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Belumosudil Mesilate

Belumosudil Mesilate, also known as KD025 or SAR445761, is a promising drug currently being studied in clinical trials for various conditions, including multiple myeloma and immune system disorders. These trials aim to evaluate the safety, effectiveness, and optimal dosing of the drug in both patients and healthy volunteers. The research spans different phases and explores the drug’s potential as a standalone treatment and in combination with other medications.

Table of Contents

Overview of Belumosudil Mesylate

Belumosudil mesylate, also known by its alternative names KD025, SAR445761, and SLx-2119, is a promising drug currently being studied for its potential in treating various medical conditions[2][3][4]. This medication is primarily being investigated for its effectiveness in treating multiple myeloma, a type of blood cancer, and certain immune system disorders[1].

Belumosudil Mesylate for Multiple Myeloma

One of the main focuses of research for belumosudil mesylate is its potential use in treating multiple myeloma, particularly in patients whose disease has relapsed or become resistant to other treatments[1]. Multiple myeloma is a cancer that affects plasma cells, a type of white blood cell that produces antibodies to fight infections. When these cells become cancerous, they can accumulate in the bone marrow and interfere with the production of healthy blood cells.

The ongoing clinical trials are exploring how belumosudil mesylate works in patients with relapsed or refractory multiple myeloma. These terms refer to cases where the cancer has either returned after initial treatment (relapsed) or has not responded well to standard treatments (refractory)[1].

Potential Use in Immune System Disorders

While the primary focus appears to be on multiple myeloma, some of the clinical trials are also investigating the potential of belumosudil mesylate in treating immune system disorders[2][3][4]. These studies are currently being conducted on healthy volunteers to understand how the drug interacts with the immune system. This research could potentially lead to new treatments for various autoimmune conditions in the future.

Current Clinical Trials

Several clinical trials are currently underway to evaluate the effectiveness and safety of belumosudil mesylate:

  • A Phase I/II study for patients with relapsed/refractory multiple myeloma, which aims to determine the appropriate dosage and assess the drug’s ability to control the disease[1].
  • Studies on healthy volunteers to examine the safety, tolerability, and how the body processes the drug (pharmacokinetics) at various doses[2][3][4].

Dosage and Administration

Belumosudil mesylate is administered orally, typically in the form of capsules[2][3][4]. The dosage and frequency of administration are still being studied and may vary depending on the condition being treated and individual patient factors. Some of the dosages being investigated include:

  • Single doses ranging from 20 mg to 640 mg[2]
  • 500 mg twice daily for 28 days[3]
  • Various regimens including 500 mg once daily, 800 mg once daily, 500 mg twice daily, and 1000 mg once daily, each for 7 days[4]

Potential Side Effects and Safety

As with any medication, belumosudil mesylate may cause side effects. The ongoing clinical trials are closely monitoring participants for any adverse events. These studies use standardized criteria, such as the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), to grade and report any side effects[1].

Safety assessments in these trials typically include:

  • Monitoring for adverse events and serious adverse events
  • Safety laboratory tests
  • Vital sign measurements
  • Physical examinations
  • Electrocardiograms (ECGs)[2][3][4]

It’s important to note that as belumosudil mesylate is still in the clinical trial phase, its full safety profile and potential side effects are not yet fully known. Patients considering participation in clinical trials should discuss the potential risks and benefits with their healthcare providers.

Aspect Details
Drug Name Belumosudil Mesilate (also known as KD025, SAR445761, SLx-2119)
Conditions Studied Multiple Myeloma, Immune System Disorders
Trial Phases Phase I/II
Administration Oral capsules
Dosage Range 20 mg to 1000 mg, varying by study
Primary Objectives Safety, tolerability, pharmacokinetics, efficacy
Key Measurements Adverse events, drug concentration in blood, response rates
Study Populations Patients with multiple myeloma, healthy volunteers
Duration Varies by study, ranging from 7 days to over 1 year

FAQ

  • What is Belumosudil Mesilate? Belumosudil Mesilate, also known as KD025 or SAR445761, is a drug being studied in clinical trials for treating conditions like multiple myeloma and immune system disorders. It is taken orally in capsule form.
  • What conditions are being studied with Belumosudil Mesilate? The clinical trials are primarily focusing on multiple myeloma, a type of blood cancer, and immune system disorders. Some studies also involve healthy volunteers to assess the drug's safety and effects.
  • How is Belumosudil Mesilate administered in these trials? In the trials, Belumosudil Mesilate is given orally in capsule form. The dosage and frequency vary depending on the specific study, ranging from once daily to twice daily administration.
  • What are the main goals of these clinical trials? The main goals include determining the safety and tolerability of Belumosudil Mesilate, finding the optimal dosage, understanding its pharmacokinetics (how the body processes the drug), and assessing its effectiveness in treating the targeted conditions.
  • Are there any side effects being monitored in these trials? Yes, all the trials are closely monitoring for adverse events and serious adverse events. This includes regular safety assessments such as laboratory tests, vital sign measurements, physical examinations, and ECGs (electrocardiograms).

Ongoing Clinical Trials on Belumosudil Mesilate

  • Study of belumosudil in children aged 1 to 18 years with moderate to severe chronic graft versus host disease requiring systemic treatment

    Recruiting

    1 1
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Spain

  • A Study of Belumosudil for Patients with Steroid-Resistant Overlap Syndrome Graft-versus-Host Disease

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on the Effectiveness of Belumosudil and Azithromycin for Adults with Chronic Lung Rejection After Lung Transplant

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +8

  • Study of isatuximab, belumosudil and dexamethasone combination treatment for patients with relapsed or refractory multiple myeloma

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Greece Italy Norway Portugal

  • Study of Belumosudil and Prednisone for Patients Aged 12 and Older with Newly Diagnosed Chronic Graft Versus Host Disease

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +7

Glossary

  • Multiple Myeloma: A type of blood cancer that affects plasma cells, which are a type of white blood cell in the bone marrow.
  • Pharmacokinetics: The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Cmax: The maximum concentration of a drug in the blood after it has been administered.
  • AUC (Area Under the Curve): A measure of the total exposure to a drug over time, used to understand how much of the drug is in the body.
  • Half-life (t1/2): The time it takes for the concentration of a drug in the body to decrease by half.
  • Adverse Event: Any unfavorable and unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it's related to the treatment being studied.
  • Placebo: An inactive substance that looks like the drug being tested, used as a control in clinical trials to help determine the true effects of the study drug.
  • Dose Escalation: A process in clinical trials where the dose of a drug is gradually increased to find the optimal balance between effectiveness and side effects.
  • Relapsed/Refractory: In cancer treatment, this refers to disease that has returned after treatment (relapsed) or does not respond to treatment (refractory).
  • CTCAE: Common Terminology Criteria for Adverse Events, a standardized system for classifying the severity of side effects in cancer therapy clinical trials.

References

  1. https://clinicaltrials.gov/study/NCT06105554
  2. https://clinicaltrials.gov/study/NCT05918627
  3. https://clinicaltrials.gov/study/NCT05918614
  4. https://clinicaltrials.gov/study/NCT05918588