Mineralys Therapeutics Presents New Late-Breaking Data from Transform-HTN Open-Label Extension Trial of Lorundrostat in Hypertension at AHA Scientific Sessions 2026
Key Highlights
- ➤Lorundrostat cut AOSBP 17.8 mmHg from Launch-HTN baseline at Week 48
- ➤56% of participants reached AOSBP below 130 mmHg at Week 48
- ➤FDA review is underway, with a December 22, 2026 PDUFA target date
- ➤Lorundrostat had no new clinically relevant safety findings beyond Launch-HTN
- ➤Hyperkalemia requiring trial drug modification occurred in 5.1% of participants
Expert Statements
Manish Saxena, Clinical Co-Director of Queen Mary University of London’s William Harvey Clinical Research Centre and Hypertension Specialist at Barts Health NHS Trust
“For patients whose blood pressure remains uncontrolled despite multiple medications, particularly those in high-risk populations disproportionately affected by hypertension, the question in practice is whether a treatment can deliver both rapid and sustained blood pressure control?”
Manish Saxena, Clinical Co-Director of Queen Mary University of London’s William Harvey Clinical Research Centre and Hypertension Specialist at Barts Health NHS Trust
“In Transform-HTN, lorundrostat demonstrated sustained blood pressure reductions for nearly a year, with more than half of participants achieving the guideline-recommended systolic blood pressure target of less than 130 mmHg, an important goal for reducing long-term cardiovascular and kidney risks.”
Jon Congleton, Chief Executive Officer of Mineralys Therapeutics
“Across multiple large clinical trials that included a diverse set of patients, lorundrostat has repeatedly demonstrated its potential to improve blood pressure control in patients with difficult-to-treat hypertension, while also being consistently well tolerated.”
Jon Congleton, Chief Executive Officer of Mineralys Therapeutics
“As we advance toward a potential FDA approval, these findings further strengthen the evidence supporting lorundrostat as an important new treatment option, with demonstrated durability of blood pressure reduction in the patients who need additional treatment options most.”
– In the largest long-term hypertension trial of an aldosterone synthase inhibitor to date, lorundrostat demonstrated sustained reduction in automated office systolic blood pressure (AOSBP) of 17.8 mmHg at Week 48 from Launch-HTN baseline –
– 56% of participants reached AOSBP below 130 mmHg at Week 48 –
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