FDA Grants Priority Review To AstraZeneca’s Baxdrostat For Hard-to-Control Hypertension; Advances First-In-Class Aldosterone Synthase Inhibitor

AstraZeneca announced that the U.S. FDA has accepted the New Drug Application (NDA) for baxdrostat and granted it Priority Review. The drug is being evaluated as an add-on therapy for adults with hard-to-control hypertension, either uncontrolled or treatment-resistant, when existing antihypertensive drugs fail to adequately lower blood pressure. A decision is expected in the second quarter of 2026, supported by AstraZeneca’s use of a Priority Review voucher.

Hypertension affects 1.4 billion people globally, and nearly half of U.S. patients remain uncontrolled despite multiple treatments. Aldosterone, a hormone increasingly recognised as a major contributor to treatment-resistant hypertension, drives cardiovascular and renal complications. Baxdrostat specifically targets this pathway, offering a potentially new therapeutic option for this large, underserved population.

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, said: “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.”

Clinical trial data demonstrated that baxdrostat, when added to standard antihypertensive therapy, achieved significant reductions in systolic blood pressure (SBP). At week 12, both the 1 mg and 2 mg doses met the primary and all secondary endpoints, reducing seated SBP by up to 15.7 mmHg from baseline and achieving significant placebo-adjusted reductions. The results were consistent in both uncontrolled and treatment-resistant groups. The drug also showed a favourable safety profile, with no unexpected adverse events and mostly mild reactions.

As a highly selective aldosterone synthase inhibitor (ASI), baxdrostat represents a potential first-in-class approach to hypertension management. AstraZeneca is studying the drug in more than 20,000 patients worldwide across multiple programs, including monotherapy for hypertension and primary aldosteronism, as well as in combination with dapagliflozin for the treatment of chronic kidney disease and heart failure prevention in high-risk groups.