Lorundrostat lowers blood pressure by 9.6 mmHg in kidney disease patients in post hoc analysis
Key Facts
Mineralys Therapeutics presented results from a post hoc analysis of a lorundrostat trial showing a reduction in systolic blood pressure in patients with chronic kidney disease, as its application for approval to treat hypertension remains under review. The placebo-adjusted reduction in this group was 9.6 mmHg at week 12, according to the company's announcement of data from the Launch-HTN trial. By comparison, the reduction was 12.2 mmHg among participants without chronic kidney disease over the same period. The company announced these figures on May 30, 2026, and later announced the presentation of trial data at the American Society of Nephrology's Kidney Week conference. The analysis included 800 participants, including 192 with chronic kidney disease, according to Investing's coverage.
The findings examined differences by kidney disease status in a post hoc analysis of the Phase 3 trial, which was primarily designed to assess the drug's effect on blood pressure. Its primary endpoint was the change in automated office systolic blood pressure from baseline versus placebo after 6 weeks, according to the company's annual report filed with the U.S. Securities and Exchange Commission. On albuminuria, Investing's coverage of the company's presentation at the Stifel forum reported a reduction of about 52% among participants with elevated levels at the start of the study. This finding also came from a post hoc analysis, presented at the European Society of Hypertension meeting. The results of this analysis thus focused on participants with elevated albuminuria at baseline, while the change in blood pressure remained the trial's prespecified primary endpoint.
Lorundrostat aims to lower levels of the hormone aldosterone by inhibiting the enzyme responsible for its production, according to Mineralys' disclosure filed with the U.S. Securities and Exchange Commission. The company previously tested the drug in the Explore-CKD study, which included measuring the urine albumin-to-creatinine ratio. In that study, the placebo-adjusted reduction in the ratio was 25.6%. The result was recorded after 4 weeks of treatment, according to the company's disclosure of the earlier results. As investors assessed Mineralys shares ahead of the anticipated regulatory date, UBS initiated coverage with a neutral rating in October 2026. The bank set a price target of $29 per share, according to Investing.
On the regulatory front, the U.S. Food and Drug Administration has already accepted the new drug application for lorundrostat, according to Mineralys' quarterly report filed with the U.S. Securities and Exchange Commission. The application covers treatment of adults with hypertension in combination with other blood pressure-lowering drugs. Meanwhile, the Transform-HTN open-label extension study continues to provide treatment to participants. The company said the study aims to "collect additional long-term safety and efficacy data." The U.S. agency set December 22, 2026, as the target date for regulatory action on the application.