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AstraZeneca’s Baxdrostat Meets Primary Endpoints in Phase III Trial for Resistant Hypertension

AstraZeneca’s Baxdrostat Meets Primary Endpoints in Phase III Trial for Resistant Hypertension

Baxdrostat represents a new drug class targeting aldosterone dysregulation, offering potential add-on therapy for difficult-to-control hypertension.

AstraZeneca’s investigational drug baxdrostat met the primary and all secondary endpoints in the BaxHTN Phase III trial for patients with uncontrolled or treatment resistant hypertension. Taken once daily at 2 mg or 1 mg doses alongside standard treatments, baxdrostat significantly lowered average seated systolic blood pressure compared to placebo after 12 weeks.

What Is Resistant Hypertension?

Resistant hypertension is high blood pressure that remains uncontrolled despite treatment with three or more antihypertensive medications, including a diuretic.

According to a study from the European Cardiology Review, resistant hypertension affects an estimated 10% of patients treated for high blood pressure worldwide, with prevalence varying by population and measurement methods. It is linked to diabetes, kidney disease, obesity, sleep apnea and increased cardiovascular risk.

What Is Baxdrostat? Its Mechanism of Action

Baxdrostat is a selective aldosterone synthase inhibitor, a drug class not yet approved for clinical use. It is an oral drug that selectively blocks aldosterone synthase, the enzyme responsible for producing aldosterone — a hormone that causes the body to retain sodium and water. This retention raises blood pressure and can harm the heart and kidneys.

By reducing aldosterone production, baxdrostat helps lower blood pressure, particularly in patients whose hypertension is hard to control with other treatments. In the BaxHTN trial, the drug was administered once daily alongside existing antihypertensive therapies.


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Baxdrostat Phase III Data: Reduction in Blood Pressure

The BaxHTN Phase III trial involved 796 patients with uncontrolled or resistant hypertension. Participants were randomly assigned to receive baxdrostat 2 mg, baxdrostat 1 mg or placebo once daily alongside their current blood pressure medications. The main goal was to assess how much baxdrostat lowered seated systolic blood pressure after 12 weeks compared to placebo.

Results showed that both doses significantly reduced systolic blood pressure compared to placebo. The study also measured reductions in diastolic blood pressure and the number of patients reaching a target systolic blood pressure below 130 mmHg — both of which improved with baxdrostat. Safety was closely monitored, and the drug was generally well tolerated, with no major safety concerns or increased treatment discontinuations.

The trial included a follow-up phase where some patients stopped taking baxdrostat to confirm the durability of its blood pressure-lowering effects. Long-term safety data will continue to be collected over a 52-week period.

The positive results highlight baxdrostat’s targeting of aldosterone dysregulation and provide evidence for its potential as an add-on therapy for patients whose blood pressure is hard to control.

AstraZeneca acquired baxdrostat by purchasing CinCor Pharma in 2023. The company will present the findings in a late-breaking session at the European Society of Cardiology Congress in August 2025.

Baxdrostat is also being tested for other conditions, including primary aldosteronism, chronic kidney disease and preventing heart failure in high-risk hypertensive patients, both alone and combined with other treatments.

Treating Hypertension: Diversity in Approaches

Hypertension’s complexity has encouraged a multitude of innovative approaches.

Newel Health recently received CE Mark approval in the European Union (EU) for Amicomed, a remote cardiovascular health monitoring device designed to track blood pressure and support hypertension management outside clinical settings. This digital health tool aims to improve patient monitoring and treatment adherence.

Geneticure secured a new US patent for a genetic test that predicts patient response to renal denervation, an interventional procedure for resistant hypertension. The test could personalize treatment decisions and may help identify patients most likely to benefit from this therapy.

George Medicines gained FDA approval for Widaplik, the first single-pill triple-combination therapy approved for initial treatment of hypertension. Widaplik, which combines three blood pressure-lowering drugs into one tablet, could simplify treatment regimens and therefore likely improve adherence.

And rounding off novel avenues, Olfactive Biosolutions was granted a second patent for its innovative approach to repurposing food-derived molecules that target key biological pathways involved in hypertension, including resistant hypertension.


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