Friday, May 20, 2022 8:14:35 AM
IHL-42X is a fixed dose combination of dronabinol and acetazolamide that is being developed as a treatment for obstructive sleep apnoea ('OSA') in adults. Incannex submitted a pre-IND meeting package and meeting request to the FDA in February 2022. The meeting package included an overview of the development program, and specific questions Incannex had on the regulatory requirements for opening an investigational new drug ('IND') application. Opening an IND is required to conduct clinical trials in the U.S and ensures that trials are designed so that they meet the data requirements necessary for FDA marketing approval.
Recent IXHL News
- Form 8-K - Current report • Edgar (US Regulatory) • 09/10/2024 12:00:12 PM
- Incannex Healthcare Announces Strategic Financing for up to $60 Million with Arena Investors • GlobeNewswire Inc. • 09/10/2024 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/10/2024 11:30:22 AM
- Form RW - Registration Withdrawal Request • Edgar (US Regulatory) • 09/10/2024 11:00:07 AM
- FDA Review of PsiGAD2 IND complete; clinical trial for Psilocybin Assisted Psychotherapy in Patients with Generalised Anxiety Disorder to Proceed • GlobeNewswire Inc. • 08/05/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/30/2024 01:00:09 PM
- Dosing completed in 115 participant bioavailability/bioequivalence clinical trial for proprietary sleep apnea drug candidate IHL-42X • GlobeNewswire Inc. • 07/30/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/30/2024 12:30:34 PM
- Patient dosing commenced in RePOSA Phase 2/3 Clinical Trial Protocol to Assess IHL-42X Drug in Patients with Obstructive Sleep Apnea • GlobeNewswire Inc. • 05/30/2024 11:30:00 AM
- Incannex Complete Successful Pre-IND Meeting with the FDA for CannQuit-O for treatment of opioid use disorder • GlobeNewswire Inc. • 05/07/2024 11:30:00 AM
- Incannex Healthcare Inc. Quarterly Update, Q1 2024 • GlobeNewswire Inc. • 04/16/2024 12:00:00 PM
- Incannex Announces Positive Topline Results from Phase 2 Psi-GAD1 Clinical Trial of Psilocybin in Generalised Anxiety Disorder • GlobeNewswire Inc. • 02/28/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/16/2024 01:00:11 PM
- Incannex Completes Successful Pre-IND Meeting with the FDA for CannQuit-N; a Novel Solution for Tobacco Smoking Cessation • GlobeNewswire Inc. • 02/16/2024 12:30:00 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/14/2024 11:16:51 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/01/2024 12:30:16 PM
- Clarion Clinics Open for Psychedelic-Assisted Treatments • GlobeNewswire Inc. • 02/01/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/24/2024 09:30:18 PM
- Incannex Commences Dosing in Phase 2 Clinical Trial Assessing IHL-675A in Patients with Rheumatoid Arthritis • GlobeNewswire Inc. • 01/24/2024 09:05:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/18/2024 02:08:33 PM
- Incannex Completes Dosing and Therapy in Phase 2 “PsiGAD” Clinical Trial Assessing Psilocybin-assisted Psychotherapy for Generalized Anxiety Disorder; Data Analysis Commences • GlobeNewswire Inc. • 01/18/2024 01:22:34 PM
- Incannex Receives IRB Approval for the RePOSA Phase 2/3 Clinical Trial Protocol to Assess IHL-42X Drug in Patients with Obstructive Sleep Apnea • GlobeNewswire Inc. • 01/17/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/17/2024 11:05:45 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/22/2023 11:07:13 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/22/2023 01:54:45 AM
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