Pathalys Pharma reports Phase 3 trial results for upacicalcet
Pathalys Pharma announced that its investigational treatment upacicalcet met primary endpoints in two Phase 3 clinical trials for patients with end-stage kidney disease.
Pathalys Pharma presented data from the PATH-1 and PATH-2 Phase 3 clinical trials at the American Society of Nephrology Kidney Week 2026. The studies evaluated the efficacy of upacicalcet in managing secondary hyperparathyroidism (SHPT) in patients undergoing hemodialysis.
According to the trial results, the drug successfully met primary and key secondary endpoints, demonstrating a reduction in parathyroid hormone (PTH) levels. The study also observed a decrease in fibroblast growth factor 23 (FGF23) and markers associated with bone turnover in the patient population.
Secondary hyperparathyroidism is a common complication for individuals with end-stage kidney disease, often requiring precise hormonal management to prevent bone and mineral disorders. These findings provide clinical data on the drug's performance compared to existing therapeutic standards.
The company is expected to utilize these late-stage trial results to support future regulatory filings. No timeline for a formal submission to the FDA was provided in the initial announcement.