Metadoxine extended-release - Alcobra

Drug Profile

Metadoxine extended-release - Alcobra

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

Latest Information Update: 02 Feb 2017

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
  • New Molecular Entity No

Highest Development Phases

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

Most Recent Events

  • 09 Jan 2017 US FDA agreed to modify the Full Clinical Hold to a Partial Hold for metadoxine
  • 09 Jan 2017 US FDA approves a protocol for a 6-month phase I clinical trial of metadoxine
  • 01 Jan 2017 Alcobra terminates a phase III trial for Attention deficit hyperactivity disorder due to FDA clinical hold in USA and Israel (NCT02477748)
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