Trial Profile
A Randomized, Double-blind, Multicenter Study to Determine the Effect of Triheptanoin Compared with Even-chain, Medium-chain Triglycerides (MCT) on Major Clinical Events (MCEs) in Pediatric Patients with Long-chain Fatty Acid Oxidation Disorders (LC-FAOD )
Status:
Recruiting
Phase of Trial:
Phase III
Latest Information Update: 13 Mar 2024
Price :
$35
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At a glance
- Drugs Triheptanoin (Primary) ; Triheptanoin (Primary) ; Medium-chain triglyceride; Medium-chain triglyceride
- Indications Lipid metabolism disorders
- Focus Registrational; Therapeutic Use
- Sponsors Ultragenyx Pharmaceutical
- 11 Jan 2023 Status changed from planning to recruiting.
- 06 May 2020 According to Ultragenyx Pharmaceutical media release, New Drug Application (NDA) under review by U.S. FDA .The U.S. FDA is currently reviewing the NDA and has set a Prescription Drug User Fee Act (PDUFA) date of July 31, 2020. The review process is currently on track for a decision by the PDUFA date.
- 05 Nov 2018 According to Ultragenyx Pharmaceutical media release, The FDA accepted Ultragenyxs proposal to submit a New Drug Application (NDA) for UX007 for the treatment of LC-FAOD based on currently available data.