FDA Accepts BridgeBio Encaleret NDA for ADH1

Key Takeaways

• FDA accepted BridgeBio's NDA for encaleret in ADH1 with a May 8, 2027 PDUFA date; no AdComm currently planned.
• Phase 3 CALIBRATE (NCT05680818) met all pre-specified primary and key secondary endpoints, per the company.
• Encaleret is an oral negative modulator of the calcium-sensing receptor with Fast Track and multi-region Orphan Drug designations.
• Pediatric CALIBRATE-PEDS (NCT07080385) is enrolling; RECLAIM-HP in chronic hypoparathyroidism is planned for later summer 2026.

Encaleret at a glance

Field	Detail
Drug	Encaleret (oral CaSR negative modulator)
Company	BridgeBio Pharma, Inc.
FDA action	NDA accepted for filing; PDUFA May 8, 2027
Indication sought	Autosomal dominant hypocalcemia type 1 (ADH1)
Adult pivotal	CALIBRATE Phase 3 (NCT05680818)
Pediatric	CALIBRATE-PEDS Phase 2/3 (NCT07080385)
AdComm	FDA not currently planning a meeting (per company)

What did the FDA accept?

BridgeBio said the FDA accepted for filing an NDA for encaleret in people living with ADH1 and assigned a Prescription Drug User Fee Act target action date of May 8, 2027. The company also said FDA notified it that an advisory committee meeting is not currently planned.

Full company details are in BridgeBio's July 22 GlobeNewswire NDA acceptance release.

What is ADH1 and why does it matter?

ADH1 is a genetic form of hypoparathyroidism driven by gain-of-function variants in the calcium-sensing receptor gene (CASR). Patients typically have hypocalcemia, hypercalciuria, and inappropriately low PTH, with risks that include tetany, seizures, nephrocalcinosis, kidney stones, and kidney failure.

BridgeBio cited claims data showing more than 2,100 U.S. individuals diagnosed with autosomal dominant hypocalcemia since October 2023 as of April 2026, arguing diagnostic suspicion is rising.

What did CALIBRATE show?

BridgeBio said Phase 3 CALIBRATE achieved all pre-specified primary and key secondary efficacy endpoints and supported a disease-modifying profile by targeting the genetic cause of ADH1. Additional presentations at ECE 2026 and ENDO 2026 reportedly showed simultaneous restoration of blood and urine calcium and restoration of physiologic PTH production without the need for calcium and vitamin D supplements, with a favorable safety and tolerability profile.

Adult trial registration: ClinicalTrials.gov NCT05680818 (CALIBRATE).

What expansion studies are underway?

• CALIBRATE-PEDS (NCT07080385) is a global registrational Phase 2/3 study in pediatric ADH1, currently enrolling.
• RECLAIM-HP, a global Phase 3 study in chronic hypoparathyroidism, is planned to start later this summer, building on Phase 2 proof-of-concept renal calcium-handling data.
• An EMA Marketing Authorization Application for ADH1 is planned for the second half of 2026.

Encaleret has Fast Track Designation from FDA and Orphan Drug Designation in the U.S., EU, and Japan, per the company.

What remains uncertain?

NDA acceptance is not approval. Exact primary-endpoint effect sizes, adverse-event frequencies, and labeled dosing will come from the FDA action package and prior topline materials, not the acceptance wire alone. BridgeBio's "potential blockbuster" framing is a commercial projection, not a clinical endpoint. Pediatric and hypoparathyroidism indications are still investigational programs.

Related NovaPharma coverage

• FDA expands Tzield to certain pediatric patients with recent Stage 3 T1D
• FDA approves Merck oral PCSK9 drug
• Compounded GLP-1s Why doctors worry and FDA acts

Frequently Asked Questions

Primary Sources

1. GlobeNewswire: BridgeBio — encaleret NDA acceptance for ADH1 — July 22, 2026
2. ClinicalTrials.gov: CALIBRATE (NCT05680818)
3. ClinicalTrials.gov: CALIBRATE-PEDS (NCT07080385)