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Fenfluramine - Zogenix

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Drug Profile

Fenfluramine - Zogenix

Alternative Names: Brabafen; Fenfluramine hydrochloride - Zogenix; FINTEPLA; Fintepla; FINTEPLA® CIV; Low-dose fenfluramine; ZX-008

Latest Information Update: 21 Aug 2024

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At a glance

  • Originator Brabant Pharma
  • Developer Nippon Shinyaku; NYU Langone Medical Center; University Hospital Schleswig-Holstein; Zogenix
  • Class Amines; Amphetamines; Anorectics; Antiepileptic drugs; Fluorinated hydrocarbons; Small molecules
  • Mechanism of Action Serotonin receptor agonists; Serotonin release stimulants; Serotonin uptake inhibitors; Sigma-1 receptor agonists
  • 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
  • New Molecular Entity No

Highest Development Phases

  • Marketed Dravet syndrome; Lennox-Gastaut syndrome
  • Phase III Early infantile epileptic encephalopathy 2
  • Phase II Myoclonic epilepsies

Most Recent Events

  • 02 Jul 2024 Zogenix completes the phase II FFA-MAE trial in Myoclonic epilepsies (Adjunctive treatment, In children, In infants, In adolescents) in Germany (PO) (EudraCT2018-001664-38)
  • 17 Apr 2024 Registered for Lennox-Gastaut syndrome (Adjunctive treatment, In adolescents, In children, In adults) in Japan (PO)
  • 13 Nov 2023 Phase-III clinical trials in Dravet syndrome (In infants) in USA (PO) (NCT06118255)

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