USFDAMay 13, 2026, 04:08 PM
BridgeBio Submits NDA to FDA for Encaleret for ADH1
AI Summary
BridgeBio Pharma, Inc. announced the submission of a New Drug Application (NDA) to the FDA for encaleret, a potential targeted treatment for autosomal dominant hypocalcemia type 1 (ADH1). The submission is supported by positive Phase 3 CALIBRATE trial results, which met all primary and key secondary efficacy endpoints, demonstrating rapid and durable benefits. If approved, encaleret could be the first therapy specifically indicated for ADH1, with a U.S. launch anticipated in early 2027. The company also plans to submit an MAA to the EMA in the second half of 2026 and initiate a Phase 3 study for chronic hypoparathyroidism in Summer 2026.
Key Highlights
- BridgeBio submitted NDA to FDA for encaleret for autosomal dominant hypocalcemia type 1 (ADH1).
- Phase 3 CALIBRATE trial met all primary and key secondary efficacy endpoints.
- 76% of encaleret participants achieved target serum and urine calcium vs. 4% on conventional therapy (p<0.0001).
- Encaleret restored endogenous parathyroid hormone in 91.1% of participants at Week 24.
- Anticipated U.S. launch for encaleret in early 2027.
- Company plans to submit Marketing Authorization Application (MAA) to EMA in H2 2026.
- BridgeBio intends to initiate RECLAIM-HP Phase 3 study for chronic hypoparathyroidism in Summer 2026.
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