About Us

Incannex is a clinical stage pharmaceutical company developing proprietary medicinal cannabinoid drugs and psychedelic medicine therapies.

We have a diversified portfolio of 28 distinct research and development (R&D) programs, 6 clinical trials underway and more being planned.
Our key drug candidates are aimed at treating obstructive sleep apnoea (OSA), rheumatoid arthritis, inflammatory bowel disease, lung inflammation (ARDS, COPD, asthma, bronchitis), traumatic brain injury (TBI) and concussion, anxiety disorders, addiction disorders, and pain, among other indications.

Our mission

28 Clinical Programs, 1 Primary Goal – Alleviate Human Suffering.

Our mission is to alleviate human suffering by creating novel and ethical drugs and therapies for patients with unmet medical needs using compounds and delivery systems that have strong pre-existing scientific signals of efficacy. In all instances, we are working on fulfilling regulatory approval by the US Food and Drug Administration (FDA), and other relevant regulatory agencies. The clinical indications we pursue include inadequately addressed medical conditions, representing compelling short and long-term commercial opportunities for our shareholders.
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Develop & Focus

We have developed combination cannabinoid drugs (CBD or THC combined with expired patent pharmaceutical compounds) observed to have superior therapeutic outcomes to cannabinoids alone, affording the company valuable patent opportunities, based on synergistic drug actions. We develop cannabinoid drugs with novel delivery systems not seen in the marketplace before. We also work on providing psychotherapies combined with psychedelic agents for superior mental health outcomes through our subsidiary Psychennex.

FDA Registration and Patents

We are pursuing FDA registration and marketing approval for each product and therapy under development. Incannex also has a strong patent filing strategy, holding 19 granted patents and 30 pending patent applications over its portfolio of R&D programs.

To achieve our goals, we intend to:

Advance our novel drug candidates to FDA approval in the US and elsewhere

Pre-clinical and clinical trials are structured to ensure that each R&D program is FDA compliant. We intend to undertake New Drug Applications (NDAs) with the FDA for each of our key drug candidates. Subject to NDA approval, the product may be marketed in the United States. Once approved in the United States, we plan to pursue marketing approval in other regions including the European Union, Japan, Australia and Israel, among other jurisdictions.

Utilise accelerated commercialization pathways for our drug candidates

Our expert regulatory staff and consultants believe that our drug candidates will qualify for one or more FDA expedited review programs (breakthrough designation, accelerated approval, priority review and/or fast track) due to treatment limitations for our target indications in the United States. These expedited review programs often result in accelerated and less-costly pathways to approval compared with traditional regulatory pathways.

Maintain a strong intellectual property portfolio

Our intellectual property and patent strategy has been instituted to protect the investment made in our R&D programs, underpinning our commercial potential. Incannex holds 19 granted patents and 30 pending patent applications over our portfolio of R&D programs. We are constantly monitoring the results of our research to identify new intellectual property opportunities to grow patent families over our drug candidates. We take a global approach to our intellectual property strategy and intend to pursue patent protection in key global markets, including the United States, European Union, Japan, Australia and Israel, among other jurisdictions.

Various opportunities to develop revenue streams

We have identified significant opportunities to develop revenue streams in jurisdictions where our products may be permitted for sale, even prior to FDA marketing approval. Special access schemes in Australia and abroad potentially will see some of our products for distribution in the short term. The Company is working on jurisdiction-based over the counter (OTC) opportunities for some of our products and also commercial opportunities related to the provision of psychedelic medicines in Australia.

Three-fold Business Model

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Development of scientifically validated products for FDA registration and marketing approval.

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Short term revenue opportunities within certain jurisdictions through special access schemes.

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Potential out-licensing of products, fast-tracking commercialisation.

Unique Value

  • 28 R&D projects in the exciting fields of medicinal cannabinoids and psychedelic therapies.
  • Successful pre-clinical studies and clinical trial outcomes already achieved.
  • Expedited FDA registration strategy as well as short term commercialisation opportunities.
  • Very large addressable markets in patients with unmet medical requirements.
  • Large and growing patent portfolio of 19 granted and 30 pending patents.
  • Listed on Nasdaq with share code “IXHL”.
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2023 Strategic Outlook

  1. Funded for commencement of phase 2 clinical trials.
  2. Multiple clinical trial data readouts expected.
  3. Opening INDs with FDA for multiple drug candidates.
  4. Completion of cGMP manufacturing with major pharmaceutical organisations.
  5. Assessment of out-licensing opportunities.
  6. Advancement of commercialisation opportunities.
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