The FDA has approved AstraZeneca’s Baxfendy to treat uncontrolled hypertension, marking the first approval for an aldosterone synthase inhibitor in the indication.
Baxfendy, also known as baxdrostat, is indicated for patients with uncontrolled or treatment-resistant hypertension and is intended for use alongside other antihypertensive therapies, according to a May 18 news release. AstraZeneca said the drug could address a U.S. market of about 23 million treatable patients.
The approval was supported by data from the phase 3 BaxHTN trial, published in August 2025 in The New England Journal of Medicine. In the study, a 2-mg dose lowered systolic blood pressure by 9.8 mmHg versus placebo after 15 weeks. A 1-mg dose lowered systolic blood pressure by 8.7 mmHg compared with placebo.
AstraZeneca acquired baxdrostat through its $1.3 billion purchase of CinCor Pharma in 2023. The company identified Baxfendy as one of the key launches expected to support its goal of reaching $80 billion in annual revenue by 2030.
Mineralys Therapeutics is also developing an aldosterone synthase inhibitor, lorundrostat, for hypertension. The FDA accepted the drug’s new drug application in March, with a decision expected in December.
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