Phase 3 study of UX007 in patients with Long-Chain Fatty Acid Oxidation Disorder

Trial Profile

Phase 3 study of UX007 in patients with Long-Chain Fatty Acid Oxidation Disorder

Planning
Phase of Trial: Phase III

Latest Information Update: 20 Feb 2018

At a glance

  • Drugs Triheptanoin (Primary)
  • Indications Lipid metabolism disorders
  • Focus Therapeutic Use
  • Sponsors Ultragenyx Pharmaceutical
  • Most Recent Events

    • 20 Feb 2018 According to an Ultragenyx Pharmaceutical media release, the study design has been completed for this study and was discussed in an end-of-phase 2 meeting.
    • 04 Jan 2018 According to an Ultragenyx Pharmaceutical media release, if the FDA agrees to an early submission based on the Phase 2 study, this trial would serve as a post-approval commitment for label expansion. Alternatively, this study could serve as a registrational study if an early filing is not possible.
    • 02 Nov 2017 According to an Ultragenyx media release, the company continue to plan for discussions with regulators regarding the study by the end of 2017.
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