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
| Date | Article |
|---|
| 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 |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
