Baxdrostat NDA for Uncontrolled Hypertension Receives FDA Priority Review

The US Food and Drug Administration (FDA) has announced its Priority Review acceptance of a New Drug Application (NDA) for baxdrostat, an investigative potential first-in-class small molecule aldosterone synthase inhibitor, for the treatment of hard-to-control hypertension.1

Announced on December 2, 2025, by parent company AstraZeneca, the NDA submission was based on positive results from the BaxHTN phase 3 clinical trial. This study investigated multiple doses of baxdrostat compared to placebo in lowering systolic blood pressure among patients with uncontrolled hypertension despite the use of ≥2 antihypertensive medications.3

“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,” Sharon Barr, executive vice president of BioPharmaceuticals R&D, said in a statement. “The substantial reduction in systolic blood pressure seen in the BaxHTN trial underscores baxdrostat’s novel mechanism of action and its potential to bring innovation to a disease area that has seen limited progress over two decades.”1

BaxHTN was a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel group study aiming to evaluate the safety, tolerability, and efficacy of baxdrostat in patients with uncontrolled hypertension being treated with ≥2 different antihypertensive medications. The trial was conducted at 263 locations worldwide and saw patients randomly assigned in a 1:1:1 ratio to either baxdrostat 2 mg, baxdrostat 1 mg, or placebo once daily. The study’s primary efficacy endpoint was the difference in mean change from baseline in seated systolic blood pressure at week 12 between participants treated with baxdrostat and those treated with placebo. The efficacy’s persistence was assessed during a randomized withdrawal period from week 24 to 32.1,2

To be eligible for inclusion, patients were required to have a mean sitting systolic blood pressure of ≥140 mmHg and ≤170 mmHg based on automated office blood pressure measurements, as well as an estimated glomerular filtration rate ≥45 mL/min/1.73m2 and a serum potassium level ≥3.5 and <5 mmol/L at screening. Patients also had to have a stable regimen of either 2 or ≥3 antihypertensive medications from different classes at the maximum dose, of which ≥1 must be a diuretic. Patients with a mean sitting systolic blood pressure ≥170 mmHg, a mean seated diastolic blood pressure ≥110 mmHg, serum sodium levels <135 mmol/L, or New York Heart Association functional heart failure class IV at screening, among other criteria, were excluded.2

A total of 796 patients were included in the study and were randomized to either baxdrostat 2 mg (n = 266), 1 mg (n = 264), or placebo (n = 264). At 12 weeks, investigators saw a -14.5 mmHg change from baseline in mean systolic blood pressure (95% CI, -16.5 to -12.5) with baxdrostat 1 mg, -15.7 mmHg (95% CI, -17.6 to -13.7) with baxdrostat 2 mg, and -5.8 mmHg (95% CI, -7.9 to -3.8) with placebo. The estimated difference from placebo was -8.7 mmHg (95% CI, -11.5 to -5.8) with baxdrostat 1 mg and -9.8 mmHg (95% CI, -12.6 to -7) with baxdrostat 2 mg (P <.001 for both comparisons).3

“Many people continue to struggle with high blood pressure that is hard to control, even when taking multiple medications,” Bryan Williams, chair of medicine at University College London and a lead investigator in BaxHTN, said in a statement. “The highly promising BaxHTN phase 3 results show that once-daily baxdrostat on top of standard care can meaningfully lower systolic blood pressure and offer a potential new treatment approach for controlling hypertension, the leading risk factor for cardiovascular disease.”4

According to the press release, AstraZeneca expects to receive the Prescription Drug User Fee Act date during the second quarter of 2026, following the use of a Priority Review voucher.1

References

1. AstraZeneca. Baxdrostat New Drug Application accepted under FDA Priority Review in the US for patients with hard-to-control hypertension. December 2, 2025. Accessed December 2, 2025. https://www.astrazeneca-us.com/media/press-releases/2025/Baxdrostat-New-Drug-Application-accepted-under-FDA-Priority-Review-in-the-US-for-patients-with-hard-to-control-hypertension.html

2. AstraZeneca. A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension (BaxHTN). ClinicalTrials.gov Identifier: NCT06034743. Updated July 11, 2025. Accessed December 2, 2025. https://clinicaltrials.gov/study/NCT06034743

3. Flack JM, Azizi M, Brown JM, et al. Efficacy and safety of Baxdrostat in uncontrolled and resistant hypertension. New England Journal of Medicine. 2025;393(14):1363-1374. doi:10.1056/nejmoa2507109

4. AstraZeneca. Baxdrostat met the primary and all secondary endpoints in BaxHTN Phase III trial in patients with uncontrolled or treatment resistant hypertension. July 14, 2025. Accessed December 2, 2025. https://www.astrazeneca-us.com/media/press-releases/2025/baxdrostat-met-the-primary-and-all-secondary-endpoints-in-BaxHTN-Phase-III-trial-in-patients-with-uncontrolled-or-treatment-resistant-hypertension.html