US FDA Accepts AstraZeneca’s Baxdrostat for Priority Review in Resistant Hypertension
- ipharmaservices
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The U.S. Food and Drug Administration (FDA) has accepted AstraZeneca’s New Drug Application (NDA) for baxdrostat under Priority Review, marking a key regulatory milestone for patients with hard‑to‑control or treatment‑resistant hypertension. The application seeks approval for baxdrostat as an add‑on therapy to existing antihypertensive treatments in adult patients whose blood pressure remains inadequately controlled despite standard care.
Prescription Drug User Fee Act (PDUFA) target date
The FDA has set a Prescription Drug User Fee Act (PDUFA) target date in the second quarter of 2026, following the use of a Priority Review voucher. If approved, baxdrostat could become the first aldosterone synthase inhibitor approved for clinical use—a potential breakthrough for patients struggling to achieve target blood pressure levels with current therapies.
BaxHTN Phase III Trial Highlights
The NDA submission is supported by data from the Phase III BaxHTN trial, which evaluated baxdrostat as an adjunct to standard care in patients with uncontrolled and treatment‑resistant hypertension. The study met its primary and secondary endpoints, showing a statistically significant and clinically meaningful reduction in systolic blood pressure compared to placebo at 12 weeks.
Patients receiving baxdrostat 2 mg experienced a mean reduction in seated systolic blood pressure of 15.7 mmHg, while those on 1 mg achieved a 14.5 mmHg reduction. After placebo adjustment, the reductions were 9.8 mmHg and 8.7 mmHg, respectively. The results were consistent across both the uncontrolled and resistant hypertension subgroups.
Baxdrostat also demonstrated a favorable safety and tolerability profile, with no unexpected adverse events and mostly mild side effects. Its mechanism selectively inhibits aldosterone production without affecting cortisol levels, offering a more targeted approach to lowering blood pressure.
Hypertension: An Ongoing Global Challenge
Hypertension affects more than 1.4 billion people worldwide and remains one of the leading causes of heart disease, stroke, and chronic kidney disease. Patients with resistant hypertension face particularly high cardiovascular risks, as blood pressure remains elevated despite treatment with multiple agents. Lowering systolic blood pressure by even 10 mmHg can significantly reduce the risk of heart attack, stroke, and overall mortality, underlining the urgent need for novel therapies like baxdrostat.
Expanding Baxdrostat’s Clinical Development
Baxdrostat is a first‑in‑class, highly selective aldosterone synthase inhibitor (ASI) designed to block the production of aldosterone—a hormone that increases blood pressure and contributes to heart and kidney damage. The molecule is being studied in more than 20,000 patients globally across multiple late‑stage trials. These include investigations of baxdrostat as a monotherapy for hypertension and primary aldosteronism, and in combination with dapagliflozin for chronic kidney disease and heart failure prevention in high‑risk patients.
AstraZeneca gained ownership of baxdrostat through its acquisition of CinCor Pharma in 2023. The deal included a contingent payment tied to the NDA submission milestone.
If approved, baxdrostat would represent a major advance in the management of hypertension, offering a novel mechanism of action for patients whose condition remains uncontrolled under current antihypertensive regimens.