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Relacorilant

Relacorilant is an investigational drug being studied in clinical trials for various conditions, primarily Cushing syndrome. It works as a glucocorticoid receptor antagonist, potentially helping to manage the effects of excess cortisol in the body. This article summarizes key information about ongoing clinical trials evaluating Relacorilant’s safety, efficacy, and potential applications.

Table of Contents

What is Relacorilant?

Relacorilant is an investigational drug being developed to treat several medical conditions. It is also known by the names CORT125134 and CORT-125134[1][2]. Relacorilant comes in the form of capsules that are taken by mouth[3].

How Does Relacorilant Work?

Relacorilant works by blocking the effects of cortisol, a hormone produced by the body in response to stress. Specifically, it is a glucocorticoid receptor antagonist, which means it prevents cortisol from binding to and activating its receptor[3]. By doing this, Relacorilant can help reduce the harmful effects of having too much cortisol in the body.

What Conditions Does Relacorilant Treat?

Relacorilant is being studied as a treatment for several conditions, including:

  • Cushing’s syndrome: A disorder caused by having too much cortisol in the body for long periods. This can lead to weight gain, high blood pressure, diabetes, and other health problems[4].
  • Adrenocortical carcinoma: A rare cancer of the adrenal glands that can produce excess cortisol[5].
  • Prostate cancer: Relacorilant is being studied in combination with other drugs for treating advanced prostate cancer[2].

Ongoing Clinical Trials

Relacorilant is currently being tested in several clinical trials to determine its safety and effectiveness. Some of these studies include:

  • A study looking at how Relacorilant affects blood sugar and blood pressure in patients with Cushing’s syndrome[4].
  • A trial examining Relacorilant’s effects in patients with adrenal tumors that produce excess cortisol[6].
  • A study combining Relacorilant with another drug called pembrolizumab to treat adrenocortical carcinoma[5].
  • An investigation of Relacorilant in combination with enzalutamide for treating advanced prostate cancer[2].

Potential Side Effects

As Relacorilant is still being studied, all of its potential side effects are not yet known. The clinical trials are carefully monitoring patients for any adverse events. Some of the things being watched for include:

  • Changes in blood pressure
  • Changes in blood sugar levels
  • Effects on heart rhythm
  • Changes in laboratory tests (like blood and urine tests)
  • Any other unexpected health issues

It’s important to note that not all patients will experience side effects, and the benefits of the medication may outweigh the risks for many people[7][4].

Drug Interactions

Researchers are also studying how Relacorilant interacts with other medications. Some specific interactions being investigated include:

  • How Relacorilant affects the levels of a blood thinner called dabigatran in the body[8].
  • The interaction between Relacorilant and a drug called itraconazole, which is used to treat fungal infections[9].

These studies will help doctors understand how to safely use Relacorilant with other medications in the future.

Aspect Details
Drug Name Relacorilant (also known as CORT125134)
Drug Class Glucocorticoid receptor antagonist
Primary Conditions Studied Cushing syndrome, Adrenocortical carcinoma, Prostate cancer, Cortisol-secreting adrenal adenomas
Administration Oral capsules, typically once daily
Key Outcome Measures Blood pressure, glucose levels, quality of life, body composition, safety assessments
Trial Phases Phase 1, Phase 3
Notable Study Designs Randomized, double-blind, placebo-controlled, dose-escalation, food effect studies
Combination Therapies Studied with pembrolizumab for adrenocortical carcinoma, enzalutamide for prostate cancer

FAQ

  • What is Relacorilant? Relacorilant is an investigational drug that acts as a glucocorticoid receptor antagonist. It is being studied primarily for the treatment of Cushing syndrome, a condition characterized by excess cortisol production in the body.
  • What conditions is Relacorilant being studied for? Relacorilant is being studied for several conditions, including Cushing syndrome, adrenocortical carcinoma, prostate cancer, and in patients with cortisol-secreting adrenal adenomas or hyperplasia.
  • How is Relacorilant administered? Relacorilant is typically administered orally in the form of capsules. The dosage and frequency may vary depending on the specific clinical trial and condition being studied.
  • What are the main outcomes being measured in Relacorilant clinical trials? The main outcomes being measured include changes in blood pressure, glucose levels, quality of life, body composition, and safety assessments such as adverse events. Some trials also look at specific markers related to the condition being studied, like prostate-specific antigen levels in prostate cancer trials.
  • Are there any known side effects of Relacorilant? As Relacorilant is still in clinical trials, its full side effect profile is not yet established. The trials are designed to assess the safety and tolerability of the drug, including monitoring for any adverse events that may occur during treatment.

Ongoing Clinical Trials on Relacorilant

  • Study of Relacorilant, Nab-Paclitaxel, and Bevacizumab for Patients with Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy Poland Spain

  • Study of Relacorilant and Nab-Paclitaxel for Patients with Advanced, Platinum-Resistant Ovarian, Fallopian Tube, or Peritoneal Cancer

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Hungary Italy Poland Spain

Glossary

  • Glucocorticoid receptor antagonist: A type of drug that blocks the effects of glucocorticoids (stress hormones like cortisol) in the body by preventing them from binding to their receptors.
  • Cushing syndrome: A condition characterized by excessive levels of cortisol in the body, which can lead to various symptoms including weight gain, high blood pressure, and diabetes.
  • Adrenocortical carcinoma: A rare cancer that develops in the outer layer of the adrenal glands, which are responsible for producing various hormones including cortisol.
  • Cortisol: A hormone produced by the adrenal glands that helps regulate metabolism, immune function, and the body's response to stress.
  • Hypercortisolism: Another term for Cushing syndrome, referring to the state of having too much cortisol in the body.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • QT interval: A measurement on an electrocardiogram that represents the time it takes for the heart's electrical system to fire and then recharge. It's important in assessing the heart's rhythm and potential drug effects on the heart.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a set of rules used to assess how well a cancer patient responds to treatment.
  • Ambulatory blood pressure monitoring (ABPM): A method of measuring blood pressure at regular intervals over a 24-hour period while patients go about their normal daily activities.
  • HbA1c: Glycated hemoglobin, a form of hemoglobin used to diagnose diabetes and assess long-term blood sugar control.

References

  1. https://clinicaltrials.gov/study/NCT03442621
  2. https://clinicaltrials.gov/study/NCT03674814
  3. https://clinicaltrials.gov/study/NCT03604198
  4. https://clinicaltrials.gov/study/NCT03697109
  5. https://clinicaltrials.gov/study/NCT04373265
  6. https://clinicaltrials.gov/study/NCT04308590
  7. https://clinicaltrials.gov/study/NCT04795479
  8. https://clinicaltrials.gov/study/NCT05347979
  9. https://clinicaltrials.gov/study/NCT03512548