Mineralys Therapeutics Presents New Data for Lorundrostat at the American Heart Association Hypertension Scientific Sessions 2026

Launch-HTN pivotal analysis

Mineralys presented a new analysis from its Phase 3 Launch-HTN trial reporting that, at Week 12, 46% of participants receiving lorundrostat 50 mg achieved the AHA/ACC office systolic blood pressure target of <130 mmHg. The company also reported that 70% of lorundrostat-treated participants achieved a systolic blood pressure reduction of 10 mmHg or more. The release characterizes the Launch-HTN population as adults with uncontrolled or treatment-resistant hypertension receiving two to five antihypertensive medications, and notes the trial design as randomized, double-blind and placebo-controlled with automated office blood pressure as the primary endpoint at six weeks.

Sources: S1

Explore-OSA Phase 2 results

Mineralys reported final results from its randomized, double-blind, placebo-controlled crossover Phase 2 Explore-OSA trial in overweight or obese adults with moderate-to-severe OSA and hypertension. In that study, participants receiving lorundrostat 50 mg once daily in the evening achieved a morning systolic blood pressure reduction of 11.1 mmHg at Week 4 versus a 1.0 mmHg reduction for placebo. The company states there was no measurable change in apnea-hypopnea indices, and it describes lorundrostat as having a favorable safety and tolerability profile with no evidence of significant safety events, including hyperkalemia.

Sources: S1

Drug profile and clinical program context

Mineralys describes lorundrostat as an investigational, orally administered, highly selective aldosterone synthase inhibitor designed to inhibit CYP11B2. The release reports an observed half-life of 10-12 hours and a demonstrated 40-70% reduction in plasma aldosterone concentration in participants with hypertension. The company notes completion of six late-stage clinical trials and highlights Launch-HTN and the Phase 2 Advance-HTN trial as part of its registrational program.

Sources: S1

Why this matters (inference)

If the reported reductions in systolic blood pressure are reproducible and durable, a larger proportion of patients with uncontrolled or treatment-resistant hypertension could reach guideline-recommended blood pressure targets. For the Explore-OSA population, the blood pressure effect is reported without changes in apnea-hypopnea indices, suggesting a blood-pressure-specific pharmacologic effect rather than an effect on airway mechanics. These points are company inferences presented in the release and are labeled as such.

Sources: S1

What remains uncertain

• All numerical outcomes and safety descriptions are reported by the issuer (Mineralys Therapeutics) and are not independently verified in this draft.
• The Launch-HTN primary endpoint is described as change from baseline in systolic blood pressure at six weeks measured by automated office blood pressure; the presented 12-week outcome is a later analysis and the durability beyond reported timepoints is not independently demonstrated in the source.
• Explore-OSA reported a crossover design and a Week 4 blood pressure secondary endpoint; the source states the primary efficacy endpoint was absolute change in apnea-hypopnea index, which showed no measurable change, and the clinical implications of the blood pressure change over longer follow-up are not established in the release.