board of Directors of a subsidiary company and take key roles within the venture. Incannex owned subsidiary is being... Read More

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... Read More

Highlights: Incannex has engaged Catalent for the development and cGMP manufacture of Incannex’s own psilocybin drug product. The psilocybin is designed for use in Incannex’s ongoing psilocybin-assisted psychotherapy “PsiGAD” clinical development program for generalised anxiety disorder and for potential future commercial use or supply as a cGMP pharmaceutical grade product. Development of the drug product includes... Read More

Highlights: Incannex has commenced a Phase 2, Blinded, Placebo Controlled Clinical Trial to Determine the Safety and Effect on Pain and Function of IHL-675A in Patients with Rheumatoid Arthritis. The Phase 2 trial follows a successful Phase 1 trial, where IHL-675A was observed to be well tolerated, and animal studies whereby IHL-675A was observed to reduce inflammatory disease scores to a greater extent than... Read More

MELBOURNE, Australia, Jan. 18, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’), a pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that the PsiGAD1 clinical trial, designed to assess Incannex’s psilocybin-assisted psychotherapy for the treatment of... Read More

MELBOURNE, Australia, Nov. 29, 2022 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing medicinal cannabinoid and psychedelic therapies for unmet medical needs, is delighted to announce that it has engaged multinational contract development and manufacturing organisation (CDMO) Eurofins Scientific (‘Eurofins’) to... Read More

Incannex has engaged CMAX Clinical Research and Novotech CRO to undertake a bioavailability/bioequivalence (‘BA/BE’) study to assess the pharmacokinetics and tolerability of IHL-42X in 116 participants Incannex is well progressed in drafting an Investigational New Drug (‘IND’) Application for submission to the US Food and Drug Administration (‘FDA’) in Q1 of 2023 Once the IND is open, Incannex will commence pivotal,... Read More

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... Read More

Highlights: Patient dosing has been completed in the Phase 1 clinical trial measuring the safety, tolerability, and pharmacokinetic profiles of IHL-675A IHL-675A has been well tolerated, with no adverse events of concern reported to date Incannex is arranging Phase 2 studies for patients with rheumatoid arthritis and planning Phase 2 studies for patients with inflammatory bowel disease and lung inflammation Incannex is... Read More

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 completed a constructive pre-Investigational New Drug Application (‘pre-IND’) meeting with the U.S. Food and Drug Administration (‘FDA’) for its... Read More

Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a pharmaceutical company developing medicinal cannabinoid pharmaceutical products and psychedelic therapies for unmet medical needs, is pleased to announce that it will be featured as a presenting company at the H.C. Wainwright 24 th Annual Global Investment Conference. The conference is being held as a hybrid event on September 12-14, 2022,... Read More

Highlights: Highly experienced pharmaceutical executive with 20+ years at Pfizer and 10+ years at Novo Nordisk Secured 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 Affairs Personal leadership of more than 15 successful US FDA Advisory Committee Meetings on behalf of Novo Nordisk and Pfizer Nationally recognized... Read More

Highlights: Incannex have engaged Curia to scale up cGMP fill-finish manufacture of IHL-216A Engagement of Curia follows achievement of "proof-of-concept" formulation development A patent has been filed on the composition of IHL-216A The first cGMP batch of IHL-216A manufactured at Curia will be used in a phase 1 clinical trial Incannex is targeting a pre-IND meeting with FDA in Q3 2022 to discuss the most efficient clinical... Read More

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... Read More

Highlights: Bellberry human research ethics committee approved the phase 1 clinical trial investigating safety and pharmacokinetics of IHL-675A on July 20, 2022 The trial will be performed at CMAX Clinical Research, a dedicated and experienced clinical trial centre in Australia , and managed by Avance Clinical The trial will assess the pharmacokinetics, safety, and tolerability of combination cannabinoid drug IHL-675A Trial... Read More

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, today announced that Dr. Paul Liknaitzky , Head of Clinical Psychedelic Research at Monash University and Chief Principal Investigator for Incannex's psilocybin-assisted... Read More

Highlights: IHL-42X reduced primary endpoint apnoea hypopnea index relative to baseline at all three doses that were assessed Low dose IHL-42X exhibited superior safety and efficacy metrics to mid and high doses Low dose IHL-42X reduced AHI by an average of 50.7% compared to baseline with 25% of participants experiencing a reduction in the apnoea hypopnea index of greater that 80% Oxygen desaturation index was reduced by... Read More

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 completed a highly constructive Pre-Investigational New Drug Application ('pre-IND') meeting with the U.S. Food and Drug Administration ('FDA') to... Read More

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, advises that it has entered into a Share Sale and Purchase Agreement to acquire 100% of the issued share capital in APIRx Pharmaceuticals USA , LLC ( APIRx ) ( Acquisition ). The... Read More

Highlights: The study compared IHL-216A to its component drugs, cannabidiol (CBD) and isoflurane, in a model developed in collaboration with the US National Football League (NFL) IHL-216A restored spatial memory after twenty-four hours in injured rodent models whilst those that only received the vehicle as treatment did not... Read More

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... Read More

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, today announced that it has finalised its loyalty option offer to shareholders to raise A$23.6M . Loyalty options expired on April 22, 2022 and a total of 67.3M new shares are to... Read More

Highlights: APIRx has twenty-two (22) active clinical and pre-clinical research and development projects therapeutic candidates are targeted at treating pain, dementia, Parkinson's disease, restless leg syndrome, gastrointestinal diseases, periodontitis, addiction disorders, skin conditions and ophthalmic conditions therapeutic candidates are underpinned by an extensive intellectual property portfolio that includes 19... Read More

Highlights: 20% of trial participants experienced a reduction in AHI of greater than 80% (range: 82.7% to 91.5%) during at least one treatment compared to baseline 60% of trial participants experienced a reduction in AHI of greater than 50% (range: 55.0% to 91.5%) during at least one treatment compared to baseline Average of low, mid and high-dose IHL-42X reduced AHI in trial participants by 44.4%, compared to baseline... Read More