Last reviewed · How we verify
Marinol (DRONABINOL)
Dronabinol acts on cannabinoid receptors in the CNS, potentially through central sympathomimetic activity.
Dronabinol (Marinol), marketed by Wellhouse Pharma, is a cannabinoid receptor agonist primarily indicated for anorexia associated with weight loss in AIDS patients. Its key strength lies in its well-established mechanism of action and market presence, with a key composition patent expiring in 2028. The primary risk is competition from off-patent drugs like scopolamine and nabilone, as well as patent-protected alternatives such as aprepitant and rolapitant.
At a glance
| Generic name | DRONABINOL |
|---|---|
| Sponsor | Wellhouse Pharma |
| Drug class | Cannabinoid [EPC] |
| Target | Cannabinoid receptors |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1985 |
Mechanism of action
Dronabinol is an orally active cannabinoid that affects the central nervous system (CNS) in complex ways, including central sympathomimetic activity. It interacts with cannabinoid receptors found in neural tissues, which may mediate its effects.
Approved indications
- Anorexia associated with weight loss in AIDS
- Nausea and vomiting with cancer chemotherapy
Common side effects
- abdominal pain
- nausea
- vomiting
Drug interactions
- Inhibitors of CYP2C9 (e.g., amiodarone, fluconazole)
- Inducers of CYP2C9
- Inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, grapefruit juice)
- Inducers of CYP3A4
- Highly protein-bound drugs (e.g., warfarin, cyclosporine, amphotericin B)
- CNS depressants
- Drugs with similar effects on the cardiovascular system
Key clinical trials
- EFFECTS OF A FULL SPECTRUM CANNABIS EXTRACT WITH DIFFERENT DOSES OF CBD AND THC ON THE MODULATION OF FIBROMYALGIA: A PILOT, MULTICENTER, OPEN LABEL CLINICAL TRIAL (FRIDINHA) (PHASE1,PHASE2)
- Dronabinol in Total Knee Arthroplasty (TKA) (PHASE4)
- AnalgeSiC and appEtite-stimulating Effects of caNnabigerol and THC (ASCENT) (PHASE1)
- Effects of Dronabinol in Opioid Maintained Patients (EARLY_PHASE1)
- Dose-Ranging Trial of Inhaled Cannabis for Acute Migraine Treatment (PHASE2)
- Dronabinol as an Adjunct for Reducing Pain (PHASE2)
- Dronabinol As an Adjunct for Reducing Pain (DARP)-Texas Children's Hospital (PHASE2)
- Efficacy and Safety of VER-01 in the Treatment of Patients With Radicular Chronic Low Back Pain (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Marinol CI brief — competitive landscape report
- Marinol updates RSS · CI watch RSS
- Wellhouse Pharma portfolio CI