Baxfendy Approved for Hypertension
On May 18, 2026, the US Food and Drug Administration (FDA) approved AstraZeneca’s Baxfendy™ (baxdrostat – AstraZeneca) for the treatment of hypertension in adults whose blood pressure is not adequately controlled with other antihypertensive therapies, to be used in combination with other antihypertensive drugs. Baxfendy is a first-in-class aldosterone synthase inhibitor that lowers blood pressure by inhibiting aldosterone production. This hormone contributes to elevated blood pressure and increases cardiovascular and kidney risk. The recommended dose is 1mg or 2mg orally once daily. Pricing and detailed launch timing have not yet been announced. Full prescribing information can be found here.
At a Glance
- Brand Drug: Baxfendy™ (baxdrostat)
- Manufacturer: AstraZeneca
- Date Approved: May 18, 2026
- Indication: Treatment of hypertension in adults who are not adequately controlled with other antihypertensive medications, to be used in combination with other antihypertensive drugs
- Dosage Forms Available: Oral tablet (1 mg, 2 mg)
- Launch Date: TBD
- Estimated Annual Cost: TBD
- FDA Designation: Priority Review
- Baxfendy is a selective aldosterone synthase inhibitor that reduces aldosterone production, targeting a key driver of resistant hypertension. Aldosterone contributes to sodium and water retention, and its excess is linked to cardiovascular and kidney disease risk.
- Baxfendy was approved as an add-on therapy for patients who remain uncontrolled despite treatment with two or more antihypertensive agents.
- In the US, an estimated 23 million patients remain uncontrolled despite treatment with two or more antihypertensive medications.
- Approval was based on phase III data demonstrating statistically significant, clinically meaningful reductions in systolic blood pressure compared with placebo at 12 weeks, including an approximately 9.8 mmHg placebo-adjusted reduction at the 2mg dose.
- Warnings and precautions recommend monitoring serum potassium and sodium at baseline and periodically thereafter, with more frequent assessment in patients at increased risk of hyperkalemia or hyponatremia.
- Lorundrostat (Mineralys Therapeutics), a competing aldosterone synthase inhibitor, is under FDA review with approval expected by Dec. 22, 2026.