Drugs / Encaleret
Encaleret
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | autosomal dominant hypocalcemia 1 | 2026-05-12 | “today announced the submission of its New Drug Application (NDA) to the FDA for encaleret as a potential targeted treatment for autosomal dominant hypocalcemia type 1 (ADH1)” bridgebio.com ↗ |
Trials 7
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-07-22 | Eidos Therapeutics, a BridgeBio company | Regulatory BridgeBio Announces FDA Acceptance of NDA for Encaleret for ADH1 bridgebio.com ↗
BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced the FDA has accepted for filing its New Drug Application (NDA) for encaleret for the treatment of individuals living with autosomal dominant hypocalcemia type 1 (ADH1). |
| 2026-05-12 | Eidos Therapeutics, a BridgeBio company | Regulatory BridgeBio Submits NDA to FDA for Encaleret for Individuals Living with ADH1 bridgebio.com ↗
today announced the submission of its New Drug Application (NDA) to the FDA for encaleret |
| 2023-10-10 | Eidos Therapeutics, a BridgeBio company | Results bridgebio pharma announces new england journal of medicine publication of positive encaleret proof-of-concept phase 2b results in patients with autosomal dominant hypocalcemia type 1 (adh1) bridgebio.com ↗
In our study, encaleret restored physiologic mineral homeostasis in 13 participants with ADH1, specifically correcting hypocalcemia and reducing hypercalciuria |
| 2021-06-01 | Eidos Therapeutics, a BridgeBio company | Regulatory bridgebio pharma receives fda fast track designation for encaleret for the treatment of autosomal dominant hypocalcemia type 1 bridgebio.com ↗ |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-22 | Eidos Therapeutics, a BridgeBio company | BridgeBio Announces FDA Acceptance of NDA for Encaleret for ADH1 bridgebio.com ↗ |
| 2026-05-12 | Eidos Therapeutics, a BridgeBio company | BridgeBio Submits NDA to FDA for Encaleret for Individuals Living with ADH1 bridgebio.com ↗ |
| 2023-10-10 | Eidos Therapeutics, a BridgeBio company | bridgebio pharma announces new england journal of medicine publication of positive encaleret proof-of-concept phase 2b results in patients with autosomal dominant hypocalcemia type 1 (adh1) bridgebio.com ↗ |
| 2021-06-01 | Eidos Therapeutics, a BridgeBio company | bridgebio pharma receives fda fast track designation for encaleret for the treatment of autosomal dominant hypocalcemia type 1 bridgebio.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | encaleret | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05735015 ↗ |
| Known as | ENCALERET SULFATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1672973 ↗ |
| Known as | Jit-305 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1672973 ↗ |
| Known as | JTT-305 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1672973 ↗ |
| Known as | MK-5442 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00996801 ↗ |
| Action | Inhibit | “calcium-sensing receptor antagonist” PMID 25166719 ↗ Aug 2014 |
| Modality | Small molecule | — CHEMBL1672973 ↗ |
| Route | Oral | “administered daily oral MK-5442” PMID 25166719 ↗ Aug 2014 |