Tilray Brands Applauds Cannabis Rescheduling to Schedule III

Tilray Brands Applauds Cannabis Rescheduling to Schedule III

Tilray Brands, Inc. issued a statement applauding President Donald Trump’s actions leading to the rescheduling of cannabis from Schedule I to Schedule III under the Controlled Substances Act. This pivotal moment represents a fundamental shift in U.S. drug policy, unlocking significant opportunities for medical cannabis clinical research, patient access, and industry standardization. Tilray emphasized that this aligns federal policy with science and patient needs, benefiting individuals fighting cancer, managing chronic pain, veterans with PTSD, and children with epilepsy. With its global platform and extensive experience in highly regulated markets, Tilray is prepared to lead the emergence of a regulated medical cannabis market in the U.S.

• The rescheduling of cannabis from Schedule I to Schedule III under the Controlled Substances Act marks a historic and fundamental shift in U.S. drug policy. This action is expected to significantly accelerate clinical research into medical cannabis, broaden patient access to treatments, and establish higher quality, consistency, and safety standards, thereby legitimizing medical cannabis as a crucial component of modern healthcare.
• Tilray Brands highlights its robust global platform, which includes over 7 million square feet of cultivation capacity and operations across more than 20 highly regulated international markets. Through Tilray Medical, the company has successfully served hundreds of thousands of patients globally, demonstrating pharmaceutical-quality production, deep regulatory fluency, and a comprehensive portfolio of cannabinoid formulations, positioning it as a leader for the emerging U.S. medical cannabis market.
• Looking ahead, Tilray is actively evaluating participation in the Center for Medicare and Medicaid Innovation (CMMI) pilot program. This strategic initiative would enable Tilray to partner with Accountable Care Organizations and oncology practices, providing hemp-derived medical cannabis to underserved patient populations. Concurrently, this program would generate vital clinical outcomes data, helping to shape the standards of an evolving regulated industry and responsibly expand access.

Expanding Medical Cannabis Indications Post-Rescheduling

Clinical trials for cannabis are expanding across numerous therapeutic areas, with evidence emerging from both controlled studies and real-world registries. Current research spans neurological, rheumatological, gastrointestinal, and psychiatric conditions, employing diverse intervention models from pharmacological approaches to behavioral therapies.

• Pain and inflammatory conditions represent the largest clinical focus, with chronic non-cancer pain, fibromyalgia, inflammatory bowel disease, and rheumatological disorders being extensively studied through randomized controlled trials, open-label studies, and large-scale patient registries

• Neurological and psychiatric indications include multiple sclerosis spasticity, seizure disorders, PTSD, anxiety, depression, and insomnia, with intervention models ranging from Brief Behavioral Treatment for Insomnia (BBTI) to combination therapies with traditional medications

• Cannabis use disorders are being addressed through multiple pharmacological intervention models including selective serotonin reuptake inhibitors, buspirone, cannabinoids themselves, and long-acting injectable naltrexone, though evidence shows mixed efficacy

• Combination therapy approaches are being evaluated, particularly cannabis plus opioids for fibromyalgia, which demonstrated a 35% reduction in oxycodone consumption but poor cannabis tolerability leading to high discontinuation rates

• Real-world evidence studies employ prospective noncomparative registry designs, such as the 4-year Quebec study of 2,991 patients, providing longitudinal data on patient-reported outcomes across multiple conditions with interim assessments at 3, 6, and 9 months

• Behavioral intervention models focus on psychosocial treatments for cannabis dependence, including behaviorally-based interventions for adults and family-based interventions for adolescents, though response rates remain modest even with potent treatments

Safety and Tolerability of Medical Cannabis Across Indications

Published safety and tolerability data for medical cannabis demonstrates a generally acceptable profile across studied indications, though adverse events are common and appear to increase with longer treatment durations. Recent comprehensive analyses indicate that adverse events occur in approximately 26% of patients using medical cannabis for chronic pain, with psychiatric adverse events affecting 13.5% of users. The most frequently reported adverse effects include dry mouth (3.2-12.8% depending on population), nausea (3.8%), dizziness (2.2-4.0%), drowsiness (8.6%), and somnolence (2.2%). Serious adverse events, discontinuation due to adverse effects, cognitive impairment, accidents, and dependence syndrome each typically affect fewer than 1 in 20 patients.

Population-specific safety profiles reveal important considerations for clinical practice. In older adults (mean age 73.2 years), medical cannabis demonstrated favorable tolerability with no serious adverse events reported over six-month studies, though dry mouth (12.8%), drowsiness (8.6%), and dizziness (4.0%) remained the most common effects. Cancer patients showed good tolerance with mixed efficacy for symptom management, while epilepsy studies reported that 78% of patients experienced no adverse effects, with occasional increases in sedation and gastrointestinal upset. French addictovigilance data from recreational use highlighted more concerning patterns, including psychiatric effects (51.2%), neurological effects (15.6%), and emergence of cannabinoid hyperemesis syndrome (2.8%), though this data primarily reflects non-medical use patterns.

Current evidence reveals significant gaps that complicate clinical decision-making and risk assessment. Most safety studies have examined products with THC concentrations of 16-22%, with no evidence available for products containing THC concentrations above 22% w/w despite higher concentrations being available for prescription. Major cannabinoids serve as substrates for cytochrome P450 enzymes, creating potential for drug interactions that require enhanced monitoring, yet validated cannabis use disorder screening tools are notably absent from clinical studies. The complexity and variability of cannabis products, delivery routes, and formulations significantly complicate extrapolation of safety data to clinical practice, emphasizing the need for standardized assessment approaches and long-term safety studies.

Biomarkers and Patient Selection in Medical Cannabis Trials

Recent research has identified several biomarker and patient selection approaches in cannabis trials, though most studies focus on observational assessments rather than prospective biomarker-driven selection strategies. Current evidence spans inflammatory markers, neuroimaging biomarkers, and various demographic and clinical selection criteria across different patient populations.

• Inflammatory biomarkers in HIV patients: A 2026 study examined 13 plasma biomarkers in people with HIV on antiretroviral therapy, finding current cannabis use associated with higher soluble CD14 levels (β = 0.35; 95% CI: 0.09, 0.61) and former use linked to lower C-reactive protein levels (β = -0.25; 95% CI: -0.47, -0.04)

• Neuroimaging biomarkers: Brain activation patterns during cognitive tasks (working memory, reward, inhibitory control) were assessed in adults obtaining medical cannabis cards, though no statistically significant differences in brain activation were found between baseline and 1-year follow-up

• Cannabinoid receptor recovery patterns: A 2026 systematic review documented CB1 receptor normalization within 4 weeks of cessation, with cognitive improvements occurring within the first week, though recovery patterns varied by age of onset and use intensity

• Immunometabolic phenotyping: Cannabis use was associated with anti-inflammatory immunometabolic profiles in monocyte-derived macrophages, including metabolic shifts from glycolysis to oxidative phosphorylation and altered cytokine expression patterns

• Symptom-based selection criteria: Studies recruited patients seeking medical cannabis cards for specific indications including anxiety, depression, pain, or insomnia, while others focused on military veterans with chronic PTSD or individuals with risky cannabis use (ASSIST score ≥4)

• Age-stratified approaches: Patient selection strategies included age restrictions (18-65 years in most studies, 15-17 years for adolescent cohorts) and exclusion of participants with daily cannabis use or cannabis use disorder at baseline to minimize confounding factors

Federal Rescheduling Ignites Medical Cannabis Landscape

The federal decision to reschedule cannabis from Schedule I to Schedule III represents a landmark moment, signaling a fundamental shift in how the U.S. government views and regulates cannabis. For the pharmaceutical industry, this move is poised to unlock unprecedented opportunities, particularly in clinical research and market development.

Historically, cannabis's Schedule I status has severely hampered scientific inquiry, making it difficult to conduct the rigorous, large-scale randomized controlled trials necessary to establish clear efficacy, optimal dosing, and safety profiles for various medical conditions. With rescheduling, these barriers are significantly lowered, paving the way for accelerated research into cannabis-based therapies for conditions like chronic pain, cancer-related symptoms, and epilepsy. While real-world evidence and patient-reported outcomes have shown promise, the ability to conduct more robust studies will be critical for gaining broader acceptance within the medical community and developing evidence-based treatment guidelines.

This regulatory change also promises to bring much-needed standardization to a currently fragmented market. The existing patchwork of state-level regulations has led to inconsistencies in product quality, testing, and patient access. A federal framework under Schedule III can facilitate the development of consistent, quality-controlled medical cannabis products, attracting traditional pharmaceutical investment and fostering a more legitimate, integrated market. Companies with established experience in highly regulated environments, such as Tilray, are well-positioned to capitalize on this shift, driving innovation and ensuring product integrity.

However, this evolution is not without its challenges. Despite federal rescheduling, harmonizing state and federal regulations will be crucial to avoid continued fragmentation and ensure patient safety from contaminants. Furthermore, the current gaps in clinical evidence mean that significant investment in research is still required to educate healthcare providers and guide appropriate use. Increased accessibility also necessitates careful consideration of public health implications, including potential for misuse and risks associated with impaired driving. Addressing these complexities will be essential to fully realize the therapeutic potential of medical cannabis while safeguarding public health.