Bardoxolone FDA Approval Status
Last updated by Judith Stewart, BPharm on March 3, 2021.
FDA Approved: No
Generic name: bardoxolone
Company: Reata Pharmaceuticals, Inc.
Treatment for: Alport Syndrome
Bardoxolone is an investigational, once-daily, orally administered activator of Nrf2 in development for the treatment of Alport syndrome and autosomal dominant polycystic kidney disease (ADPKD).
Development timeline for bardoxolone
|Feb 25, 2022||Reata Pharmaceuticals Receives Complete Response Letter From The FDA for Bardoxolone for the Treatment of Patients with Chronic Kidney Disease Caused by Alport Syndrome|
|Dec 8, 2021||Reata Pharmaceuticals Announces Outcome of FDA Advisory Committee Meeting of Bardoxolone for the Treatment of Patients with Chronic Kidney Disease Caused by Alport Syndrome|
|Apr 26, 2021||Reata Announces FDA Accepted for Filing the NDA for Bardoxolone for the Treatment of Patients With Chronic Kidney Disease Caused by Alport Syndrome|
|Mar 1, 2021||Reata Pharmaceuticals, Inc. Submits NDA for Company’s Lead Program: Bardoxolone in Alport Syndrome|
|Jan 5, 2019||Reata Announces Clinical Trial Design for FALCON, a Phase 3 Trial of Bardoxolone Methyl for the Treatment of Autosomal Dominant Polycystic Kidney Disease|
|May 25, 2018||Bardoxolone Methyl Improved Kidney Function in Patients With Autosomal Dominant Polycystic Kidney Disease and IgA Nephropathy in the Ongoing Phase 2 Phoenix Study|
|Mar 22, 2018||Reata Announces Positive Top-Line Data for Treatment of PH-ILD With Bardoxolone Methyl From the Phase 2 Lariat Trial|
|Jul 10, 2017||Reata Pharmaceuticals, Inc. Receives Orphan Drug Designation for Bardoxolone Methyl for the Treatment of Alport Syndrome|
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