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