Metadoxine extended-release - Alcobra

Drug Profile

Metadoxine extended-release - Alcobra

Alternative Names: MDX; Metadoxine sustained-release; MG-01CI; Pyridoxine pyrrolidone carboxylate

Latest Information Update: 13 Oct 2016

Price : $50

At a glance

  • Originator Alcobra
  • Class Drug withdrawal therapies; Imino acids; Picolines; Pyrrolidinones; Small molecules; Vitamins
  • Mechanism of Action Biogenic monoamine uptake modulators; Neurotransmitter stimulants; Serotonin 2B receptor antagonists
  • Orphan Drug Status

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

    Yes - Fragile X syndrome
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    Fragile X syndrome
  • New Molecular Entity No

Highest Development Phases

  • Phase III Attention-deficit hyperactivity disorder
  • Phase II Fragile X syndrome

Most Recent Events

  • 10 Oct 2016 Suspended - Phase-II for Fragile X syndrome (In adolescents, In adults) in USA (PO)
  • 10 Oct 2016 Suspended - Phase-III for Attention-deficit hyperactivity disorder (In adults) in USA (PO)
  • 10 Oct 2016 Alcobra receives written full clinical hold notice from the Division of Psychiatry Products of the US FDA
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