USFDAMay 12, 2026, 07:32 AM
BridgeBio Submits NDA for Encaleret in ADH1 After Positive Phase 3 Results
AI Summary
BridgeBio Pharma submitted a New Drug Application (NDA) to the FDA for encaleret, a potential targeted treatment for autosomal dominant hypocalcemia type 1 (ADH1). This follows successful Phase 3 CALIBRATE trial results, where encaleret met all primary and key secondary efficacy endpoints, demonstrating rapid and durable benefits. If approved, encaleret could be the first specific therapy for ADH1, with a U.S. launch anticipated in early 2027. The company also plans to submit an MAA to the EMA in H2 2026 and initiate a Phase 3 study for chronic hypoparathyroidism in Summer 2026.
Key Highlights
- BridgeBio submitted New Drug Application (NDA) to FDA for encaleret for autosomal dominant hypocalcemia type 1 (ADH1).
- Phase 3 CALIBRATE trial met all primary and key secondary efficacy endpoints for encaleret in ADH1.
- 76% of encaleret participants achieved target serum and urine calcium levels vs. 4% on conventional therapy (p<0.0001).
- Encaleret restored endogenous parathyroid hormone in 91.1% of participants vs. 0% on standard of care at Week 24.
- Anticipates U.S. launch of encaleret in early 2027, potentially as the first approved ADH1 therapy.
- Plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in H2 2026.
- Intends to initiate RECLAIM-HP Phase 3 study for encaleret in chronic hypoparathyroidism in Summer 2026.