An international, double-blind, placebo-controlled, parallel group Pivotal trial of Bardoxolone in the patients with Autosomal-dominant-polycystic-kidney-disease
Phase of Trial: Phase III
Latest Information Update: 03 Jan 2019
At a glance
- Drugs Bardoxolone methyl (Primary)
- Indications Autosomal dominant polycystic kidney disease
- Focus Registrational; Therapeutic Use
- Acronyms FALCON
- Sponsors Reata Pharmaceuticals
- 03 Jan 2019 According to a Reata Pharmaceuticals media release,Based upon guidance from the FDA, the 52-week retained eGFR benefit data of this trial may support accelerated approval under subpart H. Based upon guidance from the FDA, the year-two retained eGFR benefit data may support full approval.
- 03 Jan 2019 According to a Reata Pharmaceuticals media release, has completed an end-of-Phase 2 meeting with the US FDA regarding the design of this trial. Company expects to initiate enrollment in the trial during mid-2019.
- 22 Nov 2018 New trial record