Mineralys lorundrostat hits BP target in 46% of resistant HTN patients
Mineralys Therapeutics has presented two new datasets for its aldosterone synthase inhibitor lorundrostat at the American Heart Association Hypertension Scientific Sessions 2026, held in Arlington, Virginia. The readouts strengthen the clinical narrative for a drug whose new drug application (NDA) is currently under FDA review.
The first presentation offered a new analysis from the pivotal Phase 3 Launch-HTN trial, which enrolled adults whose blood pressure remained uncontrolled despite two to five antihypertensive medications. At 12 weeks, 46% of participants receiving lorundrostat 50 mg achieved the AHA/ACC guideline-recommended office systolic blood pressure (SBP) target of below 130 mmHg. More than two-thirds of those on active treatment achieved a reduction of at least 10 mmHg in SBP, a threshold the company notes is associated, when sustained, with a roughly 20% reduction in cardiovascular event risk.
Manish Saxena, deputy clinical co-director of Queen Mary University of London's William Harvey Heart Centre and a principal investigator on the study, said the results "reinforce the potential of lorundrostat to deliver clinically meaningful reductions in blood pressure in patients with difficult-to-treat hypertension." The context matters: fewer than half of hypertension patients achieve their blood pressure goal on currently available therapies, and dysregulated aldosterone is thought to drive the condition in approximately 30% of hypertensive patients.
Explore-OSA: blood pressure benefit without apnoea improvement
The second dataset came from the Phase 2 Explore-OSA trial, a randomised, double-blind, crossover study in overweight or obese adults with moderate-to-severe obstructive sleep apnoea (OSA) and hypertension. Participants taking lorundrostat 50 mg once daily in the evening showed a reduction in morning SBP of 11.1 mmHg at week four, compared with 1.0 mmHg for placebo recipients. The difference was highly statistically significant (p less than 0.0001 versus p not significant for placebo).
Notably, lorundrostat produced no measurable change in the apnoea-hypopnoea index, the trial's primary endpoint. The drug was not designed as an OSA treatment per se; the question was whether aldosterone suppression could reduce the elevated overnight blood pressure that frequently accompanies OSA. On that secondary endpoint it delivered, while the safety profile remained clean, with no evidence of hyperkalemia, the key safety concern for drugs acting on the aldosterone pathway.
Regulatory and competitive context
Mineralys' NDA for lorundrostat in uncontrolled and resistant hypertension is already accepted for FDA review, and the company has disclosed a government shutdown or funding cuts as one of the risks that could delay the agency's timeline. The AHA-HTN data presentations are consistent with a standard pre-approval conference strategy: keeping the clinical story visible to prescribers and payers ahead of a potential launch.
The aldosterone synthase inhibitor class has historically struggled at this stage. AstraZeneca's finerenone (a mineralocorticoid receptor antagonist rather than a synthase inhibitor) established proof of concept that targeting the aldosterone axis can deliver cardiovascular and renal benefit beyond blood pressure alone, opening payer appetite for the mechanism. Lorundrostat differs structurally in that it inhibits aldosterone production directly via CYP11B2 rather than blocking the receptor downstream; Mineralys claims 374-fold selectivity for aldosterone synthase over cortisol synthase in vitro, which is relevant to the tolerability argument.
For investors, the Explore-OSA data extend the potential addressable population to the estimated 30-50% of hypertensive adults who also have OSA, a cohort that rises to 70-80% among those with resistant hypertension. Full regulatory clarity remains the near-term catalyst to watch.