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Nabiximols - GW Pharmaceuticals

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Drug Profile

Nabiximols - GW Pharmaceuticals

Alternative Names: Cannabidiol/tetrahydrocannabinol; CBD/THC; CBD:THC; Delta-9-tetrahydrocannabinol/cannabidiol; Delta-9-THC/cannabidiol; Dronabinol/cannabidiol; GW 1000; GW-1000-02; JZP-378; Medicinal cannabis - GW Pharmaceuticals; Nabidiolex®/Tetranabinex®; Sativex; Tetrahydrocannabinol/cannabidiol; THC/CBD; THC:CBD

Latest Information Update: 05 Nov 2023

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At a glance

  • Originator GW Pharmaceuticals
  • Developer Almirall S.A.; GW Pharmaceuticals; Neopharm Ltd; Novartis; Otsuka Pharmaceutical
  • Class Analgesics; Anti-inflammatories; Anti-ischaemics; Antidementias; Antiemetics; Antiepileptic drugs; Antihyperglycaemics; Antineoplastics; Antiparkinsonians; Antipsoriatics; Antipsychotics; Antirheumatics; Anxiolytics; Appetite stimulants; Cannabinoids; Chromans; Cyclohexenes; Drug withdrawal therapies; Heart failure therapies; Hepatoprotectants; Muscle relaxants; Neuroprotectants; Non-opioid analgesics; Obesity therapies; Phytotherapies; Skin disorder therapies
  • Mechanism of Action Antioxidants; Cannabinoid receptor agonists; Cannabinoid receptor CB1 inverse agonists; Cannabinoid receptor CB2 inverse agonists
  • Orphan Drug Status

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

    Yes - Glioma
  • New Molecular Entity No

Highest Development Phases

  • Marketed Cancer pain; Muscle spasticity; Neuropathic pain
  • Discontinued Bladder dysfunction; Glioblastoma; Post-traumatic stress disorders; Stomatitis

Most Recent Events

  • 24 Mar 2023 Jazz Pharmaceuticals terminates the phase III RELEASE MSS3 trial for Muscle spasticity in Czech Republic, Poland, Romania, United Kingdom and USA based on a business decision by the sponsor (EudraCT2019-002623-14) (NCT04203498)
  • 27 Feb 2023 GW Pharmaceuticals completes the phase III RELEASE MSS3 trial for Muscle spasticity in Czech Republic, Poland, Romania, United Kingdom and USA (EudraCT2019-002623-14) (NCT04203498)
  • 11 Nov 2022 Jazz Pharmaceuticals terminates a phase III RELEASE MSS5 trial in Muscle spasticity related to Multiple sclerosis in Czech Republic, Spain, Poland, USA and United Kingdom (Buccal, Spray) based on a business decision by the Sponsor (EudraCT2020-003271-18) (NCT04984278)

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