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Cesamet (NABILONE)
Nabilone (Cesamet), marketed by Bausch Health, is a cannabinoid receptor agonist approved for the treatment of chemotherapy-induced nausea and vomiting. Its key strength lies in its mechanism of action, which effectively mimics the effects of THC, providing a unique therapeutic option in the market. The primary risk is the competitive landscape, particularly from dronabinol, which has a similar patent expiry date in 2028, and other patent-protected drugs like aprepitant and rolapitant.
At a glance
| Generic name | NABILONE |
|---|---|
| Sponsor | Bausch Health |
| Drug class | Cannabinoid [EPC] |
| Target | Cannabinoid receptor 1 |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 1985 |
Approved indications
- Nausea and Vomiting from Chemotherapy
Common side effects
- Vertigo
- Drowsiness
- Dry Mouth
- Ataxia
- Euphoria
- Sleep Disturbance
- Dysphoria
- Headache
- Nausea
- Disorientation
- Depersonalization
Drug interactions
- diazepam
- sodium secobarbital
- alcohol
- codeine
- CNS depressants
- highly protein-bound drugs
- amphetamines, cocaine, other sympathomimetic agents
- atropine, scopolamine, antihistamines, other anticholinergic agents
- amitriptyline, amoxapine, desipramine, other tricyclic antidepressants
- barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, antihistamines, muscle relaxants, other CNS depressants
- disulfiram
- fluoxetine
Key clinical trials
- The Role of Endocannabinoids in Insulin Production and Action (PHASE1)
- Investigating the Effects of Nabilone on Endocannabinoid Metabolism (PHASE4)
- Nabilone for Agitation Blinded Intervention Trial (PHASE3)
- Clinical Trial of Nabilone for Aggression in Adults With Intellectual and Developmental Disabilities (PHASE1)
- Cannabinoids and an Anti-inflammatory Diet for the Treatment of Neuropathic Pain After Spinal Cord Injury (PHASE3)
- Nabilone for Agitation in Frontotemporal Dementia (PHASE2)
- Effect of PP-01 on Cannabis Withdrawal Syndrome (PHASE2)
- Multimodal Assessment of Cannabinoid Target Engagement in Adults With Obsessive-Compulsive Disorder (PHASE1,PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |