What is the mechanism of action of this treatment?

Calcium-sensing receptor (CaSR) antagonists like Encaleret treat hypocalcemia by inhibiting CaSR in the parathyroid gland, leading to increased secretion of parathyroid hormone (PTH). PTH raises calcium levels by enhancing kidney reabsorption, bone resorption, and intestinal absorption of calcium. Other treatments include calcium supplements and vitamin D analogs, which directly increase serum calcium and improve gut absorption. These mechanisms are crucial for hypocalcemia patients to prevent symptoms like muscle cramps, tetany, and cardiac issues, thereby improving their quality of life.

What side effects are associated with this type of intervention?

Common treatments for hypocalcemia include calcium supplements, vitamin D analogs, and parathyroid hormone analogs. Side effects of calcium supplements can include gastrointestinal issues such as constipation and, in rare cases, hypercalcemia if overdosed. Vitamin D analogs may cause hypercalcemia and hypercalciuria. Parathyroid hormone analogs can lead to nausea, joint pain, and in some cases, an increased risk of osteosarcoma. For Calcium-Sensing Receptor Antagonists like Encaleret, potential side effects may include gastrointestinal disturbances, hypercalcemia, and possible cardiovascular effects, although specific data on Encaleret's side effects are still being studied.

What prior FDA approvals exist?

The FDA has approved several treatments for hypocalcemia, primarily focusing on calcium supplements and vitamin D analogs to manage calcium levels. Notably, drugs like calcitriol (active form of vitamin D) are commonly used to enhance calcium absorption. While Encaleret, a calcium-sensing receptor antagonist, is under study, similar drugs like cinacalcet, which modulates the calcium-sensing receptor, have been approved for conditions like secondary hyperparathyroidism but not specifically for hypocalcemia. These treatments aim to maintain normal serum calcium levels in patients with calcium regulation disorders.

What other types of research exist?

Promising novel alternatives to Encaleret for hypocalcemia patients in 2024 may include other calcium-sensing receptor antagonists that are currently under investigation or have recently been approved. Additionally, therapies such as recombinant parathyroid hormone (PTH) analogs, which help regulate calcium levels, and newer formulations of vitamin D analogs that enhance calcium absorption, could be considered. It is essential to consult with a healthcare provider to determine the most appropriate treatment based on the latest clinical evidence and individual patient needs.

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Calcium-sensing receptor antagonist

Encaleret for Hypocalcemia (CALIBRATE Trial)

Phase 3

Recruiting

Research Sponsored by Calcilytix Therapeutics, Inc., a BridgeBio company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 24

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new medication called encaleret for people with a rare genetic condition known as ADH1. ADH1 causes low calcium levels, and current treatments may not be effective or safe enough. Encaleret aims to help by balancing calcium levels in the blood.

Who is the study for?

This trial is for people with a genetic variant causing hypoparathyroidism (ADH1), aged 16-18 with closed growth plates, not on certain diuretics or supplements, and meeting specific treatment criteria. Excluded are those recently on PTH treatments, had seizures or thyroid surgery, pregnant/nursing women, low Vitamin D levels, certain viral infections, or severely reduced kidney function.

What is being tested?

The study aims to compare the effectiveness and safety of encaleret against standard care in treating ADH1. Participants will receive either encaleret or the usual treatment without knowing which one they're getting to measure differences in health outcomes.

What are the potential side effects?

While the side effects of encaleret aren't detailed here, common reactions to new medications may include nausea, headaches, allergic reactions or skin rashes. The trial will monitor participants closely for any adverse effects that arise during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Responders who Achieve Both Albumin-Corrected Blood Calcium (cCa) and 24-hour Urinary Calcium (UCa) Within the Target Range

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Standard of Care (SoC)Experimental Treatment1 Intervention

Participants will continue receiving calcium supplements and/or active Vitamin D (calcitriol, alfacalcidol, falecalcitriol, etc.)

Group II: EncaleretExperimental Treatment1 Intervention

Participants will receive encaleret at a dose as needed based on calcium levels.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard of Care

2017

Completed Phase 4

~4420

Encaleret

2020

Completed Phase 2

~20

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Calcium-sensing receptor (CaSR) antagonists like Encaleret treat hypocalcemia by inhibiting CaSR in the parathyroid gland, leading to increased secretion of parathyroid hormone (PTH). PTH raises calcium levels by enhancing kidney reabsorption, bone resorption, and intestinal absorption of calcium. Other treatments include calcium supplements and vitamin D analogs, which directly increase serum calcium and improve gut absorption. These mechanisms are crucial for hypocalcemia patients to prevent symptoms like muscle cramps, tetany, and cardiac issues, thereby improving their quality of life.