GlobeNewswire·Nov 8, 2026, 4:35 PM ET

Mineralys Therapeutics Presents New Late-Breaking Data from Transform-HTN Open-Label Extension Trial of Lorundrostat in Hypertension at AHA Scientific Sessions 2026

Long-term data from the Transform-HTN trial showed lorundrostat reduced automated office systolic blood pressure by 17.8 mmHg at Week 48 compared to Launch-HTN baseline
56% of participants achieved systolic blood pressure below 130 mmHg at Week 48
Treatment was well tolerated over 36 weeks of the open-label extension with no new clinically relevant safety findings compared to the initial Launch-HTN trial
92% of the 632 enrolled participants completed 48 weeks of follow-up
Serious adverse events occurred in 4.3% of participants, with only 0.3% considered treatment-related
5.9% of participants discontinued the trial drug due to adverse events, including 1.6% for hyperkalemia
Hyperkalemia requiring dose modification occurred in 5.1% of participants
Serum potassium levels increased while eGFR decreased early in treatment but remained stable through Week 48
The U.S. FDA is currently reviewing lorundrostat for hypertension treatment with a PDUFA target date of December 22, 2026
The Transform-HTN trial included 632 participants transitioning from Launch-HTN, with an efficacy analysis of 504 participants
The study population had a mean age of 61 years, with 41% on two antihypertensive medications and 59% on three or more at baseline
Lorundrostat is an investigational aldosterone synthase inhibitor designed to treat uncontrolled or resistant hypertension