Mineralys Therapeutics has reported sustained blood pressure reductions with investigational drug lorundrostat in a long-term hypertension trial involving 632 participants.

Lorundrostat maintains blood pressure reduction over 48 weeks

Mineralys Therapeutics has presented new long-term clinical trial data showing that lorundrostat maintained reductions in systolic blood pressure over 48 weeks in people with uncontrolled or resistant hypertension.

The results from the Transform-HTN open-label extension trial were presented in a late-breaking oral session at the American Heart Association (AHA) Scientific Sessions 2026.

Participants receiving lorundrostat demonstrated a mean reduction of 17.8 mmHg in automated office systolic blood pressure (AOSBP) at Week 48 compared with their baseline measurements in the parent Launch-HTN trial (n=504; p less than 0.0001).

More than half (56%) achieved an AOSBP below 130 mmHg at Week 48. Results were similar among participants taking two background antihypertensive medicines and those taking three or more.

Manish Saxena, clinical co-director of Queen Mary University of London’s William Harvey Clinical Research Centre and hypertension specialist at Barts Health NHS Trust, said: “For patients whose blood pressure remains uncontrolled despite multiple medications, particularly those in high-risk populations disproportionately affected by hypertension, the question in practice is whether a treatment can deliver both rapid and sustained blood pressure control. In Transform-HTN, lorundrostat demonstrated sustained blood pressure reductions for nearly a year, with more than half of participants achieving the guideline-recommended systolic blood pressure target of less than 130 mmHg, an important goal for reducing long-term cardiovascular and kidney risks.”

Safety results from the Transform-HTN extension

The safety analysis included 632 participants, of whom 583 (92%) completed 48 weeks of follow-up.

Serious adverse events occurred in 27 participants (4.3%), with investigators considering two (0.3%) to be treatment-related. Thirty-seven participants (5.9%) discontinued treatment because of an adverse event, including 10 (1.6%) due to hyperkalaemia.

Hyperkalaemia requiring a treatment modification, including dose reduction, interruption or discontinuation, occurred in 32 participants (5.1%).

As expected from lorundrostat’s mechanism of action, serum potassium increased and estimated glomerular filtration rate (eGFR) decreased early in treatment. Both measures remained stable through the open-label extension to Week 48.

Mineralys said there were no new clinically relevant safety findings compared with the parent Launch-HTN trial.

FDA review underway ahead of December decision

Transform-HTN enrolled participants who had completed one of three eligible parent studies: Advance-HTN, Launch-HTN or Explore-CKD.

The results presented at AHA came from participants originally assigned to either lorundrostat treatment arm in the 12-week, double-blind, placebo-controlled Phase 3 Launch-HTN trial.

Of the 808 participants in the lorundrostat arms of Launch-HTN, 632 were eligible and enrolled in Transform-HTN. They received a further 36 weeks of open-label treatment alongside their existing antihypertensive medicines.

The efficacy analysis excluded participants assigned to placebo during a four-week randomised treatment-withdrawal substudy between Weeks 24 and 28.

Lorundrostat is an investigational oral aldosterone synthase inhibitor designed to reduce aldosterone production by inhibiting the CYP11B2 enzyme. Mineralys is developing it for uncontrolled and resistant hypertension, as well as related conditions including chronic kidney disease and obstructive sleep apnoea.

The drug is under review by the US Food and Drug Administration (FDA) for use alongside other antihypertensive medicines. The agency has set a Prescription Drug User Fee Act (PDUFA) target date of 22 December 2026.

Jon Congleton, CEO of Mineralys Therapeutics, said: “Across multiple large clinical trials that included a diverse set of patients, lorundrostat has repeatedly demonstrated its potential to improve blood pressure control in patients with difficult-to-treat hypertension, while also being consistently well tolerated.”

He added: “As we advance toward a potential FDA approval, these findings further strengthen the evidence supporting lorundrostat as an important new treatment option, with demonstrated durability of blood pressure reduction in the patients who need additional treatment options most.”