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DEC 22 2026
UPCOMING · 84 DAYS TO PDUFA

Mineralys Therapeutics — lorundrostat $MLYS

for uncontrolled hypertension (add-on therapy)

NDA · Standard Review

Accepted MAR 9 2026.

About

Lorundrostat is a pill designed to selectively block aldosterone synthase, the enzyme your body uses to produce the hormone aldosterone. High aldosterone levels can cause the body to retain excess salt and water, raising blood pressure even when people are on multiple medications. By directly reducing aldosterone production at its source, lorundrostat may provide a new way to lower blood pressure in cases that remain difficult to control.

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