Drugs / Nabilone
last change Jun 2026 re-read 9 days ago

Nabilone

Other / unclassified targets CNR1 via activation

Developed for
cannabis dependence · fibromyalgia · multiple sclerosis · neuropathy, painful · Alzheimer disease · diabetic neuropathy · diabetic polyneuropathy · end stage renal failure
+12 more · insomnia · non-small cell lung carcinoma · obesity disorder · obsessive-compulsive disorder · Parkinson disease · peripheral neuropathy · sleep disorder, initiating and maintaining sleep · behavioral variant of frontotemporal dementia · inflammatory bowel disease · primary progressive aphasia · spinal cord injury · substance withdrawal syndrome
Investigated by
Bausch Health Americas, Inc. · NEMA Research, Inc. · University of Manitoba · Centre for Addiction and Mental Health · National Institute on Drug Abuse (NIDA) · New York State Psychiatric Institute
+14 more · Valeant Canada Limited · Alzheimer's Drug Discovery Foundation · Hsiang-Yuan Lin · McGill University Health Centre/Research Institute of the McGill University Health Centre · Mclean Hospital · Medical University Innsbruck · National Cancer Institute of Mexico · Population Health Research Institute · Sunnybrook Health Sciences Centre · The University of Texas Health Science Center, Houston · University Health Network, Toronto · University of Calgary · Veeda Oncology · Winnipeg Regional Health Authority

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) CESAMET — 1985-12-26 fda.gov ↗

Trials 21

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT05273320 Mar 2022 → Aug 2025 developmental disability, intellectual disability Hsiang-Yuan Lin Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT02911324 Sep 2016 → Jan 2019 obsessive-compulsive disorder New York State Psychiatric Institute Completed No outcome recorded
Phase 1/2 NCT03251326 Oct 2015 → Jun 2019 cannabis dependence, post-traumatic stress disorder New York State Psychiatric Institute Terminated No outcome recorded Stop: Enrollment
Phase 25 trials
Phase 2 NCT04801641 Sep 2021 → Aug 2023 obesity disorder Centre for Addiction and Mental Health Terminated No outcome recorded
Phase 2 NCT04807829 Apr 2021 → Apr 2022 — The University of Texas Health Science Center, Houston Withdrawn No outcome recorded
Phase 2 NCT00699634 Jan 2009 → Feb 2011 neuropathy, painful University of Manitoba Completed No outcome recorded
Phase 2 NCT00272207 Apr 2006 → Feb 2007 fibromyalgia Winnipeg Regional Health Authority Completed No outcome recorded
Phase 2 NCT00384410 Dec 2005 → ? insomnia University Health Network, Toronto Unknown No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT02802540 Dec 2014 → Jul 2017 non-small cell lung carcinoma National Cancer Institute of Mexico Unknown No outcome recorded
Phase 2/3 NCT01347762 Jun 2010 → Jun 2017 cannabis dependence Mclean Hospital Completed No outcome recorded
Phase 34 trials
Phase 3 NCT05180968 Aug 2022 → Aug 2023 end stage renal failure University of Manitoba Completed No outcome recorded
Phase 3 NCT04516057 Feb 2021 → Apr 2027 expected Alzheimer disease Sunnybrook Health Sciences Centre Recruiting No outcome recorded
Phase 3 NCT03773796 Aug 2018 → Jan 2020 Parkinson disease Medical University Innsbruck Completed No outcome recorded
Phase 3 NCT01035281 Jan 2008 → Jan 2011 diabetic neuropathy University of Calgary Unknown No outcome recorded
Phase 46 trials
Phase 4 NCT05885685 Oct 2023 → Dec 2025 — Centre for Addiction and Mental Health Completed No outcome recorded
Phase 4 NCT00480181 Jun 2007 → Jul 2012 multiple sclerosis, neuropathy, painful University of Manitoba Completed No outcome recorded
Phase 4 NCT00380965 Oct 2006 → Oct 2007 chemotherapy-induced toxicity, peripheral neuropathy NEMA Research, Inc. Completed No outcome recorded
Phase 4 NCT00381264 Sep 2006 → Oct 2007 multiple sclerosis NEMA Research, Inc. Completed No outcome recorded
Phase 4 NCT00380913 Sep 2006 → Oct 2007 diabetic polyneuropathy NEMA Research, Inc. Completed No outcome recorded
Phase 4 NCT00418678 Aug 2006 → Dec 2007 — Veeda Oncology Terminated No outcome recorded Stop: Enrollment
Phase not applicable1 trial
— NCT00381199 Apr 2006 → Mar 2007 fibromyalgia, sleep disorder, initiating and maintaining sleep McGill University Health Centre/Research Institute of the McGill University Health Centre Completed No outcome recorded
Comparator or background therapy11 trials
Phase 1/2 NCT04880278 Comparator Mar 2022 → May 2024 obsessive-compulsive disorder New York State Psychiatric Institute Withdrawn No outcome recorded
Phase 2 NCT05742698 Comparator Mar 2023 → Apr 2026 overdue behavioral variant of frontotemporal dementia, primary progressive aphasia Simon Ducharme, MD Recruiting No outcome recorded
Phase 2 NCT05494437 Comparator Oct 2022 → Aug 2023 substance withdrawal syndrome PleoPharma, Inc. Completed Met primary
Phase 2 NCT03769896 Comparator Oct 2017 → Jul 2019 Parkinson disease Medical University Innsbruck Completed No outcome recorded
Phase 2 NCT02115529 Comparator Apr 2014 → Jan 2015 — Unity Health Toronto Completed No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 33 sources stand behind the page.

FieldValueCited text
Known as Nabilone ClinicalTrials.gov intervention name — accepted as the source's own label NCT00699634 ↗
30

NCT00380913 ↗

NCT04801641 ↗

NCT05494437 ↗

NCT01222468 ↗

NCT04880278 ↗

NCT03422861 ↗

NCT05885685 ↗

NCT00272207 ↗

NCT00381199 ↗

NCT02351882 ↗

Show 20 more sources

Known as Cesamet “To evaluate if nabilone (Cesamet) is effective in improving sleep in patients with insomnia and chronic, non-malignant pain” NCT00384410 ↗
5

“Nabilone (brand name, CESAMET®), is a synthetic cannabinoid (form of cannabis).” NCT00272207 ↗

“Cesamet™ (nabilone)” NCT00381264 ↗

“Cesamet™ (nabilone)” NCT00380965 ↗

“Cesamet™ (nabilone)” NCT00380913 ↗

NCT00418678 ↗

Known as CPD 109514 ChEMBL registry synonym — accepted as the source's own label CHEMBL2218896 ↗
Known as Nabilona ChEMBL registry synonym — accepted as the source's own label CHEMBL2218896 ↗
Known as Nabilone (Cesamet), CSA Drug Code 7379, Schedule II, NDC 0037-1221-50 “Nabilone (Cesamet), CSA Drug Code 7379, Schedule II, NDC 0037-1221-50” NCT01347762 ↗
Action Activate “The investigators intend to test a novel agonist pharmacotherapy, nabilone, for cannabis dependence” NCT01347762 ↗
1

“Cannabinoid CB1 receptor agonist” CHEMBL2218896 ↗

Modality Other / unclassified “Nabilone (brand name, CESAMET®), is a synthetic cannabinoid (form of cannabis).” NCT00272207 ↗
Route Oral “Oral nabilone” NCT00272207 ↗
Target CNR1 “Cannabinoid CB1 receptor agonist” CHEMBL2218896 ↗