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Valbenazine - Neurocrine Biosciences

Drug Profile

Valbenazine - Neurocrine Biosciences

Alternative Names: DYSVAL; DYSVAL capsules 40mg; INGREZZA; MT 5199; NBI-98854; REMLEAS; Valbenazine-tosylate; VMAT2-inhibtor-Neurocrine-Biosciences

Latest Information Update: 19 Mar 2024

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At a glance

  • Originator Neurocrine Biosciences
  • Developer Mitsubishi Tanabe Pharma Corporation; Neurocrine Biosciences
  • Class 3-ring heterocyclic compounds; Amino acids; Antipsychotics; Neuropsychotherapeutics; Small molecules
  • Mechanism of Action Vesicular monoamine transporter 2 inhibitors
  • Orphan Drug Status

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

    Yes - Huntington's disease; Gilles de la Tourette's syndrome
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Chorea; Drug-induced dyskinesia
  • Phase III Cerebral palsy; Schizophrenia
  • Phase II Gilles de la Tourette's syndrome

Most Recent Events

  • 01 Mar 2024 Neurocrine Biosciences initiates phase II trial in Chorea in Canada (PO) (NCT06312189)
  • 15 Dec 2023 Neurocrine Biosciences terminates a phase-III trial in Schizophrenia (In adolescents, In adults, In the elderly, Adjunctive treatment) in USA (PO) due to business reasons(NCT05654870)
  • 23 Nov 2023 Planned Prescription Drug User Fee Act (PDUFA) date for Chorea (In the elderly, In adults) in USA (PO) is 2023-08-20
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