Trofinetide

Drug Profile

Trofinetide

Alternative Names: G-2Me-PE; Glycyl-2-methyl-L-prolyl-L-glutamic acid; Glycyl-L-2-methylprolyl-L-glutamic acid; NNZ-2566

Latest Information Update: 23 Jun 2016

Price : $50

At a glance

  • Originator Neuren Pharmaceuticals
  • Developer Neuren Pharmaceuticals; Rettsyndrome.org; Walter Reed Army Institute of Research
  • Class Glutamates; Neuropeptides; Neuroprotectants; Oligopeptides; Pyrrolidines; Small molecules
  • Mechanism of Action Cytokine inhibitors; Glial cell modulators; Neuropeptide receptor modulators; Synaptic transmission modulators
  • Orphan Drug Status

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

    Yes - Rett syndrome; 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.

    Brain injuries; Fragile X syndrome; Rett syndrome
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase II Brain injuries; Fragile X syndrome; Rett syndrome
  • Preclinical Autistic disorder; Multiple sclerosis

Most Recent Events

  • 22 Jun 2016 Neuren initiates enrolment in a phase II trial for Rett syndrome (In children, In adolescents) in USA (PO) (NCT02715115; 9198401)
  • 22 Jun 2016 Neuren has patents pending for trofinetide in USA, Europe, Canada, Brazil and Israel
  • 22 Jun 2016 Neuren receives Notice of Grant for trofinetide in Australia
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