AstraZeneca announced FDA approval of Baxfendy (baxdrostat), the first aldosterone synthase inhibitor approved for adults with uncontrolled hypertension despite multiple therapies. In the Phase III BaxHTN trial, Baxfendy significantly reduced systolic blood pressure and was generally well tolerated.
By: Regulatory Desk
AstraZeneca announced that the US Food and Drug Administration (FDA) has approved Baxfendy, a first-in-class aldosterone synthase inhibitor (ASI), for the treatment of hypertension in adults whose blood pressure remains uncontrolled despite the use of other antihypertensive medicines.
The approval marks the first new therapeutic approach for hypertension in years that directly targets aldosterone production, a hormonal pathway strongly associated with persistently elevated blood pressure and increased cardiovascular and kidney risk. Baxfendy is approved for use in combination with existing antihypertensive therapies.
Persistent hypertension remains a leading risk factor for cardiovascular disease, stroke, kidney damage, and premature death.
Baxfendy (baxdrostat) is an oral small molecule designed to selectively inhibit aldosterone synthase, the enzyme responsible for aldosterone production in the adrenal gland. Aldosterone promotes sodium and water retention, contributing to elevated blood pressure and cardiorenal complications.
The FDA approval was supported by results from the Phase III BaxHTN trial (NCT06034743), published in the New England Journal of Medicine. The study evaluated 796 patients with uncontrolled or resistant hypertension who were already receiving at least two antihypertensive agents, including a diuretic.
At 12 weeks, patients receiving the 2 mg dose of Baxfendy achieved a 15.7 mmHg reduction in seated systolic blood pressure from baseline, with a placebo-adjusted reduction of 9.8 mmHg (p<0.001). Patients receiving the 1 mg dose achieved a 14.5 mmHg reduction from baseline and a placebo-adjusted reduction of 8.7 mmHg (p<0.001). Blood pressure reduction was consistent across both uncontrolled and treatment-resistant hypertension subgroups.
The therapy was generally well tolerated, with no unexpected safety findings reported during the trial.
Dr. Bryan Williams, Chair of Medicine at University College London and principal investigator of the BaxHTN trial, said the treatment could change hypertension management by targeting a key biological driver of uncontrolled blood pressure. He also highlighted that epidemiological evidence links a 10-mmHg reduction in systolic blood pressure with an approximately 20% reduction in major cardiovascular events.
John M. Clymer, Executive Director of the National Forum for Heart Disease & Stroke Prevention, emphasized the continued burden of uncontrolled hypertension and noted that new treatment options may help reduce long-term risks involving the heart, kidneys, brain, and blood vessels.
Ruud Dobber, Executive Vice President of Biopharmaceuticals at AstraZeneca, stated that Baxfendy addresses a major unmet need for patients whose blood pressure remains uncontrolled despite multiple therapies. He noted that around 23 million patients in the US remain uncontrolled while taking two or more antihypertensive medications.
The BaxHTN study also included a randomized withdrawal phase designed to evaluate persistence of efficacy, along with a 52-week long-term safety assessment. Additional secondary endpoints included changes in seated diastolic blood pressure and the proportion of patients achieving systolic blood pressure below 130 mmHg.
Beyond hypertension, AstraZeneca is investigating Baxfendy in several cardiorenal conditions associated with elevated aldosterone levels. Ongoing development programs include studies in primary aldosteronism, chronic kidney disease combined with hypertension, and the prevention of heart failure in hypertensive patients.
The company also highlighted positive results from the Phase III Bax24 trial (NCT06168409), which demonstrated clinically meaningful reductions in 24-hour ambulatory systolic blood pressure in patients with resistant hypertension. Full findings from that study were published in The Lancet.
AstraZeneca acquired baxdrostat through its purchase of CinCor Pharma in February 2023. Baxfendy first received regulatory approval in the United Arab Emirates earlier in May 2026, ahead of the US approval announced on May 18, 2026. The company’s New Drug Application for baxdrostat was accepted under priority review in December 2025.
Reference