Hypertension: New drug shows strong results in managing blood pressure
A clinical trial has seen promising results from a new class of medication to treat hypertension. Design by MNT; Photography by Peca King/500px/Getty Images & MementoJpeg/Getty Images A novel treatment for hard-to-control high blood pressure has shown strong results in a major global clinical trial.
The Phase 3 Launch-HTN study found that lorundrostat, an aldosterone synthase inhibitor, safely and consistently lowered blood pressure in a large, diverse group of patients who had not responded to other medications.
These findings mark a significant step forward in the development of the first targeted aldosterone synthase inhibitor for these conditions.
Blood pressure refers to the force exerted by blood against the walls of the arteries.
Hypertension, or high blood pressure, happens when this force is consistently higher than normal. Hypertension impacts one in three adults globally and significantly raises the risk of heart disease, heart attacks, and strokes.
Resistant hypertension is a form of high blood pressure that remains elevated despite a person taking three different blood pressure medications at their maximum recommended doses.
Up to 15% of individuals with hypertension have abnormal regulation of aldosterone, a hormone that helps control blood pressure.
When aldosterone levels are elevated due to this dysregulation, it can lead to hypertension.
A new study, presented at the 34th European Meeting on Hypertension and Cardiovascular Protection, shows that lorundrostat — a drug that inhibits aldosterone synthase — is both safe and effective for treating individuals with uncontrolled or resistant hypertension.
The findings are yet to be published in a peer-reviewed journal.
Lorundrostat is specifically designed to lower aldosterone levels by targeting and inhibiting CYP11B2, the enzyme that drives its production.
The study demonstrated consistent reductions in blood pressure across a large and diverse group of patients and represents the largest phase three trial to date for this class of treatment.
Manish Saxena, MD, Clinical Co-Director of the William Harvey Heart Centre at Queen Mary University of London and Hypertension Specialist from Barts Health NHS Trust and the study's lead Investigator, spoke to Medical News Today .
'Despite available treatments, more than 40% of adults with hypertension worldwide are not reaching their blood pressure goal. 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.'
— Manish Saxena, MD
'The Launch-HTN trial is the largest phase 3 hypertension study with a novel drug,' Saxena explained. 'We tested lorundostat in a large, diverse patient population recruited globally and found that it has good safety profile and lowered blood pressure consistently in all of our patient groups.' How lorundrostat works
'Hormone aldosterone secreted from adrenal glands in the body plays an important role in driving blood pressure. Now there is more awareness of dysregulated aldosterone secretion in patients with difficult to treat blood pressure. Lorundrostat blocks biosynthesis of hormone aldosterone in the body and helps reduce blood pressure.'
— Manish Saxena, MD
The Launch-HTN trial was a global, Phase 3 study that was randomized, double-blind, and placebo-controlled.
It included adult participants whose blood pressure remained uncontrolled despite taking two to five antihypertensive medications.
Designed to reflect real-world clinical practice, the trial used automated office blood pressure (AOBP) measurements and allowed participants to continue their existing treatments.
Lorundrostat, administered once daily at a 50 mg dose, showed meaningful and sustained reductions in systolic blood pressure — dropping by 16.9 mmHg at Week 6 (a 9.1 mmHg reduction compared to placebo) and by 19 mmHg at Week 12 (an 11.7 mmHg reduction versus placebo).
'The LAUNCH-HTN trial demonstrated blood pressure lowering efficacy and safety of lorundrostat in a very diverse patient group with uncontrolled and difficult to treat hypertension that were on background 2-5 blood pressure lowering medication. The blood pressure reduction observed was consistent across key sub-groups, significant and clinically meaningful.'
— Manish Saxena, MD
Two experts, not involved in the study, also spoke to MNT .
Cheng-Han Chen, MD, board certified interventional cardiologist and medical director of the Structural Heart Program at MemorialCare Saddleback Medical Center in Laguna Hills, CA, noted that 'aldosterone synthase inhibitors are a new class of drugs being studied for the treatment of hypertension.'
'This trial found that lorundrostat, one of these new types of drugs, was safe and effective for patients with uncontrolled or resistant hypertension. This puts us one step closer to having another tool in our arsenal for patients with difficult to control blood pressure despite being on multiple medications,' Chen explained.
'Many patients have high blood pressure that are not under control with multiple classes of medications. By having another class of blood pressure medications at our disposal, we will better be able to reduce rates of hypertension in our population and improve health outcomes.'
— Cheng-Han Chen, MD
Rigved Tadwalkar, MD, FACC, consultative cardiologist and director of Digital Transformation Pacific Heart Institute in Santa Monica, CA told MNT that 'this is a meaningful step forward.'
'We still see far too many patients with uncontrolled or resistant hypertension, even when they're on three, four, sometimes five medications. The reality is that for a significant subset of these patients, aldosterone is driving the problem and until now, we haven't had a way to target that mechanism directly in a safe, practical way,' Tadwalkar explained.
'Lorundrostat appears to change that. It inhibits aldosterone synthesis at the enzymatic level, and based on this trial, it does so with a good safety profile and consistent efficacy across a diverse population. The blood pressure reductions– nearly 17 mmHg at 6 weeks and close to 19 mmHg at 12– are significant, especially when you consider that these were already heavily treated patients. That kind of additional drop is not something we usually see at this stage of therapy.'
— Rigved Tadwalkar, MD, FACC
'Since patients stayed on their background medications, these results feel more clinically relevant than more tightly controlled washout studies,' Tadwalkar added. 'It's a welcome addition to the field, even as we continue to see the limitations of existing therapies, including newer device-based approaches like renal denervation.'
Tadwalkar said that lorundrostat had potential to make a real difference in patients' lives.
'If lorundrostat becomes widely available, it could offer a new option for patients who've exhausted standard pathways. For people living with resistant hypertension, many of whom are already dealing with co-morbidities like kidney disease or heart failure, having another tool, especially one that targets the underlying hormonal dysregulation, could make a real difference in long-term outcomes,' he said.
Saxena said that once lorundostat becomes commercially available, it could become a novel treatment option for hypertension for many patients.
Tadwalkar continued by noting that 'at the population level, we're still facing a huge burden from poorly controlled blood pressure.' He said untreated hypertension was a major contributor to chronic diseases and cardiovascular problems.
'A drug like this, if used properly, could help narrow that treatment gap. It's certainly not a silver bullet, but it's a step toward more personalized, mechanism-specific care. This is something the hypertension field has needed for a long time.'
— Rigved Tadwalkar, MD, FACC
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