Leading pharma MNC AstraZeneca has announced that the US FDA has accepted its New Drug Application (NDA) for baxdrostat for Priority Review. The drug is targeted at adults with hard-to-control hypertension who do not achieve adequate blood pressure reduction with existing therapies.

 

The Prescription Drug User Fee Act (PDUFA) date is expected in the second quarter of 2026, following the use of a Priority Review voucher.

 

Hypertension affects 1.4 billion people worldwide, and in the US, about half of patients on multiple treatments still struggle to control their blood pressure. Aldosterone, a hormone that drives blood pressure up, is increasingly recognized as a key factor in these difficult-to-treat cases, contributing to elevated cardiovascular and kidney risks.

 

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.”

 

The NDA is supported by results from the BaxHTN Phase III trial, presented at the European Society of Cardiology (ESC) Congress 2025 and published in the New England Journal of Medicine. The trial found that baxdrostat, added to standard care, met all primary and secondary endpoints.

 

Patients in the trial were on either two antihypertensive agents (including a diuretic) for uncontrolled hypertension or more than three agents (including a diuretic) for treatment-resistant hypertension. At week 12, mean seated systolic blood pressure reductions were found.

 

Baxdrostat is a potential first-in-class, highly selective aldosterone synthase inhibitor (ASI). It works by specifically blocking aldosterone, a hormone that raises blood pressure and increases heart and kidney risk. 

 

The drug is being studied in over 20,000 patients globally—as a monotherapy for hypertension and primary aldosteronism, and in combination with dapagliflozin for chronic kidney disease and heart failure prevention in high-risk patients.