Baxdrostat and Aldosterone Synthase Inhibitors: A New Class for Treatment-resistant Hypertension

To review the mechanistic rationale and recent Phase 3 clinical trial data for baxdrostat, a selective aldosterone synthase inhibitor, in the management of treatment-resistant hypertension.

We evaluated efficacy and safety data from the Phase 3 BaxHTN (N = 794) and Bax24 (N = 217) trials, along with a recent systematic review and meta-analysis of aldosterone synthase inhibitors.

In BaxHTN, baxdrostat 2 mg reduced seated systolic blood pressure by -15.7 mmHg (placebo-adjusted - 9.8 mmHg; P < 0.001). In Bax24, 24-hour ambulatory systolic blood pressure decreased by -16.6 mmHg (placebo-adjusted - 14.0 mmHg; P < 0.001). Hyperkalemia (> 5.5 mmol/L) occurred in approximately 12% of baxdrostat-treated patients versus 3% with placebo, with low discontinuation rates (approximately 2%). No cortisol suppression or adrenal insufficiency was observed.

Baxdrostat has demonstrated among the largest ambulatory blood pressure reductions reported in contemporary treatment-resistant hypertension trials. With FDA Priority Review underway (PDUFA Q2 2026), this first-in-class agent represents a potential therapeutic advancement for patients inadequately controlled on existing regimens.