AstraZeneca’s potential first-in-class aldosterone inhibitor could help millions with hard-to-control high blood pressure.
Global biopharmaceutical company AstraZeneca announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for Baxdrostat under priority review. The oral drug targets adult patients with hard-to-control hypertension, those whose blood pressure remains elevated despite the use of multiple medications [1].
If approved, baxdrostat would become the first aldosterone synthase inhibitor authorized for use in the US, offering a new therapeutic option for patients struggling with resistant blood pressure.
The FDA’s Prescription Drug User Fee Act (PDUFA) date is expected in the second quarter of 2026, following the use of a priority review voucher.
Hypertension, or high blood pressure, affects an estimated 1.4 billion people worldwide, and just over one in five patients on medication still don’t have their numbers under control [2].
Hard-to-control hypertension includes both uncontrolled hypertension – elevated blood pressure despite using two or more medications – and resistant hypertension, where patients remain hypertensive despite three or more drugs. Elevated aldosterone levels are a key contributor, promoting sodium and water retention and increasing cardiovascular and renal risk.
The BaxHTN trial evaluated baxdrostat in 796 patients over 12 weeks, comparing two doses (1mg and 2mg) against placebo. Patients were already on standard regimens of two or more antihypertensive medications, including a diuretic.
At week 12, baxdrostat significantly reduced SBP:
- 2mg dose: 15.7 mmHg reduction from baseline, placebo-adjusted reduction of 9.8 mmHg
- 1mg dose: 14.5 mmHg reduction from baseline, placebo-adjusted reduction of 8.7 mmHg
The reductions were consistent across both uncontrolled and resistant hypertension groups. Long-term safety and efficacy are being monitored in ongoing trials, with adverse events reported mostly mild and consistent with the drug’s mechanism of action.
Baxdrostat works by blocking the hormone aldosterone, which helps the body retain salt and water and can raise blood pressure. By reducing aldosterone without affecting other vital hormones like cortisol, the drug targets a key cause of hard-to-control high blood pressure.
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca, said that the priority review demonstrates their 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,” she added.
Baxdrostat is also being studied in over 20,000 patients globally for hypertension, primary aldosteronism, chronic kidney disease in combination with dapagliflozin, and heart failure prevention in high-risk patients.
Baxdrostat is part of AstraZeneca’s Cardiovascular, Renal & Metabolism (CVRM) portfolio, which focuses on organ protection and slowing disease progression. By targeting the underlying mechanisms of hypertension, AstraZeneca aims to detect, diagnose and treat cardiovascular and renal diseases earlier and more effectively, aligning with its broader mission to improve and save lives.
AstraZeneca acquired baxdrostat through its purchase of clinical-stage biopharmaceutical company CinCor Pharma in February 2023, paying a contingent value of $0.5 billion to CinCor shareholders upon NDA submission.
With hypertension affecting millions globally and limited progress in treatment options over the past two decades, baxdrostat represents a potential breakthrough. If FDA approval is granted, it could transform the management of hard-to-control hypertension, offering hope for patients who have struggled to keep their blood pressure under control despite multiple medications. Such an advance would be particularly timely, given the growing burden of age-associated hypertension and its outsized impact on cardiovascular risk and healthy lifespan.
[1] https://www.astrazeneca.com/media-centre/press-releases/2025/baxdrostat-new-drug-application-accepted-under-fda-priority-review-in-the-us-for-patients-with-hard-to-control-hypertension.html\
[2] https://www.who.int/news/item/23-09-2025-uncontrolled-high-blood-pressure-puts-over-a-billion-people-at-risk
