Key result
Baxdrostat lowers systolic blood pressure by up to ~10 mmHg over placebo in resistant hypertension.
Why the study?
Resistant hypertension continues to cause significant morbidity and mortality, with aldosterone excess driving treatment resistance, yet direct suppression of aldosterone synthase has long eluded clinical success due to selectivity challenges.
Does baxdrostat reduce blood pressure in patients with resistant or uncontrolled hypertension?
Does baxdrostat reduce blood pressure in patients with resistant or uncontrolled hypertension?
Effect estimate: Placebo-adjusted reduction of 8.7-9.8 mmHg
Absolute Event Rate: 15.7% vs 5.8%
Baxdrostat is a first-in-class, highly selective aldosterone synthase inhibitor that safely and effectively reduces blood pressure in patients with resistant hypertension without suppressing cortisol production.
May support aldosterone synthase inhibition in resistant hypertension; leaves open long-term outcomes and comparative efficacy.
Hypertension remains the world’s leading preventable cause of cardiovascular morbidity and mortality. Despite the availability of diverse antihypertensive drug classes, resistant hypertension continues to affect millions globally, leading to a disproportionate risk of stroke, heart failure, kidney disease, and premature death. Aldosterone excess is a central driver of treatment resistance, yet direct pharmacological suppression of aldosterone biosynthesis has long eluded clinical success due to the challenge of selectively targeting aldosterone synthase (CYP11B2) over its near-identical paralog 11β-hydroxylase (CYP11B1). Baxdrostat (CIN-107, RO6836191), an orally bioavailable, highly selective aldosterone synthase inhibitor (ASI), has now demonstrated robust blood pressure reduction in phase 3 clinical trials, marking a potential paradigm shift in the management of resistant hypertension. This Review summarizes the pathophysiology of aldosterone in hypertension, the molecular pharmacology of CYP11B2 inhibition, the discovery and development of Baxdrostat, and its clinical evaluation. We further discuss the broader implications of targeting steroidogenic cytochrome P450 enzymes and highlight future opportunities and challenges as Baxdrostat and related agents enter the cardiovascular pharmacopeia.
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Capriello et al. (2026) conducted a review in Resistant hypertension. Baxdrostat vs. Placebo was evaluated on Reduction in seated systolic blood pressure (Placebo-adjusted reduction of 8.7-9.8 mmHg). Baxdrostat reduced systolic blood pressure by an average of 14.5 to 15.7 mmHg compared to 5.8 mmHg with placebo after 12 weeks in patients with uncontrolled or resistant hypertension.
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