Brazil

Brazil's psychedelic history begins long before modern psychiatry. Ayahuasca has deep Indigenous and syncretic-religious roots, and Brazil's modern policy stance reflects that history. CONAD Resolution 1/2010 consolidated a long-running state position that ritual and religious ayahuasca use can be legitimate, while drawing clear lines against commercialisation, tourism-style exploitation and unproven therapeutic claims outside research. #

Modern clinical credibility arrived through academic work rather than commercial rollout. The strongest symbolic milestone remains the Brazilian randomised placebo-controlled ayahuasca trial in treatment-resistant depression, linked to UFRN and USP collaborators and published in 2019. A same-year secondary analysis reported suicidality findings from the same trial dataset. # # #

Brazil also became part of the international esketamine development wave. ReBEC and ClinicalTrials.gov records show Brazilian participation in major multinational esketamine programmes for treatment-resistant depression from 2015 onward, including TRANSFORM and SUSTAIN studies. This created operational experience in supervised ketamine-class treatment inside regulated psychiatric settings, although esketamine should not be conflated with classical psychedelic therapy. # # # # #

The research environment then changed through broader governance reforms. ANVISA overhauled the clinical-trial framework with RDC 945/2024 and related implementation guidance, while Brazil adopted Law 14.874/2024 and Decree 12.651/2025 to restructure the national human-research ethics system. These reforms are not psychedelic-specific, but they shape how future psychedelic trials are approved, monitored and run. # # # #

Sao Paulo state is the broadest ecosystem hub, with Sao Paulo-based academic depth and a particularly strong clinical-research node in Ribeirao Preto. The Ribeirao Preto cluster is where psychiatry, biomarker work and comparative ayahuasca-esketamine studies most clearly intersect in the current source set. # # # # #

Natal is Brazil's most distinctive psychedelic-science node. The UFRN Brain Institute and affiliated hospital teams underpin the country's best-known ayahuasca and DMT programmes, including the 2019 ayahuasca RCT and the inhaled DMT studies in healthy volunteers and people with depression. # # # # #

Salvador is an emerging node for intravenous esketamine work through the Federal University of Bahia and Hospital Universitario Professor Edgard Santos. Current ReBEC records show protocol-level activity in PTSD, obsessive-compulsive disorder and psychotic depression. These are research programmes, not market-access pathways. # # #

Porto Alegre remains relevant through Hospital de Clinicas de Porto Alegre, Hospital Moinhos de Vento and collaborators. Its contribution is more ketamine-clinic and naturalistic than ayahuasca-led, but it matters for implementation science and for understanding supervised ketamine-class treatment in Brazilian psychiatric populations. #

Over the next 12 to 24 months, the likeliest changes are in evidence generation and operational maturity, not sweeping legal reform. Brazil already has the institutional ingredients for more investigator-led work: ANVISA's updated clinical-trial rules, the 2024-2025 human-research reforms and active registry signals in esketamine, DMT and newer compounds. # # # # # # #

Regulatory authorisation for classical psychedelics is much less likely than incremental trial expansion. The current official structure still points to classical psychedelics as controlled investigational substances rather than near-term registered medicines. Special-access or expanded-access mechanisms may matter for selected investigational products, but they should not be confused with broad patient availability. # # # # #

The hardest near-term bottleneck is reimbursement. Even if more evidence arrives, patient access will still hinge on payer decisions, clinical-site capability, protocol standardisation and professional comfort. In Brazil, those pieces are less mature than the academic science, so access growth is most likely to be uneven: more trial participation and private supervised care first, with public-system incorporation and broad plan coverage lagging behind. # # # #