Lorundrostat: A Game-Changer in Hypertension Treatment and Its Disruption Potential in the $60B Cardiovascular Drugs Market

The cardiovascular drugs market, valued at $60 billion in 2025, is poised for disruption by lorundrostat, a novel aldosterone synthase inhibitor (ASI) developed by Mineralys Therapeutics. The Phase 3 Launch-HTN trial has demonstrated lorundrostat’s ability to address unmet needs in high-risk hypertension populations, including Black/African American adults, elderly patients, and those with obesity or resistant hypertension. With statistically significant and sustained blood pressure reductions, coupled with a favorable safety profile, lorundrostat is positioned to redefine treatment paradigms and capture a growing share of the ASI market, which is projected to grow at a 7.3% CAGR through 2032 [1].

Subgroup Efficacy: Targeting High-Unmet-Need Populations

The Launch-HTN trial enrolled a diverse cohort of 1,083 patients, with 29% Black/African American, 41% aged ≥65 years, 47% women, and 63% with obesity [1]. Lorundrostat 50 mg, added to existing therapies, achieved a 16.9 mmHg reduction in systolic blood pressure (AOSBP) at Week 6, with a sustained 19.0 mmHg reduction at Week 12 [1]. These results were consistent across subgroups:
- Black/African American patients: -6.7 mmHg reduction (p < 0.0222) [1].
- Patients aged ≥75 years: -11.6 mmHg reduction [1].
- Obese patients: -9.6 mmHg reduction [1].
- Resistant hypertension: -9.0 mmHg reduction in patients on ≥3 antihypertensive medications [1].

These findings are particularly impactful given the challenges these populations face in achieving blood pressure control. For instance, Black/African American adults and older adults are disproportionately affected by hypertension and its complications, yet they often respond poorly to existing therapies [1]. Lorundrostat’s efficacy in these groups, combined with its low incidence of hyperkalemia (0.6% in treated patients vs. 0.4% on placebo) [1], positions it as a superior alternative to traditional mineralocorticoid receptor antagonists (MRAs) like spironolactone, which carry higher risks of hyperkalemia and metabolic side effects [2].

Market Dynamics: ASIs as a Disruptive Force

The ASI segment, though currently small ($225.9 million in 2025), is expanding rapidly due to its targeted mechanism of action and favorable safety profile. Osilodrostat, the only approved ASI, dominates the market with a 63.5% share, but emerging competitors like lorundrostat and baxdrostat (AstraZeneca) are challenging its position [1]. Baxdrostat recently met all endpoints in its Phase 3 trial, but lorundrostat’s robust subgroup data and broader applicability (e.g., chronic kidney disease, obstructive sleep apnea) give it a competitive edge [3].

The treatment-resistant hypertension (TRH) market, valued at $6.8 billion in 2024, is a key growth driver for ASIs. TRH affects 10–14% of hypertensive patients and remains a significant unmet need, with current therapies often failing to achieve adequate control [4]. Lorundrostat’s ability to reduce systolic blood pressure by nearly 20 mmHg in resistant populations—without the adverse effects of MRAs—positions it to capture a substantial portion of this market. A survey of 300 cardiologists and primary care physicians revealed that 95% would likely prescribe lorundrostat if approved, underscoring strong physician demand [3].

Commercialization Strategy and Market Access

Mineralys Therapeutics plans to file a New Drug Application (NDA) with the FDA between Q4 2025 and Q1 2026, with a projected 2027 launch [1]. The company’s strategy includes partnerships to maximize market penetration and a focus on real-world evidence to reinforce lorundrostat’s value proposition. Additionally, the drug’s potential in chronic kidney disease (CKD)—demonstrated by a significant reduction in urinary albumin-to-creatinine ratio (UACR) in the Phase 2 Explore-CKD trial—opens avenues for expansion into nephrology and cardiorenal care [3].

The ASI market’s projected growth to $369.6 million by 2032 [1], combined with lorundrostat’s first-mover advantage in key subgroups, suggests the drug could capture 15–20% of the TRH market within five years of launch. This would translate to annual revenues of $1–1.5 billion, assuming a $500–$750 per patient per month price point, which aligns with the pricing of other specialty hypertension therapies [5].

Conclusion: A Win-Win for Patients and Investors

Lorundrostat’s Phase 3 results, coupled with its favorable safety profile and broad applicability, make it a compelling candidate to disrupt the $60 billion cardiovascular drugs market. By addressing unmet needs in high-risk populations and outperforming existing therapies, the drug is poised to become a cornerstone treatment for resistant hypertension and related conditions. For investors, the combination of a robust clinical pipeline, strong physician adoption signals, and a growing ASI market offers a high-conviction opportunity in a sector with significant long-term growth potential.

Source:
[1] Mineralys Therapeutics Presents Subgroup Analyses of Phase 3 Launch-HTN Trial Demonstrating Efficacy and Safety of Lorundrostat in Hypertension Participants with High Unmet Medical Need [https://www.globenewswire.com/news-release/2025/09/05/3145274/0/en/Mineralys-Therapeutics-Presents-Subgroup-Analyses-of-Phase-3-Launch-HTN-Trial-Demonstrating-Efficacy-and-Safety-of-Lorundrostat-in-Hypertension-Participants-with-High-Unmet-Medical.html]
[2] Emerging Pharmacological Approaches for the Treatment of Resistant Hypertension [https://pmc.ncbi.nlm.nih.gov/articles/PMC12024671/]
[3] Mineralys Therapeutics Q2 2025 Earnings Report [https://www.marketbeat.com/earnings/reports/2025-8-12-mineralys-therapeutics-inc-stock/]
[4] Treatment Resistant Hypertension Market Set to Transform at a CAGR of 5% [https://finance.yahoo.com/news/treatment-resistant-hypertension-market-set-214600425.html]
[5] Aldosterone Synthase Inhibitors Market Poised for Growth [https://www.biospace.com/press-releases/aldosterone-synthase-inhibitors-market-poised-for-growth-expected-to-hit-usd-369-6-million-by-2032-coherent-market-insights]