Cesamet (nabilone) / Bausch Health, Viatris - LARVOL DELTA

Efficacy and Safety of Cannabinoid-Based Interventions for Low Back Pain and Migraine: A Systematic Review of Randomized Controlled Trials. (PubMed, Cannabis Cannabinoid Res) - "Current randomized evidence does not support a class-wide effect of cannabinoid-based therapies for low back pain or headache disorders. Efficacy appears to depend on indication, formulation, route of administration, and cannabinoid composition. Moderate-certainty evidence supports vaporized THC + CBD for acute migraine outcomes, including 2-h efficacy and sustained response for selected outcomes through 24-48 h and VER-01 for chronic low back pain; evidence for single-dose oral cannabidiol and nabilone remains very uncertain. Larger independently replicated trials using analytically standardized formulations, harmonized outcomes, active-placebo strategies when THC is present, and additional studies evaluating repeated use across multiple migraine attacks and longer-term safety are needed."

Clinical • Journal • Review • Back Pain • CNS Disorders • Lumbar Back Pain • Migraine • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Proof-of-concept trial of PP-01 for mitigating cannabis withdrawal syndrome in participants with cannabis use disorder. (PubMed, Am J Addict) - "PP-01 is intended as a potential treatment for cannabis withdrawal syndrome (CWS)/CUD, a serious and unmet need for which there is no Food and Drug Administration (FDA)-approved medication."

Clinical • Journal • Substance Abuse

AgiNab: Nabilone for Agitation in Frontotemporal Dementia (clinicaltrials.gov) - P2 | N=3 | Terminated | Sponsor: Simon Ducharme, MD | No participants on treatment, no safety concerns. All sites are now closed.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration

Evaluation of the use of different forms of medical cannabis in the treatment of fibromyalgia: a systematic review. (PubMed, EULAR Rheumatol Open) - "To systematically review, based on randomised controlled trials (RCTs), some forms of medical cannabis (nabilone, tetrahydrocannabinol-rich oil, and Bediol) in the treatment of fibromyalgia syndrome (FMS)...It is not possible to conclude whether different forms of medical cannabis are an effective and safe therapeutic option for the treatment of FMS symptoms, with tolerable adverse effects. This prescription should be made individually for each patient."

Journal • CNS Disorders • Fibromyalgia • Insomnia • Musculoskeletal Pain • Pain • Rheumatology • Sleep Disorder

Efficacy of PP-01 in Mitigating Cannabis Withdrawal Symptoms in Adults With Cannabis Use Disorder (clinicaltrials.gov) - P3 | N=420 | Recruiting | Sponsor: PleoPharma, Inc.

New P3 trial • Substance Abuse

Therapeutic Drug Monitoring of Cannabinoids: Therapeutic Reference Ranges for Delta-9-tetrahydrocannabinol in Medical Cannabis, Nabiximols, Dronabinol and Nabilone. (PubMed, Pharmacopsychiatry) - "In conclusion, relatively low concentrations may be sufficient to achieve therapeutic effects across all substances studied, with medical cannabis demonstrating these effects at lower concentrations than typically observed in recreational use. Nevertheless, adverse effects at therapeutic reference ranges cannot be excluded."

Journal • Chemotherapy-Induced Nausea and Vomiting • CNS Disorders • Diabetic Neuropathy • Movement Disorders • Multiple Sclerosis • Neuralgia • Pain • Peripheral Neuropathic Pain

Synthetic CB1 Modulators in Clinical Trials: A Medicinal Chemistry Review. (PubMed, ChemMedChem) - "Despite its therapeutic potential, clinical translation has been limited, with only dronabinol and nabilone approved since the 1980s, largely due to central adverse effects associated with CB1 modulation. Central nervous system adverse effects remain the principal challenge, driving the development of peripherally restricted ligands, biased modulators, and compounds with improved metabolic profiles. Collectively, the insights discussed herein highlight how the integration of structural, pharmacological, and clinical data can guide the rational design of safer and more effective CB1 receptor modulators."

Journal • Review • Autism Spectrum Disorder • Cognitive Disorders • Developmental Disorders • Genetic Disorders • Immunology • Neuralgia • Obesity • Osteoarthritis • Pain • Rheumatology

Efficacy, effectiveness and safety of medical cannabis in PTSD: a scoping review. (PubMed, J Cannabis Res) - "The current evidence from high-quality RCTs remains insufficient to support clinical use of cannabinoids in treating PTSD. The therapeutic role of cannabinoids in PTSD should be further evaluated through rigorous RCTs."

Journal • Review • CNS Disorders • Mood Disorders • Post-traumatic Stress Disorder • Psychiatry • Xerostomia

Cannabinoids: Therapeutic Applications, Mechanisms, and Challenges in Modern Medicine. (PubMed, Curr Med Chem) - "Nabilone is a commercially available cannabinoid derivative licensed for use in cancer patients to relieve chemotherapy-induced emesis (CIE)...Several in vitro and preclinical studies have been discussed in this review, which validate the effective role of cannabinoids. However, there is a need to perform clinical trials involving human subjects to establish standard formulations, doses, and safety profiles to consider such substances as drugs."

Journal • Anesthesia • CNS Disorders • Fatigue • Gastroenterology • Gastrointestinal Disorder • Mood Disorders • Oncology • Pain • Psychiatry

Computational Characterization of Nabilone-Induced Disruption of the CB2-HER2 Receptor Complex in HER2+ Breast Cancer. (PubMed, Bioinform Biol Insights) - "Our in silico model predicts that Nabilone may disrupt the HER2-CB2 complex, suggesting a hypothesis that it could serve as a potential therapeutic agent. These computational findings warrant urgent experimental validation."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Therapeutic effects of cannabinoids on Parkinson's disease: an updated systematic review and meta-analysis of randomized controlled trials. (PubMed, Acta Neurol Belg) - "Cannabinoids have not shown significant benefit in PD; however, our findings should be interpreted with caution. The nabilone benefit signal for non-motor symptoms represents a distinct question warranting dedicated trials. Future studies should use standardized, pharmacologically stratified protocols."

Journal • Retrospective data • Review • CNS Disorders • Movement Disorders • Parkinson's Disease

Acute metabolic effects of cannabinoid receptor modulators during sequential hyperglycemic, euglycemic-hyperinsulinemic clamps in healthy individuals. (PubMed, Am J Physiol Endocrinol Metab) - "In this physiological study of twenty-one healthy men, we investigated the acute effects of a non-specific cannabinoid receptor agonist nabilone (NAB 2mg) and a specific cannabinoid receptor 1 (CB1R) antagonist CP-945,598 at two concentrations (LDCP 15mg and HDCP 45 mg) on insulin secretion, insulin action, and glucose disposal - all compared to placebo (PL)...Additionally, we measured serum levels of endocannabinoids and various N-acylethanolamines over the course of the sequential clamps. Our major findings were as follows: (1) insulin secretion was not impacted by NAB or CP during the hyperglycemic clamp compared to PL; (2) insulin sensitivity was significantly increased by NAB but decreased by HDCP, both compared to PL, during the euglycemic-hyperinsulinemic clamp; (3) under the conditions of the experiments outlined, non-esterified fatty acids, and many circulating N-acylethanolamines levels, including the endocannabinoid anandamide (AEA), were reduced in a..."

Journal • Diabetes

Investigating the Effects of Nabilone on Endocannabinoid Metabolism (clinicaltrials.gov) - P4 | N=10 | Completed | Sponsor: Centre for Addiction and Mental Health | Recruiting ➔ Completed | N=30 ➔ 10 | Trial completion date: Oct 2026 ➔ Dec 2025 | Trial primary completion date: Oct 2026 ➔ Dec 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date

NAB-IT: Nabilone for Agitation Blinded Intervention Trial (clinicaltrials.gov) - P3 | N=112 | Recruiting | Sponsor: Sunnybrook Health Sciences Centre | Trial completion date: Oct 2025 ➔ Apr 2027 | Trial primary completion date: Oct 2025 ➔ Apr 2027

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

N-AND: Clinical Trial of Nabilone for Aggression in Adults With Intellectual and Developmental Disabilities (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Hsiang-Yuan Lin | Recruiting ➔ Completed | N=30 ➔ 20 | Trial completion date: Dec 2025 ➔ Aug 2025 | Trial primary completion date: Dec 2025 ➔ Aug 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Developmental Disorders • Mental Retardation • Psychiatry

Assessment of clinical factors that predict response to nabilone for agitation in Alzheimer's disease: A post hoc analysis of a randomized placebo-controlled trial. (PubMed, Int Psychogeriatr) - "A reliable clinical profile of persons with AD related agitation likely to respond to nabilone may be established with additional research."

Journal • Retrospective data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Pain • Psychiatry

A Combination of Low-Dose Δ9-THC and Celecoxib as a Therapeutic Strategy for Alzheimer's Disease. (PubMed, Aging Dis) - "These findings suggest that the combination of low-dose Δ9-THC and Celecoxib holds promise as an early intervention strategy for preventing AD onset or treating mild cognitive impairment (MCI). Importantly, both Δ9-THC (in the form of Dronabinol and Nabilone) and Celecoxib are FDA-approved medications already in clinical use, supporting the strong translational potential of this combination therapy and its feasibility for rapid advancement to clinical trials to assess its efficacy in preventing or delaying AD onset in humans."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Inflammation

Clinical Manifestations. (PubMed, Alzheimers Dement) - "AD patients with pain, apathy and appetite changes, and with less cognitive impairment and not on ChEIs, were most likely to benefit from nabilone. If replicated with phase 3 data, these predictors may assist in guiding clinicians on who is likely to benefit from nabilone when managing agitation."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Pain • Psychiatry

Clinical Manifestations. (PubMed, Alzheimers Dement) - "Participants with higher levels of inflammation, oxidative stress, and cholesterol metabolite were more likely to benefit from nabilone for agitation in AD. A combination of biomarkers could help in distinguishing responders and non-responders to nabilone."

Journal • Alzheimer's Disease • CNS Disorders • Inflammation • Psychiatry • CLU • IL6

Clinical Manifestations. (PubMed, Alzheimers Dement) - "In addition to the efficacy for improving agitation shown previously, these exploratory results suggest that nabilone can also alleviate anxiety and depression symptoms in moderate-severe AD patients. The change in appetite/eating habits required further attention, as the specific changes (increase or decrease in appetite) were unclear."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Developmental Disorders • Mood Disorders • Psychiatry

Cannabis-Based Products for Chronic Pain : An Updated Systematic Review. (PubMed, Ann Intern Med) - "Among THC-only products, nabilone moderately reduced pain severity but dronabinol did not (pooled differences, -1.59 and -0.23 points, respectively). Studies are needed on long-term outcomes and other cannabis product types. Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services (PROSPERO: CRD42021229579)."

Journal • Review • Anesthesia • Neuralgia • Pain

Pain Severity Moderates Efficacy of Nabilone for Agitation in Alzheimer's Disease (CTAD 2025) - No abstract available

Clinical • Alzheimer's Disease • CNS Disorders • Pain

Therapeutic Use of Cannabis and Cannabinoids: A Review. (PubMed, JAMA) - "A meta-analysis of randomized clinical trials reported a small but significant reduction in nausea and vomiting from various causes (eg, chemotherapy, cancer) when comparing prescribed cannabinoids (eg, dronabinol, nabilone) with placebo or active comparators (eg, alizapride, chlorpromazine; standardized mean difference [SMD], -0.29 [95% CI, -0.39 to -0.18]). Clear guidance from clinicians is essential to support safe, evidence-based decision-making. Clinicians should weigh benefits against risks when engaging patients in informed discussions about cannabis or cannabinoid use."

Clinical • Journal • Anorexia • Cardiovascular • Chemotherapy-Induced Nausea and Vomiting • CNS Disorders • Coronary Artery Disease • Epilepsy • General Anxiety Disorder • Heart Failure • Human Immunodeficiency Virus • Infectious Disease • Insomnia • Mood Disorders • Myocardial Infarction • Oncology • Pain • Pediatrics • Psychiatry • Schizophrenia • Sleep Disorder • Substance Abuse

Identifying a combination of biomarkers to predict treatment response to nabilone for agitation in Alzheimer's disease - an exploratory post hoc analysis. (PubMed, Neurodegener Dis Manag) - "The proportion of responders was significantly higher in T1 (91%, n = 11) compared to T2 + 3 (32%, n = 19) (Fisher's p = .002). A combination of biomarkers could help characterize responders and non-responders to nabilone."

Biomarker • Journal • Retrospective data • Alzheimer's Disease • CNS Disorders • Inflammation • CLU • IL6

CATNP: Cannabinoids and an Anti-inflammatory Diet for the Treatment of Neuropathic Pain After Spinal Cord Injury (clinicaltrials.gov) - P3 | N=14 | Completed | Sponsor: Eldon Loh, MD | Recruiting ➔ Completed | N=140 ➔ 14 | Trial completion date: Dec 2026 ➔ Dec 2024

Enrollment change • Trial completion • Trial completion date • CNS Disorders • Musculoskeletal Diseases • Neuralgia • Orthopedics • Pain