Amifampridine

Drug Profile

Amifampridine

Alternative Names: 3,4-DAP; 3,4-DAP phosphate; 3,4-Diaminopyridine; Amifampridine phosphate; Firdapse; Zenas

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Assistance Publique Hopitaux de Paris
  • Developer BioMarin Pharmaceutical; Catalyst Pharmaceutical; Fondazione Istituto Neurologico Carlo Besta
  • Class Aminopyridines; Small molecules
  • Mechanism of Action Acetylcholine stimulants; Potassium channel antagonists
  • Orphan Drug Status

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

    Yes - Myasthenia gravis; Lambert-Eaton myasthenic syndrome; Congenital myasthenic syndromes
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Lambert-Eaton myasthenic syndrome
  • Preregistration Congenital myasthenic syndromes
  • Phase II/III Myasthenia gravis

Most Recent Events

  • 17 Oct 2017 Catalyst Pharmaceuticals plans to initiate a phase III trial for Myasthenia gravis in USA (NCT03304054)
  • 30 Aug 2017 Catalyst Pharmaceutical Partners plans to conduct a pre-NDA meeting with US FDA for Lambert-Eaton myasthenic syndrome by January 2018
  • 30 Aug 2017 Catalyst Pharmaceutical Partners reaches agreement with US FDA on a Special Protocol Assessment (SPA) for a phase III trial for Myasthenia gravis
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