Drug Profile

Synthetic cannabidiol - Benuvia Therapeutics/Radius Health

Alternative Names: Pharmaceutical cannabidiol (CBD) - Benuvia Therapeutics/Radius Health; RAD-011

Latest Information Update: 28 Feb 2025

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At a glance

Originator INSYS Therapeutics, Inc
Developer Benuvia Therapeutics; California Pacific Medical Center; INSYS Therapeutics, Inc; Radius Health Inc.; The University of Montreal Hospital Research Center; University of Chicago
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; 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 - Absence epilepsy; Glioma; Dravet syndrome; Lennox-Gastaut syndrome; Infantile spasms; Glioblastoma; Prader-Willi syndrome; Schizophrenia
New Molecular Entity No

Phase II/III Prader-Willi syndrome
No development reported Endocrine disorders
Discontinued Dravet syndrome; Epilepsy; Glioblastoma; Infantile spasms; Lennox-Gastaut syndrome; Pain; Peripheral nervous system diseases; Substance-related disorders

28 Feb 2025 No recent reports of development identified for preclinical development in Endocrine-disorders in USA (PO, Liquid)
07 Dec 2022 Radius Pharmaceuticals terminates phase-II/III clinical trials in Prader-Willi syndrome (In adolescents, In children, In the elderly, In adults) in US, Spain and Sweden due to change in corporate priorities (PO) (NCT05098509)
06 Oct 2022 Radius Pharmaceuticals withdraws prior to enrollment a phase III trial for Prader-Willi Syndrome (In adolescents, In adults, In children, In the elderly) (PO) (NCT05387798)

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