Baxdrostat NDA Accepted Under FDA Priority Review for Hard-to-Control High Blood Pressure

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s New Drug Application (NDA) for baxdrostat under Priority Review status, targeting adults with hard-to-control hypertension, including uncontrolled or treatment-resistant cases, as an add-on therapy to existing antihypertensives. This decision, announced in early December 2025, sets a Prescription Drug User Fee Act (PDUFA) target action date in Q2 2026, potentially marking baxdrostat as the first approved aldosterone synthase inhibitor (ASI) for clinical use. The Priority Review reflects the drug’s potential to address essential needs in a condition affecting millions, where blood pressure remains elevated despite multiple medications.​

Baxdrostat selectively inhibits aldosterone synthase (the CYP11B2 enzyme), reducing aldosterone production in the adrenal glands without significantly impacting cortisol synthesis via the related CYP11B1 enzyme. Elevated aldosterone contributes to sodium retention, fluid buildup, and resistant hypertension by dysregulating the renin-angiotensin-aldosterone system (RAAS). This novel, highly selective oral small-molecule approach lowers aldosterone while showing no meaningful effect on cortisol in studies so far, which may reduce the side effects seen with less specific therapies.

The new drug application is supported by results from the Phase 3 BaxHTN trial (NCT06034743), which enrolled 796 adults with uncontrolled hypertension on at least two drugs or resistant hypertension on three or more, including a diuretic. At 12 weeks, baxdrostat produced placebo-adjusted reductions in seated systolic blood pressure of 8.7 mmHg with the 1 mg dose and 9.8 mmHg with the 2 mg dose.

Benefits were consistent across patient subgroups. In exploratory analyses, the 2 mg dose reduced 24-hour ambulatory systolic pressure by 16.9 mmHg, while pooled data from the 1 mg and 2 mg groups showed nighttime reductions of 11.7 mmHg. The Phase 3 Bax24 trial added confirmation in 218 patients with treatment-resistant hypertension, where baxdrostat 2 mg achieved a statistically significant and clinically meaningful reduction in 24-hour systolic blood pressure over 12 weeks compared with placebo.

Originally developed by CinCor Pharma (acquired by AstraZeneca in 2023 for $1.8 billion), baxdrostat strengthens AstraZeneca’s cardiorenal pipeline for conditions like resistant hypertension, primary aldosteronism, and chronic kidney disease.

Phase 2 BrigHTN data supported dose-dependent SBP lowering, paving the way for Phase 3 confirmation of safety and tolerability, with no adrenocortical insufficiency reported.

Sharon Barr, AstraZeneca’s EVP of BioPharmaceuticals R&D, stated that “This Priority Review demonstrates our commitment to advancing baxdrostat as a potential first- and best-in-class aldosterone synthase inhibitor for the millions of people living with hard-to-control hypertension as quickly as possible. The substantial reduction in systolic blood pressure seen in the BaxHTN trial underscores Baxdrostat novel mechanism of action and its potential to bring innovation to a disease area that has seen limited progress in over two decades.”

Hard-to-control high blood pressure increases the risk of heart problems and strokes, but it affects many people even when they take standard medications. Baxdrostat provides a precise way to balance the body’s salt-regulating system (RAAS) for these tough cases. If approved, it could change how we add treatments for resistant hypertension, where few good options exist today, while ongoing studies check its long-term safety worldwide.