The FDA approved baxdrostat based on meaningfully positive results from the phase 3 BaxHTN trial.
The FDA has approved baxdrostat (Baxfendy; AstraZeneca) for the treatment of hypertension in adults whose condition is not adequately controlled on existing antihypertensive medications. The drug is the first and only aldosterone synthase inhibitor (ASI) to receive regulatory approval in the US, marking a meaningful advancement for a condition that has seen limited therapeutic innovation over the past 2 decades.1
“This FDA approval is a big win for patients with treatment-resistant hypertension,” Craig Beavers, PharmD, FACC, FAHA, FCCP, BCCP, BCPS (AQ-Cardiology), CACP, a cardiovascular clinical pharmacist with Baptist Health System and the University of Kentucky College of Pharmacy in Lexington, told Pharmacy Times. "It provides an additional option that improves blood pressure control, with a tolerable safety profile, and could lead to positive patient outcomes.”
Baxdrostat is a first-in-class, highly selective, and potent oral small molecule designed to lower blood pressure by specifically inhibiting the production of aldosterone, which is a hormone that raises blood pressure to unhealthy levels and increases the risk of heart and kidney problems. Unlike existing agents, baxdrostat is capable of significantly lowering aldosterone levels without impacting cortisol, helping to address a root cause of persistently uncontrolled hypertension while avoiding disruption of related hormonal pathways. Elevated aldosterone levels in the body can make elevated blood pressure complicated to treat and heighten the risk of adverse cardiovascular events, including heart attack.1-3
Approximately 1.4 billion people worldwide have hypertension, and in the US, approximately 50% of patients already taking multiple antihypertensive medications still experience persistently elevated blood pressure, a leading risk factor for cardiovascular disease and premature death. Hypertension is the most prevalent and significant modifiable cardiovascular risk factor worldwide, accounting for more deaths and disability than any other modifiable risk.1
The FDA approval was based on results from the phase 3 BaxHTN trial (NCT06034743), published in The New England Journal of Medicine, which evaluated baxdrostat in adults with uncontrolled or treatment-resistant hypertension receiving 2 or more antihypertensive agents at baseline. At week 12, there was a significant reduction from baseline in mean seated systolic blood pressure (SBP) of 15.7 mm Hg for the 2-mg dose (95% CI, –17.6 to –13.7), whereas the placebo-adjusted reduction was 9.8 mm Hg (95% CI, –12.6 to –7.0; P < .001). For the 1-mg dose, the absolute reduction from baseline was 14.5 mm Hg, with a placebo-adjusted reduction of 8.7 mm Hg (95% CI, –11.5 to –5.8; P < .001). These results were consistent across both the uncontrolled and treatment-resistant subgroups.1,4,5
Trial Name: 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 ID: NCT06034743
Sponsor: AstraZeneca
Completion Date: May 21, 2025
Confirmatory secondary end points were also successfully met, including durable long-term blood pressure reductions with the 2-mg dose, significant reductions in diastolic blood pressure at both doses, and results showing that baxdrostat nearly tripled the odds of patients reaching a target SBP of less than 130 mm Hg compared with placebo. Primary investigator Bryan Williams, MD, chair of medicine at University College London, noted that a placebo-adjusted reduction of nearly 10 mm Hg in systolic blood pressure is associated with a substantially lower risk of heart attack, stroke, heart failure, and kidney disease.1,5
Baxdrostat was well tolerated among the patient population, with no unanticipated safety signals identified by investigators. Low rates of confirmed hyperkalemia (serum potassium > 6 mmol/L) were observed in both dose groups compared with placebo. Pharmacists dispensing baxdrostat should counsel patients on the signs of hyperkalemia, including muscle weakness, palpitations, and gastrointestinal symptoms, and should monitor renal function and electrolyte levels as part of ongoing patient management.5
With baxdrostat now approved, pharmacists are positioned on the front lines of educating patients with hypertension about this new therapeutic option. Pharmacists already help lead hypertension clinics that directly address underlying risk factors before they progress to worsened outcomes and are essential in ensuring patients adhere to prescribed medications and initiate dose escalation if goals are not met. As baxdrostat enters clinical practice, pharmacists will be integral to identifying appropriate candidates, particularly those with uncontrolled hypertension despite multiple existing therapies, and counseling them on the drug's mechanism, dosing, and adverse effect profile.2,6
The approval of baxdrostat also carries broader cardiovascular implications. Uncontrolled hypertension is a well-established driver of heart failure risk, and pharmacists embedded in cardiology and health system practices are well-positioned to ensure this first-in-class agent reaches the patients who need it most. AstraZeneca is currently investigating baxdrostat in additional clinical trials for conditions where high aldosterone plays a role in elevating cardiorenal risk, including primary aldosteronism, chronic kidney disease, and the prevention of heart failure in patients with hypertension.1,2
“Pharmacists should take time to become familiar with the product and how it can be integrated in hypertension care,” Beavers noted.
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