Baxdrostat Phase 3 Trial for Hypertension Completes Primary Phase

The Phase 3 clinical trial investigating Baxdrostat for uncontrolled and resistant hypertension, NCT06344104, reached its primary completion on 2025-11-24. This study aimed to assess the efficacy and safety of baxdrostat in participants with hypertension not adequately controlled by existing medications.

Background

Baxdrostat is being developed for the treatment of hypertension, specifically in individuals whose blood pressure remains elevated despite being on two or more medications, including those with resistant hypertension. The trial focuses on a population for whom current treatments may not be sufficient to achieve blood pressure control.

Trial design

The study, NCT06344104, is a Phase 3, randomized, placebo-controlled trial. It enrolled 326 participants with uncontrolled hypertension or resistant hypertension. The interventions included different doses of baxdrostat (2 mg or 1 mg tablets) compared to placebo tablets. The primary objective is to compare the difference in systolic blood pressure (SBP) change from baseline at Week 12 of treatment between the baxdrostat groups and the placebo group.

What this means

The primary completion of this Phase 3 trial indicates that all planned primary data collection for the main efficacy and safety endpoints has concluded. While specific results are not yet available, this milestone brings baxdrostat closer to potential regulatory review, pending the analysis and reporting of the collected data. The trial's focus on uncontrolled and resistant hypertension addresses a significant unmet medical need, as these patients often face higher risks of cardiovascular events.

Source

Information regarding the primary completion of this trial was sourced from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT06344104, titled "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," was recorded on 2025-11-24 on clinicaltrials.gov.