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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

DateArticle
Feb 25, 2022Reata 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, 2021Reata 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, 2021Reata Announces FDA Accepted for Filing the NDA for Bardoxolone for the Treatment of Patients With Chronic Kidney Disease Caused by Alport Syndrome
Mar  1, 2021Reata Pharmaceuticals, Inc. Submits NDA for Company’s Lead Program: Bardoxolone in Alport Syndrome
Jan  5, 2019Reata Announces Clinical Trial Design for FALCON, a Phase 3 Trial of Bardoxolone Methyl for the Treatment of Autosomal Dominant Polycystic Kidney Disease
May 25, 2018Bardoxolone Methyl Improved Kidney Function in Patients With Autosomal Dominant Polycystic Kidney Disease and IgA Nephropathy in the Ongoing Phase 2 Phoenix Study
Mar 22, 2018Reata Announces Positive Top-Line Data for Treatment of PH-ILD With Bardoxolone Methyl From the Phase 2 Lariat Trial
Jul 10, 2017Reata Pharmaceuticals, Inc. Receives Orphan Drug Designation for Bardoxolone Methyl for the Treatment of Alport Syndrome

Further information

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