FDA accepts BridgeBio NDA for encaleret to treat ADH1

BridgeBio Pharma (Nasdaq: BBIO) announced that the U.S. Food and Drug Administration has accepted for filing its New Drug Application for encaleret, an investigational oral treatment for autosomal dominant hypocalcemia type 1 (ADH1), a genetic form of hypoparathyroidism.

The FDA assigned a PDUFA target action date of May 8, 2027. The agency also notified BridgeBio that it does not currently plan to hold an advisory committee meeting to discuss the application.

Encaleret is a small molecule designed to selectively modulate the calcium-sensing receptor. The drug has received Fast Track Designation and Orphan Drug Designation in the U.S., European Union, and Japan. If approved, BridgeBio claims it would be the first therapy specifically indicated for ADH1.

The NDA is supported by results from CALIBRATE, a Phase 3 clinical trial in which encaleret met all pre-specified primary and key secondary efficacy endpoints. Trial data showed simultaneous restoration of blood and urine calcium levels and restoration of physiologic parathyroid hormone production.

BridgeBio also said it plans to submit a Marketing Authorization Application to the European Medicines Agency for encaleret in ADH1 in the second half of 2026.

The company is currently enrolling CALIBRATE-PEDS, a Phase 2/3 registrational study of encaleret in pediatric ADH1, and plans to initiate RECLAIM-HP, a Phase 3 study of encaleret in chronic hypoparathyroidism, later this summer.

According to claims data cited by BridgeBio, more than 2,100 individuals in the U.S. have been diagnosed with ADH1 since October 2023 as of April 2026.

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