Rezurock (belumosudil) / Meiji Seika, Nano Terra, Romeck Pharma, BioNova Pharma, Sanofi - LARVOL DELTA

Belumosudil versus Ruxolitinib for Steroid-Refractory or Breakthrough Hepatic cGVHD (ChiCTR) - P4 | N=170 | Not yet recruiting | Sponsor: The FIrst Affiliated Hospital, College of Medicine, Zhejiang University; The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

New P4 trial • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Dermatology • Fatigue • Graft versus Host Disease • Hepatology • Immunology • Liver Failure • Portal Hypertension • Pruritus • Transplantation

Effect of Belumosudil on Cyclosporine Blood Concentrations in Patients with Chronic Graft-versus-Host Disease (cGVHD): A Single-Center, Bidirectional, Self-Controlled Observational Study (ChiCTR) - P=N/A | N=40 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Guangxi Medical University; The First Affiliated Hospital of Guangxi Medical University

New trial • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

Efficacy, Safety, and Pharmacokinetics of Belumosudil Mesylate in Pediatric Patients with Chronic Graft-Versus-Host Disease. (ChiCTR) - P=N/A | N=120 | Not yet recruiting | Sponsor: Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine; Shanghai Children's Medical Center, Shanghai Jiao Tong Universit

New trial • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Pediatrics • Transplantation

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 (clinicaltrialsregister.eu) - P4 | N=7 | Sponsor: Sanofi-Aventis Recherche & Développement

New P4 trial • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

ROCKnrol-1: 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. (clinicaltrials.gov) - P3 | N=260 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

ROCKnrol-1: 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. (clinicaltrials.gov) - P3 | N=240 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

ROCKnrol-1: 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. (clinicaltrials.gov) - P3 | N=240 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease (clinicaltrials.gov) - P2 | N=25 | Suspended | Sponsor: Northside Hospital, Inc. | Recruiting ➔ Suspended | Trial primary completion date: Dec 2026 ➔ Mar 2027

Trial primary completion date • Trial suspension • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: Northside Hospital, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease (clinicaltrials.gov) - P2 | N=25 | Not yet recruiting | Sponsor: Northside Hospital, Inc.

New P2 trial • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

Optimizing cGVHD Management After Ruxolitinib Failure: The Role of Belumosudil in Clinical Practice (ICBMT 2026) - "This presentation reviews evidence supporting strategic treatment sequencing after ruxolitinib failure, practical approaches to early identification of non-responders and intolerant patients, and multidisciplinary strategies for optimizing belumosudil therapy. Emphasis is placed on enhancing consistency in cGVHD management criteria across institutions to improve long-term outcomes for patients navigating this complex therapeutic landscape."

Clinical • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Fibrosis • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Successful Multi-Modal Management of Refractory CMV-Associated Hemophagocytic Lymphohistiocytosis and Idiopathic Pneumonia Syndrome Following HLA-Mismatched Bone Marrow Transplantation for Severe Aplastic Anemia (ICBMT 2026) - "The conditioning regimen included TBI (3Gy), rATG (5mg/kg), fludarabine (125mg/m²), and melphalan (140mg/m²)...Initial treatment with foscarnet led to worsening AKI (creatinine 1.57 mg/dL)... This case demonstrates that a timely transition to maribavir can be vital for managing CMV-HLH in patients with renal dysfunction. Furthermore, the integration of MSCs and belumosudil provided an effective salvage strategy for steroid-refractory IPS. A multi-modal approach targeting different pathways of immune dysregulation is essential for improving outcomes in complex post-transplant settings."

Acute Kidney Injury • Anemia • Aplastic Anemia • Bone Marrow Transplantation • Cytomegalovirus Infection • Graft versus Host Disease • Hematological Disorders • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Nephrology • Pneumonia • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Transplantation

Real-World Analysis of Belumosudil in Chronic Graft-versus-Host Disease: Early Progression May Reflect Ruxolitinib Discontinuation-Associated Flare (ICBMT 2026) - "Belumosudil provided meaningful disease control in heavily pretreated, multi-organ cGVHD. Early progression clustered after immediate ruxolitinib discontinuation, suggesting that transition-associated flare may confound early response assessment. Gradual tapering or temporary overlap strategies warrant further investigation."

Clinical • Real-world • Real-world evidence • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

BELRUX: Belumosudil With Ruxolitnib as Third Line Therapy for Chronic Graft Versus Host Disease (cGvHD) (clinicaltrials.gov) - P2 | N=63 | Not yet recruiting | Sponsor: Dennis Kim

New P2 trial • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

Belumosudil Versus Ruxolitinib for Steroid-Refractory or Breakthrough Hepatic cGVHD (clinicaltrials.gov) - P=N/A | N=170 | Recruiting | Sponsor: First Affiliated Hospital of Zhejiang University

New trial • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Transplantation

BELRUX: Belumosudil With Ruxolitnib as Third Line Therapy for Chronic Graft Versus Host Disease (cGvHD) (clinicaltrials.gov) - P2 | N=53 | Not yet recruiting | Sponsor: Dennis Kim | Trial completion date: Jul 2030 ➔ Nov 2030 | Initiation date: Jul 2026 ➔ Nov 2026 | Trial primary completion date: Jul 2029 ➔ Nov 2029

Trial completion date • Trial initiation date • Trial primary completion date • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

Inhibition of ROCK2 via KD025/Belumosudil Alleviates Hypertensive End-Organ Damage. (PubMed, Hypertension) - "Despite no blood pressure change, KD025 reduced cardiac and aortic fibrosis, improved echocardiographic and invasive hemodynamic indices, and attenuated albuminuria and renal T-cell infiltration. ROCK2 inhibition may serve as an adjunct immune-modulating therapy to mitigate the end-organ damage that occurs in the heart, vasculature, and kidney in hypertension."

Journal • Cardiovascular • Fibrosis • Hypertension • Immunology • Inflammation • Renal Disease

Efficacy and safety of the ROCK2-inhibitor belumosudil for chronic GVHD: results from a multicenter retrospective analysis of a large German-Austrian cohort of the belumosudil MAP. (PubMed, Bone Marrow Transplant) - "In Europe, so far there were no standard treatment options available after failure of corticosteroids and ruxolitinib. Treatment-emergent adverse reactions CTCAE grade III-IV were mostly infectious complications and occurred in 28 patients (22%). This retrospective analysis of a large real-world cohort demonstrates efficacy and safety of belumosudil in refractory chronic GvHD patients."

Clinical • Journal • Retrospective data • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Transplantation

PHASE 1/2 UMBRELLA TRIAL EVALUATING ISATUXIMAB IN COMBINATION WITH NOVEL AGENTS IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA: STUDY DESIGN TO EVALUATE ISATUXIMAB WITH DEXAMETHASONE AND BELUMOSUDIL OR EVORPACEPT (SIE 2026) - "The objectives are to determine the recommended dose of belumosudil and evorpacept in combination with Isa and dex and evaluate their clinical benefit in different settings of RRMM. The sub study with belumosudil is in dose escala- tion and the sub study with evorpacept is in dose optimiza- tion as of February 26, 2026."

Combination therapy • P1/2 data • Hematological Malignancies • Multiple Myeloma

COMPASSIONATE USE PROGRAMS IN HEMATOLOGY: CLINICAL, ORGANIZATIONAL, AND ECONOMIC IMPACT OF A DEDICATED MULTIDISCIPLINARY TRIAL OFFICE (SIE 2026) - "Programs involving belumosudil, mesenchymal cells, and fecal microbiota ap- proaches highlighted the value of CUPs in making complex options available to fragile patients...A dedicated trial office is essential to manage the in- creasing complexity of these programs. Institutional recogni- tion of these roles, together with collaborative engagement with pharmaceutical sponsors, is needed to harmonize inno- vation with the long-term sustainability of the National Health Service"

Clinical • HEOR • Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Disorders • Immunology

A MULTI-COUNTRY RETROSPECTIVE STUDY ON THE EFFECTIVENESS OF BELUMOSUDIL FOR CHRONIC GRAFT VERSUS HOST DISEASE (ROCKREAL II STUDY) (SIE 2026) - "Despite a heavily pretreated population—with 80% having received prior ruxolitinib and two-thirds initiat- ing belumosudil at third or fourth line—more than nearly half of evaluable patients achieved a clinical response at six months. This study was funded by Sanofi"

Retrospective data • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

Potential clinical benefits of early belumosudil treatment in chronic graft-versus-host disease. (PubMed, Int J Hematol) - "Although these findings are at the organ level, this study suggests that, regardless of prior treatment, early administration of belumosudil following the onset of cGVHD may be associated with improved response."

Journal • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Fibrosis • Graft versus Host Disease • Immunology • Transplantation

From Flank Pain to Graft-vs.-Host Disease-Related Autoimmune Podocytopathy: A Case of FAT1+ Membranous Nephropathy (KIDNEY WEEK 2026) - "Case Description Our patient underwent an allogeneic HSCT in November 2023 which was complicated by multiorgan chronic GVHD for which he was started on ruxolitinib and belumosudil. While LC-MS/MS identified the antigen target in this case, cohort data show that FAT1+MN can also be identified by immunofluorescence. In FAT1+ MN, IgG subtyping may vary, with IgG4 dominance ranging from the majority of cases to as low as 30%."

Clinical • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Glomerulonephritis • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Nephrology • Pain • CDH23 • FAT1 • NELL1 • PCDH

Belumosudil Improves Experimental Pulmonary Fibrosis via the ROCK2/Smad3/CTGF Pathway. (PubMed, Pulm Pharmacol Ther) - "We conducted in vivo investigations and examined belumosudil effects on PF using an intratracheal bleomycin (BLM) infusion rat model. In vitro, belumosudil (100 nM) reduced LPS or IL-4-induced macrophage polarization, lowered Arg-1 and iNOS levels, reduced TGF-β1-induced fibroblast proliferation, and generated lower ROCK2, p-Smad3, and CTGF levels. Belumosudil appeared to alleviate experimental PF by reducing fibroblast proliferation and macrophage polarization by inhibiting ROCK2/Smad3/CTGF signaling."

Journal • Immunology • Pulmonary Disease • Respiratory Diseases • CTGF • IL4 • SMAD3 • TGFB1

A Decade of Progress Towards Safer and More Broadly Applicable Allogeneic Stem Cell Transplantation (ASH 2026) - "Hany Elmariah (Stanford) presenting "New Standards in GVHD Prophylaxis: Towards a Future Without GVHD," which examines the latest advances in prophylactic strategies, including Orca-T, abatacept, and post-transplant cyclophosphamide (PTCy), and how these approaches are reshaping the standard of care...These include ruxolitinib and mesenchymal stromal cells (MSCs) for acute GVHD (with pediatric indications), as well as belumosudil, ruxolitinib, and axatilimab for chronic GVHD, and how they are improving outcomes for patients with steroid-refractory disease...Holtan's talk, "A Donor for All: Increasing Access and Improving Outcomes," which addresses expanding donor options through mismatched unrelated donor (MMURD), haploidentical, and cord blood transplantation, emphasizing the data supporting broader access and equitable outcomes across donor types. These presentations chart a bold trajectory for the field, illuminating how scientific innovation,..."

Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • Transplantation