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The FDA on May 15, 2026 approved Baxfendy (baxdrostat), AstraZeneca's once-daily tablet, in combination with other antihypertensive drugs for adults whose hypertension is not adequately controlled on other agents.
Baxdrostat inhibits aldosterone synthase, the enzyme that produces aldosterone in the adrenal gland. Excess aldosterone raises blood volume through renal sodium and water retention and contributes to vascular inflammation and fibrosis. Mineralocorticoid receptor antagonists such as spironolactone address the receptor downstream, constrained by hyperkalemia and, for spironolactone, antiandrogenic effects; baxdrostat stops the hormone being made at all.
BaxHTN (NCT06034743) randomized 794 patients equally to baxdrostat 1 mg, 2 mg or placebo after a two-week placebo run-in. Every patient was on a diuretic, 90% on an ACE inhibitor or ARB, and roughly 41% were taking three background antihypertensives, with mean baseline pressure of 149/87 mmHg. At Week 12 systolic pressure fell 15.7 mmHg on 2 mg and 14.5 mmHg on 1 mg against 5.8 mmHg on placebo, placebo-adjusted reductions of 9.8 and 8.7 mmHg. In an eight-week randomized withdrawal the effect held, separating from placebo by 5.1 mmHg.
Potassium monitoring is the predictable consequence of suppressing aldosterone, and will determine how comfortably this sits in primary care.
Clinically, it adds a mechanism upstream of the mineralocorticoid receptor antagonists for patients already taking several agents, in the labeled population.
Sources: FDA prescribing information; Drugs@FDA, NDA 219878; AstraZeneca press release; BaxHTN (NCT06034743); Nature Reviews Drug Discovery
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