Drug Profile

Cannabidiol - GW Pharmaceuticals

Alternative Names: CBD - GW Pharmaceuticals; Epidiolex; Epidiolex/Epidyolex; Epidyolex; GW-42003; GWP-42003; GWP-42003-P

Latest Information Update: 12 Feb 2025

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At a glance

Originator GW Pharmaceuticals
Developer GW Pharmaceuticals; Jazz Pharmaceuticals Inc; University of Alabama at Birmingham; University of Utah
Class Analgesics; Anti-inflammatories; Anti-ischaemics; Antiacnes; Antibacterials; Antiepileptic drugs; Antihyperglycaemics; Antihyperlipidaemics; Antineoplastics; Antiparkinsonians; Antipsoriatics; Antipsychotics; Antirheumatics; Anxiolytics; Behavioural disorder therapies; Cannabinoids; Cardiovascular therapies; Cyclohexenes; Drug withdrawal therapies; Heart failure therapies; Hepatoprotectants; Muscle relaxants; Neuroprotectants; Obesity therapies; Resorcinols; Skin disorder therapies; Small molecules
Mechanism of Action 5-HT1 serotonin receptor modulators; Antioxidants; Cannabinoid receptor CB1 inverse agonists; Cannabinoid receptor CB2 inverse agonists; Transient receptor potential channel modulators

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Lennox-Gastaut syndrome; Dravet syndrome; Cerebral ischaemia; Infantile spasms; Tuberous sclerosis; Myoclonic epilepsies
New Molecular Entity No

Marketed Dravet syndrome; Lennox-Gastaut syndrome; Tuberous sclerosis
Phase III Epilepsy; Infantile spasms; Rett syndrome
Phase II/III Blepharospasm
Phase II Heroin-related disorders; Opioid-related disorders; Parkinson's disease; Pervasive child development disorders; Sturge-Weber syndrome
No development reported Cerebral ischaemia; Duchenne muscular dystrophy; Ovarian cancer
Discontinued Dyslipidaemias; Myoclonic epilepsies; Non-alcoholic fatty liver disease; Schizophrenia; Type 2 diabetes mellitus; Ulcerative colitis

17 Jan 2025 GW Research terminates a phase-III trial in Epilepsy (Adjunctive treatment, In infants, Treatment-resistant) in the US, Italy and Spain (PO), due to business strategy (NCT04485104),
22 Aug 2024 Jazz Pharmaceuticals plans to engage with Japanese regulatory authorities regarding a potential new drug application (JNDA)
22 Aug 2024 Efficacy and adverse events data from a phase III trial in Lennox-Gastaut syndrome, Dravet syndrome and Tuberous sclerosis released by Jazz Pharmaceuticals

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