HQ Team
August 31, 2025: Swedish-British AstraZeneca Plc’s medicine baxdrostat lowered blood pressure in trial patients during an end-stage study, and the company plans to file for regulatory approvals by the end of the year.
The medicine was tested in 796 patients, and when taken once a day in two different doses of 1 mg and 2 mg, it lowered pressure in the arteries, “significantly” more than a dummy pill over 12 weeks, according to a company statement.
Baxdrostat helps lower high blood pressure, especially for people whose blood pressure has been hard to control, even though they are already taking several other medicines.
On average, those taking the higher dose of baxdrostat had their top blood pressure number (systolic blood pressure) drop by about 16 points.
The lower dose also reduced pressure by almost 15 points. A 10-point drop in blood pressure can greatly reduce the risk of heart attacks, strokes, kidney problems, and heart failure.
Aldosterone
Baxdrostat works by blocking a hormone called aldosterone. Aldosterone helps the body retain salts and water, which raises blood pressure. The medicine was found to be safe with mild side effects, and a few patients had high potassium levels, which is a potential concern with this type of drug.
The study found that baxdrostat helped people reach a healthy blood pressure goal more often and worked well even during the night, when blood pressure control is vital.
“Positive full results from the BaxHTN Phase III trial showed baxdrostat demonstrated a statistically significant and clinically meaningful reduction in mean seated systolic blood pressure at two doses (2mg and 1mg) compared with placebo at 12 weeks,” according to the statement.
A statistically significant reduction implies that the lowering of the blood pressure was real and not due to random chance. Or the results were strong enough for scientists to be confident that baxdrostat actually caused the drop in blood pressure.
A clinically meaningful reduction indicates that the amount of blood pressure reduction was big enough to be important for a patient’s health. The reduction is enough to reduce the risk of serious problems like heart attacks or strokes.
Hard-to-control hypertension
“Achieving a nearly 10 mmHg placebo-adjusted reduction in systolic blood pressure with baxdrostat in the BaxHTN Phase III trial is exciting, as this level of reduction is linked to substantially lower risk of heart attack, stroke, heart failure and kidney disease,” said Dr Bryan Williams, Chair of Medicine at University College London, primary investigator.
“These data show that aldosterone plays a greater role in hard-to-control hypertension than previously recognised, underscoring the importance of baxdrostat’s novel mechanism of action, and potential impact for the millions of people living with hard-to-control hypertension despite being on multiple treatments.”
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, said: “The BaxHTN Phase III results demonstrate baxdrostat’s potential in tackling one of the toughest challenges in cardiovascular care, which is hypertension that is hard to control despite multiple therapies.
“We look forward to advancing our regulatory filings for baxdrostat with health authorities in the months ahead, in addition to rapidly progressing a robust clinical development programme across indications where aldosterone plays a key role, including chronic kidney disease and heart failure prevention.”
New treatments
There are 1.3 billion people worldwide living with hypertension. Over time, hypertension can damage blood vessels and vital organs, increasing the risk of serious health problems such as heart attack, stroke, heart failure and kidney disease.
In the US, approximately 50% of patients living with hypertension on multiple treatments do not have their blood pressure under control.
A large meta-analysis found that lowering systolic blood pressure by 10 mmHg can reduce the risk of major adverse cardiovascular events by around 20%, underscoring the urgent need for new treatments that target hypertension at its source.
AstraZeneca acquired baxdrostat through its acquisition of CinCor Pharma, Inc. in February 2023.