Results from a Phase 3 clinical trial for baxdrostat were posted on 2026-07-30, evaluating its efficacy and safety in participants with uncontrolled and resistant hypertension. The study demonstrated that a 2 mg dose of baxdrostat significantly reduced seated systolic blood pressure (SBP) by 9.8 mmHg more than placebo in the resistant hypertension subpopulation.

Background

Hypertension, particularly when uncontrolled or resistant to multiple medications, presents a significant health challenge. This study focused on participants with hypertension despite a stable regimen of at least two antihypertensive agents, including a diuretic (uncontrolled hypertension), or three or more antihypertensive agents, including a diuretic (treatment-resistant hypertension).

Trial design

The Phase 3 study, NCT06034743, was a multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial. It enrolled 796 participants with uncontrolled or resistant hypertension. The trial evaluated the safety and efficacy of 1 mg or 2 mg doses of baxdrostat administered once daily orally, compared to placebo, focusing on systolic blood pressure reduction.

Key results

  • During the double-blind treatment period (Weeks 0-12) in participants with resistant hypertension, 2 mg baxdrostat significantly reduced seated systolic blood pressure (SBP) by a least squares mean difference of -9.8 mmHg (95.0% CI: -13.1, -6.4) compared to placebo (p-value of 0.0001). The least squares mean change from baseline for 2 mg baxdrostat was -15.2 mmHg (Standard Error: 1.2 mmHg), versus -5.4 mmHg (Standard Error: 1.3 mmHg) for placebo.
  • For 1 mg baxdrostat in the resistant hypertension subpopulation, the least squares mean difference in seated SBP versus placebo was -9.1 mmHg (95.0% CI: -12.6, -5.7), with a p-value of 0.0001. The least squares mean change from baseline was -14.5 mmHg (Standard Error: 1.2 mmHg).
  • In the randomized withdrawal period (Weeks 25-32), 2 mg baxdrostat showed a least squares mean difference of -5.1 mmHg (95.0% CI: -8.3, -1.9) in seated SBP compared to placebo (p-value of 0.0016).
  • Both 1 mg and 2 mg baxdrostat also demonstrated significant reductions in seated diastolic blood pressure (DBP) during Weeks 0-12. The least squares mean difference for 2 mg baxdrostat versus placebo was -3.9 mmHg (95.0% CI: -5.7, -2.0, p-value of 0.0001), and for 1 mg baxdrostat, it was -3.3 mmHg (95.0% CI: -5.2, -1.4, p-value of 0.0008).
  • A greater proportion of participants on 2 mg baxdrostat achieved seated SBP < 130 mmHg (106 participants) compared to placebo (49 participants), with an odds ratio of 2.9 (95.0% CI: 1.9, 4.4, p-value of 0.0001).

What this means

The Phase 3 trial results for baxdrostat demonstrate its potential to significantly reduce both systolic and diastolic blood pressure in patients with uncontrolled and resistant hypertension. The notable SBP reduction in the resistant hypertension subpopulation, especially with the 2 mg dose, suggests a promising new therapeutic option for individuals whose blood pressure remains elevated despite current multi-drug treatments. The increased proportion of patients achieving SBP below 130 mmHg with baxdrostat further highlights its clinical relevance for managing difficult-to-treat hypertension.

Source

This information is based on trial results posted on ClinicalTrials.gov for study NCT06034743 on 2026-07-30. The full details are available on clinicaltrials.gov.