The FDA cleared Baxfendy based on Phase III data showing that the drug significantly reduced systolic blood pressure when added to standard hypertension therapy.
High blood pressure, or hypertension, is a common condition in which the force of blood against the artery walls stays consistently high. If left uncontrolled, it can raise the risk of heart disease, stroke, heart failure and kidney disease. It affects nearly half of US adults, but only about one in four has the condition under control.
The FDA has approved AstraZeneca’s Baxfendy (baxdrostat) for adults with hypertension whose blood pressure is not adequately controlled on other medications.
Baxfendy is approved for use in combination with other antihypertensive drugs. It is the first and only aldosterone synthase inhibitor approved in the US for hypertension.
The drug blocks aldosterone synthase, an enzyme involved in producing aldosterone. Aldosterone is a hormone that helps the body retain salt and water. When aldosterone activity is too high, blood volume and blood pressure can rise, making hypertension harder to control.
By lowering aldosterone production, Baxfendy targets a pathway that contributes to persistently elevated blood pressure.
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The FDA approval was supported by results from the Phase III BaxHTN trial, which evaluated Baxfendy in adults with uncontrolled or resistant hypertension.
BaxHTN enrolled 796 patients who were already taking standard blood pressure medicines. Patients with uncontrolled hypertension were receiving at least two antihypertensive agents, including a diuretic. Patients with resistant hypertension were receiving at least three antihypertensive agents, also including a diuretic.
The main goal of the study was to measure the change in seated systolic blood pressure after 12 weeks. Systolic blood pressure is the “top number” in a blood pressure reading. It measures the pressure in the arteries when the heart beats.
At Week 12, both tested doses of baxdrostat significantly lowered systolic blood pressure compared with placebo.
Patients who received baxdrostat 2 mg had a mean systolic blood pressure reduction of 15.7 mmHg from the start of the study. The placebo group had a 5.8 mmHg reduction. After accounting for the drop also seen in the placebo group, the placebo-adjusted reduction with Baxfendy 2 mg was 9.8 mmHg.
Baxdrostat at 1 mg dose also lowered systolic blood pressure by 14.5 mmHg from baseline. That translated to an 8.7 mmHg improvement over placebo. These results were statistically significant.
Baxdrostat also lowered diastolic blood pressure, the “bottom number,” which measures pressure in the arteries when the heart rests between beats. The blood pressure-lowering effect was generally consistent across patient subgroups, including age, sex, body mass index and kidney function.
The trial also tested whether the effect continued after longer treatment. Some patients who had been taking baxdrostat were later switched to placebo for eight weeks, while others stayed on the drug. Patients who continued baxdrostat maintained better blood pressure control, suggesting the treatment effect was sustained with continued use.
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AstraZeneca is also studying Baxfendy in other conditions where aldosterone may contribute to cardiovascular and kidney risk. These include primary aldosteronism, chronic kidney disease with hypertension and prevention of heart failure in patients with hypertension.
The company acquired baxdrostat as part of its 2023 purchase of CinCor Pharma.
Several other hypertension-related programs are in late-stage development. Mineralys Therapeutics’ lorundrostat, a similar oral aldosterone synthase inhibitor, is currently under FDA review with a target action date of December 22, 2026.
Meanwhile, Roche and Alnylam advanced zilebesiran, an RNA interference therapy, in a global Phase III trial in 2025. Zilebesiran is designed to reduce the liver’s production of angiotensinogen, a protein involved in blood pressure regulation.
Pentixapharm is also entering Phase III with [68Ga]Ga-PentixaFor, an imaging agent being studied in treatment-resistant hypertension linked to primary aldosteronism. This hormone-driven condition causes the body to make too much aldosterone, and the imaging agent is designed to help doctors identify patients who may benefit from more targeted care.
FAQs
What does a placebo-adjusted reduction in blood pressure mean?
A placebo-adjusted reduction shows how much of the blood pressure drop was linked to the drug after accounting for changes also seen in the placebo group.
What is resistant hypertension?
Resistant hypertension is high blood pressure that remains difficult to control even when a person is taking several blood pressure medicines.
What is systolic blood pressure?
Systolic blood pressure is the “top number” in a blood pressure reading. It measures the pressure in the arteries when the heart beats.
What is diastolic blood pressure?
Diastolic blood pressure is the “bottom number” in a blood pressure reading. It measures the pressure in the arteries when the heart rests between beats.
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