Incannex Healthcare Ltd. announced that it has received ethics board endorsement for psychedelic assisted therapy at its first clinic based in Melbourne, Australia, a city of approximately 5.2M people. In order to prescribe schedule-8 drugs under the Therapeutic Goods Administration (TGA) Authorised Prescriber Scheme, psychiatrists are required to receive HREC endorsement for their qualifications, experience, the qualifications and experience of the treatment team, and the protocols to be used in the treatment of patients with psychedelic compounds. Clarion announced that it has received HREC endorsement for both Psilocybin and MDMA assisted therapy for the treatment of Treatment Resistant Depression (TRD) and Post-Traumatic Stress Disorder respectively (PTSD).

The Australian TGA, which is akin to the FDA in the United States, selectively down-scheduled psilocybin for the treatment of TRD and MDMA for the treatment of PTSD from schedule 9 to schedule 8 in July 2023, which allows authorized psychiatrists to prescribe both drugs under the Authorised Prescriber Scheme. The Melbourne Clarion Clinic will be the first dedicated Psychedelic-assisted therapy clinic in Australia. Located on the Yarra Riverfront in Abbottsford, Melbourne, it has been designed and fitted out specifically to facilitate an optimal environment for psychedelic-assisted therapy.

With seven treatments rooms and a group therapy room, the clinic is a commercial scale prototype and has the capacity to treat approximately 600 people per annum in normal working hours and substantially more in extended hour operations. Clarion has received a substantial number of expressions of interest in treatment submissions from potential patients since opening its application process earlier this year. It's estimated that 670,000 people suffer from either TRD, PTSD or both in Australia at any given time and many patients do not respond to traditional treatments for both indications, or experience diminishing efficacy.

Psychedelic-assisted therapy has been proved through clinical trials to help a substantial proportion of people who do not respond to traditional treatments.