28 Clinical Programs, 1 Primary Goal – Alleviate Human Suffering.
Incannex is a clinical stage pharmaceutical company developing proprietary medicinal cannabinoid drugs and psychedelic medicine therapies.
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.
- 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” and ASX with share code “IHL”.
2023 Strategic Outlook
- Funded for commencement of phase 2 clinical trials.
- Multiple clinical trial data readouts expected.
- Opening INDs with FDA for multiple drug candidates.
- Completion of cGMP manufacturing with major pharmaceutical organisations.
- Assessment of out-licensing opportunities.
- Advancement of commercialisation opportunities.
Stay up to date with Incannex’s research and development program.