Encaleret

Encaleret is an oral calcium-sensing receptor antagonist developed by BridgeBio Pharma for autosomal dominant hypocalcemia type 1 (ADH1). The next event is the FDA decision on Encaleret, on May 8, 2027 (source).

Company: BridgeBio Pharma (BBIO) · Developer
How it works: Calcium-sensing receptor antagonist (calcilytic)
Approved: Not approved in any market we track

Development by disease

Autosomal dominant hypocalcemia type 1

Filed

Upcoming events

Firm dates · a specific day set by the company or regulator

Later

May 8
in 207 days
Encaleret · FDA decision · Autosomal dominant hypocalcemia type 1
BridgeBio Pharma (BBIO)·Source
May 8
in 207 days
Encaleret · FDA decision · ADH1
BridgeBio Pharma (BBIO)·Source

Past results and milestones

Oct 11, 2026
BridgeBio has submitted a Marketing Authorization Application to the EMA for encaleret in ADH1. Source
Aug 10, 2026
reported
BridgeBio submitted the encaleret NDA to the FDA for ADH1, which was accepted with Priority Review designation granted and a PDUFA target action date set for May 8, 2027. Source
May 7, 2026
reported
CALIBRATE Phase 3 study achieved primary success with 76% of participants achieving calcium targets. Study confirmed enrollment completion with approximately 95% of randomized participants entered into long-term extension. Source

Trials

CALIBRATE RECLAIM-HP

The investment thesis, what each upcoming event depends on and the competitive landscape are on the BridgeBio Pharma page. Upcoming FDA decisions · All drugs