Mineralys Targets Sleep Apnea and Hypertension With Lorundrostat: What Investors Should Watch

Mineralys Therapeutics, Inc. (MLYS) announced an update on their ongoing clinical study.

Mineralys Therapeutics (MLYS) has completed a Phase 2 study titled “A 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.” The study set out to see if lorundrostat, an oral drug in development, can improve sleep apnea severity and blood pressure in patients who have both obstructive sleep apnea and hypertension. This update matters for investors because it tests whether Mineralys can expand lorundrostat beyond blood pressure into a larger, sleep‑related market.

The trial tested lorundrostat tablets taken once daily, compared with a matching placebo tablet. Lorundrostat is a drug designed to help control blood pressure by targeting hormonal pathways that drive high blood pressure. In this study, the goal was to see if the same mechanism could also reduce events of blocked or shallow breathing during sleep, measured by the Apnea‑Hypopnea Index (AHI).

The study used a simple but rigorous design. Participants were randomly assigned to one of two sequences: lorundrostat followed by placebo, or placebo followed by lorundrostat. This “crossover” setup means each patient served as their own control at different times, which can give cleaner signals on drug effect with fewer patients. The trial was double‑blind, so neither the patients nor their care providers knew which treatment was given at any point. The main goal was treatment focused: to check whether lorundrostat can safely reduce sleep apnea events and support better blood pressure control.

The study was first submitted on January 16, 2025, marking the official launch of the program in this new indication. The trial status is now listed as completed, signaling that patient dosing and follow‑up have finished and data are being analyzed. The most recent update was posted on January 12, 2026, which is important for investors because it confirms the timing of data readouts and potential news flow. No results have been posted yet, so the market is still waiting for clarity on efficacy and safety in this setting.

For investors, this update signals that Mineralys is moving lorundrostat into a broader cardio‑metabolic space that includes sleep apnea, a large and under‑treated segment. Positive data could support a premium valuation for MLYS by adding a second major use case on top of resistant hypertension and may strengthen the company’s position against larger cardiovascular players exploring sleep apnea, such as firms developing GLP‑1 drugs or other blood‑pressure agents. If results show meaningful improvements in both AHI and blood pressure with a clean safety profile, sentiment could turn more bullish and drive interest from partners or acquirers. On the other hand, weak or mixed data would likely pressure the stock in the near term, as investors reassess the size of lorundrostat’s overall opportunity. The study is now completed and recently updated, with further details and future result postings available on the ClinicalTrials.gov portal.

To learn more about MLYS’s potential, visit the Mineralys Therapeutics, Inc. drug pipeline page.