Bardoxolone Methyl CAS# 218600-53-4, an Antioxidant Inflammation Modulator, is currently in clinical trials as a potential once a day treatment for those patients suffering from Chronic Kidney Disease (CKD). Developed by Reata Pharmaceuticals, Inc. in partnership with Abbott Laboratories and Kyowa Hakko Kirin, this drug will treat people suffering from CKD due to conditions such as Type 2 Diabetes Mellitus. Both oxidative stress and inflammation occur as a result of CKD, and Bardoxolone Methyl acts as an agent to activate the Nrf2 pathway, thus helping to preserve and aid kidney function in affected patients.
In phase 2 of the study a new formulation of Bardoxolone Methyl was tested, and showed an improved oral bioavailability when compared to the formulation used in previous studies. All dose levels of this new formulation were well tolerated, and the pharmacodynamic profile was deemed safe and consistent. The results from this improved formulation were presented at the World Congress of Nephrology meeting in 2011.
Phase 3 (BEACON) of the current multinational, double-blind and placebo-controlled study are underway, with results expected sometime in 2013. This last phase of the study is assessing and determining the efficacy of Bardoxolone Methyl as a treatment for patients with CKD, and the progression of the disease to End Stage Renal Disease (ESRD).
The majority of patients who experienced side effects noted muscle spasms. Other side effects noted to date include hypoglycemia, nausea and peripheral edema. However, hypoglycemia was reported in approximately equal proportions of patients, in both the Bardoxolone Methyl and placebo groups.
Researchers are optimistic that Bardoxolone Methyl Treatment will prove to be a viable and successful treatment for the vast number of patients suffering from CKD.
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