A phase 3 clinical trial evaluating bardoxolone methyl for the treatment of chronic kidney disease (CKD) was terminated in October 2012[1] after patients treated with the drug were found to have experienced a higher rate of heart-related adverse events, including heart failure, hospitalizations, and deaths.

[2][3][4] An advisory committee meeting of experts voted unanimously that bardoxolone methyl was not effective in slowing the progression of chronic kidney disease in Alport syndrome and that its benefits did not outweigh its risks.

Adverse events in bardoxolone methyl-treated patients were generally manageable and mild to moderate in severity, with muscle spasm being reported most frequently.

[7] In 2014, Reata announced the initiation of a placebo-controlled, multicenter Phase 2 study (LARIAT), to assess the effects of bardoxolone methyl in pulmonary arterial hypertension.

[4] A Phase 3 multinational RCT (BEACON) designed to test the effect of bardoxolone methyl on progression to end-stage renal disease or cardiovascular death in patients with stage 4 CKD and type 2 diabetes was initiated by Reata in June 2011 and halted in October 2012 after bardoxolone methyl-treated patients were found to have experienced a higher rate of heart-related adverse events, including heart failure, hospitalizations, and deaths.