Regulatory action – FDA hypertension approval (aldosterone synthase inhibitor)

The U.S. FDA approved AstraZeneca’s Baxfendy (baxdrostat) for hypertension in combination with other antihypertensive medications in patients not adequately controlled. The drug is a first-in-class aldosterone synthase inhibitor and the clearance was based on results from the Phase 3 BaxHTN trial meeting both primary and secondary endpoints. AstraZeneca positions the approval as part of its broader cardiometabolic pipeline while it prepares for potential patent pressure on existing products. The label also keeps competitive attention on Mineralys Therapeutics, which has a December 2026 PDUFA date for its aldosterone synthase inhibitor lorundrostat.