Mineralys Therapeutics, Inc.

Mineralys Therapeutics, Inc. is a biopharmaceutical company that develops medicines for diseases caused by dysregulated aldosterone. The company's primary product candidate is lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI). Mineralys Therapeutics is developing lorundrostat to treat cardiorenal conditions affected by dysregulated aldosterone, including hypertension and related comorbidities such as chronic kidney disease (CKD) and obstructive sleep apnea (OSA). In the United States, approximately 120 million patients have sustained elevated blood pressure, or hypertension. Of these, approximately 60 million patients are treated, and over 30 million do not achieve their blood pressure goal, with approximately 20 million having systolic blood pressure levels greater than 140 mmHg. Patients with hypertension that persists despite taking two or more medications have 1.8 and 2.5 times greater mortality risk due to cardiovascular disease or stroke, respectively. Dysregulated aldosterone levels are a key factor in uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) in approximately 30% of patients. Mineralys Therapeutics completed five clinical trials for lorundrostat, supporting its efficacy and safety profile and validating aldosterone as a therapeutic target in uHTN or rHTN. These trials include two pivotal, registrational trials: the Phase 3 Launch-HTN trial and the Phase 2 Advance-HTN trial, which demonstrated robust, durable, and clinically meaningful reductions in systolic blood pressure by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile. The company submitted a New Drug Application (NDA) in December 2025 for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs. The FDA accepted the NDA submission and provided a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026. Mineralys Therapeutics is also investigating lorundrostat's potential benefits in participants with hypertension and CKD and in participants with hypertension and OSA.