tetrahydrocannabinol
Nabiximols (USAN), sold under the brand name Sativex, is a specific Cannabis extract that was approved in 2010 as a botanical drug in the United Kingdom. Nabiximols is sold as a mouth spray intended to alleviate neuropathic pain, spasticity, overactive bladder, and other symptoms of multiple sclerosis; it was developed by the UK company GW Pharmaceuticals. In 2019, it was proposed that following application of the spray, nabiximols is washed away from the oral mucosa by the saliva flow and ingested into the stomach, with subsequent absorption from the gastro-intestinal tract. Nabiximols is a combination drug standardized in composition, formulation, and dose. Its principal active components are the cannabinoids: tetrahydrocannabinol (THC) and cannabidiol (CBD). Each spray delivers a dose of 2.7 mg THC and 2.5 mg CBD. — Wikipedia
Clinical trial activity
175 trials · 148 clinical orgs · 0 marketing orgs
Earliest trial started May 1, 2001 (NCT01610713)
Timeline
Indications
Approved for
Studied for
- Abdominal Pain · Phase 2
- Accidents, Traffic · Phase 4
- Acute Pain · Phase 2
- Affect · Phase 2
- Aging · Phase 1
- Agoraphobia · Phase 3
- Alcohol Drinking · Phase 4
- Alcohol-Induced Disorders · Phase 1
- Alcoholism · Phase 2
- Alzheimer Disease · Phase 1/Phase 2
- Anorexia · Phase 1
- Anxiety · Phase 2/Phase 3
- Anxiety Disorders · Phase 3
- Appetite · Phase 2
- Back Pain · Phase 3
- Biological Availability · Phase 1
- Bipolar Disorder · Phase 1
- Brain Neoplasms · Phase 2
- Breakthrough Pain · Phase 2
- Breast Neoplasms · Early Phase 1
- Cachexia · Phase 3
- Cancer Pain · Phase 3
- Cannabidiol · Phase 2
- Cannabinoids · Phase 2
- Cannabis · Phase 4
- Cerebral Palsy · Phase 3
- Chronic Pain · Phase 4
- Cigarette Smoking · Phase 1
- Cognition Disorders · Phase 1
- Cognitive Dysfunction · Early Phase 1
- Colonic Neoplasms · Early Phase 1
- Dementia · Phase 2
- Depression · Phase 2
- Diabetes Mellitus, Type 2 · Phase 1
- Diabetic Neuropathies · Phase 3
- Dialysis · Phase 1
- Dronabinol · Phase 3
- Drug Interactions · Phase 1
- Drug-Related Side Effects and Adverse Reactions · Early Phase 1
- Drugs, Investigational · Phase 1
- Dysmenorrhea · Phase 2
- Emergency Service, Hospital · Phase 1
- Endometriosis · Phase 2
- Epilepsy · Phase 1
- Essential Tremor · Phase 1/Phase 2
- Fatigue · Phase 2
- Fibromyalgia · Phase 2/Phase 3
- Glioblastoma · Phase 2
- Headache Disorders, Secondary · Phase 4
- Healthy Volunteers · Phase 1
- HIV · Phase 2
- HIV Infections · Phase 2
- Inflammation · Phase 2
- Ketamine · Phase 1
- Kidney Diseases · Phase 1
- Liver Diseases · Phase 1
- Magnetic Resonance Imaging · Phase 1
- Major Depressive Disorder · Phase 2
- Malnutrition · Phase 1
- Marijuana Abuse · Phase 2
- Marijuana Use · Early Phase 1
- Microbiota · Phase 2
- Migraine Disorders · Phase 4
- Mood Disorders · Phase 2
- Morbidity · Phase 2
- Mortality · Phase 2
- Multiple Sclerosis · Phase 4
- Muscle Spasticity · Phase 4
- Musculoskeletal Diseases · Phase 1
- Nausea · Phase 2
- Neck Pain · Phase 3
- Neoplasms · Phase 3
- Neuralgia · Phase 3
- Neuroinflammatory Diseases · Phase 2
- Neuromyelitis Optica · Phase 2
- Osteoarthritis, Knee · Phase 2
- Pain · Phase 3
- Pain Threshold · Phase 2
- Palliative Care · Phase 3
- Palliative Medicine · Phase 2
- Pancreatic Neoplasms · Phase 2
- Pancreatitis, Chronic · Phase 2
- Panic Disorder · Phase 3
- Peripheral Nervous System Diseases · Phase 3
- Pharmacokinetics · Phase 1
- Pharmacology · Phase 1
- Phobia, Social · Phase 3
- Postoperative Nausea and Vomiting · Phase 2/Phase 3
- Postoperative Pain · Phase 2/Phase 3
- Psychological Distress · Early Phase 1
- Psychomotor Agitation · Early Phase 1
- Psychomotor Disorders · Early Phase 1
- Quality of Life · Phase 2
- Renal Insufficiency · Phase 1
- Renal Insufficiency, Chronic · Phase 1
- Schizophrenia · Phase 1
- Skin Absorption · Phase 1
- Sleep · Phase 2
- Sleep Apnea, Obstructive · Phase 1
- Sleep Initiation and Maintenance Disorders · Phase 2
- Sleep Wake Disorders · Phase 2
- Squamous Cell Carcinoma of Head and Neck · Phase 1
- Stress Disorders, Post-Traumatic · Phase 4
- Substance Abuse, Oral · Phase 1
- Substance-Related Disorders · Phase 1
- Suicide · Phase 1/Phase 2
- Tic Disorders · Phase 3
- Tobacco Use · Phase 1
- Tourette Syndrome · Phase 3
- Urinary Bladder · Phase 3
- Vaping · Phase 3
- Vasopressins · Early Phase 1
- Veterans · Phase 1/Phase 2
Mechanism of action
- Cannabinoid receptorAGONIST
Cannabinoid receptor agonist
Chemistry & pharmacology
SMILES
C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O.CCCCCc1cc(O)c2c(c1)OC(C)(C)[C@@H]1CCC(C)=C[C@@H]21- Mol. weight
- 628.94 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL3833333 ↗
- WikipediaNabiximols ↗
- ChEMBLCHEMBL465 ↗
- ChEMBLCHEMBL267227 ↗
- WikipediaTetrahydrocannabinol ↗
Also known as
- delta-8-thc
- delta-8-thc
- delta-9-thc
- delta-9-thc
- delta-9-thc
- gw1000
- gw 1000
- gw-1000
- gw-1000
- gw-1000-02
- gw-1000-02
- nabiximols
- nabiximols
- nabiximols
- namisol
- namisol
- sativex
- sativex
- sativex
- sativex
- tetrahydrocannabinol
- tetrahydrocannabinol
- tetrahydrocannabinol
- tetrahydrocannabinol
- tetrahydrocannabinol
- tetrahydrocannabinol
- tetrahydrocannabinol
- tetrahydrocannabinol-cannabidiol combination
- thc
- thc
- thc
- til-tc150
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07296874 | Phase 2 | Feb 28, 2026 | Washington State University |
| NCT07146945 | Phase 1 | Aug 30, 2025 | Delphian Therapeutics Australia Pty, Ltd |
| NCT06758596 | Early Phase 1 (Phase 1) | Jul 15, 2025 | University of Illinois at Chicago |
| NCT06948136 | Phase 1 | Jun 6, 2025 | National Institute on Drug Abuse (NIDA), Yale University |
| NCT06859723 | Phase 1 | Jun 1, 2025 | State of California, University of California, Los Angeles |
| NCT06859710 | Phase 1 | Jun 1, 2025 | University of California, Los Angeles |
| NCT06967051 | N/A | May 22, 2025 | KGK Science Inc., Sobereye Inc. |
| NCT06878417 | N/A | May 1, 2025 | Canadian Institutes of Health Research (CIHR), University of Toronto |
| NCT07091747 | Phase 1/Phase 2 (Phase 2) | Apr 7, 2025 | Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Latin American Integration |
| NCT06772753 | Phase 1 | Feb 5, 2025 | Johns Hopkins University |
| NCT06609083 | Phase 1 | Dec 1, 2024 | Johns Hopkins University, National Institute on Drug Abuse (NIDA) |
| NCT06609109 | Phase 1 | Dec 1, 2024 | Johns Hopkins University, National Institute on Drug Abuse (NIDA) |
| NCT06236815 | Early Phase 1 (Phase 1) | Nov 30, 2024 | University of Wisconsin |
| NCT06647524 | Phase 2 | Nov 30, 2024 | Yale University |
| NCT06601218 | Phase 1 | Nov 1, 2024 | University of Kentucky |
| NCT06671977 | Phase 1 | Nov 1, 2024 | Yale University |
| NCT06381180 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2024 | Wayne State University |
| NCT06218550 | Phase 1 | Jul 1, 2024 | Johns Hopkins University, State of Michigan |
| NCT06471647 | Early Phase 1 (Phase 1) | Jul 1, 2024 | University of Chicago |
| NCT05974293 | Phase 2 | Apr 30, 2024 | Harvard University, Jazz Pharmaceuticals |
Organizations
Research & Development (148)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GW Pharmaceuticals Ltd. | For profit | 42 | 41 | 4 | 2001 |
| National Institute on Drug Abuse (NIDA) | Government | 17 | 2 | 2 | 2007 |
| Yale University | Academic/Hospital | 17 | 17 | 3 | 2011 |
| Johns Hopkins University | Academic/Hospital | 12 | 12 | 1 | 2018 |
| University of California, San Diego | Academic/Hospital | 8 | 6 | 2 | 2019 |
| University of London | Academic/Hospital | 8 | 3 | 3 | 2001 |
| Tetra Bio-Pharma | For profit | 7 | 6 | 4 | 2017 |
| Hebrew University | Academic/Hospital | 6 | 4 | 5 | 2004 |
| University of California, Los Angeles | Academic/Hospital | 5 | 5 | 1 | 2020 |
| University of Toronto | Academic/Hospital | 5 | 5 | 3 | 2013 |
| GW Research | For profit | 4 | 4 | 2 | 2013 |
| McMaster University | Academic/Hospital | 4 | 2 | 3 | 2018 |
| National Center for Complementary and Integrative Health (NCCIH) | Government | 4 | 0 | 2 | 2020 |
| Otsuka | For profit | 4 | 0 | 1 | 2010 |
| Radboud University | Academic/Hospital | 4 | 4 | 1 | 2011 |
| Tilray | For profit | 4 | 0 | 2 | 2017 |
| University of Liverpool | Academic/Hospital | 4 | 0 | 2 | 2002 |
| Canadian Institutes of Health Research (CIHR) | Academic/Hospital | 3 | 0 | 2 | 2013 |
| IQVIA | For profit | 3 | 0 | 2 | 2007 |
| McGill University | Academic/Hospital | 3 | 1 | 3 | 2018 |