Mineralys Therapeutics’ Hypertension Drug Achieves Breakthrough in Major Phase 3 Trial
Mineralys Therapeutics (NASDAQ: MLYS) has unveiled compelling results from its Phase 3 Launch-HTN clinical trial for lorundrostat, positioning the novel aldosterone synthase inhibitor as a potential game-changer in treating resistant hypertension. The study of over 1,000 patients demonstrated:
- 16.9 mmHg systolic blood pressure reduction at Week 6 (-9.1 mmHg vs placebo)
- 19.0 mmHg reduction sustained through Week 12 (-11.7 mmHg vs placebo)
The trial’s real-world design allowed participants to maintain existing antihypertensive regimens (2-5 medications), with only 0.1% reporting treatment-related serious adverse events. This marks lorundrostat’s second successful pivotal trial following results published in The New England Journal of Medicine. Analysts suggest the compound could capture a $10B+ market opportunity in difficult-to-treat hypertension cases.
Market Catalysts
- Week 12 placebo-adjusted reduction exceeds FDA’s 5-7 mmHg benchmark for approval
- Clean safety profile may support first-line use potential
- Patent protection extends through 2041 with Hatch-Waxman provisions
Considerations
- Hyperkalemia rates (0.6-1.1%) require monitoring in real-world use
- Competitive landscape includes emerging RNAi therapies from Big Pharma
Strategic Implications
Lorundrostat emerges as first targeted hypertension therapy addressing root aldosterone dysfunction with dual Phase 3 validation.
The 1,000+ participant trial demonstrated clinically meaningful blood pressure control in patients typically requiring multiple medications. By selectively inhibiting aldosterone synthesis while avoiding cortisol pathway disruption, lorundrostat achieves what analysts call “precision hypertension management.”
Notably, the 19.0 mmHg absolute reduction at Week 12 translates to an estimated 20-40% reduction in cardiovascular event risk. With regulatory submission expected Q1 2026, Mineralys could capture first-mover advantage in the $33B global hypertension market. The company’s $1.2B market cap suggests significant upside potential given comparable cardiovascular drug valuations of 5-7x peak sales.
05/24/2025 – 04:30 AM
Late-breaking data presented at ESH 2025 positions lorundrostat as potential first-in-class therapy for 30M+ resistant hypertension patients globally.
NASDAQ:MLYS
Key Metrics
Market Cap: $1.2B
52-Week Range: $8.50 – $24.75
Institutional Ownership: 87%
Pipeline: Phase 3-ready CKD/OSA programs
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