Bardoxolone methyl (AbbVie/Kyowa Hakko Kirin), under development by the research-stage company Reata Pharmaceuticals, is a Phase III candidate in clinical trials for the treatment of pulmonary arterial hypertension. Bardoxolone methyl acts as an activator for the transcription factor Nrf2, which is involved in many different pathways and acts to reduce oxidative stress, promote mitochondrial function, and reduce inflammatory signaling.
While bardoxolone methyl (AbbVie/Kyowa Hakko Kirin) may hold promise considering its differentiated mechanism of action, the repercussions may be mixed. The drug modulates transcription factors Nrf2 and nuclear factor-kappa B (NF-kB), which act ubiquitously. Thus, bardoxolone methyl may have the potential to elicit broader effects than other pulmonary hypertension (PH) drugs. Conversely, its broad mechanism may lead to undesirable effects, as evident from its discontinued development for chronic kidney disease due to an increased risk of heart failure. Consequently, more data in larger trials are essential to consolidate bardoxolone methyl’s clinical profile. Ideally, these will further expand the drug’s clinical relevance to PH indications beyond the narrow targeting of pulmonary arterial hypertension associated with connective tissue disease (PAH-CTD) in its current Phase III trial. Targeting a broad label would aid in distinguishing bardoxolone methyl from other products and allow it to capture a larger patient share. Nonetheless, the drug will certainly benefit from the substantial commercial resources of AbbVie and Kyowa Hakko Kirin, which may be advantageous over other pipeline competitors.
LIST OF FIGURES
9 Figure 1: Bardoxolone methyl for pulmonary hypertension – SWOT analysis
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of bardoxolone methyl for pulmonary hypertension
11 Figure 3: Datamonitor Healthcare’s drug assessment summary of bardoxolone methyl for pulmonary hypertension
13 Figure 4: Bardoxolone methyl sales for pulmonary hypertension across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
6 Table 1: Bardoxolone methyl drug profile
7 Table 2: Bardoxolone methyl Phase II data in pulmonary hypertension
9 Table 3: Bardoxolone methyl Phase III trials in pulmonary arterial hypertension
14 Table 4: Bardoxolone methyl sales for pulmonary hypertension across the US, Japan, and five major EU markets, by country ($m), 2016–25
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