N Engl J Med

ESC 2025: Aldosterone synthase inhibitor shows promise in lowering BP in resistant hypertension

September 8, 2025

Study details: The phase 3 BaxHTN trial (NCT06034743) enrolled 796 adults with uncontrolled or resistant hypertension across 214 sites in 29 countries. Participants had seated systolic BP between 140–170 mm Hg despite treatment with multiple antihypertensives. After a 2-week placebo run-in, participants were randomized to receive baxdrostat 1 mg, 2 mg, or placebo daily for 12 weeks. The primary end point was the change in seated systolic BP from baseline to week 12.

Results: At 12 weeks, baxdrostat significantly reduced seated systolic BP: −14.5 mm Hg (1 mg) and −15.7 mm Hg (2 mg) vs. −5.8 mm Hg with placebo. Placebo-adjusted reductions were −8.7 mm Hg and −9.8 mm Hg, respectively (p<0.001). Approximately 40% of patients achieved BP <130 mm Hg with baxdrostat vs. 18.7% with placebo. Ambulatory and nighttime BP also improved. Baxdrostat was well tolerated; hyperkalemia (>6 mEq/L) occurred in ~1–3% of patients.

Clinical impact: Baxdrostat, a selective aldosterone synthase inhibitor, offers a novel mechanism for addressing difficult-to-control hypertension. Its efficacy and safety profile suggest potential as an adjunct therapy for patients not achieving BP targets with current regimens.

Source:

Flack JM, et al; BaxHTN Investigators. (2025, August 30). N Engl J Med. Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension. https://pubmed.ncbi.nlm.nih.gov/40888730/

(2025, August 30). European Society of Cardiology. Blood-pressure reductions with baxdrostat in pateints with uncontrolled or resistant hypertension. [Press release]. https://www.escardio.org/The-ESC/Press-Office/Press-releases/Blood-pressure-reductions-with-baxdrostat-in-patients-with-uncontrolled-or-resistant-hypertension