for uncontrolled or resistant hypertension
FDA approved Baxfendy as the first-in-class aldosterone synthase inhibitor (ASI) for the treatment of hypertension in adults whose blood pressure is not adequately controlled on other antihypertensives. Approval establishes the ASI class commercially and creates the competitive bar for Mineralys's lorundrostat (also tracking in this Docket).
Hypertension is a long-term condition of persistently high blood pressure that is a major risk factor for stroke, heart failure, kidney disease, and dementia. Baxfendy is a pill that selectively inhibits the enzyme aldosterone synthase, which is responsible for producing the hormone aldosterone. By reducing aldosterone production, the drug may help lower blood pressure in adults whose hypertension is not controlled by other medications.
The purpose of this study is to measure the efficacy and safety of baxdrostat in participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets.
Source: ClinicalTrials.gov