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Press Release: Incannex to open psychedelic psychotherapy clinic’s. Image: Getty Incannex to open psychedelic clinic’s business with leading Australian experts

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IHL is undergoing a pivotal point in its journey as a company moving from pure research to service delivery as Australia becomes the first country to recognise psychedelics as medicine.

Incannex Healthcare (ASX: IHL) has announced that it has developed plans for the commercialisation and launch of multiple psychedelic-assisted psychotherapy clinics, the first of which will open in Melbourne in 2023.

Incannex is at an advanced stage of negotiation on riverfront premises for its first clinic in Melbourne and hopes to roll out many more as the market potential is what it has referred to as a “multi-billion dollar opportunity”.

IHL said it has been developing commercialisation plans for psychedelic clinics for some time, well before the Therapeutic Goods Administration (TGA) decision to down-schedule psilocybin for treatment-resistant depression (TRD) and MDMA for Post-Traumatic Stress Disorder (PTSD) was announced.

Psychedelic Clinics have been developed under the leadership of Peter Widdows, a long-standing IHL director.

“When the TGA announced the down-scheduling of MDMA and psilocybin for two indications, we were in a perfect position to expand our plans to cover this wider set of related therapies for certain indications,” Widdows said.

“This is both an amazing opportunity to do some good for humankind by delivering high-quality, effective treatments for  debilitating conditions that often don’t respond to available treatments, and a great business opportunity, with a market that is predicted to mature into a multi-billion-dollar industry segment.”

Partnerships with clinical professionals

IHL has entered a partnership with Australia’s leading clinical psychedelic professionals, who all have extensive experience within clinical psychedelic research, treatment, and training.

Co-founder, director, chief strategy, and chief scientific officer Paul Liknaitzky has played a central role in establishing the clinical psychedelic field in Australia and leads the largest group of psychedelic researchers and clinicians in the country.

He is the chief principal investigator on a program of psychedelic trials and collaborates on numerous others nationally.

He has led the development of psychedelic trial protocols, treatment design, trial coordination, therapist selection and training, and has established active collaborations with an extensive network of international experts and organisations in the field.

His work is focused on developing innovative therapies, evaluating benefits, exploring potential drawbacks, predicting treatment response, mitigating risks, understanding therapeutic mechanisms, and translating research into practice.

“The safe, useful, and ethical translation of clinical psychedelic research into practice has been at the forefront of my mind for some years, as we conduct trials and learn first-hand about the potential and the complexity of providing  psychedelic therapies,” Liknaitzky said.

“Very few people in Australia have the unique expertise and experience in delivering psychedelic therapies, and it is incumbent on those who do, to set the highest standards in patient safety, quality of care, ethical conduct, and accessibility.”

Leading transition to psychedelic-assisted psychotherapy

Co-founder, director chief medical officer and head of psychiatry Professor Suresh Sundram has led more than 50 clinical trials and studies in psychiatric disorders and has extensive experience with the use of psychedelics within psychotherapy.

“The down-scheduling of certain psychedelic treatments for certain conditions is an important  transition point to establish the  utility and role of psychedelic-assisted psychotherapy in mental illness,” Sundram said.

“Providing a custom-tailored environment to deliver the best possible therapeutic experience is critical.

“To enable this, and to evaluate and deliver outcomes, is a rare opportunity.”

Co-founder, director and head of psychotherapy Sean O’Carroll is an integrative psychotherapist and academic specialising  in  experiential, relational, and transpersonal psychotherapy.

Since 2019, he has developed and delivered psychedelic-assisted psychotherapy training for several clinical psychedelic research  teams.

O’Carroll began lecturing in transpersonal psychology in 2011 and has more than 10 years’ experience working with what he calls “psychedelic casualties”.

Through the Wild Mind Institute, he offers training for mental health practitioners in psychedelic-assisted psychotherapy, “bad trip” integration, and eco-psychotherapy.

“Many of us in the research community were surprised by the recent TGA announcement, understanding this research is still in its early stages here in Australia, and that a good deal of necessary infrastructure is not yet in place,” O’Carroll  said.

“With this decision, those of us who have the experience and  expertise in this field feel a responsibility to contribute to the best  possible care and provide a benchmark for safe and ethical practice. “

“There are very few experienced psychedelic-assisted psychotherapists in Australia, and the team we are assembling includes many of the most experienced practitioners in the country.”

Pivotal point in IHL’s journey

IHL is at an advanced stage of negotiations over locations in Melbourne with the first model clinic expected to open before the end of 2023.

Once the operation of the model clinic is running smoothly, IHL plans to begin rapid expansion within Australia and overseas, where legislation allows.

“This opportunity is something the IHL team have been working towards for some time now and presents a pivotal point in the journey of the company, turning from pure research into service delivery,” IHL managing director and CEO Joel Latham said.

“The opportunity is to deliver the highest-quality care and make a real difference in people’s lives, alongside substantial and imminent revenue potential.”

He said implementation of Psychedelic Clinics won’t impact development of its core clinical assets and will be run as an IHL-owned subsidiary in parallel.

IHL is currently undergoing a Phase 2 clinical trial for its proprietary psilocybin-assisted psychotherapy program for Generalised Anxiety Disorder (GAD), in a clinical trial program also known as “PsiGAD”.

“Implementation of this strategy will in part provide the platform to allow an accelerated path to commercialisation for our drug assets post clinical success,” he said.

This article was developed in collaboration with Incannex Healthcare, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

 

Incannex to open psychedelic clinic’s business with leading Australian experts



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Article: Early 2025 Empire State Psychedelic Policy Roundup

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Unique NY-Born Licensing Model for Therapeutic Psilocybin Use Gains Momentum in State Senate Amid Flurry of Psychedelic Bills Filed Across the US

(Albany, NY) As New York’s cannabis industry continues to turn a hefty profit in the earliest days of 2025 so far, many plant medicine community members both within and just beyond the cannabis industry have been steadily laying the groundwork for the next state-level drug policy reform movement rife with seemingly-incompatible, arguably-intertwined intersectional equity enhancement opportunities and profit margin maximization priorities at play: psychedelics.

For those unfamiliar, 2024 brought about a number of presumed-to-be momentum-stalling psychedelic setbacks – first with the FDA’s stunning rejection of a first-of-its-kind MDMA-Assisted Therapy Treatment developed by the Multidisciplinary Association of  Psychedelic Studies (MAPS) and their Public Benefit Corporation (PBC) spin-off Lykos Therapeutics. To compound public misperception of psychedelic policy reform efforts further, a much-discussed and deep-pocketed legal psychedelic therapy-personal possession and home cultivation decrim-focused psychedelic ballot campaign in Massachusetts failed spectacularly – leading some pundits – both pro-legalization and prohibitionists alike – to speculate that “the psychedelic renaissance” as it’s been called by some, had in fact stalled out at large.

Fortunately for the plant medicine community, those naysayers were largely wrong, as in January 2025 alone, a record-breaking 38 psychedelics-related bills were filed in 14 states across the country. Here in New York, prominent psychedelic policy reform advocates have gained serious traction within the state’s legislature, especially after a recent lobbying day at the state Capitol.

Led by the increasingly diverse coalition known as New Yorkers for Mental Health Alternatives and backed by a growing bipartisan interest in alternative mental health treatments, New York’s burgeoning intersectional community of psychedelic activists and legal experts recently gathered in Albany to rally support for two proposed bills aimed at expanding access to psychedelics for therapeutic and personal use.

Avery Stempel NYMHA

“Our 2025 New York State Capitol Lobby Day was a huge success,” said Avery Stempel, co-founder of New Yorkers for Mental Health Alternatives (NYMHA) and founder of Collar City Mushrooms. “Advocates, doctors, and lawyers from Brooklyn to Buffalo traveled to Albany to participate. We had individual meetings with 10 senators and assembly members and talked to many more in the hall while they passed by our tables. There is a lot of energy gathering around the New York bills, and we are hopeful that we will be making some serious traction this year.”

At the forefront of the legislative push is Assembly Bill A2142, introduced by Assemblywoman Amy Paulin (D) alongside four co-sponsors. The bill would create a state-supervised program allowing licensed facilitators, including health and social care professionals, to administer psilocybin-assisted therapy to eligible patients. The measure mirrors a growing movement across the country, following in the footsteps of states like Oregon and Colorado, which have already established legal frameworks for psychedelic-assisted treatment.

A second measure, House Bill 628, introduced by Assemblymember Linda Rosenthal (D) with eight co-sponsors, takes a broader approach. If passed, the legislation would legalize the adult possession and use of several plant- and fungus-based hallucinogens, including psilocybin, mescaline, DMT, ibogaine, and psilocin. The bill is currently under review by the state’s public health committee and, if advanced, would require approval from Governor Kathy Hochul (D) to become law.

Momentum for these reforms received a boost with the recent filing of Senate Bill S5303 by State Senator Julia Salazar (D). The measure serves as a companion bill to A2142, signaling increased legislative interest in the possibility of a hearing on psychedelic policy in Albany later this year. According to NYMHA leaders, this marks a critical step in New York’s efforts to bring psychedelic-assisted therapy into the mainstream.

Jonah Martindale, Rick Doblin, Gina Giorgio

“We are seeing that in the last few years, there has been a shift in the popularity of alternative treatments for the worsening mental health crisis, such as psychedelics,” said Jonah Martindale, a New York City resident, NYMHA coalition member, and advocate with Students for Sensible Drug Policy (SSDP). “The openness of various politicians across the political spectrum for these bills seems to reflect that. Now is the time to keep building momentum.”

Supporters of the bills argue that psychedelic-assisted therapy has the potential to revolutionize mental health care, offering new hope for individuals suffering from treatment-resistant conditions such as PTSD, depression, and substance use disorders. Medical research and clinical trials have shown promising results in recent years, prompting lawmakers in various states to reconsider their stance on these substances.

However, despite the growing enthusiasm, challenges remain. Critics have raised concerns about public safety, regulatory oversight, and the potential for misuse. Law enforcement officials and some health professionals caution that broader legalization could lead to unintended consequences, particularly if access to psychedelics is not accompanied by rigorous safety protocols.

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Early 2025 Empire State Psychedelic Policy Roundup

 



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Linked In Post – Jon Dennis, Psychedelic Lawyer: Washington SB 5201, the regulated psilocybin access bill, was considered today by the Senate Committee on Labor & Commerce ( 18 Feb 2025)

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Washington SB 5201, the regulated psilocybin access bill, was considered today by the Senate Committee on Labor & Commerce. The bill would require low-income and other taxpayers to subsidize regulated access that is cost-prohibitive for many, while continuing to criminalize the same activities outside of the regulated marketplace.

For context, Oregon’s regulated system was promised to be self-funded by licensing fees and sales taxes, but the program needed a $3.1MM bailout in 2023, and the program is now seeking an additional $3.5MM bailout from the legislature. This is despite already-exorbitant licensing fees, including a $2,000 annual fee for facilitators. (By contrast, the annual fee for an Oregon law license is $683; the annual fee for medical doctors is $702.)

Taxing residents for the administration of a costly access program, while criminalizing affordable access outside the program, is problematic–particularly in Washington where local governments representing 14% of the entire population have already called on state lawmakers to decriminalize psilocybin and other plant-based psychedelic substances. Washington lawmakers must do better and not ignore the socio-economic and criminal justice impacts of a regulated-only access program.



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Alert: We are just over a week away from the Natural Medicine Division opening our application process to individuals who are interested in becoming business Owners or Natural Medicine Handlers, and to business applications for Healing Centers, Cultivations, Testing Facilities and Product Manufacturers.

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Dear Interested Parties:

 

We are just over a week away from the Natural Medicine Division opening our application process to individuals who are interested in becoming business Owners or Natural Medicine Handlers, and to business applications for Healing Centers, Cultivations, Testing Facilities and Product Manufacturers.

 

This week, we wanted to share some logistical information about the application process.

 

We encourage you to submit your application online, and there will be instructions on how to submit applications on the Natural Medicine Division website.

However, based on stakeholder feedback, we will be opening up limited appointment slots for in-person assistance at our Lakewood office starting on Friday, Jan. 10, 2025. At this time, Fridays will be the only day that we will be offering in-person natural medicine licensing application assistance. We will be open from 9 a.m. to noon and 1 p.m. to 4 p.m. for in-person Friday appointments.

We are finalizing the applications and will be sharing those prior to our application process coming online. You can always check out our Public Resources folder to find information and compliance tools.

As always, please reach out to us at [email protected].us if you have any questions.

 

Stay tuned!

The Natural Medicine Division



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