Key Facts
- Baxdrostat is an aldosterone synthase inhibitor.
- FDA approved May 18, 2026.
- Indication: add-on treatment for uncontrolled adult hypertension.
- Phase 3 BaxHTN met SBP endpoint.
- Key risks: hyperkalemia, hyponatremia.
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FDA Approves Baxdrostat for Uncontrolled Hypertension on Background Therapy
FDA approved baxdrostat as add-on therapy for adults with hypertension not controlled on other medications.
On May 18, 2026, the US Food and Drug Administration (FDA) approved baxdrostat as an add-on treatment for adults with hypertension not adequately controlled on other antihypertensive agents.1
Announced by parent company AstraZeneca, the agency cleared the oral aldosterone synthase inhibitor for use in combination with other blood pressure medications, making it the first approved drug in this class for hypertension. The approval was based on the phase 3 BaxHTN trial, which enrolled patients with uncontrolled or resistant hypertension already receiving ≥2 antihypertensive drugs, including a diuretic.1,2
“We have been waiting for an innovative medication like BAXFENDY for hypertension for many years,” Bryan Williams, MD, chair of medicine at University College London and a primary investigator for BaxHTN, said in a statement. “Its novel way of lowering blood pressure has the potential to transform clinical practice by targeting a root cause of persistently uncontrolled hypertension. In addition, the nearly double-digit placebo-adjusted systolic blood pressure reduction achieved with BAXFENDY is exciting and clinically meaningful for clinicians and patients.”1
Phase 3 BaxHTN Trial Data
In the press release and linked publication, AstraZeneca reported results from the placebo-controlled 12-week portion of BaxHTN, a phase 3 trial that randomly assigned 796 participants in a 1:1:1 ratio to baxdrostat 2 mg, baxdrostat 1 mg, or placebo once daily on top of standard care. Patients with uncontrolled hypertension were taking 2 agents at baseline, including a diuretic, while those with resistant hypertension were taking ≥3 agents, also including a diuretic. The primary endpoint was change from baseline in seated systolic blood pressure at week 12.1,2,3
A total of 794 patients were randomized, of whom 264 received baxdrostat 1 mg, 266 received baxdrostat 2mg, and 264 received placebo. At week 12, mean seated systolic blood pressure fell by 15.7 mm Hg in the 2-mg group and 14.5 mm Hg in the 1-mg group, compared with 5.8 mm Hg in the placebo group. Placebo-adjusted reductions were 9.8 mm Hg (95% CI, -12.6 to -7.0; P <.001) for 2 mg and 8.7 mm Hg (95% CI, -11.5 to -5.8; P <.001) for 1 mg. These effects were consistent in both uncontrolled and treatment-resistant subgroups.1,2
BaxHTN also included a randomized withdrawal period from weeks 24 to 32 to assess persistence of effect and a 52-week safety assessment, although the press release did not provide detailed results from those components. Because the announcement emphasized systolic blood pressure reduction rather than cardiovascular outcomes, the approval rests on a surrogate endpoint commonly used in antihypertensive drug development rather than direct event reduction data.1,3
Safety Findings Reported With Baxdrostat
The approved labeling summarized in the announcement identifies hyperkalemia and hyponatremia as key warnings and precautions. Serum potassium and sodium should be assessed before initiation and monitored periodically during treatment, with more frequent checks suggested for patients at increased risk, including older adults, those with diabetes, chronic kidney disease, or concomitant therapies that raise potassium. Investigators reported no unanticipated safety findings in BaxHTN, but adverse effects associated with the mechanism were evident.1
In pooled placebo-controlled trials, the most frequently reported adverse reactions occurring in ≥2% of baxdrostat-treated patients were hyperkalemia (6.6% of 1mg recipients and 10.2% of 2mg recipients), hypotension (2.1% and 3.6%), hyponatremia (2.1% and 3.2%), dizziness (3% and 2.9%), and muscle spasms (1.8% and 2.9%). The labeling also notes potential interactions with drugs that increase serum potassium and with strong or moderate CYP3A inducers, because baxdrostat is a CYP3A substrate. The recommended dosage is 2 mg once daily, with 1 mg once daily suggested for patients at increased risk of hyperkalemia or hyponatremia.1
Baxdrostat Mechanism and Prior Clinical Development
Baxdrostat inhibits aldosterone synthase, the CYP11B2-encoded enzyme responsible for aldosterone production in the adrenal gland. The rationale for the drug is grounded in the recognized contribution of aldosterone excess to sodium retention, volume expansion, and persistent hypertension. The class differs from mineralocorticoid receptor antagonists by targeting hormone synthesis upstream rather than receptor blockade. Whether that distinction translates into meaningful differences in long-term comparative effectiveness or tolerability remains unanswered by the current approval materials.1,4
Clinical development of baxdrostat has been underway for several years. A phase 2 trial previously reported blood pressure reductions in treatment-resistant hypertension, helping establish proof of concept for the mechanism. More recently, the phase 3 Bax24 trial published in The Lancet evaluated ambulatory blood pressure in resistant hypertension and, according to the company release, also yielded positive findings.1,4
“Hypertension remains a staggeringly widespread silent killer and a leading risk factor for stroke, heart attack, kidney damage, and dementia,” John Clymer, executive director of the National Forum for Heart Disease and Stroke Prevention, said in a statement. “Tens of millions of people struggle to control their blood pressure despite lifestyle changes and currently available treatments. Innovative, new treatments could help millions protect their heart, kidney, and brain health.”1
References
AstraZeneca. BAXFENDY approved in the US as the first and only aldosterone synthase inhibitor treatment for adults with hypertension. BusinessWire. May 18, 2026. Accessed May 18, 2026. https://www.businesswire.com/news/home/20260518258445/en/BAXFENDY-approved-in-the-US-as-the-first-and-only-aldosterone-synthase-inhibitor-treatment-for-adults-with-hypertension
Flack JM, et al. Efficacy and safety of baxdrostat in uncontrolled and resistant hypertension. N Engl J Med. 2025. doi:10.1056/NEJMoa2507109
ClinicalTrials.gov. 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). Updated November 10, 2025. Accessed April 2026. https://clinicaltrials.gov/study/NCT06034743
Freeman MW, et al. Phase 2 trial of baxdrostat for treatment-resistant hypertension. N Engl J Med. 2023;388(5):395-405. doi:10.1056/NEJMoa2213169
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