Bardoxolone methyl is under clinical development by Reata Pharmaceuticals and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.
According to GlobalData, the latest event to affect Bardoxolone methyl’s likelihood of approval (LoA) and phase transition for Polycystic Kidney Disease took place on 09 Dec 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.
In addition, the same event on 09 Dec 2022 decreased Bardoxolone methyl’s Phase Transition Success Rate (PTSR) for IgA Nephropathy (Berger’s Disease), and decreased LoA and PTSR for Type 1 Diabetes (Juvenile Diabetes).
GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Bardoxolone methyl Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.
Bardoxolone methyl overview
Bardoxolone methyl (RTA 402) is under development for the treatment of pulmonary arterial hypertension associated with connective tissue disease (CTD-PAH), pulmonary hypertension associated with interstitial lung diseases (PH-ILD), idiopathic pulmonary arterial hypertension (I-PAH) and chronic kidney disease (chronic renal failure) caused by Alport syndrome and various forms of chronic kidney disease (CKD) including autosomal dominant polycystic kidney disease, IgA nephropathy (Berger's disease), type 1 diabetes and complications associated with COVID-19. It is administered orally in the form of a capsule. RTA 402 is a synthetic triterpenoid compound. The drug candidate is based on a proprietary technology platform known as Antioxidant Inflammation Modulators (AIMs). The drug candidate acts by targeting the mutated kelch like ECH associated protein 1 (KEAP1).
It was also under development for the treatment of focal segmental glomerulosclerosis, metastatic melanoma, pancreatic cancer, chronic kidney disease due to alport syndrome, liver diseases, solid tumors and rheumatoid arthritis.
Reata Pharmaceuticals overview
Reata Pharmaceuticals (Reata) is a clinical-stage biopharmaceutical company. It develops innovative medicines for the treatment of serious and life-threatening diseases. The company’s clinical candidates include bardoxolone methyl and omaveloxolone, which target Nrf2, a transcription factor, for restoring mitochondrial function, reducing oxidative stress, and resolving inflammation. Its products also include HSP90 modulators, RTA 901, ROR?t inhibitors, and RTA 1701. Reata is evaluating bardoxolone methyl in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH), alport syndrome and other kidney diseases; and omaveloxolone in Friedreich’s ataxia. The company works in partnership with academics, biotechnology, and pharmaceutical companies to develop technologies. It has operations in the US, the UK, Ireland, Australia and Switzerland. Reata is headquartered in Plano, Texas, the US.
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