Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which focuses on developing medicines to target diseases driven by abnormally elevated aldosterone. Its clinical-stage product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that are initially developing for the treatment of cardiorenal conditions affected by abnormally elevated aldosterone, including hypertension and chronic kidney disease. The company was founded by Brian Taylor Slingsby on May 31, 2019 and is headquartered in Radnor, PA.
Clinical Trials
10
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2020
Active, not recruiting
2
20.0%
Completed
6
60.0%
Recruiting
2
20.0%
No approval data available
- Mineralys Therapeutics' Phase 3 Launch-HTN trial of lorundrostat was selected as one of nine most impactful studies of 2025 by JAMA editors for its breakthrough approach to treatment-resistant hypertension. - The trial demonstrated that lorundrostat 50 mg once daily achieved significant systolic blood pressure reductions of 16.9 mmHg at Week 6 and 19.0 mmHg at Week 12 when added to existing treatments. - Lorundrostat offers a novel mechanism by inhibiting aldosterone synthase enzyme production rather than blocking hormone receptors, potentially benefiting up to 40% of hypertension patients with uncontrolled disease. - The drug showed favorable safety profile with discontinuation rates below 1% despite some increased occurrence of hyponatremia, hyperkalemia, and reduced kidney function.
- Precigen received FDA approval for Papzimeos, the first and only treatment for recurrent respiratory papillomatosis, a rare disease affecting an estimated 27,000 patients in the US. - In clinical trials, 18 out of 35 patients treated with Papzimeos avoided tumor removal surgery for at least 12 months, with 15 patients remaining surgery-free at 24 months. - The cell-based immunotherapy is priced above $200,000 per patient annually and could generate over $1 billion in peak annual sales. - Precigen's stock surged 155% following the approval, with analysts maintaining positive outlooks despite the company's current $1.3 billion market cap.
- Cleveland Clinic-led clinical trial demonstrates lorundrostat, an aldosterone synthase inhibitor, reduced systolic blood pressure by 8 points more than placebo in patients with uncontrolled hypertension. - The 12-week Advance-HTN trial included 285 participants with 53% being Black Americans, a population that carries disproportionately high risk for hypertension complications. - Lorundrostat represents a new class of blood pressure medications that directly reduces aldosterone production, potentially offering treatment options for the 30-40% of patients whose hypertension remains uncontrolled with current therapies.
- Mineralys Therapeutics has priced its public offering at $13.50 per share, raising approximately $175 million to fund the clinical development of lorundrostat, its aldosterone synthase inhibitor. - The biopharmaceutical company is targeting multiple conditions driven by dysregulated aldosterone, including hypertension, chronic kidney disease (CKD), and obstructive sleep apnea (OSA). - The offering, expected to close around March 13, 2025, includes an option for underwriters to purchase an additional 1.94 million shares within 30 days.
- Mineralys Therapeutics' lorundrostat receives FDA clearance for a Phase 2 trial targeting obstructive sleep apnea (OSA) in hypertensive patients. - The trial aims to assess lorundrostat's efficacy in reducing upper airway obstruction and nocturnal hypertension in moderate-to-severe OSA. - The Phase 2 study is set to commence in Q1 2025, evaluating 50mg of lorundrostat daily in approximately 40 participants. - Mineralys' Explore-CKD Phase 2 trial, evaluating lorundrostat for hypertension in CKD patients with albuminuria, has completed enrollment.
• Mineralys Therapeutics completed enrollment in the pivotal Advance-HTN trial for uncontrolled or resistant hypertension, with topline data expected in March 2025. • The company also completed enrollment ahead of schedule in the Phase 3 Launch-HTN trial, anticipating topline data in the first half of 2025. • Enrollment is ongoing in the Explore-CKD Phase 2 trial, which is evaluating lorundrostat in patients with hypertension and Stage 2 to 3b chronic kidney disease, with topline data expected in Q2 2025.
• Mineralys Therapeutics completed enrollment in the Launch-HTN trial, a Phase 3 study evaluating lorundrostat for uncontrolled or resistant hypertension, ahead of schedule. • The Launch-HTN trial is a randomized, double-blinded, placebo-controlled study assessing the efficacy and safety of lorundrostat in adult participants on multiple antihypertensive medications. • Topline data from the Launch-HTN trial, which models real-world treatment in the primary care setting, is now expected in mid first half of 2025. • Lorundrostat is a selective aldosterone synthase inhibitor being developed for hypertension and chronic kidney disease, targeting dysregulated aldosterone levels.
