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Encaleret

Alternative Names: encaleret, mk-5442, mk5442, mk 5442, CLTX-305, CLTX305, CLTX 305
Latest Update: 2024-11-19
Latest Update Note: Clinical Trial Update

Product Description

Mechanisms of Action: CaSR Antagonist

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: Fast Track - Hypocalcemia *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Merck
Company Location: KENILWORTH NJ 07033
Company CEO: Robert M. Davis
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Encaleret

Countries in Clinic: Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Italy, Japan, Netherlands, Taiwan, United Kingdom, United States

Active Clinical Trial Count: 4

Highest Development Phases

Phase 3: Arthrogryposis|Hypocalcemia

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
jRCT2031230392

P3

Recruiting

Hypocalcemia

2028-12-15

CLTX-305-302

P3

Unknown Status

Hypocalcemia

2026-11-30

CALIBRATE

P3

Recruiting

Hypocalcemia|Arthrogryposis

2025-04-01

CLTX-305-201

P2

Completed

Arthrogryposis|Hypocalcemia

2023-09-07

Recent News Events

Date

Type

Title

04/01/2024

PubMed

 Treatment of Hypoparathyroidism by Re-Establishing the Effects of Parathyroid Hormone.

02/17/2024

PubMed

 In vivo treatment with calcilytic of CaSR knock-in mice ameliorates renal phenotype reversing downregulation of the vasopressin-AQP2 pathway.

10/10/2023

News Article

 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)

09/28/2023

PubMed

 Efficacy and Safety of Encaleret in Autosomal Dominant Hypocalcemia Type 1.

06/20/2023

News Article

 BridgeBio Pharma Presents Updated Six Month Results from its Phase 2 Cohort 5 Trial of Infigratinib in Achondroplasia at the Endocrine Society (ENDO) 2023 Annual Conference

06/08/2023

News Article

 BridgeBio Pharma to Present Updated Six Month Results from its Phase 2 Cohort 5 Study of Infigratinib in Achondroplasia in a Late Breaker Oral Presentation at the Endocrine Society (ENDO) 2023 Annual Conference

12/22/2022

News Article

 BridgeBio Pharma Initiates CALIBRATE, A Pivotal Phase 3 Study of Encaleret in Autosomal Dominant Hypocalcemia Type 1

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