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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: 03 Jul 2025

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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; Reflex epilepsy
  • Phase II Myoclonic epilepsies

Most Recent Events

  • 30 Jun 2025 Efficacy and adverse events data from a phase III trial in Early infantile epileptic encephalopathy 2 released by UCB
  • 12 Jun 2025 UCB Biosciences completes a phase I trial in Healthy volunteers in the US (PO) (NCT06679413)
  • 08 May 2025 Zogenix completes a phase-III clinical trials in Dravet syndrome (Adjunctive treatment, In adolescents, In adults, In children) in United Kingdom, Spain, Sweden, Poland, Netherlands, Mexico, Italy, France, Denmark, Canada, Belgium, Australia, Germany (PO) (NCT03936777)

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