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JAN 9 2027
UPCOMING · 220 DAYS TO PDUFA

Mineralys Therapeutics lorundrostat $MLYS

for uncontrolled hypertension (add-on therapy)

NDA · Standard Review

Accepted MAR 9 2026.

About

Uncontrolled hypertension is a persistent form of high blood pressure that resists standard treatments, increasing the risk of heart attacks, strokes, and kidney damage. Lorundrostat blocks aldosterone synthase, an enzyme that drives excess production of the hormone aldosterone, which stiffens blood vessels and retains salt. By reducing aldosterone levels, the drug may help lower blood pressure in patients who don’t respond adequately to existing medications.

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