logo-loader

Incannex Healthcare targeting $120 billion global addressable market with cannabinoid and psychedelic therapeutics

Last updated: 13:31 10 Feb 2022 AEDT, First published: 12:39 10 Feb 2024 AEDT

Snapshot

  • Incannex Healthcare completes pre-IND meeting with FDA for new tobacco cessation treatment
  • Incannex preparing psilocybin therapy FDA IND application
Incannex Healthcare Ltd - Incannex is targeting $120 billion global addressable market with cannabinoid and psychedelic therapeutics

About the company

Incannex Healthcare Inc is a clinical-stage pharmaceutical development company that is developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of generalised anxiety disorder (GAD), obstructive sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease.

U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. 

How it is doing

19 Feb 2024

Incannex Healthcare Inc (NASDAQ:IXHL) has welcomed feedback from the US Federal Drug Administration in a pre-investigational new drug (IND) meeting concerning the development of CannQuit-N, a treatment designed to help patients quit smoking tobacco and control relapses.

The FDA provided several recommendations on key design aspects of the proposed clinical trials for CannQuit-N, including the timing of efficacy endpoints and specific details on safety endpoints.

The FDA also confirmed IXHL’s proposed strategies for manufacturing and quality control are appropriate.

The successful meeting marks an important milestone in the development of CannQuit-N, plotting a pathway to continued development of the product within the FDA’s framework.

01 Feb 2024

Incannex Healthcare Inc (NASDAQ:IXHL), a pharmaceutical company developing novel medicinal cannabinoid pharmacotherapies and psychedelic medicine therapies for unmet medical needs, has started patient dosing in a Phase 2 clinical trial assessing IHL-675A in patients with rheumatoid arthritis (RA).

IHL-675A is the company’s proprietary combination drug candidate composed of Hydroxychloroquine Sulfate (HCQ) and cannabidiol (CBD), both of which have well-characterized anti-inflammatory activity when administered individually.

17 Nov 2023

Incannex Healthcare Inc, the soon-to-be parent company of Incannex Australia Ltd, plans to appoint Computershare Trust Company, N.A. as its US transfer agent and registrar following the implementation of its schemes of arrangement.

The proposed scheme involves redomiciling Incannex Australia shares on the Nasdaq ahead of an ASX de-listing.

What management says

24 Aug 2023

Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) chief medical officer Dr Mark Bleakley tells Proactive the company is preparing an application to gain key regulatory approval to begin clinical trials in the US for its psilocybin-assisted psychotherapy development program (Psi-GAD). PsiGAD is a unique and proprietary form of therapy to treat patients with generalised anxiety disorder (GAD). Interim analysis for the Phase 2 Psi-GAD clinical trial in March at Monash University predicted a greater than 85% chance of the trial showing statistically significant benefit for the psilocybin treatment arm versus the placebo arm. Work on the draft IND application comes ahead of final results from the Psi-GAD clinical trial, which are expected in Q4 2023 or Q1 2024.

Incannex preparing psilocybin therapy FDA IND application

Incannex Healthcare Ltd (ASX:IHL, NASDAQ:IXHL) chief medical officer Dr Mark Bleakley tells Proactive the company is preparing an application to gain key regulatory approval to begin clinical trials in the US for its psilocybin-assisted psychotherapy development program (Psi-GAD). PsiGAD is a...

on 24/8/23