Lorundrostat Secures FDA NDA Acceptance for Hypertension, Falls Short in Phase 2 OSA Trial

The US Food and Drug Administration has accepted Mineralys Therapeutics’ New Drug Application (NDA) for lorundrostat for the treatment of adult patients with hypertension in combination with other antihypertensive drugs.1

As described in a March 9, 2026, press release from the Company, the NDA was based on positive data from the phase 3 Launch-HTN and phase 2 Advance-HTN trials demonstrating favorable safety and blood pressure reduction in adults with hypertension. With the acceptance, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026.1

Mineralys additionally announced topline results from the phase 2 Explore-OSA exploratory trial showing that lorundrostat did not reduce apnea-hypopnea index (AHI) but demonstrated a clinically meaningful reduction in blood pressure and favorable safety and tolerability in overweight or obese adults with moderate-to-severe obstructive sleep apnea (OSA) and hypertension.1

“The FDA’s acceptance of our NDA for lorundrostat marks an important milestone in our efforts to address the clinically significant need faced by millions of patients living with uncontrolled or resistant hypertension,” Jon Congleton, Chief Executive Officer of Mineralys Therapeutics, said in a statement.1 “While the Explore-OSA trial did not demonstrate a reduction in AHI, the blood pressure reductions and safety profile were clinically meaningful, especially for this difficult to control population. We believe lorundrostat has the potential to become an important new treatment option for resistant and uncontrolled hypertension, and we look forward to working with the FDA as we advance toward potential approval.”

Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as chronic kidney disease and OSA. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production.1

The Company has now completed 5 successful phase 2/3 clinical trials of lorundrostat supporting the efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. This includes 2 pivotal, registrational trials, including the phase 3 Launch-HTN trial and phase 2 Advance-HTN trial.2,3

Explore-OSA was a phase 2 randomized, double-blind, placebo-controlled, crossover trial designed to evaluate the efficacy, safety, and tolerability of lorundrostat in overweight or obese adults with moderate-to-severe OSA and hypertension. Participants in Explore-OSA received 50 mg of oral, once daily (QD) lorundrostat and placebo in sequential treatment periods, with continuous monitoring of BP during overnight polysomnography.1

The primary efficacy endpoint of the trial was absolute change from baseline in AHI after 4 weeks of active treatment compared to placebo. The first secondary endpoint was AOBP, and additional endpoints were nighttime BP and sleep and cardiovascular health measures.1

Explore-OSA enrolled 48 participants with an average body mass index (BMI) of 38.2 kg/m2, an average AHI of 48.5 events/hr, and an average systolic blood pressure (BP) of 142.3 mmHg (range 131-175 mmHg). After 4 weeks of treatment, lorundrostat 50 mg dosed in the evening did not demonstrate a clinically meaningful difference relative to placebo on the AHI.1

At week 4, the trial demonstrated an 11.1 mmHg (P <.0001) and a 1.0 mmHg (P = NS) BP reduction with lorundrostat and placebo, respectively, in the pre-planned parallel arm analysis of the first period. There was a 6.2 mmHg placebo-adjusted reduction (P <.0003) in BP in the crossover analysis.1

Of note, lorundrostat demonstrated a favorable safety profile and was well tolerated, with no serum potassium excursions above 5.5 mmol/L. Analysis is ongoing for other endpoints in the trial and will be reported in future publications or medical meetings.1

References

1. Mineralys Therapeutics. Mineralys Therapeutics Announces FDA Acceptance of NDA for Lorundrostat for Treatment of Adults with Hypertension and Topline Explore-OSA Trial Results. March 9, 2026. Accessed March 9, 2026. https://www.globenewswire.com/news-release/2026/03/09/3252329/0/en/Mineralys-Therapeutics-Announces-FDA-Acceptance-of-NDA-for-Lorundrostat-for-Treatment-of-Adults-with-Hypertension-and-Topline-Explore-OSA-Trial-Results.html

2. Saxena M. Launch-HTN: Lorundrostat Proves Efficacy in Adults with Hypertension, With Manish Saxena, MBBS. HCPLive. October 23, 2025. Accessed March 9, 2026. https://www.hcplive.com/view/launch-htn-lorundrostat-proves-efficacy-in-adults-with-hypertension-with-manish-saxena-mbbs

3. Campbell P. Lorundrostat Improves Blood Pressure in Uncontrolled Hypertension. HCPLive. March 30, 2025. Accessed March 9, 2026. https://www.hcplive.com/view/lorundrostat-improves-blood-pressure-in-uncontrolled-hypertension