From Medical Cannabis to Psilocybin Therapies: The Regulatory Future of “Magic Mushrooms”

The Charlotte Figi Case: A Turning Point for Medical Cannabis

The Stanley brothers came into the spotlight after a CNN interview covering the case of Charlotte Figi, a young American girl suffering from a rare and severe form of epilepsy. Thanks to a CBD tincture developed by the Stanleys, Charlotte's seizures were reduced from 300 per day to just three per month.

This remarkable outcome revolutionised the medical cannabis sector and helped transform global attitudes toward the plant, prompting regulatory shifts around the world to legitimise its medical use.

Now, the Stanley brothers are making headlines again with their latest project: AJA001 - a botanical drug derived from cannabis and psilocybin. AJA001 has already passed Phase I clinical trials and is preparing to enter Phase II under the supervision of the U.S. Food and Drug Administration (FDA). This case is part of a much larger story involving the integration of psilocybin into modern medicine.

What Is Psilocybin?

Psilocybin is a psychoactive compound found in over 200 species of fungi, commonly referred to as "magic mushrooms." It primarily affects the brain's serotonin receptors (5-HT2A), leading to temporary alterations in perception, cognition, and mood. In controlled clinical settings, psilocybin has shown great therapeutic potential, particularly for helping restructure rigid mental patterns, alleviate depressive symptoms, and enhance emotional processing.

Unlike many psychiatric medications used to treat anxiety or depression, psilocybin has a low toxicity profile, minimal or no physical dependency, and a favourable safety record in clinical trials.

From Tradition to Science: A Brief History of Psilocybin Use

Magic mushrooms have a long and varied history. While they became globally recognised during the rise of Dutch coffee shops - where both cannabis and magic mushrooms were accessible -, their use dates back centuries.

Mesoamerican cultures, such as that of the Mazatec people of Oaxaca, traditionally used these mushrooms in rituals and healing practices. In the 1950s, Western science rediscovered psilocybin thanks to ethnomycologist R. Gordon Wasson, who travelled to Mexico to study ancestral plant medicine and met María Sabina, a healer who introduced him to ceremonial mushroom use.

During the 1960s, as part of the hippie counterculture movement, magic mushrooms gained popularity among young Americans. This surge led to their prohibition in the 1970s - alongside other psychedelics - under the "War on Drugs." After decades of prohibition, scientific interest in psilocybin has resurged again.

Today, prestigious institutions like John Hopkins University, NYU, and Imperial College London are leading clinical research studies into its therapeutic potential. Clinical Research and Therapeutic Applications of Psilocybin Although still emerging, research into psilocybin's therapeutic applications has gained traction in recent years.

Clinical trials have shown promising results, particularly in the area of mental health. Psilocybin has demonstrated benefits in cases of:

• Chronic or treatment-resistant depression Anxiety related to terminal illness
• Substance addiction (alcohol, tobacco)
• Eating disorders PTSD (Post-Traumatic Stress Disorder)

In 2018, the FDA granted psilocybin "Breakthrough Therapy" status for depression - an official recognition that speeds up the approval process for treatments with significant therapeutic potential.

Although research is still developing, these studies suggest that psilocybin could become a valuable tool in the treatment of mental health conditions - provided it is administered under professional supervision and in controlled environments. Dr. Leor Roseman, from the University of Exeter and an Honorary Lecturer in the Department of Brain Sciences, explains: "Psychedelics can't be viewed as independent therapies without considering the context, which creates challenges in regulating psychedelic-assisted psychotherapy."

A Question of Policy: How Should Psilocybin Be Regulated to Ensure Fairness and Safety?

As psilocybin moves closer to therapeutic acceptance, the debate around its regulation intensifies. How can we ensure it remains both safe and accessible? Will psilocybin become a treatment monopolised by a handful of powerful pharmaceutical companies?

The process of drug approval is notoriously rigorous and can often take more than a decade to complete, with the associated cost. For this reason, only large pharmaceutical companies with significant financial backing can afford to navigate this process, which creates a risk of market concentration and the exclusion of small producers.

One possible solution is active government involvement: public funding for clinical trials through grants or national programmes could reduce reliance on private capital and help prevent monopolies from forming.

A compelling example of this is Colombia's cannabis regulation model, where the government has financed and supported a comprehensive regulatory framework - sometimes referred to as the "Cannabis Hub" - to develop the sector inclusively.

Are We Witnessing the Birth of a New Industry?

In addition to the development of compound-based treatments, research is also exploring microdosing protocols combined with psychotherapy, which may open up additional therapeutic applications.

Little by little, psilocybin is shedding its stigma and gaining recognition as a powerful tool for mental healthcare. The possibility of developing certified, pharmaceutical-grade psilocybin medications, as Ajna BioSciences intends, represents a major step forward in terms of safety, regulation, and patient access.

Still, it's crucial to foster an open conversation about building a fair and ethical legal framework - one that ensures equitable access, upholds therapeutic integrity, and respects traditional knowledge. Integrating therapies based on psychedelic mushrooms could mark a turning point in modern medicine - a path that must be shaped with responsibility, inclusion, and forward-thinking vision.

References

1. Therapeutic Revolution. Neuropharmacology. 2023 Sep 15;236:109610. doi: 10.1016/j.neuropharm.2023.109610.
2. Kamal S, Jha MK, Radhakrishnan R. Role of Psychedelics in Treatment-Resistant Depression. Psychiatr Clin North Am. 2023 Jun;46(2):291–305.
3. Wingert AM, Agnorelli C, Peill J, et al. Serotonergic psychedelics for depression: A comprehensive overview. Int Rev Neurobiol. 2025;181:271–304.
4. Psiuk D, Nowak EM, et al. Esketamine and Psilocybin – The Comparison of Two Mind-Altering Agents in Depression Treatment: Systematic Review. Int J Mol Sci. 2022 Sep 28;23(19):11450.