Mineralys Therapeutics is a clinical-stage biopharmaceutical company developing lorundrostat, an oral, once-daily aldosterone synthase inhibitor (ASI) that reduces aldosterone levels by blocking CYP11B2, the enzyme that produces the hormone. The company is targeting uncontrolled hypertension (uHTN) and resistant hypertension (rHTN) — patients who cannot reach their blood pressure goal despite taking multiple antihypertensive medications. Mineralys submitted an NDA to the FDA in December 2025, with a target review deadline of December 22, 2026. The NDA is supported by two pivotal trials: Launch-HTN, a Phase 3 trial showing a placebo-adjusted 9.1 mmHg systolic blood pressure reduction at 6 weeks, and Advance-HTN, a Phase 2 pivotal trial in harder-to-treat patients showing a 7.9 mmHg reduction at 12 weeks. Beyond hypertension, Mineralys is exploring lorundrostat in chronic kidney disease and obstructive sleep apnea. Mineralys has no revenue today and funds operations through equity and debt financing. If approved, lorundrostat would be positioned as a third- or fourth-line antihypertensive added on top of existing generics, making payer access and net pricing critical to commercial success. Mineralys is evaluating a direct salesforce, commercial partnerships, or a combination for go-to-market. Mineralys licensed lorundrostat from Tanabe Pharma and owes up to $155M in milestones plus tiered royalties on net sales.