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 37 indications[4].[1]

Marinol is one of 627 small molecule programs targeting Anorexia. It is currently in Approved.

Indications

Total Trials

Active Trials

626

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

FibromyalgiaActive, not recruiting

OralActive, not recruiting

Cognitive ImpairmentApproved

Chronic PainApproved

Drug DependenceApproved

Alzheimer DiseaseApproved

Autism Spectrum DisorderApproved

Cancer PainApproved

Alcohol DrinkingApproved

HIV InfectionApproved

FibromyalgiaPreclinical

Active, not recruiting

OralPhase 1

Active, not recruiting

Cognitive ImpairmentApproved

Approved

Chronic PainApproved

Approved

Drug DependenceApproved

Approved

Alzheimer DiseaseApproved

Approved

Autism Spectrum DisorderApproved

Approved

Cancer PainApproved

Approved

Alcohol DrinkingApproved

Approved

HIV InfectionApproved

Approved

Showing 10 of 32 indications

Competition

Competitive Landscape

150 competitors in Type 2 Diabetes Mellitus

#DrugCompanyPhaseTrials

Marinol

Jazz Pharmaceuticals

Approved

73 2

Maridebart Cafraglutide

Amgen

Phase 3

3 3

Retatrutide

Eli Lilly

Phase 3

1 4

HDM1002

HHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Phase 3

3 5

Ganagliflozin

HHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Phase 3

1 6

HM11260C

Hanmi Pharmaceutical Company Limited

Phase 3

3 7

Dorzagliatin

HHua Medicine Limited

Phase 3

—8

TG103

CCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Phase 3

2 9

Adenocard

Astellas

Preclinical

1 10

NOVOLIN R

Novo Nordisk

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

COPD

NCT06473701

Phase 1Recruiting

Humans

NCT02811510

PreclinicalRecruiting

Obstructive Sleep Apnea

NCT06477952

Q1 2027

Phase 1Recruiting

Pain

NCT04025359

Q2 2027

Phase 2Recruiting

Inflammation

NCT05519111

Phase 3Recruiting

Surgery

NCT05335252

Clinical

Trials by Indication[1]

Obstructive Sleep Apnea4 trials

Safety and Efficacy Study of Dronabinol to Treat Obstructive Sleep Apnea

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

Effects Of Nocturnal Dronabinol Use On Obstructive Sleep Apnea Treatment And Physiological Outcomes

Not yet recruiting·MMayo Clinic·Preclinical·NCT07570953·72 enrolled

Targeted Treatment of Obstructive Sleep Apnea With Dronabinol: Proof of Concept and Phase II Clinical Trial

Recruiting·VVA Office of Research and Development·Preclinical·NCT06477952·120 enrolled

Show 1 more trial

A Phase II/III, Randomised, Double-Blind Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnoea Who Are Intolerant, Non-Compliant, or Naïve to Positive Airway Pressure

Completed·IIncannex Healthcare Ltd·Preclinical·NCT06146101·121 enrolled

Nausea and vomiting3 trials

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

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

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

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

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

Pain3 trials

Dronabinol On the Pain Experience

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

Dronabinol as an Adjunct for Reducing Pain

Recruiting·—·Phase 2·NCT06454669·75 enrolled

The Effects of Dronabinol in Opioid-Related Outcomes

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

48 more indications

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 2 - 1

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

Ph1 Marinol Interaction Study - Part 1 - 1

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

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

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

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

Cannabis Use Disorder2 trials

The Contribution of the Endocannabinoid System to Sex Differences in THC-associated Reward

Not yet recruiting·MMedical University of South Carolina·Phase 2·NCT07815691·78 enrolled

Sex Differences in Neurobehavioral Response to Acute THC in Adults With Cannabis Use Disorder

Terminated·MMedical University of South Carolina·Phase 2·NCT07225777·5 enrolled

Chest pain1 trial

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

Withdrawn·TTemple University·Phase 4·NCT02569073

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

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

Opioid1 trial

Dronabinol Opioid Sparing Evaluation (DOSE) Trial

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

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

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

Effectiveness1 trial

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

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

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

Peripheral Neuropathy1 trial

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

Recruiting·—·Phase 2·NCT06731894·120 enrolled

Anorexia Nervosa1 trial

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

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

Impairment1 trial

Developing a Mobile Method to Measure THC-induced Impairment

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

Cognition1 trial

Activation of the Endocannabinoid System and Cognition

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

Children1 trial

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

Withdrawn·—·Phase 2·NCT06834997

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

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

Withdrawal1 trial

Effect of Lofexidine and Oral THC on Marijuana Withdrawal and Relapse

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

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

Trauma1 trial

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

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

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

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

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

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

Treatment1 trial

Dronabinol Treatment for Marijuana Addiction

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

COPD1 trial

BONG: Reducing Severe Breathlessness With Dronabinol in the Severe and Very Severe Chronic Obstructive Pulmonary Disease Patient Group - A Randomized, Double-Blind, Placebo-Controlled, Crossover Study

Active, not recruiting·VVejle Hospital·Phase 3·NCT06473701·30 enrolled

Tolerance1 trial

Pharmacokinetics and Pharmacodynamics of Oral and Vaporized Delta-9-Tetrahydrocannabinol (THC) in Older Adults

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

Unspecified1 trial

Effects Of Cannabis Products On Blood Pressure Control

Not yet recruiting·MMayo Clinic·Preclinical·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 — 73 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 — Jazz 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: Jazz 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

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Obstructive Sleep Apnea4 trials

Nausea and vomiting3 trials

Agitation3 trials

Schizophrenia3 trials

Pain3 trials

Humans2 trials

Interaction2 trials

Trichotillomania2 trials

Fasting Conditions2 trials

Irritable Bowel Syndrome2 trials

Age2 trials

Drug2 trials

Oral2 trials

Cannabis Use Disorder2 trials

Chest pain1 trial

Post-Traumatic Stress Disorder1 trial

Marijuana1 trial

Opioid1 trial

Low back pain1 trial

Cannabis Dependence1 trial

Bipolar Disorder1 trial

Effectiveness1 trial

Surgery1 trial

Oncology Patients1 trial

Familial dysautonomia1 trial

Peripheral Neuropathy1 trial

Anorexia Nervosa1 trial

Total Joint Arthroplasty1 trial

Impairment1 trial

Inflammation1 trial

Cognition1 trial

Children1 trial

Glaucoma1 trial

Cannabis1 trial

Sleep1 trial

Withdrawal1 trial

Sickle Cell Disease1 trial

Abuse Potential1 trial

Buprenorphine1 trial

Trauma1 trial

Amyotrophic Lateral Sclerosis1 trial

Multiple Sclerosis1 trial

Chemotherapy-induced nausea and vomiting1 trial

Hemodynamic1 trial

Imaging1 trial

Cervical Dystonia1 trial

Pregnancy1 trial

Combination Therapy1 trial

Glioma1 trial

Treatment1 trial

COPD1 trial

Tolerance1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News