Largest phase 3 trial of novel treatment for hypertension shows promising results

The data from the Launch-HTN trial, announced at the 34th European Meeting on Hypertension and Cardiovascular Protection, show that lorundrostat, an aldosterone synthase inhibitor, is a safe and effective treatment for people with uncontrolled or resistant hypertension, demonstrating consistent blood pressure reductions across a large and diverse patient population. It is the largest phase three trial of an aldosterone synthase inhibitor for the treatment of hypertension.

The results are a major milestone toward delivering the first targeted aldosterone synthase inhibitor treatment for uncontrolled or resistant hypertension, which could benefit millions of people affected by the conditions.

Dr Manish Saxena, Clinical Co-Director of Queen Mary University of London’s William Harvey Heart Centre and Hypertension Specialist at Barts Health NHS Trust, is the study’s lead investigator. He said:

“Despite available treatments, more than 40% of adults with hypertension worldwide are not reaching their blood pressure goal. There’s a major need to explore novel therapies for hypertension and the Launch-HTN trial addressed this need.

“Aldosterone pathway plays important role in blood pressure regulation, and leads to blood pressure related complications such as heart failure and kidney problems. In the Launch-HTN trial, we explored the safety and effectiveness of lorundostat, which belongs to a new class of drugs called aldosterone synthase inhibitors that block production of hormone aldosterone from the adrenal glands.

“The Launch-HTN trial is the largest phase 3 hypertension study with a novel drug. We tested lorundostat in a large, diverse patient population recruited globally, and found that it has a good safety profile and lowered blood pressure consistently in our patient groups. Once commercially available, lorundostat could be novel treatment option for hypertension in millions of patients worldwide.”

Hypertension affects 1 in 3 adults worldwide and increases the risk of heart disease, heart attack and stroke.

30% of people with hypertension have dysregulated aldosterone, meaning that the body’s natural mechanism for controlling aldosterone is disrupted. Increased aldosterone levels can cause hypertension. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production.

Results

The Launch-HTN trial was a global, randomized, double-blinded, placebo-controlled Phase 3 trial, which enrolled eligible adult participants who failed to achieve their blood pressure goal despite being on two to five antihypertensive medications. Launch-HTN reflects the real-world setting for clinicians by utilizing automated office blood pressure (AOBP) measurement and allowing participants to stay on their existing medications.

Lorundrostat 50 mg dosed once daily demonstrated clinically meaningful and sustained reductions in systolic blood pressure, with a 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted) and a 19 mmHg reduction at Week 12 (-11.7mm placebo adjusted).

Reference:

Largest phase 3 trial of novel treatment for hypertension shows promising results, Queen Mary University of London, Meeting: 34th European Meeting on Hypertension and Cardiovascular Protection (ESH 2025).