The U.S. Food and Drug Administration (FDA) has approved baxdrostat, a first-in-class oral aldosterone synthase inhibitor, as an add-on therapy for hypertension in adults whose blood pressure (BP) is not adequately controlled with other antihypertensive medications.

The approval comes following results from the BaxHTN Phase III trial, presented at ESC 2025 and simultaneously published in NEJM, which found that adding baxdrostat (1 mg or 2 mg once daily) to background antihypertensive therapy saw statistically significant reductions in systolic BP at 12 weeks compared with placebo in patients with uncontrolled or resistant hypertension.

Learn more in an AstraZeneca press release.

Clinical Topics: Prevention, Hypertension

Keywords: United States Food and Drug Administration, Antihypertensive Agents, Blood Pressure, Hypertension, ACC Advocacy