Phase 2 Trial of Baxdrostat for Treatment-Resistant Hypertension

This multicenter, randomized, placebo-controlled phase 2 trial (BrigHTN) investigated the efficacy and safety of baxdrostat, a highly selective aldosterone synthase inhibitor, in 274 patients with treatment-resistant hypertension. Participants were on stable regimens of at least three antihypertensive agents, including a diuretic. Baxdrostat at 0.5, 1, or 2 mg daily produced dose-dependent reductions in systolic blood pressure (–12.1 to –20.3 mm Hg) compared to placebo (–9.4 mm Hg), with statistically significant differences for 1- and 2-mg groups. Diastolic pressures and serum aldosterone also declined without reductions in cortisol. Adverse events, including hyperkalemia, were infrequent and manageable; no serious drug-related events or adrenal insufficiency were observed. The trial suggests that baxdrostat may offer a novel pathway for managing resistant hypertension, bypassing limitations of mineralocorticoid receptor antagonists.

This multicenter, randomized, placebo-controlled phase 2 trial (BrigHTN) investigated the efficacy and safety of baxdrostat, a highly selective aldosterone synthase inhibitor, in 274 patients with treatment-resistant hypertension. Participants were on stable regimens of at least three antihypertensive agents, including a diuretic. Baxdrostat at 0.5, 1, or 2 mg daily produced dose-dependent reductions in systolic blood pressure (–12.1 to –20.3 mm Hg) compared to placebo (–9.4 mm Hg), with statistically significant differences for 1- and 2-mg groups. Diastolic pressures and serum aldosterone also declined without reductions in cortisol. Adverse events, including hyperkalemia, were infrequent and manageable; no serious drug-related events or adrenal insufficiency were observed. The trial suggests that baxdrostat may offer a novel pathway for managing resistant hypertension, bypassing limitations of mineralocorticoid receptor antagonists.