Mineralys Therapeutics Secures FDA Acceptance Of NDA For Lorundrostat, Setting PDUFA Date For December 22, 2026

Mineralys Therapeutics, Inc., a company developing therapies for hypertension and related conditions such as chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other diseases linked to dysregulated aldosterone, announced that the U.S. Food and Drug Administration has accepted its New Drug Application (NDA) for lorundrostat. The treatment is intended for adults with hypertension and is designed to be used alongside other antihypertensive medications. The agency has set a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026.

Commenting on the news, Jon Congleton, Chief Executive Officer of Mineralys Therapeutics, said the acceptance of the NDA marks a meaningful step forward in addressing the needs of patients dealing with uncontrolled or resistant hypertension. He acknowledged that the Explore-OSA trial did not show an improvement in the apnea-hypopnea index (AHI), but noted that the blood pressure reductions observed in the study, along with the safety results, were encouraging for a patient group that is often difficult to treat. He added that lorundrostat has the potential to become a valuable treatment option for these individuals and that the company looks forward to continuing its work with the FDA.

The Explore-OSA study was conducted as a Phase 2 exploratory trial to evaluate lorundrostat in patients living with obstructive sleep apnea and elevated blood pressure. A total of 48 participants were enrolled, and they presented with an average body mass index (BMI) of 38.2 kg/m², an average apnea-hypopnea index (AHI) of 48.5 events per hour, and an average systolic blood pressure (BP) of 142.3 mmHg, with values ranging between 131 and 175 mmHg.

Participants received a 50 mg evening dose of lorundrostat for four weeks. At the end of the treatment period, the study did not find a clinically meaningful difference in AHI compared with placebo, which served as the primary endpoint. However, the trial did show notable effects on blood pressure. By week four, patients taking lorundrostat achieved an 11.1 mmHg reduction in systolic blood pressure (p < 0.0001), while the placebo group showed a 1.0 mmHg reduction (p = NS) in the planned parallel-arm analysis of the first study period. The crossover portion of the study further demonstrated a 6.2 mmHg placebo-adjusted reduction (p < 0.0003).

Lorundrostat also demonstrated a favorable safety profile. It was well tolerated by participants, and no cases of serum potassium levels exceeding 5.5 mmol/L were observed. Mineralys Therapeutics is currently completing further analysis of additional study endpoints, and more detailed results are expected to be shared through upcoming publications or scientific meetings.