FDA Approves Baxdrostat for Uncontrolled Hypertension on Background Therapy

The Food and Drug Administration has approved AstraZeneca’s baxdrostat, branded Baxfendy, for adults with hypertension that remains inadequately controlled on other blood pressure medicines.

AstraZeneca said the drug is approved for use as combination or add-on therapy on a background of existing antihypertensive treatment. Coverage of the decision described Baxfendy as the first U.S.-approved aldosterone synthase inhibitor.

The company said the FDA decision was based on results from the BaxHTN phase 3 trial, which enrolled 796 people with uncontrolled or resistant hypertension.

The approval was first reported on May 18, 2026, with AstraZeneca later issuing its own announcement the same day.

Hypertension remains one of the most common chronic conditions, and the approval adds a new treatment option for patients whose blood pressure is still not controlled despite standard therapy. The open questions now are the final prescribing details and how quickly the drug will be available to patients and prescribers.