On March 29, 2025, Mineralys Therapeutics presented detailed results from their Phase 2 Advance-HTN trial at the American College of Cardiology’s Annual Scientific Session & Expo (ACC.25).  This is one of two pivotal trials that evaluated lorundrostat in patients with confirmed uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). Lorundrostat is a proprietary, oral medication that acts as a highly selective inhibitor of aldosterone synthase. It is being developed for the treatment of uncontrolled or resistant hypertension, chronic kidney disease (CKD), and obstructive sleep apnea (OSA).

In the trial, lorundrostat 50 mg resulted in an absolute decrease of 15.4 mmHg and a placebo-adjusted reduction of 7.9 mmHg at week 12. The treatment also showed a favorable safety and tolerability profile, with only slight changes in potassium, sodium, and eGFR levels, and a low rate of discontinuation. In the Advance-HTN trial, lorundrostat demonstrated a similar safety and tolerability profile, with modest alterations in potassium, sodium, and eGFR, and a low discontinuation rate. The expected effects on serum electrolytes, including a mild increase in serum potassium and a decrease in sodium, were reversible shortly after discontinuing lorundrostat. No suppression of cortisol production was observed, and serious adverse events (SAEs) related to the drug were rare, leading to few discontinuations or dose adjustments.

Here is a brief overview of the study:

A Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects with Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen

Study Details | Source

  • Sponsor: Mineralys Therapeutics Inc.
  • A Phase 2 trial to evaluate the blood pressure-lowering effect of lorundrostat, an aldosterone synthase inhibitor (ASI), administered as an add-on to a standardized anti-hypertensive (AHT) medication regimen, in subjects with hypertension.
  • Interventions:
    • Drug: Placebo
    • Drug: lorundrostat Dose 1
    • Drug: lorundrostat Dose 2
  • Primary Outcome Measures
    • Change in 24-hour average ambulatory blood pressure monitoring (ABPM) systolic blood pressure (SBP)
      • Time frame - Baseline (Randomization) to Week 12

Mineralys plans to release additional data from the pivotal Phase 3 Launch-HTN Study at an upcoming medical conference as well as in a peer-reviewed journal. Furthermore, the ongoing Transform-HTN open-label extension trial enables participants to continue receiving lorundrostat, providing further safety and efficacy data.

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