Marinol

(Dronabinol)

ApprovedSmall molecule

Dronabinol is used to treat nausea and vomiting caused by chemotherapy in cancer patients and to help stimulate appetite in people with HIV/AIDS who are losing weight.[2] Marinol is currently approved and in use across 47 indications[4].[1]

Marinol is one of 945 small molecule programs targeting Glioma. It is currently in Approved.

Indications

Total Trials

Active Trials

944

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

GliomaActive, not recruiting

ArthropathyApproved

Total Joint ArthroplastyActive, not recruiting

HIV InfectionApproved

Cervical DystoniaActive, not recruiting

Neuropathic PainApproved

Migraine Without AuraApproved

Low Back PainActive, not recruiting

Cognitive ImpairmentApproved

Familial DysautonomiaActive, not recruiting

GliomaPhase 1

Active, not recruiting

ArthropathyApproved

Approved

Total Joint ArthroplastyPhase 3

Active, not recruiting

HIV InfectionApproved

Approved

Cervical DystoniaPhase 2

Active, not recruiting

Neuropathic PainApproved

Approved

Migraine Without AuraApproved

Approved

Low Back PainPhase 2

Active, not recruiting

Cognitive ImpairmentApproved

Approved

Familial DysautonomiaPhase 2

Active, not recruiting

Showing 10 of 43 indications

Competition

Competitive Landscape

676 competitors in Type 2 Diabetes Mellitus

#DrugCompanyPhaseTrials

Marinol

Alnylam Pharmaceuticals

Approved

71 2

Byetta

AstraZeneca

Preclinical

20 3

Tanzeum

GSK

Preclinical

10 4

Insulin 320

Novo Nordisk

Preclinical

43 5

Adenocard

Astellas

Preclinical

1 6

NOVOLIN R

Novo Nordisk

Preclinical

1 7

Cipro

Myrbetriq

Dostinex

Lantus

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1Recruiting

Adult

NCT05906511

Phase 1Recruiting

Opioid

NCT04025359

Q4 2026

Phase 2/3Active, not recruiting

Efficacy

NCT06146101

Phase 1Recruiting

Humans

NCT02811510

Phase 1/2Recruiting

Treatment

NCT06477952

Q2 2027

Phase 2Recruiting

Inflammation

NCT05519111

Clinical

Trials by Indication[1]

Agitation3 trials

Dronabinol for Agitation in Dementia Crossover Trial

Withdrawn·—·Phase 2·NCT05612711

Trial of Dronabinol Adjunctive Treatment of Agitation in Alzheimer's Disease

Completed·JJohns Hopkins University·Phase 2·NCT02792257·84 enrolled

To Evaluate the Efficacy, Safety, and Tolerability of Dronabinol Oral Solution for Agitation in Patients With Alzheimer's Disease

Not yet recruiting·BBenuvia Therapeutics Inc.·Phase 2/3·NCT07422311·140 enrolled

Schizophrenia3 trials

Cannabis and Schizophrenia: Self-Medication and Agonist Treatment

Completed·—·Phase 1·NCT00946348·12 enrolled

Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?

Completed·—·Phase 1·NCT01964404·263 enrolled

The Effects of Cannabis Use in People With Schizophrenia on Clinical, Neuropsychological and Physiological Phenotypes

Terminated·UUniversity of Colorado, Denver·Phase 1/2·NCT01832766·13 enrolled

Nausea and vomiting3 trials

Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT00553059·62 enrolled

Prevention of Postoperative Nausea and Vomiting (PONV) in Surgical Patients

Completed·VVA Office of Research and Development·N/A·NCT00757822·216 enrolled

Dronabinol Versus Placebo in Treatment and Prevention of Highly Active Anti-Retroviral Therapy (HAART)-Related Nausea and Vomiting

Completed·SSolvay Pharmaceuticals·Phase 2·NCT00642499·103 enrolled

Irritable Bowel Syndrome2 trials

Effect of a Cannabinoid Agonist on Colonic Sensory Functions in Patients With Irritable Bowel Syndrome

Completed·MMichael Camilleri·Phase 2·NCT01786109·75 enrolled

Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor Functions in Patients With Irritable Bowel Syndrome (IBS)

Completed·MMayo Clinic·Phase 2·NCT01253408·36 enrolled

Age2 trials

Age-Related Effects of THC

Completed·UUniversity of Chicago·Phase 1·NCT04294966·24 enrolled

Influence of a Medicinal Cannabinoid Agonist on Responses to Food Images and Food Intake

Active, not recruiting·UUniversitaire Ziekenhuizen KU Leuven·N/A·NCT02310347·18 enrolled

49 more indications

Opioid2 trials

Effects of Dronabinol in Opioid Maintained Patients

Recruiting·YYale University·Phase 1·NCT04025359·36 enrolled

Dronabinol Opioid Sparing Evaluation (DOSE) Trial

Unknown status·DDaisy Pharma Opioid Venture, LLC·Phase 2·NCT03766269·280 enrolled

Drug2 trials

Individual Differences in Drug Response

Completed·UUniversity of Chicago·Phase 1·NCT03809546·60 enrolled

Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs

Completed·IIncannex Healthcare Ltd·Phase 1·NCT05857384·125 enrolled

Treatment2 trials

Dronabinol Treatment for Marijuana Addiction

Completed·NNew York State Psychiatric Institute·Phase 2·NCT00217971·156 enrolled

DRonabinol Treatment of OSA

Recruiting·VVA Office of Research and Development·Phase 1/2·NCT06477952·120 enrolled

Humans2 trials

Cannabinoid Control of Fear Extinction Neural Circuits in Humans

Completed·UUniversity of Illinois at Chicago·Phase 4·NCT02472847·85 enrolled

Recruiting·YYale University·Phase 1·NCT02811510·40 enrolled

Interaction2 trials

Ph1 Marinol Interaction Study - Part 1 - 1

Terminated·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00438139·6 enrolled

Ph1 Marinol Interaction Study - Part 2 - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00490269·12 enrolled

Pain2 trials

Dronabinol as an Adjunct for Reducing Pain

Recruiting·—·Phase 2·NCT06454669·75 enrolled

Dronabinol On the Pain Experience

Terminated·TThe University of Texas Health Science Center, Houston·Phase 4·NCT05820685·484 enrolled

Trichotillomania2 trials

Dronabinol in Trichotillomania and Other Body Focused Repetitive Behaviors

Completed·UUniversity of Chicago·Phase 2/3·NCT03530800·50 enrolled

Marinol in Trichotillomania or Obsessive Compulsive Disorder

Completed·UUniversity of Chicago·Phase 2·NCT01093976·14 enrolled

Fasting Conditions2 trials

Bioavailability Study of Dronabinol Capsules 10 mg Under Fasting Conditions

Completed·PPar Pharmaceutical, Inc.·Phase 1·NCT01380457·69 enrolled

Comparative Bioavailability of Dronabinol Oral Solution Versus Branded Capsule 5 mg Under Fasting Conditions

Completed·IINSYS Therapeutics Inc·Phase 1·NCT01448772·88 enrolled

Oral2 trials

Oral Dronabinol-HIV

Active, not recruiting·YYale University·Phase 1·NCT06034314·160 enrolled

Age-dependent Effects of Smoked and Oral Delta-9-THC

Recruiting·UUniversity of California, Los Angeles·Phase 1·NCT05865470·103 enrolled

Cervical Dystonia1 trial

Efficacy of Dronabinol for the Treatment of Cervical Dystonia

Unknown status·UUniversity Health Network, Toronto·Phase 2·NCT00418925·38 enrolled

Pregnancy1 trial

Effects of Pregnancy-associated Hormones on THC Metabolism in Women

Active, not recruiting·UUniversity of Washington·Phase 4·NCT04374773·12 enrolled

Efficacy1 trial

RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA

Active, not recruiting·IIncannex Healthcare Ltd·Phase 2/3·NCT06146101·560 enrolled

Peripheral Neuropathy1 trial

Phytocannabinoids for Reducing Chronic Chemotherapy-Induced Peripheral Neuropathy in Breast and Colon Cancer Survivors

Recruiting·—·Phase 2·NCT06731894·120 enrolled

Surgery1 trial

Dronabinol After Arthroscopic Surgery

Recruiting·NNorthwestern University·Phase 3·NCT05335252·30 enrolled

Oncology Patients1 trial

Nutrition and Pharmacological Algorithm for Oncology Patients Study

Terminated·MMontefiore Medical Center·Phase 4·NCT04155008·1 enrolled

Anorexia Nervosa1 trial

Cannabinoid Receptor (CB1) Agonist Treatment in Severe Chronic Anorexia Nervosa

Completed·OOdense University Hospital·Phase 3·NCT00760695·24 enrolled

Combination Therapy1 trial

A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000737·56 enrolled

Glioma1 trial

A Pilot Study of Dronabinol for Adult Patients With Primary Gliomas

Completed·—·Phase 1·NCT00314808·33 enrolled

Total Joint Arthroplasty1 trial

A RCT Comparing Dronabinol to a Placebo for Post-operative Pain in Total Joint Arthroplasty

Unknown status·CColorado Joint Replacement·Phase 3·NCT04298528·460 enrolled

Familial dysautonomia1 trial

The Safety, Tolerability and Efficacy of Dronabinol, for the Treatment of Nausea and Vomiting in Familial Dysautonomia

Withdrawn·NNYU Langone Health·Phase 2·NCT02608931

Low back pain1 trial

Trial of Dronabinol and Vaporized Cannabis in Chronic Low Back Pain

Completed·UUniversity of California, San Diego·Phase 2·NCT02460692·131 enrolled

Obstructive Sleep Apnea1 trial

Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea

Completed·UUniversity of Illinois at Chicago·Phase 2·NCT01755091·75 enrolled

Post-Traumatic Stress Disorder1 trial

Cannabinoid Control of Fear Extinction Neural Circuits in Post-traumatic Stress Disorder

Completed·WWayne State University·N/A·NCT02069366·86 enrolled

Amyotrophic Lateral Sclerosis1 trial

Randomized Placebo-Controlled Crossover Trial With THC (Delta 9-Tetrahydrocannabinol) for the Treatment of Cramps in Amyotrophic Lateral Sclerosis (ALS)

Completed·—·N/A·NCT00812851·24 enrolled

Cannabis Dependence1 trial

Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia

Terminated·MMclean Hospital·Phase 2/3·NCT01598896·12 enrolled

Bipolar Disorder1 trial

Effects of Cannabis on Cognition and Endocannabinoid Levels in Bipolar Disorder Patients and Healthy Volunteers

Terminated·UUniversity of California, San Diego·Phase 1·NCT04231643·19 enrolled

Chemotherapy-induced nausea and vomiting1 trial

Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting

Completed·SSolvay Pharmaceuticals·Phase 3·NCT00642512·64 enrolled

Hemodynamic1 trial

The Effect of Tetrahydrocannabinol on Ocular Hemodynamics in Healthy Subjects

Completed·MMedical University of Vienna·N/A·NCT03907163·24 enrolled

Imaging1 trial

Using Imaging to Assess Effects of THC on Brain Activity

Completed·MMassachusetts General Hospital·N/A·NCT03655717·316 enrolled

Effectiveness1 trial

Effectiveness Study of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal

Completed·UUniversity of Pennsylvania·Phase 2·NCT00480441·61 enrolled

Withdrawal1 trial

Effect of Lofexidine and Oral THC on Marijuana Withdrawal and Relapse

Completed·NNew York State Psychiatric Institute·Phase 2·NCT00373503·8 enrolled

Marijuana1 trial

Comparing the Effects of Smoked and Oral Marijuana in Individuals With HIV/AIDS

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1/2·NCT00079560·30 enrolled

Chest pain1 trial

Investigation of Cannabinoid Receptor Agonist Dronabinol in Patients With Functional Chest Pain

Withdrawn·TTemple University·Phase 4·NCT02569073

Sex Differences1 trial

Sex Differences in Neurobehavioral Response to THC

Not yet recruiting·MMedical University of South Carolina·Phase 2·NCT07225777·40 enrolled

Trauma1 trial

The Effect of Dronabinol on the Acquisition and Consolidation of Trauma-Associated Memories

Active, not recruiting·—·N/A·NCT04871269·291 enrolled

Multiple Sclerosis1 trial

Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple Sclerosis

Completed·BBionorica Research GmbH·Phase 3·NCT00959218·240 enrolled

Sickle Cell Disease1 trial

Dronabinol for Pain and Inflammation in Adults Living With Sickle Cell Disease

Terminated·YYale University·Phase 1·NCT03978156·6 enrolled

Abuse Potential1 trial

A Study of the Abuse Potential of Dronabinol in Recreational Cannabinoid Users

Completed·IINSYS Therapeutics Inc·Phase 1·NCT02094599·43 enrolled

Adult1 trial

PK/PD of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults

Recruiting·YYale University·Phase 1·NCT05906511·20 enrolled

Buprenorphine1 trial

Dronabinol and Epidiolex to Manage Uncontrolled Residual Symptoms of Buprenorphine Initiation Trial

Not yet recruiting·MMontefiore Medical Center·Phase 3·NCT07148206·40 enrolled

Cognition1 trial

Activation of the Endocannabinoid System and Cognition

Completed·—·N/A·NCT05226351·192 enrolled

Glaucoma1 trial

The Effect of Dronabinol on Ocular Hemodynamics in Patients With Primary Open Angle Glaucoma

Completed·MMedical University of Vienna·Phase 2·NCT04596826·51 enrolled

Children1 trial

Dronabinol As an Adjunct for Reducing Pain (DARP)-Texas Children's Hospital

Withdrawn·—·Phase 2·NCT06834997

COPD1 trial

Reducing Breathlessness With Dronabinol in COPD Patients

Recruiting·VVejle Hospital·Phase 3·NCT06473701·30 enrolled

Impairment1 trial

Developing a Mobile Method to Measure THC-induced Impairment

Completed·UUniversity of Chicago·Phase 1·NCT03804840·72 enrolled

Cannabis1 trial

Combined Pharmacotherapy for Cannabis Dependency

Completed·NNew York State Psychiatric Institute·Phase 2/3·NCT01020019·156 enrolled

Sleep1 trial

Tetrahydrocannabinol (THC) and Sleep

Completed·OOregon Health and Science University·Phase 1·NCT03560934·18 enrolled

Inflammation1 trial

Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT05519111·60 enrolled

Blood Pressure1 trial

Synthetic THC And Blood Pressure

Not yet recruiting·MMayo Clinic·Phase 2/3·NCT07231965·50 enrolled

Regulatory

FDA Approval Timeline[5]

May 31, 1985

MARINOL

NDA NDA018651

Mar 23, 2017

SYNDROS

NDA NDA205525

Sources

References

[1]
ClinicalTrials.gov — 71 trial records for Dronabinol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Marinol drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Dronabinol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Dronabinol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA205525). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Marinol. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Alnylam Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cannabinoid CB1 Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Alnylam Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Aug 6, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10265293Aug 6, 2028

9345771Aug 6, 2028

11253472Aug 6, 2028

8222292Aug 6, 2028

Marinol

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q2 2027

Trials by Indication[1]

Agitation3 trials

Schizophrenia3 trials

Nausea and vomiting3 trials

Irritable Bowel Syndrome2 trials

Age2 trials

Opioid2 trials

Drug2 trials

Treatment2 trials

Humans2 trials

Interaction2 trials

Pain2 trials

Trichotillomania2 trials

Fasting Conditions2 trials

Oral2 trials

Cervical Dystonia1 trial

Pregnancy1 trial

Efficacy1 trial

Peripheral Neuropathy1 trial

Surgery1 trial

Oncology Patients1 trial

Anorexia Nervosa1 trial

Combination Therapy1 trial

Glioma1 trial

Total Joint Arthroplasty1 trial

Familial dysautonomia1 trial

Low back pain1 trial

Obstructive Sleep Apnea1 trial

Post-Traumatic Stress Disorder1 trial

Amyotrophic Lateral Sclerosis1 trial

Cannabis Dependence1 trial

Bipolar Disorder1 trial

Chemotherapy-induced nausea and vomiting1 trial

Hemodynamic1 trial

Imaging1 trial

Effectiveness1 trial

Withdrawal1 trial

Marijuana1 trial

Chest pain1 trial

Sex Differences1 trial

Trauma1 trial

Multiple Sclerosis1 trial

Sickle Cell Disease1 trial

Abuse Potential1 trial

Adult1 trial

Buprenorphine1 trial

Cognition1 trial

Glaucoma1 trial

Children1 trial

COPD1 trial

Impairment1 trial

Cannabis1 trial

Sleep1 trial

Inflammation1 trial

Blood Pressure1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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