WILMINGTON, Delaware — The U.S. Food and Drug Administration has accepted AstraZeneca’s New Drug Application for baxdrostat under Priority Review for the treatment of adults with hard-to-control hypertension when existing antihypertensive medicines do not adequately lower blood pressure.
The Prescription Drug User Fee Act decision is expected in the second quarter of 2026, supported by a Priority Review voucher. If approved, baxdrostat would become the first aldosterone synthase inhibitor to receive regulatory authorization.
Hypertension affects an estimated 1.4 billion people worldwide. In the U.S., about half of patients living with hypertension who take multiple medications still do not achieve adequate control. Aldosterone has been increasingly identified as a significant contributor to hard-to-control hypertension and is linked to elevated cardiovascular and kidney risk.
“This Priority Review demonstrates our commitment to advancing baxdrostat as a potential first- and best-in-class aldosterone synthase inhibitor for the millions of people living with hard-to-control hypertension as quickly as possible. The substantial reduction in systolic blood pressure seen in the BaxHTN trial underscores baxdrostat’s novel mechanism of action and its potential to bring innovation to a disease area that has seen limited progress in over two decades,” said Sharon Barr, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca.
The application is supported by results from the Phase III BaxHTN trial, which were presented at the 2025 European Society of Cardiology Congress and published in the New England Journal of Medicine. The study evaluated baxdrostat in patients with uncontrolled or treatment-resistant hypertension who were already taking a stable regimen of standard therapies, including a diuretic.
At week 12, baxdrostat met all primary and secondary endpoints. For the 2 mg dose, the mean seated systolic blood pressure was reduced by 15.7 mmHg from baseline and by 9.8 mmHg compared with placebo. For the 1 mg dose, the reductions were 14.5 mmHg from baseline and 8.7 mmHg versus placebo. Both findings were statistically significant with p<0.001 and were consistent across both uncontrolled and treatment-resistant subgroups.
Baxdrostat was generally well tolerated, with no unexpected safety findings and mostly mild adverse events.
The therapy is a highly selective aldosterone synthase inhibitor designed to reduce blood pressure by lowering aldosterone production, a hormone that increases cardiovascular and renal risk. Baxdrostat is currently being evaluated in global clinical programs enrolling more than 20,000 patients. Studies include monotherapy for hypertension and primary aldosteronism, as well as combination trials with dapagliflozin for chronic kidney disease and the prevention of heart failure in high-risk patients.
