At Mineralys, we are advancing the clinical development of lorundrostat in people with aldosterone-driven hypertension and beyond.

Science Overview

Lorundrostat is a highly selective aldosterone synthase inhibitor.

Lorundrostat Clinical Trials

TRIAL

INDICATION

PHASE 1

PHASE 2

PHASE 3

TARGET-HTN

PROOF OF CONCEPT

Hypertension

COMPLETED

A randomized, double-blind, placebo-controlled, dose-ranging phase 2 trial that evaluated the efficacy, safety, and tolerability of lorundrostat in participants with uncontrolled hypertension, including treatment-resistant hypertension.

 

LAUNCH-HTN

PIVOTAL

Hypertension

COMPLETED

A randomized, double-blind, placebo-controlled, parallel-arm, multicenter, phase 3 trial that evaluated the blood pressure-lowering effects of lorundrostat in participants with uncontrolled hypertension, including treatment-resistant hypertension, taking 2-5 antihypertensive medications (one of which had to be a thiazide or thiazide-like diuretic).

ADVANCE-HTN

PIVOTAL

Hypertension

COMPLETED

A randomized, double-blind, placebo-controlled, parallel-arm, multicenter, pivotal phase 2 trial that evaluated the blood pressure-lowering effect of lorundrostat administered on a background of a standardized antihypertensive medication regimen in participants with uncontrolled hypertension, including treatment-resistant hypertension.

 

TRANSFORM-HTN

OPEN-LABEL EXTENSION*

Hypertension

ONGOING

An ongoing open-label extension study to evaluate the long-term efficacy, safety, and tolerability of lorundrostat in participants with uncontrolled hypertension, including treatment-resistant hypertension. 

EXPLORE-CKD

PROOF OF CONCEPT

Hypertension with chronic kidney disease

COMPLETED

A randomized, crossover, double-blind, placebo-controlled, phase 2 study that evaluated the efficacy and safety of lorundrostat alone and in combination with sodium-glucose cotransporter-2 inhibitors in participants with hypertension and chronic kidney disease with albuminuria.

 

EXPLORE-OSA

PROOF OF CONCEPT

Hypertension with obstructive sleep apnea

COMPLETED

A phase 2, multicenter, randomized, double-blind, placebo-controlled, crossover study that evaluated the efficacy and safety of lorundrostat in participants with moderate to severe obstructive sleep apnea and hypertension.

*Randomized treatment withdrawal substudy completed.

Science Overview

Lorundrostat is an aldosterone-reduction therapy with highly selective inhibition of aldosterone synthase.

Lorundrostat Clinical Trials

PHASE 1

PHASE 2

PHASE 3

TARGET-HTN

PROOF OF CONCEPT

Hypertension

A randomized, double-blind, placebo-controlled, dose-ranging phase 2 trial that evaluated the efficacy, safety, and tolerability of lorundrostat in adults with uncontrolled hypertension, including treatment-resistant hypertension.

ADVANCE-HTN

PIVOTAL

Hypertension

An ongoing, randomized, double-blind, placebo-controlled, parallel arm, multicenter, pivotal phase 2 trial to evaluate the blood pressure-lowering effect of lorundrostat administered on a background of a standardized antihypertensive medication regimen in adults with uncontrolled hypertension, including treatment-resistant hypertension.

LAUNCH-HTN

PIVOTAL

Hypertension

An ongoing, randomized, double-blind, placebo-controlled, parallel arm, multicenter, phase 3 trial to evaluate the blood pressure-lowering effects of lorundrostat in adults with uncontrolled hypertension, including treatment-resistant hypertension, who are taking 2-5 antihypertensive medications (one of which must be a thiazide or thiazide-like diuretic).

OPEN-LABEL EXTENSION

OPEN-LABEL EXTENSION

Hypertension

An ongoing open-label extension study to evaluate the long-term efficacy, safety, and tolerability of lorundrostat in adults with uncontrolled hypertension, including treatment-resistant hypertension. 

EXPLORE-CKD

PROOF OF CONCEPT

Hypertension

An ongoing randomized, crossover, double-blind, placebo-controlled, phase 2 study to evaluate the efficacy and safety of lorundrostat alone and in combination with sodium-glucose cotransporter-2 inhibitors in adults with hypertension and chronic kidney disease with albuminuria. 

EXPLORE-OSA

PROOF OF CONCEPT

Obstructive Sleep Apnea and 
Hypertension

An ongoing phase 2, multicenter, randomized, double-blind, placebo-controlled, crossover study to evaluate the efficacy and safety of lorundrostat in participants with moderate to severe obstructive sleep apnea and hypertension.