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 17 indications[4].[1]

Rezurock is one of 328 small molecule programs targeting Systemic Lupus Erythematosus. It is currently in Approved.

Indications

Total Trials

Active Trials

327

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Systemic Lupus ErythematosusApproved

Bronchiolitis ObliteransRecruiting

AgeRecruiting

Type II Hypersensitivity Reaction DiseaseActive, not recruiting

Immune System DiseaseActive, not recruiting

Diffuse SclerodermaApproved

Chronic Graft Versus Host DiseaseNot yet recruiting

Liver DiseaseApproved

Multiple MyelomaApproved

Rheumatoid ArthritisApproved

Systemic Lupus ErythematosusApproved

Approved

Bronchiolitis ObliteransPhase 2

Recruiting

AgePreclinical

Recruiting

Type II Hypersensitivity Reaction DiseasePreclinical

Active, not recruiting

Immune System DiseaseApproved

Active, not recruiting

Diffuse SclerodermaApproved

Approved

Chronic Graft Versus Host DiseaseApproved

Not yet recruiting

Liver DiseaseApproved

Approved

Multiple MyelomaApproved

Approved

Rheumatoid ArthritisApproved

Approved

Showing 10 of 17 indications

Competition

Competitive Landscape

259 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

Rezurock

KKadmon, a Sanofi Company

Approved

28 2

Fludara

Sanofi

Phase 3

47 3

Belamaf

GSK

Phase 3

39 4

TALVEY

Johnson & Johnson

Phase 3

22 5

Venclexta

AbbVie

Phase 3

17 6

Keytruda

Merck & Co.

Phase 3

17 7

Sarclisa

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

Phase 3

42 8

Opdivo

Bristol-Myers Squibb

Phase 3

11 9

Azatiq

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Vepesid

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

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Lung Transplant

NCT06476132

Q4 2027

Phase 2Recruiting

Bronchiolitis Obliterans

NCT05922761

Phase 1Recruiting

Chronic Graft Versus Host Disease

NCT07127926

Q1 2028

ApprovedNot yet recruiting

Chronic Graft Versus Host Disease

NCT07135973

Q2 2028

PreclinicalRecruiting

Plasma Cell Myeloma

NCT04643002

Phase 1Not yet recruiting

Cgvhd

NCT07484113

Clinical

Trials by Indication[1]

Chronic Graft Versus Host Disease10 trials

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

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

A Multi-center, Single-arm Phase IV Clinical Trial to Evaluate the Safety of Belumosudil in Indian Participants, 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)

Not yet recruiting· Sanofi logo

Sanofi·Approved·NCT07135973·26 enrolled

Show 7 more trials

A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of Belumosudil in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease (cGVHD)

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT06143891·260 enrolled

Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-host Disease

Suspended·NNorthside Hospital, Inc.·Phase 2·NCT06046248·25 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

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, 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

cGVHD2 trials

Phase 2, Single Arm, Belumosudil and Ruxolitinib Combination 3rd Line Therapy After 2nd Line Ruxolitinib Failure for Chronic Graft vs Host Disease (cGvHD) Treatment (BELRUX)

Not yet recruiting·DDennis Kim·Phase 2·NCT07643025·53 enrolled

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

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

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

12 more indications

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

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

Bronchiolitis Obliterans1 trial

BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)

Recruiting·—·Phase 2·NCT05922761·45 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

Absorption1 trial

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

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

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

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

Plasma Cell Myeloma1 trial

Phase 1-2 UMBRELLA Trial Evaluating Isatuximab With or Without Dexamethasone in Combination With Novel Agents Compared to Isatuximab With Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (RRMM) - Master Protocol

Recruiting· Sanofi logo

Sanofi·Preclinical·NCT04643002·258 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

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 — 28 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

Q2 2027

Q4 2027

Q1 2028

Q2 2028

Trials by Indication[1]

Chronic Graft Versus Host Disease10 trials

Systemic Sclerosis2 trials

cGVHD2 trials

Oral1 trial

Idiopathic Pulmonary Fibrosis1 trial

Glucocorticoids1 trial

Psoriasis Vulgaris1 trial

Bronchiolitis Obliterans1 trial

Psoriasis1 trial

Absorption1 trial

Interaction1 trial

Efficacy and Safety1 trial

Lung Transplant Rejection1 trial

Plasma Cell Myeloma1 trial

Lung Transplant1 trial

Graft Versus Host Disease1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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