Rezurock

(Belumosudil)

ApprovedSmall molecule

Belumosudil is used to treat a type of cancer called chronic graft-versus-host disease, which is a serious complication that can occur after a bone marrow or stem cell transplant when the new immune cells attack the patient's own body.[2] Rezurock is currently approved and in use across 19 indications[4].[1]

Rezurock is one of 333 small molecule programs targeting Chronic Graft Versus Host Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

332

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Chronic Graft Versus Host DiseaseActive, not recruiting

Rheumatoid ArthritisApproved

SclerodermaApproved

Psoriatic ArthritisApproved

Multiple MyelomaApproved

Immune System DiseaseActive, not recruiting

Type II Hypersensitivity Reaction DiseaseActive, not recruiting

Diffuse SclerodermaApproved

Systemic Lupus ErythematosusApproved

Liver DiseaseApproved

Chronic Graft Versus Host DiseasePhase 3

Active, not recruiting

Rheumatoid ArthritisApproved

Approved

SclerodermaApproved

Approved

Psoriatic ArthritisApproved

Approved

Multiple MyelomaApproved

Approved

Immune System DiseaseApproved

Active, not recruiting

Type II Hypersensitivity Reaction DiseasePreclinical

Active, not recruiting

Diffuse SclerodermaApproved

Approved

Systemic Lupus ErythematosusApproved

Approved

Liver DiseaseApproved

Approved

Showing 10 of 19 indications

Competition

Competitive Landscape

282 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

Rezurock

KKadmon, a Sanofi Company

Approved

27 2

Empliciti

Bristol-Myers Squibb

Phase 3

45 3

TALVEY

Johnson & Johnson

Phase 3

24 4

Keytruda

Merck & Co.

Phase 3

17 5

Sarclisa

AAzienda U.S.L. 1 di Massa e Carrara

Phase 3

42 6

Biaxin

AbbVie

Phase 3

15 7

Opdivo

Bristol-Myers Squibb

Phase 3

11 8

Vepesid

AAvyxa

Phase 3

17 9

Cytosar

Teva

Phase 3

4 10

Mozobil

GGenzyme, a Sanofi Company

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1Not yet recruiting

Chronic Graft Versus Host Disease

NCT07726914

Q2 2027

Phase 2Recruiting

Lung Transplant

NCT06476132

Q4 2027

Phase 2Recruiting

Chronic Graft Versus Host Disease

NCT06046248

Phase 2Recruiting

Bronchiolitis Obliterans

NCT05922761

Phase 1Recruiting

Chronic Graft Versus Host Disease

NCT07127926

Q1 2028

Post-ApprovalNot yet recruiting

Chronic Graft-Versus-Host Disease (cgvhd)

NCT07135973

Clinical

Trials by Indication[1]

Chronic Graft Versus Host Disease9 trials

Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease

Recruiting·NNorthside Hospital, Inc.·Phase 2·NCT06046248·25 enrolled

A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease

Completed·KKadmon, a Sanofi Company·Phase 2·NCT02841995·54 enrolled

Safety and Efficacy of Oral Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Male and Female Participants Aged 12 Years and Above With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy

Withdrawn·KKadmon, a Sanofi Company·Phase 2·NCT05567406

Show 6 more trials

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.

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT06143891·260 enrolled

Randomized Phase II Study of Belumosudil vs. Placebo for Preemptive Treatment of Chronic Graft Versus Host Disease

Recruiting·FFred Hutchinson Cancer Center·Phase 2·NCT05996627·82 enrolled

A Parallel Group, Phase 3, Randomized, Open-label, 2-arm Study to Demonstrate the Superiority of Belumosudil Versus Best Available Therapy (BAT) in Participants at Least 12 Years of Age With Chronic Graft Versus Host Disease (cGVHD) Refractory to or Recurrent After 2 to 5 Prior Lines of Systemic Therapy

Not yet recruiting· Sanofi logo

Sanofi·Phase 3·NCT07771439·356 enrolled

Evaluation of Belumosudil Whole Tablets vs. Crushed Tablets Pharmacokinetics in Patients Suffering From Chronic Graft Versus Host Disease

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT07127926·8 enrolled

An Open-label, Phase 1/2, Multicenter Study of Belumosudil in Children Aged 1 to <18 Years Requiring Systemic Treatment for Active Moderate-to-severe Chronic Graft Versus Host Disease (cGVHD)

Recruiting· Sanofi logo

Sanofi·Phase 2·NCT07116031·37 enrolled

An Open-label, Randomized, Phase 1, 2-treatment, 2-period, 2-sequence, Cross-over, Bioequivalence Study Comparing Belumosudil Oral Suspension (Test Formulation) With Belumosudil Tablet (Commercially Available Reference Formulation) in Healthy Adult Male Participants Under Fed Condition

Not yet recruiting· Sanofi logo

Sanofi·Phase 1·NCT07726914·58 enrolled

Systemic Sclerosis2 trials

KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis

Terminated·KKadmon, a Sanofi Company·Phase 2·NCT03919799·36 enrolled

Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis

Terminated·KKadmon, a Sanofi Company·Phase 2·NCT04680975·10 enrolled

Psoriasis1 trial

A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis

Completed·KKadmon Corporation, LLC·Phase 2·NCT02852967·110 enrolled

Oral1 trial

A Study to Assess the Effect of Oral Belumosudil on Inhibition of Various Proteins in the Fed State in Healthy Male Subjects

Completed·KKadmon, a Sanofi Company·Phase 1·NCT05806567·52 enrolled

Interaction1 trial

Drug-drug Interaction Between Belumosudil, Itraconazole, Rifampicin, Rabeprazole, and Omeprazole in Healthy Volunteers

Completed·KKadmon Corporation, LLC·Phase 1·NCT03530995·73 enrolled

13 more indications

Efficacy and Safety1 trial

Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy

Terminated·KKadmon, a Sanofi Company·Phase 2·NCT03640481·159 enrolled

Absorption1 trial

Human Absorption, Distribution and Metabolism Study (hAME) [14C]-KD025

Completed·KKadmon Corporation, LLC·Phase 1·NCT03907540·5 enrolled

Idiopathic Pulmonary Fibrosis1 trial

A 2-Part, Phase 2 Open-label and Crossover Study of Belumosudil for Treatment of Idiopathic Pulmonary Fibrosis

Completed·KKadmon Corporation, LLC·Phase 2·NCT02688647·76 enrolled

Bronchiolitis Obliterans1 trial

BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)

Recruiting·—·Phase 2·NCT05922761·45 enrolled

Psoriasis Vulgaris1 trial

A Safety and Tolerability Study of Belumosudil (KD025) Treatment in Subjects With Moderately Severe Psoriasis Vulgaris

Completed·KKadmon Corporation, LLC·Phase 2·NCT02106195·8 enrolled

Chronic Graft-Versus-Host Disease (cGVHD)1 trial

A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)

Not yet recruiting· Sanofi logo

Sanofi·Phase 4·NCT07135973·26 enrolled

Age1 trial

Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

Recruiting· Sanofi logo

Sanofi·Phase 1/2·NCT04643002·258 enrolled

Glucocorticoids1 trial

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

Active, not recruiting· Sanofi logo

Sanofi·Phase 4·NCT06616415·6 enrolled

cGVHD1 trial

IL6-receptor Inhibitor in Combination With Belumosudil for the Treatment of Belumosudil-refractory Chronic Graft-versus-host Disease (cGVHD)

Not yet recruiting·SStanford University·Phase 1·NCT07484113·10 enrolled

Lung Transplant1 trial

Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients: A Randomized, Multicenter, Double Blind, Placebo-Controlled Trial (CTOT-47)

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT06476132·234 enrolled

Lung Transplant Rejection1 trial

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study, Followed by Open-label Extensions, to Evaluate the Efficacy of Oral Belumosudil in Adult Participants With Chronic Lung Allograft Dysfunction (CLAD) Following Bilateral Lung Transplantation

Recruiting· Sanofi logo

Sanofi·Phase 3·NCT06082037·180 enrolled

Graft Versus Host Disease1 trial

Phase II Open Label Prospective Nonrandomized Trial of Belumosudil for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07006506·46 enrolled

Unspecified1 trial

Bioavailability of Belumosudil (KD025) in Healthy Male Subjects

Completed·KKadmon Corporation, LLC·Phase 1·NCT02557139·23 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 16, 2021

REZUROCK

NDA NDA214783

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for Belumosudil. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Rezurock drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Belumosudil compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Belumosudil. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA214783). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Rezurock. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Kadmon, a Sanofi Company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Rho-Associated Protein Kinase 2 Inhibitor; Rho-Associated Protein Kinase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: KKadmon, a Sanofi Company

Patent Landscape[6]

Patent Cliff

Oct 7, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10183931Oct 7, 2033

10696660Oct 7, 2033

8357693Jun 20, 2034

11311541Apr 9, 2035

12097202Jul 14, 2042

Rezurock

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q2 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Chronic Graft Versus Host Disease9 trials

Systemic Sclerosis2 trials

Psoriasis1 trial

Oral1 trial

Interaction1 trial

Efficacy and Safety1 trial

Absorption1 trial

Idiopathic Pulmonary Fibrosis1 trial

Bronchiolitis Obliterans1 trial

Psoriasis Vulgaris1 trial

Chronic Graft-Versus-Host Disease (cGVHD)1 trial

Age1 trial

Glucocorticoids1 trial

cGVHD1 trial

Lung Transplant1 trial

Lung Transplant Rejection1 trial

Graft Versus Host Disease1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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