BridgeBio Pharma Reports Positive Phase 3 Results for Encaleret in ADH1

BridgeBio Pharma, Inc. announced positive topline results from its global Phase 3 CALIBRATE study of encaleret, an investigational treatment for autosomal dominant hypocalcemia type 1 (ADH1). The study met all pre-specified primary and key secondary efficacy endpoints. The primary endpoint showed that 76% of participants achieved both serum and urine calcium within target ranges at Week 24 compared to 4% on conventional therapy. A key secondary analysis revealed that 91% of participants achieved intact PTH above the lower limit of the reference range at Week 24. Encaleret was well-tolerated with no discontinuations related to the study drug. BridgeBio plans to submit a New Drug Application (NDA) in the first half of 2026 and initiate registrational studies in chronic hypoparathyroidism and pediatric ADH1 in 2026. The results indicate the potential for encaleret to become a new standard of care for ADH1 patients.