Psilocybin and the New Horizon of Psychedelic Science: Advances in Brazil and Worldwide

Alma Mater Cosméticos
Aug 3
14 min read

Updated: Aug 24

For decades, the idea of treating serious mental illnesses with psychedelic "magic mushrooms" seemed confined to taboo subjects or fringe experiments. In the summer of 2025 , however, a notable shift occurred. Germany became the first country in the European Union to allow patients with treatment-resistant depression access to psilocybin-assisted therapy in exceptional cases, under a compassionate use program approved by the health regulator. Almost simultaneously, the Czech Republic 's Parliament approved the legalization of the medicinal use of psilocybin, paving the way for patients to receive the compound in controlled clinical settings. These landmark decisions mark the rebirth of psychedelic medicine in the West, and their impact is already being felt even across the Atlantic, where Brazilian researchers and entrepreneurs are also advancing this frontier.

European Regulators Open the Door to Psilocybin

The German initiative, officially announced in July 2025 , created the first compassionate use program for psilocybin in the European Union. Patients with depression resistant to conventional treatments will be able to receive controlled doses of psilocybin in a supervised clinical setting, but only in exceptional, duly justified cases. The Central Institute of Mental Health (CIMH) in Mannheim, which petitioned the government for approval, celebrated the decision as an "enormously important" step that expands therapeutic options for patients without alternatives, provided they are under strict medical and ethical supervision . Dr. Gerhard Gründer , head of the project, emphasized that in some cases, psilocybin "can be a medically and ethically justifiable option, if conducted under strictly controlled conditions." In short, this is an unprecedented regulatory milestone in Europe, allowing certain patients access to a still experimental therapy—something unthinkable just a few years ago.

In the Czech Republic , the lower house of Parliament approved a comprehensive drug law reform in June 2025, which included the legalization of the therapeutic use of psilocybin in psychiatric settings. The legislation allows doctors to prescribe and pharmacies to prepare custom-made psilocybin-based medications for treatment purposes, subject to specific regulations. With final approval in the Senate and presidential signature considered likely (no significant opposition is currently expected), the country is on track to become a global pioneer in the legal provision of medicinal psychedelics, alongside countries like Switzerland, Canada, and Australia , which are already leaders in this field. A sign of the times, surveys indicate that approximately 68% of the Czech population supports the medical use of psychedelics , reflecting a cultural shift surrounding these substances. It's worth noting that psilocybin wasn't the only one to benefit from the reform: the package approved in the Czech Republic also legalized the domestic cultivation of cannabis (up to three plants per person) and eased penalties for possession of small amounts – indicating a more pragmatic shift in the country's drug policy, focused on public health rather than punishment.

In both cases—Germany and the Czech Republic—the decisions represented a break with decades of strict prohibition inherited from the 1970s. For the first time in recent history, European governments not only recognized the therapeutic potential of a classic psychedelic but also created legal pathways for its controlled use . "If confirmed by the Senate, [the measure] will place the Czech Republic alongside countries like Switzerland, Canada, and Australia at the forefront of the medical use of psychedelics," the Psychedelic Access and Research European Alliance (PAREA) said in a statement, celebrating the Czech breakthrough. Public perception has also evolved: the fact that a majority of Czechs support therapy with substances previously associated only with counterculture indicates a growing normalization of the topic in society.

International trends surrounding therapeutic psilocybin

The moves in the Czech Republic and Germany are part of a global trend toward controlled easing of access to psychedelics for medical purposes, especially in light of mental health challenges. Some international highlights and recent data:

Switzerland: Since 2014 , the Swiss government has allowed exceptional authorizations for the therapeutic use of substances such as psilocybin, LSD, and MDMA in individual cases. Although these drugs are not officially registered, doctors can request permission on a case-by-case basis. Use has been gradually increasing – in 2024, around 700 authorizations were granted, of which psilocybin accounted for 322 (indicating significant demand).
Canada: In 2021/2022, the country reactivated a special access mechanism for psychedelics, allowing healthcare professionals to request psilocybin for terminally ill patients or those with serious conditions. However, bureaucratic processes and a lack of infrastructure have limited its reach: federal agency data shows that few requests have been approved, with authorizations declining between 2022 and 2024. This highlights the practical challenges of implementing these exceptions even when the legal pathway exists.
Australia and New Zealand: Australia made a groundbreaking decision in 2023 by reclassifying psilocybin and MDMA as authorized therapies for certain disorders . Since July 2023, certified psychiatrists in Australia have been able to prescribe psilocybin for resistant depression and MDMA for post-traumatic stress disorder, within strict protocols. Access remains modest. Fewer than 100 patients received these therapies in the first 18 months of the Australian program, but it is gradually expanding. In New Zealand , similar regulations have begun to emerge: until recently, only a physician was authorized to prescribe psilocybin, but new guidelines have been published to expand the number of licensed professionals . These countries demonstrate that, although incipient, clinical programs with psychedelics can be implemented under supervision and with a low initial volume, scaling up as medical training and evidence of efficacy grow.
United States: In the US, the landscape is divided between state initiatives and federal positions. At the federal level, there is no formal compassionate program for psilocybin. The FDA has so far authorized only one expanded use initiative for psychedelics (a small program for MDMA in 2019). In contrast, some states are moving forward on their own : Oregon and Colorado were the first to legalize controlled access to psilocybin for adults (through service/licensing centers, approved by popular referendum). More recently, in 2025, the state of New Mexico passed the first state law creating a psilocybin medical program , with plans for authorized clinics to treat conditions such as resistant depression, PTSD, and palliative care. These state movements, such as Oregon and Colorado's popular vote, and New Mexico's legislative vote, demonstrate regional interest in making psychedelic therapies available even before federal approval, although full implementation of these programs is expected in the coming years. The North American experience indicates both the perceived therapeutic potential and regulatory caution : release occurs at local levels, while national authorities await research results and traditional approval processes.

Big Pharma eyes psychedelics

It's not just governments that are revisiting psychedelics. The pharmaceutical industry is also making moves. In July 2025 , news emerged that pharmaceutical giant AbbVie was in talks to acquire American biotech Gilgamesh Pharmaceuticals for approximately $1 billion . AbbVie had already entered into a partnership with the startup the previous year, paying $65 million upfront and securing options that could reach nearly $2 billion, as part of an agreement to co-develop new psychiatric therapies.

This initial investment was justified by the promising results of Gilgamesh, which reported a 94% symptom remission rate in a phase 2 clinical trial of its psychedelic drug for major depression. If the deal goes through, it will be a powerful endorsement of the field: investors celebrated the rumor as a "major endorsement" and evidence that Big Pharma is finally taking psychedelics seriously . Indeed, as Bloomberg's analysis pointed out, the interest from one of the world's largest pharmaceutical companies highlights the "growing appetite for acquisitions" in the sector.

AbbVie 's strategy is part of a broader move to renew its psychiatry portfolio. In recent years, the company has already made significant deals in the field, such as paying US$8.7 billion to acquire Cerevel Therapeutics , a startup focused on schizophrenia, and entering into collaborations to strengthen its mental health treatment portfolio.

Other giants, such as Johnson & Johnson , have also reaped financial rewards from exploring this new paradigm: their antidepressant nasal spray Spravato (esketamine, a variant of ketamine) has become a successful commercial product, with annual sales of around $1.5 billion . These developments indicate that psychedelics are moving from an alternative niche to a central axis of innovation in pharmaceutical neuroscience .

This psychedelic "gold rush" isn't limited to big labs. Estimates indicate that psychedelic-assisted psychotherapy could become a global market worth around $100 billion per year . Several specialized startups have emerged in recent years, engaging in a race to patent new molecules, formulations, and therapeutic protocols. The innovative frenzy is reminiscent, in part, of the medical cannabis boom of half a decade ago, but this time focused on substances like psilocybin, MDMA, LSD, and derivatives with the potential to reshape the treatment of psychiatric disorders .

Recent developments in psychedelic sciences

The current resurgence of psychedelic sciences caps a decades-long hiatus. There was a period of effervescence in the 1950s and 1960s , when substances such as LSD and psilocybin were intensively studied in therapeutic contexts. However, starting in 1970, with the rise of the counterculture movement and government concerns, these studies were virtually shut down, and the recreational use of psychedelics was banned almost worldwide. Thus began a long scientific winter: for nearly forty years , clinical research with psychedelics was marginalized, restricted to small groups and isolated experiments.

Around the 2000s , this scenario began to change. Researchers in countries like the US, the UK, and Brazil resumed basic and clinical studies with substances like psilocybin, paving the way for a " psychedelic renaissance ." The turning point came in 2020 , when a series of events reignited the field. Recent milestones include:

2020 (USA) – In November, Oregon became the first state in the US to legalize the therapeutic use of psilocybin for adults. The measure, approved via referendum, took effect in 2021 and allows those over 21 to access psilocybin in licensed clinics to treat conditions such as depression, anxiety, and post-traumatic stress disorder (PTSD).
2021 (USA) – In recognition of its therapeutic potential, the FDA granted Breakthrough Therapy Designation to psilocybin for the treatment of PTSD. This designation accelerates the development and review process for new drugs, signaling that the FDA sees psilocybin as a promising treatment for post-traumatic stress disorder.
2022 (Global) – A study published in the journal Nature Medicine showed that psilocybin can increase neural connections in patients with depression. These neurobiological findings helped explain the observed antidepressant effects and provided additional scientific support for the substance's clinical use.
2023 (Australia) – The Australian regulatory agency surprised by announcing in mid-2023 that the country would be the first to formally authorize psychiatrists to prescribe psilocybin and MDMA for certain disorders. As of July 2023, Australia authorized the medicinal use of psilocybin (for resistant depression) and MDMA (for PTSD) by licensed physicians, marking the first time that psychedelics have officially entered the therapeutic arsenal of an entire country.

These developments, combined with recent regulatory advances in Europe, fuel palpable enthusiasm. Academic output reflects this movement: in the last five years alone, approximately 3,000 scientific articles on psychedelics have been published globally. Several research and investment centers are dedicating themselves to the topic, and market projections indicate accelerated growth in the coming years.

According to a report by The Business Research Company , the global psychedelic medicines market grew by around 15% between 2023 and 2024, jumping from US$4.88 billion in 2023 to US$5.62 billion in 2024. In the following years, growth is expected to remain rapid, reaching US$10.2 billion by 2028. Factors behind this optimism include regulatory advancements, public awareness of mental health, and greater acceptance of this type of treatment by both patients and the medical profession. In other words, there is a favorable conjunction of science, policy, and market driving psychedelic sciences into the mainstream of medicine.

Brazil at the forefront? Psychedelic research and innovation in the country

While Europe, North America, and Oceania pioneer new policies, Brazil is building its own narrative in the psychedelic revolution, although it still faces considerable regulatory challenges. Currently, substances such as psilocybin, LSD, and MDMA remain illegal for clinical or personal use in the country, except in scientific research protocols approved by the competent authorities.

In 2020, ANVISA (National Health Surveillance Agency) approved the use of esketamine (an enantiomer of ketamine) as a treatment for resistant depression, but restricted to hospital settings and under specialized supervision. Other than that, only ibogaine operates in a gray area: it is not registered as a medication, but ANVISA allows its importation on a case-by-case basis for treatment of chemical dependency and depression in private clinics.

Psilocybin , however, remains prohibited outside of clinical studies formally authorized by ANVISA and ethics committees; in practice, only a few accredited research centers can legally administer the substance to volunteers in controlled trials. In short, from a regulatory standpoint, Brazil is moving cautiously: it is focusing on research and, for now, only authorizing ketamine (already a known anesthetic) as an innovative therapeutic option, while monitoring international developments before revising its regulations on classic psychedelics.

Despite these barriers, the Brazilian scientific community has distinguished itself internationally in the field. Thanks in part to the permission of the religious use of ayahuasca (a drink containing the psychedelic DMT) since the 1980s, Brazil has emerged as a research leader, ranking third worldwide in the number of high-impact scientific publications on psychedelics, behind only the United States and the United Kingdom.

Names like neuroscientist Sidarta Ribeiro and psychiatrist Dráulio de Araújo , both from the Brain Institute (ICe) at UFRN , are at the forefront of this effort. Together with collaborators from other institutions, such as Dr. Stevens Rehen (UFRJ and Instituto D'Or) and Dr. Luís Fernando Tófoli (UNICAMP), they have conducted pioneering studies, including basic investigations with LSD and other substances, as well as clinical trials with ayahuasca for resistant depression (published in Psychological Medicine in 2019) and with DMT .

Recently, the Advanced Center for Psychedelic Medicine (CAMP) at UFRN published the first clinical evidence of the antidepressant and anti-suicidal effects of inhaled DMT . In this unprecedented study, 27 healthy volunteers received controlled doses of inhaled DMT, demonstrating safety and intense but short-lived psychic effects (10–20 minutes), a profile very different from that of psilocybin (whose effects can last 6 hours). Subsequently, a pilot phase with depressed patients showed rapid and sustained reductions in depressive symptoms and suicidal ideation after DMT sessions.

The researchers emphasize that this brief, non-invasive treatment could be a viable and realistic alternative for the Brazilian Unified Health System (SUS) , as it requires less therapy time and fewer resources per patient, while maintaining remarkable efficacy. In other words, Brazil is already contributing an original innovation : exploring an ultra-fast-acting molecule like DMT to overcome practical obstacles to classic psychedelic therapies, which, while effective, require many hours of monitoring and infrastructure.

In addition to major academic centers, independent institutions and Brazilian startups are working to bring psychedelic science from the laboratory to society. The Phaneros Institute , founded in 2011 by neuroscientist Eduardo Schenberg , is a pioneer in psychedelic research and education in the country (even the name Phaneros alludes to the manifestation of the spirit). This nonprofit has already participated, for example, in a pilot study linked to MAPS's global research on MDMA-assisted therapy for PTSD.

Currently, Phaneros focuses on training healthcare professionals in the use of these emerging therapies: in partnership with the North American company Fluence , it began offering psychedelic psychotherapy training content translated into Brazilian Portuguese via an online platform. According to Schenberg, these initiatives aim to train doctors and therapists to manage existing treatments, such as ketamine, approved by Anvisa, more safely and effectively. By disseminating cutting-edge knowledge and building a community of professionals, Phaneros plays a crucial role in preparing the groundwork for substances like psilocybin and MDMA to be authorized in the near future.

Another notable initiative is Scirama Psychedelic Science , launched in 2021 as the first Brazilian startup focused exclusively on psychedelic innovation. Conceived by entrepreneur Marcel Grecco (creator of the cannabis accelerator The Green Hub ), Scirama was founded with the goal of financing and structuring the development of new psychedelic-derived products and therapies. To this end, it established a scientific committee led by leading figures in the field, including Stevens Rehen and Sidarta Ribeiro, and raised an initial investment of approximately R$1.5 million to boost national research.

Scirama intends to launch calls for proposals to select promising projects, ranging from psychotherapy protocols using classic psychedelics (LSD, psilocybin, ayahuasca) to Psilocybe mushroom cultivation techniques and the development of non-hallucinogenic analogues with therapeutic potential. The idea is to leverage the already known properties of these substances, such as their ability to stimulate new neural connections (neuroplasticity) and their anti-inflammatory action, to treat mental disorders and even neurodegenerative diseases in the future.

Abroad, the use of psychedelics is being investigated for conditions such as stroke, anorexia, and migraines; here, Scirama's focus also includes protocols for treating chemical dependency , revisiting past research (such as the use of LSD for alcoholism in the 1950s and 1960s). In short, Scirama aims to be a catalyst for the "psychedelic renaissance" in Brazil , connecting investors, scientists, and society to transform discoveries into health solutions.

Finally, it's worth mentioning BioCase Brasil , a company that operates at the intersection of medicinal cannabis and psychedelics. Initially focused on CBD and therapeutic cannabis products, BioCase expanded its scope to include entheogens (psychedelics for medical use) in its portfolio. In 2022 , the company entered into an unprecedented public-private partnership with the federal laboratory Certbio/UFCG and obtained authorization from Anvisa to test psilocybin extracted from mushrooms grown in Brazil .

This "Psilocybin" project allows for the collection of Psilocybe fungi on Brazilian soil, the extraction and purification of psilocybin, and subsequent in vitro testing and preclinical studies in animals, assessing potency, stability, and the absence of contaminants, as a preparatory step for future clinical trials. It was the first public-private partnership for the development of a psychedelic product in the country, something celebrated by those involved as the beginning of a virtuous cycle that is inserting Brazil into the global wave of searches for new treatments based on previously controversial substances.

Since then, BioCase (in conjunction with its educational arm, Instituto Alma Viva ) has made progress on several fronts. It launched a lato sensu postgraduate program in psychedelic-assisted psychotherapy to train healthcare professionals, replicating in the field of psychedelics the educational strategy that was crucial to the expansion of medicinal cannabis in Brazil.

And at the end of 2024 , an important announcement came: BioCase/Alma Viva received authorization to import 18 kg of Psilocybe mushrooms to produce pilot batches of a national psilocybin medication. This exceptional import, approved by Anvisa, would allow the company to manufacture the psilocybin API (active pharmaceutical ingredient) and conduct comprehensive quality, safety, and efficacy studies, including a clinical trial already authorized by the ethics system (CEP/CONEP) and registered on the ReBEC platform.

The trials will be conducted at the company's research center in São Paulo, including graduate students in psychedelics from the Alma Viva Institute. This is, therefore, an integrated research and training effort that could result in the first psychedelic medication developed entirely in Brazil. The news was received enthusiastically, as it represents "18 kg of hope," as the Alma Viva Institute announced, for thousands of patients currently suffering from resistant depression who may, perhaps in a few years, have access to a new treatment alternative, effective in a single biannual dose and with minimal side effects.

Perspectives and challenges

Given this panorama, it's clear that we are witnessing a paradigm shift in mental health. The growing body of scientific evidence and recent regulatory victories, from Germany to Australia, from São Paulo to Prague, point to the integration of psychedelics into conventional medicine in the near future.

Still, many challenges remain. Regulating the safe use of these substances will require extensive professional training (mastery of concepts such as set and setting , rigorous patient screening) and well-founded public policies. In Brazil, in particular, ongoing dialogue between scientists, regulatory agencies, and the healthcare system will be crucial to ensure that laboratory advances translate into accessible therapies for the population. Care must also be taken to balance market enthusiasm with ethical responsibility: a disorderly commercial rush or exaggerated promises could undermine public trust if scientific rigor and safety are not observed at every stage of the development of these therapies.

From my personal perspective, as an optimistic realist, I believe it's possible to envision a future in which once-marginalized substances become validated therapeutic tools , offering relief to patients who didn't respond to conventional treatments. The journey of rehabilitation of these molecules, from ostracism to recognition, from ancestral ritual to modern clinical practice, represents one of the most intriguing movements in contemporary medicine.

And Brazil, by all indications, is determined not to be left behind in this story, contributing creativity, quality research, and a unique perspective that combines tradition and innovation in psychedelic science. We face a field in full swing—scientific, industrial, and cultural—and each new step, whether regulatory approval in Europe or a pioneering study in Natal, reinforces the sense that we are entering a new horizon for mental health .

With the advancement of psychedelic science worldwide and clear signs of transformation in Brazil, this moment calls for strategic coordination, technical responsibility, and dialogue between innovation, public policy, and regulation. At IBIS , we closely monitor this emerging ecosystem and are available to support researchers, startups, policymakers, and investors in building secure bridges between scientific discoveries and real-world applications in mental health. If you work in this field and want to connect with a qualified health innovation network, contact IBIS .

References:

Gabriela Galvin. “Germany to allow some depressed patients to try psilocybin amid psychedelic medicine boom.” Euronews, July 31, 2025.
Rowan Dunne. “Home cannabis cultivation and psilocybin therapy to be legal in Czechia next year.” Mugglehead Magazine, June 11, 2025.
Nick Paul Taylor. “AbbVie crowns Gilgamesh its next M&A target with $1B buyout talks: report.” Fierce Biotech, July 31, 2025.
Psychedelic Alpha. “Psychedelic Bulletin #205: AbbVie Eyes Gilgamesh…” August 1, 2025.
Marcel Leite. “Scirama, Brazil’s first psychedelic innovation company, is born.” Folha de S.Paulo – Virada Psicodélica Blog, April 18, 2021.
Carlos Minuano. "Brazil will test psychedelic mushrooms for the first time to create medicine." UOL VivaBem, May 27, 2022.
Lara Goldstein. “Advancing therapy with psychedelics in Brazil: What does the association of Fluence and Phaneros imply?” El Planteo, July 28, 2023.
Green Rock. “Psychedelics in 2024: Studies, Expectations, and Regulations.” Greenrock.vc Blog, 2024.
Alma Viva Institute. "The best news of the year for Biocase Brasil... new hope with innovative treatment for resistant depression." November 5, 2024.
Falchi et al. “Inhaled N,N-DMT for the treatment of depression: a phase I/II clinical trial.” (preprint, CAMP/UFRN) – abstract published in Ciência Psicodélica, 2023.