Astrazeneca Baxdrostat application accepted for priority review by USFDA for hard-to-control hypertension

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

There are 1.4 billion people worldwide living with hypertension. In the US, approximately 50% of patients living with hypertension on multiple treatments do not have their blood pressure under control. Aldosterone is increasingly recognised as a key driver of hard-to-control hypertension, contributing to elevated cardiovascular and renal risk.

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 based on data from the BaxHTN Phase III trial5 which was presented during a Hot Line session at the European Society of Cardiology (ESC) Congress 2025 and simultaneously published in the New England Journal of Medicine.

The trial showed that baxdrostat, on top of standard of care, met the primary and all secondary endpoints. Standard of care consisted of a stable regimen of two antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension) or more than three antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension). At week 12, the change from baseline and placebo-adjusted change from baseline reductions in mean seated SBP were 15.7 mmHg (95% confidence interval [CI], -17.6 to -13.7) and 9.8 mmHg (95% CI, -12.6 to -7.0; p<0.001) for the 2mg dose, and 14.5 mmHg (95% CI, -16.5 to -12.5) and 8.7 mmHg (95% CI, -11.5 to -5.8; p<0.001) for the 1mg dose, respectively. The results were consistent across both uncontrolled and treatment-resistant subgroups.

Baxdrostat was generally well tolerated with a safety profile consistent with its mechanism of action. There were no unanticipated safety findings, and most adverse events were mild.

Baxdrostat is a potential first-in-class, highly selective aldosterone synthase inhibitor (ASI) designed to lower blood pressure by specifically inhibiting the production of aldosterone, a key hormone that raises blood pressure and increases the risk of heart and kidney problems. Baxdrostat is currently being investigated in clinical trials enrolling more than 20,000 patients globally, as a monotherapy for hypertension and primary aldosteronism, and in combination with dapagliflozin for chronic kidney disease and the prevention of heart failure in high-risk patients.