Drugs in Development
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Lead Product(s): Tetrahydrocannabinol,Cannabidiol
Therapeutic Area: Neurology Product Name: Nabiximols
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2020
Details:
The study is a Phase 3, double-blind, parallel, placebo-controlled study that will evaluate the safety and efficacy of nabiximols for spasm frequency over a 12-week period and is expected to enroll 446 participants.
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Lead Product(s): Cannabidiol
Therapeutic Area: Neurology Product Name: Epidyolex
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 23, 2020
Details:
Australian Therapeutic Goods Administration (TGA) has approved EPIDYOLEX® (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age and older.
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Lead Product(s): Cannabidiol
Therapeutic Area: Neurology Product Name: Epidiolex
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2020
Details:
U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older.
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Lead Product(s): Tetrahydrocannabinol,Cannabidiol
Therapeutic Area: Neurology Product Name: Nabiximols
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 30, 2020
Details:
Five new MS Spasticity Phase 3 trials are expected to commence in H2 2020 (2) and H1 2021 (3), any one of which the company believes could enable a NDA submission.
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Lead Product(s): Cannabidiol
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2020
Details:
U.S. FDA has accepted for filing with Priority Review its recently submitted supplemental New Drug Application for the use of EPIDIOLEX CV to treat seizures in Tuberous Sclerosis Complex.
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