Belumosudil (Rezurock) - Graft-versus-host disease View of Belumosudil (Rezurock) | Canadian Journal of Health TechnologiesReturn to Article DetailsBelumosudil (Rezurock)
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Belumosudil (Rezurock) - chronic graft-versus-host disease (chronic GvHD) 1 Published 10 July 2023 1 SMC2583 belumosudil film-coated tablet (Rezurock®) Sanofi 09 June 2023 The Scottish Medicines Consortium (SMC) has completed its initial assessment of the evidence , and difficulties with mobility, sight, eating, self-care and activities of daily living. There are limited effective treatment options. In pooled data from two open-label, phase II studies belumosudil was associated with clinically relevant overall response rate, 73%, in patients with chronic GvHD who had received two prior lines of therapy. The efficacy and safety of belumosudil relative to relevant
Belumosudil (Rezurock) - To treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy Drug Approval Package: REZUROCK * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular
Two-Part Phase 1 Study to Evaluate the Taste Profile of Novel Belumosudil Oral Suspensions and Assess the Relative Bioavailability and Food Effect of the Selected Belumosudil Oral Suspension Compared With Oral Tablet Reference in Healthy Male Participant Belumosudil is a selective rho-associated coiled-coil-containing protein kinase 2 inhibitor in clinical use for the treatment of chronic graft -versus-host disease. The current tablet formulation may be inappropriate for children or adults with dysphagia and/or upper gastrointestinal manifestations of chronic graft-versus-host disease. This study (NCT04735822) assessed the taste and palatability of oral suspensions of belumosudil, evaluated the relative bioavailability of an oral suspension versus the tablet formulation, and characterized
Belumosudil in diffuse cutaneous systemic sclerosis: a randomised, double-blind, open-label extension, placebo-controlled, Phase 2 study. To determine the efficacy, safety, and pharmacodynamics of belumosudil in patients with diffuse cutaneous systemic sclerosis (dcSSc) treated with background immunosuppressive therapies. Eligible patients were randomised 1:1:1 to receive belumosudil 200 mg once daily (QD) or twice daily (BID), or placebo for 28 weeks (double-blind period). After unblinding, the patients who received belumosudil continued the same dose, whereas the patients who received placebo were re-randomised for one of the belumosudil doses for 24 weeks (open-label extension). Thirty-five and 31 patients were treated in the double-blind and open-label periods, respectively. The study
A phase II study of belumosudil for chronic graft-versus-host disease in patients who failed at least one line of systemic therapy in China. Chronic graft-versus-host disease (cGVHD) is an immune-related disorder that is the most common complication post-allogenic hematopoietic stem cell transplant. Corticosteroids with or without calcineurin inhibitors (CNIs) remain the mainstay of cGVHD treatment for first-line therapy. However, for many patients, cGVHD symptoms cannot be effectively managed and thus require second-line therapy. Currently, there is no approved treatment for second-line cGVHD treatment in China. In this study, belumosudil, a highly selective and potent rho-associated coiled-coil-containing protein kinase-2 inhibitor demonstrated to be effective for cGVHD in the United
Belumosudil for chronic graft-versus-host disease after 2 or more prior lines of therapy: the ROCKstar Study Belumosudil, an investigational oral selective inhibitor of Rho-associated coiled-coil-containing protein kinase 2 (ROCK2), reduces type 17 and follicular T helper cells via downregulation of STAT3 and enhances regulatory T cells via upregulation of STAT5. Belumosudil may effectively treat patients with chronic graft-versus-host disease (cGVHD), a major cause of morbidity and late nonrelapse mortality after an allogeneic hematopoietic cell transplant. This phase 2 randomized multicenter registration study evaluated belumosudil 200 mg daily (n = 66) and 200 mg twice daily (n = 66) in subjects with cGVHD who had received 2 to 5 prior lines of therapy. The primary end point was best overall
A Phase 1 Thorough QT/QTc Study of Therapeutic and Supratherapeutic Doses of Belumosudil in Healthy Subjects. Belumosudil is a selective Rho-associated, coiled-coil-containing protein kinase-2 inhibitor. In this crossover design thorough QT/QTc study, single therapeutic (200 mg) and supratherapeutic (1000 mg) oral doses of belumosudil, moxifloxacin (positive control), and placebo were administered to 34 subjects. Twelve-lead electrocardiograms and serial pharmacokinetic sampling were acquired. The effect of belumosudil on the placebo-corrected, change-from-baseline QTcF was small, and an effect exceeding 10 ms could be excluded across all time points with both doses. Using concentration-QTc analysis, an effect on ΔΔQTcF >10 ms can be excluded up to belumosudil concentrations of ≈12 080 ng
FDA Approval Summary: Belumosudil for Adult and Pediatric Patients 12 Years and Older with Chronic GvHD after Two or More Prior Lines of Systemic Therapy. On July 16, 2021, the FDA approved belumosudil, a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic GvHD (cGvHD) after failure of at least two prior lines of systemic therapy. Approval was based on the results of Study KD025-213, which included 65 patients with cGvHD treated with belumosudil 200 mg daily in an open-label, single-arm cohort. Efficacy was determined by the overall response rate (ORR) through Cycle 7 Day 1, which included complete response (CR) or partial response (PR) according to the 2014 NIH consensus criteria, and durability of response. The ORR through Cycle 7 Day 1 was 75% [95% confidence
Belumosudil for Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation This is a randomized, double-blind, placebo-controlled trial in de novo kidney transplant patients to determine if the addition of belumosudil (brand name- REZUROCK®) on the background of standard immunosuppression will prevent fibrosis in the kidney transplant. Interstitial expansion is the precursor of interstitial fibrosis and graft loss. We hypothesize that abgrogating the fibrogenic effects of the RhoA pathway with belumosudil will reduce structural damage in transplanted kidneys and possible subsequent transplant failure. Of the 16,521 adult kidney transplants in 2008, death-censored graft loss occurred in 16% of deceased donor kidneys and 7% of living donor kidneys in the ensuing 5
Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients The purpose of this study is to see if taking the study drug, Belumosudil, for 52 weeks in addition to your usual care and medication, will prevent Chronic Lung Allograft Dysfunction (CLAD) in participants who have a lung biopsy that shows evidence of rejection or inflammation to the transplanted lung(s). For this study, biopsies that show evidence of Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP) or Acute Lung Injury (ALI) are referred to as "Qualifying Biopsies"; patients who had evidence of one or more of these conditions on a recent biopsy are eligible for enrollment in this study. Belumosudil is an investigational drug that blocks a molecule
A Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil in Chinese Adolescents With cGVHD Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies This is a single group, Phase 4, single-arm post-marketing study for treatment. The purpose of this study is to verify the pharmacokinetics, efficacy, and safety of belumosudil mesylate tablets in Chinese adolescent participants (aged from 12 to less than 18) with cGVHD who have had an inadequate response to glucocorticoids or other systemic therapies. Participants will receive treatment with belumosudil tablets 200 mg once daily in 28-day cycles during the study.
Phase I/II Open Label Study of Belumosudil Mesylate Alone, and in Combination With Dexamethasone, in Patients With Relapsed/Refractory Multiple Myeloma Phase 1 is to find the recommended dose of belumosudil mesylate that can be given to patients with relapsed/refractory MM.Phase 2 is to learn if the dose of belumosudil mesylate found in Phase 1 can help to control the disease. Primary Objectives:In Phase I, define the toxicities and recommended Phase II dose (RP2D) of belumosudil mesylate in a population of patients with relapsed/refractory multiple myeloma.In Phase II, obtain preliminary evidence of efficacy of belumosudil mesylate and further expand the safety experience in this patient population. The overall response rate (ORR) will be defined using the International Myeloma Working
A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease. This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD.The study duration for a participant includes up to 4 weeks for screening; a treatment period until
BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP) The goal of this research study is to test the efficacy of a novel immunosuppressive agent, belumosudil, in allogeneic hematopoietic stem cell transplant (HSCT) recipients who have been newly diagnosed or have developing (early stage) bronchiolitis obliterans syndrome (BOS).The name of the study drugs involved in this study are:Belumosudil (an immunotherapy)Fluticasone (an intranasal corticosteroid)Azithromycin (an antibiotic)Montelukast (a leukotriene receptor antagonist)Prednisone (a corticosteroid) This is an open-label, single-arm, single-stage phase 2 study to evaluate the activity of Belumosudil in subjects with new onset of bronchiolitis obliterans syndrome (BOS) (Cohort A) and for subjects with incipient BOS (Cohort B
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen