MARINOL (dronabinol)
MARINOL is indicated for the treatment of Anorexia; Acquired Immunodeficiency Syndrome; Nausea; Vomiting.
How MARINOL Works
Dronabinol is an orally active cannabinoid that exerts complex effects on the central nervous system (CNS), including central sympathomimetic activity. Its therapeutic effects are mediated through interaction with cannabinoid receptors discovered in neural tissues, which play a key role in regulating appetite and the emetic reflex.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1985-05-31
- Routes
- ORAL
- Dosage Forms
- CAPSULE
MARINOL Approval History
What MARINOL Treats
4 indicationsMARINOL is approved for 4 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anorexia
- Acquired Immunodeficiency Syndrome
- Nausea
- Vomiting
MARINOL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MARINOL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
32 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07231965 | 25-008291 | Ph 2, Ph 3 | not yet recruiting | Synthetic THC And Blood Pressure |
| NCT07225777 | Pro00148223 K12DA031794 | Ph 2 | recruiting | Sex Differences in Neurobehavioral Response to THC |
| NCT04374773 PrECEPT results posted | STUDY00008064 2P01DA032507-06A1 | Ph 4 | completed | Effects of Pregnancy-associated Hormones on THC Metabolism in Women |
| NCT07570953 | 25-009764 | Ph 2, Ph 3 | not yet recruiting | A Study Of Synthetic THC And Sleep |
| NCT06454669 DARP | H-51389 | Ph 2 | recruiting | Dronabinol as an Adjunct for Reducing Pain |
| NCT05865470 SAGE | 22-001292 R01DA057252 | Ph 1 | recruiting | Age-dependent Effects of Smoked and Oral Delta-9-THC |
| NCT01964404 results posted | D14061 1R01DA034699-01A1 | Ph 1 | completed | Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment? |
| NCT06731894 | 24435 NCI-2024-08847, 24435 | Ph 2 | recruiting | Phytocannabinoids for Reducing Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors |
| NCT05519111 CRISP | GCO 22-1141 K23HL151884 | Ph 2 | recruiting | Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain |
| NCT06477952 DROSA | PULM-011-23F | Ph 1, Ph 2 | recruiting | DRonabinol Treatment of OSA |
| NCT05820685 DOPE results posted | HSC-MS-22-0499 | Ph 4 | terminated | Dronabinol On the Pain Experience |
| NCT02811510 THC-Gender-I | 1505015940.A | Ph 1 | recruiting | Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I |
| NCT05335252 | STU00213383 | Ph 3 | recruiting | Dronabinol After Arthroscopic Surgery |
| NCT06146101 REPOSA | IHL42XOSAP2/3 U1111-1302-4915 | Ph 2, Ph 3 | active not recruiting | RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA |
| NCT05612711 | 1I01CX002671 | Ph 2 | withdrawn | Dronabinol for Agitation in Dementia Crossover Trial |
| NCT02460692 results posted | 1R01DA038634-01A1 R01DA038634 | Ph 2 | completed | Trial of Dronabinol and Vaporized Cannabis in Chronic Low Back Pain |
| NCT01323569 | GWCP0605 | Ph 1 | completed | Abuse Potential of Sativex |
| NCT01093976 results posted | 0909M72088 | Ph 2 | completed | Marinol in Trichotillomania or Obsessive Compulsive Disorder |
| NCT04155008 results posted | 2019-10218 | Ph 4 | terminated | Nutrition and Pharmacological Algorithm for Oncology Patients Study |
| NCT03530800 results posted | IRB18-0542 | Ph 2, Ph 3 | completed | Dronabinol in Trichotillomania and Other Body Focused Repetitive Behaviors |
| NCT01755091 PACE results posted | 2012-0095 UM1HL112856 | Ph 2 | completed | Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea |
| NCT00946348 results posted | R01DA013196 1R01DA026799-01, R01DA013196 | Ph 1 | completed | Cannabis and Schizophrenia: Self-Medication and Agonist Treatment |
| NCT00553059 results posted | 2006-0841 MDA-2006-0841, CDR0000573510 | Ph 3 | completed | Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer |
| NCT02569073 ICAMP | 22894 | Ph 4 | withdrawn | Investigation of Cannabinoid Receptor Agonist Dronabinol in Patients With Functional Chest Pain |
| NCT02608931 | 14-01577 | Ph 2 | withdrawn | The Safety, Tolerability and Efficacy of Dronabinol, for the Treatment of Nausea and Vomiting in Familial Dysautonomia |
| NCT01020019 D-LUCS results posted | #6015 P50DA009236-16 | Ph 2, Ph 3 | completed | Combined Pharmacotherapy for Cannabis Dependency |
| NCT01598896 DCCS results posted | 2010P-002262 Brain and Behavior Research | Ph 2, Ph 3 | terminated | Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia |
| NCT01598207 results posted | 201003768 | Ph 4 | completed | The Effects of Cannabinoid on Patients With Non-GERD Related Non Cardiac Chest Pain |
| NCT02472847 results posted | 2012-0242 R21MH093917 | Ph 4 | completed | Cannabinoid Control of Fear Extinction Neural Circuits in Humans |
| NCT00760695 | 033 | Ph 3 | completed | Cannabinoid Receptor (CB1) Agonist Treatment in Severe Chronic Anorexia Nervosa |
| NCT01253408 results posted | 08-008314 Part A R01DK079866, UL1RR024150 | Ph 2 | completed | Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor Functions in Patients With Irritable Bowel Syndrome (IBS) |
| NCT01786109 results posted | 08-008314 Part B R01DK079866, UL1RR024150 | Ph 2 | completed | Effect of a Cannabinoid Agonist on Colonic Sensory Functions in Patients With Irritable Bowel Syndrome |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MARINOL FDA Label Details
Indications & Usage
FDA Label (PDF)MARINOL is indicated for the treatment of Anorexia; Acquired Immunodeficiency Syndrome; Nausea; Vomiting.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment