Mineralys Therapeutics Targets Hypertension's 'Hidden Driver' with Promising New Drug

Radnor, PA – November 10, 2025 – Mineralys Therapeutics is making waves in the cardiovascular space with lorundrostat, a novel drug designed to tackle hypertension by directly addressing aldosterone production. With millions struggling with resistant hypertension and related comorbidities, the company’s approach – focusing on a pathway increasingly recognized as a “hidden driver” of cardiovascular disease – is garnering significant attention from both investors and medical professionals.

For decades, hypertension treatment has largely revolved around traditional methods like diuretics, ACE inhibitors, and ARBs. While effective for many, a substantial population – roughly 20 million Americans – suffers from uncontrolled or resistant hypertension, leaving them vulnerable to serious complications like stroke, heart attack, and kidney failure. Mineralys believes lorundrostat could offer a much-needed solution.

A New Mechanism of Action

Lorundrostat isn’t just another blood pressure-lowering medication; it’s a highly selective aldosterone synthase inhibitor (ASI). Unlike mineralocorticoid receptor antagonists (MRAs) which block the effects of aldosterone, lorundrostat aims to prevent its production. “This upstream inhibition could be a game changer,” explains one cardiologist familiar with the research. “By stopping aldosterone at the source, we may achieve a more targeted and effective reduction in blood pressure, with potentially fewer side effects.”

The company’s Phase 2 trials have demonstrated impressive results. The LAUNCH-HTN trial showcased a significant 16.9 mmHg reduction in systolic blood pressure after six weeks, increasing to 19 mmHg at 12 weeks, with over 44% of patients reaching their target blood pressure. The ADVANCE-HTN trial, focusing on high-risk patients, showed a similarly positive trend, with 41% achieving BP goals compared to 18% on placebo.

Beyond Blood Pressure: Addressing Comorbidities

Mineralys’ strategy extends beyond simply lowering blood pressure. The company is actively investigating lorundrostat’s potential to treat comorbidities like chronic kidney disease (CKD) and obstructive sleep apnea (OSA). “We’re recognizing that hypertension isn’t always an isolated problem,” says a nephrologist following the research. “It’s often intertwined with other conditions, and addressing the underlying causes—like aldosterone dysregulation—could have cascading benefits.”

The Phase 2 Explore-CKD trial showed significant reductions in both systolic blood pressure and urinary albumin-to-creatinine ratio – a marker of kidney damage – demonstrating a potential renal protective effect. The ongoing Explore-OSA trial is evaluating lorundrostat’s impact on apnea-hypopnea index and nocturnal hypertension, potentially expanding its therapeutic reach.

A Venture Capital-Backed Bet on Innovation

The story of Mineralys is also a testament to the power of venture capital in driving pharmaceutical innovation. Founded in 2019 by Catalys Pacific, the company was built around the premise that targeting aldosterone could unlock a new era of hypertension treatment. “Catalys Pacific saw the potential early on and provided the necessary resources to translate scientific breakthroughs into a viable therapy,” explains one industry analyst.

The firm's strategy of founding and investing in companies focused on novel mechanisms of action is paying off, and Mineralys is poised to become a significant player in the cardiovascular space.

Navigating the Competitive Landscape

While lorundrostat’s mechanism of action is unique, it’s entering a crowded market. Existing hypertension treatments are well-established, and several other companies are also exploring aldosterone-targeting therapies. “The competition is fierce, but lorundrostat’s demonstrated efficacy and favorable safety profile give it a strong position,” says an industry consultant. “The key will be demonstrating long-term benefits and differentiating it from other emerging therapies.”

Furthermore, the emergence of other ASIs on the horizon will intensify the competitive pressure. Mineralys must clearly articulate the advantages of lorundrostat – perhaps through a superior side effect profile or demonstrated efficacy in specific patient populations – to maintain its market share.

What's Next?

Mineralys is preparing to submit its New Drug Application (NDA) to the FDA in late 2025 or early 2026. If approved, lorundrostat could be a game-changer for millions of patients with resistant hypertension and related conditions.

The company plans an initial launch targeting those with resistant hypertension, with subsequent expansion into comorbid populations with CKD and OSA. This strategic approach allows them to capitalize on the broader impact of their research and address a significant unmet medical need.

“The potential here is enormous,” states one cardiologist. “If lorundrostat can deliver on its promise, it could significantly improve the lives of millions and reshape the way we treat hypertension.” The results of the Explore-OSA trial, expected in early 2026, will be crucial in solidifying lorundrostat’s position and expanding its therapeutic reach. The company’s success hinges on its ability to navigate the competitive landscape, demonstrate long-term benefits, and ultimately deliver on the promise of a novel therapy for a pervasive and debilitating condition.