Mineralys Therapeutics Presents Phase 3 Launch-HTN Data for Lorundrostat at ESH 2026

For contract manufacturers and CMC regulatory teams tracking the aldosterone synthase inhibitor class, Mineralys Therapeutics is bringing Phase 3 efficacy and safety data for lorundrostat to an oral session at the 35th European Meeting on Hypertension and Cardiovascular Protection (ESH 2026) on 30 May 2026 in Gdańsk, Poland, a presentation that signals the compound's advancing regulatory trajectory and sharpens the timeline for downstream manufacturing readiness.

The data originate from Launch-HTN (NCT06153693), a global, randomised, double-blind, placebo-controlled Phase 3 trial enrolling adults with uncontrolled hypertension on two to five background antihypertensive agents. Participants were allocated to placebo, lorundrostat 50 mg once daily, or a titration arm with the option to escalate to 100 mg at week six. The primary endpoint was change from baseline in systolic blood pressure at six weeks, measured by automated office monitoring. The CKD subpopulation featured in the ESH oral session adds a renally impaired cohort to the dataset, a population with distinct pharmacokinetic and safety considerations relevant to formulation and process validation planning.

Lorundrostat's mechanism, selective inhibition of CYP11B2, the enzyme responsible for aldosterone biosynthesis, places it in a chemically distinct category from mineralocorticoid receptor antagonists already on the market. For CDMOs and internal manufacturing teams, that distinction carries CMC implications: selectivity profiling against the closely related CYP11B1 (cortisol synthesis) is a known characterisation requirement, and any analytical method package submitted under 21 CFR Part 211 or an ICH Q10-aligned pharmaceutical quality system will need to demonstrate adequate specificity across both isoforms. Stability programmes for a once-daily oral solid dosage form in a renally impaired population will also need to account for the patient-specific excipient tolerability constraints that ICH Q8 formulation risk assessments typically flag at this stage.

The CKD prevalence context is operationally relevant: with an estimated 37 million U.S. adults affected and approximately 21% of hypertensive patients carrying a CKD diagnosis, commercial-scale demand projections for a successful NDA would point toward high-volume oral solid manufacturing capacity. QA directors assessing supplier qualification timelines should note that an aldosterone synthase inhibitor reaching late Phase 3 with a clean safety signal typically enters pre-NDA CMC alignment discussions with the FDA within 12 to 18 months of a pivotal readout.

The ESH oral presentation, scheduled for 17:15 CEST in the Blue Room, will be delivered by Liffert Vogt, MD, PhD, of Amsterdam UMC, with the full dataset providing the most granular public view yet of lorundrostat's benefit-risk profile in a comorbid population that will likely define the label's core indication.

Source: Mineralys Therapeutics, Inc. via GlobeNewswire, 18 May 2026.