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.

Quick View Bardoxolone methyl LOA Data

Report Segments
  • Innovator
Drug Name
  • Bardoxolone methyl
Administration Pathway
  • Oral
Therapeutic Areas
  • Cardiovascular
  • Gastrointestinal
  • Genetic Disorders
  • Genito Urinary System And Sex Hormones
  • Immunology
  • Infectious Disease
  • Metabolic Disorders
  • Oncology
Key Developers
  • Sponsor Company: Reata Pharmaceuticals
  • Originator: Dartmouth College and University of Texas MD Anderson Cancer Center
Highest Development Stage
  • Pre-Registration

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.