The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
JAN 9 2027
UPCOMING · 162 DAYS TO PDUFA

Mineralys Therapeutics lorundrostat $MLYS

for uncontrolled hypertension (add-on therapy)

NDA · Standard Review

Accepted MAR 9 2026.

About

Uncontrolled hypertension is persistently high blood pressure that raises the risk of heart attack, stroke, and kidney disease despite medication. Lorundrostat is an oral drug that selectively blocks the enzyme aldosterone synthase, which the body uses to produce the hormone aldosterone. By reducing aldosterone levels, the drug may help lower blood pressure in people whose condition is not managed by other therapies.

Pivotal trial

NCT06153693 Phase 3 completed NCT06153693

This is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications.

Source: ClinicalTrials.gov

Also in development