Encaleret Increased Bone Turnover and Improved Participant-Reported Symptoms in the Phase 3 CALIBRATE Trial in ADH1
BridgeBio presented Phase 3 CALIBRATE data showing encaleret restored endogenous PTH secretion in 91% of ADH1 participants and increased bone turnover markers versus standard of care. Patient-reported outcomes strongly favored encaleret: 100% of treated participants reported improvement in at least one ADH1 symptom versus 46% on standard of care, with gains in fatigue, muscle cramps, brain fog and daily functioning. The FDA has accepted the encaleret NDA in ADH1 with Priority Review and a PDUFA date of May 8, 2027, and an MAA has been submitted to the EMA.
Key figures
- Drug Name
- encaleret
- Phase Of Trial
- Phase 3
- Pdufa date
- May 8, 2027
- Reclaim hp enrollment
- approximately 160 participants
- Symptom improvement soc
- 46%
- Symptom improvement encaleret
- 100%
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