US regulator greenlights AstraZeneca's blood pressure drug Baxfendy

(Alliance News) - AstraZeneca PLC on Monday reported US clearance for its hypertension treatment Baxfendy.

The Cambridge, England-based pharmaceutical firm said the US Food & Drug Administration has approved Baxfendy, or baxdrostat, "as a first-in-class aldosterone synthase inhibitor" to lower blood pressure in adults with hypertension which is not adequately controlled. The approval is for Baxfendy in combination with other antihypertensive medications.

According to research cited by AstraZeneca, about 50% of US patients already taking other antihypertensive drugs continue to experience high blood pressure, which puts them at greater risk of cardiovascular disease.

AstraZeneca acquired Baxfendy through its purchase of CinCor Pharma Inc in February 2023. The drug aims to inhibit the production of aldosterone, a hormone which raises blood pressure, with a phase-three trial linking it to "statistically significant and clinically meaningful seated systolic blood pressure reduction" at doses of both one milligram and two milligrams.

The drug is in clinical trials for other conditions involving high aldosterone, including as a monotherapy for primary aldosteronism, and in combination with dapagliflozin for chronic kidney disease and hypertension, and the prevention of heart failure in patients with hypertension. Baxfendy also showed encouraging results in treating resistant hypertension.

Ruud Dobber, executive vice president of AstraZeneca's BioPharmaceuticals business unit, commented: "The approval of Baxfendy offers a much‑needed, first-in-class innovation for people living with persistently uncontrolled hypertension who have not responded to or tolerated existing medicines. In the US, about 23 million patients are uncontrolled despite being on two or more medicines for hypertension, which is a disease that has seen little therapeutic progress for the past two decades."

The greenlight for Baxfendy follows US clearance for Enhertu, AstraZeneca's breast cancer treatment, jointly developed with Tokyo-based peer Daiichi Sankyo Co Ltd. Enhertu has the FDA's approval for two new indications in adults with HER2 positive early breast cancer, meaning it is now approved for nine indications in total, with six across early and metastatic HER2 positive breast cancer.

AstraZeneca shares fell 0.3% to 13,594.00 pence on Monday morning in London.

By Holly Munks, Alliance News reporter

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