Kyowa Kirin Co., Ltd. announced the initiation of a Phase 3 study (study name: FALCON) in Japan for bardoxolone methyl (Code name: RTA 402), a small-molecular compound licensed from Reata Pharmaceuticals Inc. The FALCON study is an international, multi-center, randomized, placebo-controlled, double-blind clinical trial for patients with autosomal dominant polycystic kidney disease (ADPKD), where efficacy and safety of RTA 402 are to be evaluated by oral administration of the drug or placebo once a day. This study was initiated by Reata on May 29, 2019 and is currently ongoing in North America, the EU, and Oceania. Japan is included to the study at this time, where Kyowa Kirin is the ICCC (In-Country Clinical Care-taker). Under the license agreement signed on December 24, 2009 with Reata, Kyowa Kirin owns exclusive rights to develop and commercialize bardoxolone methyl in kidney disease and certain other indications in Japan, China, Taiwan, South Korea and Southeast Asia. The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies. Study Population: Patients with ADPKD. Primary Efficacy Endpoint: Off-treatment change from baseline in eGFR at Week 52 or following a 4-week drug treatment withdrawal period in the first year of treatment. Key Secondary Endpoint: Off-treatment change from baseline in eGFR at Week 104 or following a 4-week drug treatment withdrawal period in the second year of treatment. Estimated Enrollment: 300 participants. Location: North America, EU, Oceania, Japan. Estimated Study Completion: August 2023.