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Lorundrostat lowered blood pressure and kidney damage in high-risk patients, with results supporting an FDA submission by early 2026.
Clinical data from the Phase 2 Explore-CKD and Phase 3 Launch-HTN trials presented at Kidney Week 2025 show lorundrostat, a drug by Mineralys Therapeutics, significantly reduced blood pressure and albuminuria in patients with uncontrolled hypertension and chronic kidney disease.
The drug, when added to standard therapy including SGLT2 inhibitors, met its primary endpoint with a 9.3 mmHg systolic blood pressure reduction and a 25.6% decrease in albuminuria at four weeks.
It demonstrated a favorable safety profile and sustained effects up to 12 weeks.
Results across trials support its potential in diverse high-risk groups, including those with resistant hypertension, obesity, and Black or African American participants.
Mineralys plans to file a New Drug Application with the FDA in late 2025 or early 2026.
Lorundrostat redujo la presión arterial y el daño renal en pacientes de alto riesgo, con resultados que respaldan una presentación a la FDA a principios de 2026.