NDAORALCAPSULEPriority Review
Approved
May 1985
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
5/8 — Partial
Priority Review
MARINOL (dronabinol) by Ascentage Pharma is cns, including central sympathomimetic activity. First approved in 1985.
Drug data last refreshed 1h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MARINOL (dronabinol) is a synthetic cannabinoid oral capsule approved in 1985 for chemotherapy-induced nausea/vomiting and AIDS-related anorexia, with off-label use across pain, cachexia, dementia, and sleep disorders. It acts as a CNS agent through cannabinoid receptor modulation in neural tissue. The product is sponsored by Ascentage Pharma and faces approaching loss of exclusivity.
$35KPart D
LOE ApproachingMinimal commercial traction with only $35K in Part D spending and 20 claims in 2023 signals a mature, niche product with limited growth trajectory and likely small dedicated team.
Mechanism of Action
CNS, including central sympathomimetic activity. Cannabinoid receptors have been discovered in neural tissues. These receptors may play a role in mediating the effects of dronabinol.
Pharmacologic Class:
Cannabinoid
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Dronabinol for Agitation in Dementia Crossover Trial
Started Nov 2023
0Dementia ModerateDementia SevereAgitation,Psychomotor+1 more
Dronabinol for Post-operative Pain After Lumbar Fusion
Started Sep 2020
90 enrolled
Post-operative Pain
A RCT Comparing Dronabinol to a Placebo for Post-operative Pain in Total Joint Arthroplasty
Started Feb 2020
460 enrolled
Osteoarthritis, Knee
Investigation of Cannabinoid Receptor Agonist Dronabinol in Patients With Functional Chest Pain
Started Jun 2017
0Esophageal Diseases
Study to Evaluate the Efficacy and Safety of Dronabinol Metered Dose Inhaler (MDI) in Acute Treatment of Migraine Headache
Started Sep 2005
Migraine With AuraMigraine Without Aura
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.