Clinical TrialMay 30, 2026, 11:16 AM
Mineralys Lorundrostat shows BP, albuminuria reduction in CKD
AI Summary
Mineralys Therapeutics presented new clinical data for lorundrostat from a post hoc analysis of its pivotal Phase 3 Launch-HTN trial. The analysis showed statistically significant and clinically meaningful reductions in blood pressure in participants with chronic kidney disease (CKD), comparable to non-CKD participants. Additionally, lorundrostat significantly reduced urine albumin-to-creatinine ratio (UACR) in CKD participants with baseline albuminuria and demonstrated a favorable safety profile. The drug is currently under FDA review with a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026.
Key Highlights
- Lorundrostat reduced SBP by 9.6 mmHg in CKD participants (p=0.0022) and 12.2 mmHg in non-CKD (p<0.0001).
- 44% of CKD and 48% of non-CKD participants achieved SBP <130 mmHg with lorundrostat vs. placebo.
- Lorundrostat achieved a 52.2% placebo-adjusted reduction in UACR in CKD patients (p<0.0001).
- Confirmed hyperkalemia rates were low: 2.4% in CKD and 0% in non-CKD participants.
- Lorundrostat is under FDA review with a PDUFA target date of December 22, 2026.
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