Drugs / Nabilone
Nabilone
also known as
Cesamet · Cesemat · CPD 109514 · Nabilona · Nabilone (Cesamet), CSA Drug Code 7379, Schedule II, NDC 0037-1221-50
Other / unclassified targets CNR1 via activation
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | CESAMET | — | 1985-12-26 | fda.gov ↗ |
Trials 22 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 |
| 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| Phase 2 | NCT04807829 | Apr 2021 → Apr 2022 | — | The University of Texas Health Science Center, Houston | Withdrawn | No outcome recorded |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 2/33 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 2/3 | NCT01025700 | Jun 2009 → Jun 2010 | — | University of British Columbia | 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 |
| 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 |
Also used as a comparator or background therapy in 11 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04880278 Comparator | Mar 2022 → May 2024 | obsessive-compulsive disorder | New York State Psychiatric Institute | Withdrawn | No outcome recorded |
| Phase 26 trials | ||||||
| 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 | No outcome recorded |
| 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 |
| Phase 2 | NCT01222468 Comparator | Jun 2012 → Feb 2015 | — | University of Manitoba | Completed | No outcome recorded |
| Phase 2 | NCT00623376 Comparator | Jul → Nov 2007 | — | University of Manitoba | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02351882 Comparator | Jan 2015 → Jan 2018 | Alzheimer disease | Sunnybrook Health Sciences Centre | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07644052 Comparator | Jun 2026 → Jul 2027 expected | substance withdrawal syndrome | PleoPharma, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT04057456 Comparator | Mar 2023 → May 2024 | neuropathy, painful, spinal cord injury | Eldon Loh, MD | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03422861 Comparator | Dec 2023 → Sep 2024 | inflammatory bowel disease | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | Unknown | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 34 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nabilone | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03773796 ↗30 |
| 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)” NCT00380913 ↗ “Cesamet™ (nabilone)” NCT00380965 ↗ “Cesamet™ (nabilone)” NCT00381264 ↗ |
| Known as | Cesemat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01025700 ↗ |
| 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 ↗ |