Cesamet

(Nabilone)

ApprovedSmall molecule

Nabilone is used to reduce severe nausea and vomiting caused by chemotherapy cancer treatment, and it can also help with chronic pain and other conditions.[2] Cesamet is currently approved and in use across 9 indications[4].[1]

Cesamet is one of 207 small molecule programs targeting Post Operative Nausea and Vomiting. It is currently in Approved.

Indications

Total Trials

Active Trials

206

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Post Operative Nausea and VomitingApproved

Diabetic NeuropathyApproved

Parkinson DiseaseApproved

SpasticityApproved

InsomniaActive, not recruiting

Inflammatory Bowel DiseaseActive, not recruiting

Multiple SclerosisCompleted

Post Operative Nausea and VomitingApproved

Approved

Diabetic NeuropathyApproved

Approved

Parkinson DiseaseApproved

Approved

SpasticityApproved

Approved

InsomniaApproved

Active, not recruiting

Inflammatory Bowel DiseasePreclinical

Active, not recruiting

Multiple SclerosisApproved

Completed

Competition

Competitive Landscape

145 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

Cesamet

BBausch Health Americas, Inc.

Approved

1 2

Rinvoq

AbbVie

Phase 3

1 3

Versed

CConrado Roberto Hoffmann Filho

Phase 3

2 4

Vumerity

Biogen

Phase 3

4 5

Mayzent

Novartis

Phase 3

1 6

Antihistamine

Arrowhead Pharmaceuticals

Phase 3

2 7

Recombinant Zoster Vaccine

MMAXVAX Biotechnology Limited Liability Company

Phase 3

1 8

MRI Contrast-Enhancing Agents

Sanofi

Phase 3

3 9

Tolebrutinib

Sanofi

Phase 3

4 10

PBR06

UUniversity Hospital, Bordeaux

Phase 3

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

Timeline

Expected Milestones

Q2 2027

Phase 3Recruiting

Agitation

NCT04516057

Q3 2027

Phase 3Recruiting

Withdrawal

NCT07644052

Clinical

Trials by Indication[1]

Fibromyalgia2 trials

A Trial Assessing the Effect of Nabilone on Pain and Quality of Life in Patients With Fibromyalgia

Completed·WWinnipeg Regional Health Authority·Phase 2·NCT00272207·40 enrolled

Nabilone Versus Amitriptyline in Improving Quality of Sleep in Patients With Fibromyalgia

Completed·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·N/A·NCT00381199·32 enrolled

Parkinson's Disease2 trials

Nabilone for Non-motor Symptoms in Parkinson's Disease

Completed·MMedical University Innsbruck·Phase 2·NCT03769896·48 enrolled

Nabilone for Non-motor Symptoms in Parkinson's Disease

Completed·MMedical University Innsbruck·Phase 3·NCT03773796·22 enrolled

Withdrawal Syndrome1 trial

Effect of PP-01 on Cannabis Withdrawal Syndrome

Completed·PPleoPharma, Inc.·Phase 2·NCT05494437·234 enrolled

Refractory1 trial

Nabilone and THC/CBD for the Treatment of FBSS Refractory Pain

Completed·AAzienda Ospedaliera Universitaria Policlinico "G. Martino"··NCT03210766·20 enrolled

Inflammatory Bowel Disease1 trial

Nabilone Use For Acute Pain in Inflammatory Bowel Disease Patients

Unknown status·SSamuel Lunenfeld Research Institute, Mount Sinai Hospital·N/A·NCT03422861·80 enrolled

20 more indications

Multiple Sclerosis1 trial

Efficacy and Safety Evaluation of Nabilone as Adjunctive Therapy to Gabapentin for the Management of Neuropathic Pain in Multiple Sclerosis

Completed·UUniversity of Manitoba·Phase 4·NCT00480181·50 enrolled

Agitation1 trial

Nabilone for Agitation Blinded Intervention Trial

Recruiting·SSunnybrook Health Sciences Centre·Phase 3·NCT04516057·112 enrolled

Nausea and vomiting1 trial

Study of Prevention of Postoperative Nausea and Vomiting Using Cesamet

Completed·UUnity Health Toronto·Phase 2·NCT02115529·331 enrolled

Cannabis Use1 trial

Nabilone in Cannabis Users With PTSD

Terminated·NNew York State Psychiatric Institute·Phase 1/2·NCT03251326·4 enrolled

Neuropathic Pain1 trial

Effect of Cannabinoids on Spasticity and Neuropathic Pain in Spinal Cord Injured Persons

Completed·UUniversity of Manitoba·Phase 2·NCT01222468·12 enrolled

Pruritus1 trial

DIalysis Symptom COntrol-Pruritus Outcome Trial

Completed·UUniversity of Manitoba·Phase 3·NCT05180968·14 enrolled

Metabolism1 trial

Investigating the Effects of Nabilone on Endocannabinoid Metabolism

Completed·CCentre for Addiction and Mental Health·Phase 4·NCT05885685·10 enrolled

Spinal Cord Injury1 trial

Cannabinoids and an Anti-inflammatory Diet for the Treatment of Neuropathic Pain After Spinal Cord Injury

Completed·EEldon Loh, MD·Phase 3·NCT04057456·14 enrolled

Cannabis Dependence1 trial

Nabilone for Cannabis Dependence: A Pilot Study

Completed·MMclean Hospital·Phase 2/3·NCT01347762·84 enrolled

Developmental Disabilities1 trial

Clinical Trial of Nabilone for Aggression in Adults With Intellectual and Developmental Disabilities

Completed·HHsiang-Yuan Lin·Phase 1·NCT05273320·20 enrolled

Completed·UUniversity of Manitoba·Phase 2·NCT00699634·50 enrolled

Lung Cancer1 trial

Nabilone Effect on the Attenuation of Anorexia, Nutritional Status and Quality of Life in Lung Cancer Patients

Unknown status·IInstituto Nacional de Cancerologia de Mexico·Phase 2/3·NCT02802540·78 enrolled

Obesity1 trial

A Pilot Trial of Nabilone for the Treatment of Obesity

Terminated·CCentre for Addiction and Mental Health·Phase 2·NCT04801641·24 enrolled

Chronic1 trial

Use of the Cannabinoid Nabilone for the Promotion of Sleep in Chronic, Non-Malignant Pain Patients

Unknown status·UUniversity Health Network, Toronto·Phase 2·NCT00384410·16 enrolled

Medication1 trial

Cannabinoid Medication for Adults With OCD

Completed·NNew York State Psychiatric Institute·Phase 1/2·NCT02911324·16 enrolled

Alzheimer's Disease1 trial

Safety and Efficacy of Nabilone in Alzheimer's Disease

Completed·SSunnybrook Health Sciences Centre·Phase 2/3·NCT02351882·38 enrolled

Withdrawal1 trial

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled Clinical Trial of Titrating Doses of PP-01 for the Mitigation of Cannabis Withdrawal Symptoms in Adults With Cannabis Use Disorder: Core Study With Safety Extension Phase

Recruiting·PPleoPharma, Inc.·Phase 3·NCT07644052·420 enrolled

Frontotemporal Dementia1 trial

Double Blind Crossover Clinical Trial of Nabilone for Agitation in Frontotemporal Dementia

Terminated·SSimon Ducharme, MD·Phase 2·NCT05742698·3 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 26, 1985

CESAMET

NDA NDA018677

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for Nabilone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cesamet drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Nabilone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Nabilone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA018677). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Bausch Health Americas, Inc. 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: BBausch Health Americas, Inc.

Cesamet

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Trials by Indication[1]

Fibromyalgia2 trials

Parkinson's Disease2 trials

Withdrawal Syndrome1 trial

Refractory1 trial

Inflammatory Bowel Disease1 trial

Multiple Sclerosis1 trial

Agitation1 trial

Nausea and vomiting1 trial

Cannabis Use1 trial

Neuropathic Pain1 trial

Pruritus1 trial

Metabolism1 trial

Spinal Cord Injury1 trial

Cannabis Dependence1 trial

Developmental Disabilities1 trial

Suicidal Ideation1 trial

Obsessive-Compulsive Disorder1 trial

Treatment1 trial

Lung Cancer1 trial

Obesity1 trial

Chronic1 trial

Medication1 trial

Alzheimer's Disease1 trial

Withdrawal1 trial

Frontotemporal Dementia1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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