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 18 indications[4].[1]

Rezurock is one of 419 small molecule programs targeting Systemic Lupus Erythematosus. It is currently in Approved.

Indications

Total Trials

Active Trials

418

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Systemic Lupus ErythematosusApproved

Bronchiolitis ObliteransActive, not recruiting

Psoriasis VulgarisActive, not recruiting

Type II Hypersensitivity Reaction DiseaseActive, not recruiting

Immune System DiseaseActive, not recruiting

Diffuse SclerodermaApproved

Chronic Graft Versus Host DiseaseActive, not recruiting

Liver DiseaseApproved

Multiple MyelomaApproved

Rheumatoid ArthritisApproved

Systemic Lupus ErythematosusApproved

Approved

Bronchiolitis ObliteransPhase 2

Active, not recruiting

Psoriasis VulgarisPhase 2

Active, not recruiting

Type II Hypersensitivity Reaction DiseasePreclinical

Active, not recruiting

Immune System DiseaseApproved

Active, not recruiting

Diffuse SclerodermaApproved

Approved

Chronic Graft Versus Host DiseasePhase 3

Active, not recruiting

Liver DiseaseApproved

Approved

Multiple MyelomaApproved

Approved

Rheumatoid ArthritisApproved

Approved

Showing 10 of 18 indications

Competition

Competitive Landscape

1135 competitors in Multiple Myeloma

#DrugCompanyPhaseTrials

Rezurock

KKadmon, a Sanofi Company

Approved

24 2

Ninlaro

Takeda

Preclinical

18 3

Prolia

Amgen

Preclinical

5 4

Nolvadex

AstraZeneca

Preclinical

1 5

Oncovin

EEastern Cooperative Oncology Group

Preclinical

8 6

Intron a

Systemic Therapy

1 8

Abecma

Bristol-Myers Squibb

Preclinical

4 9

Oblimersen Sodium

NNational Cancer Institute (NCI)

Preclinical

2 10

Chemotherapy Drug

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Preclinical

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

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Lung Transplant Recipient

NCT06476132

Q4 2027

Phase 2Recruiting

Chronic Graft Versus Host Disease

NCT06046248

Phase 2Recruiting

Bronchiolitis Obliterans

NCT05922761

Q1 2028

Post-ApprovalNot yet recruiting

Chronic Graft-Versus-Host Disease (cgvhd)

NCT07135973

Q2 2028

Phase 1/2Recruiting

Age

NCT04643002

Phase 1Not yet recruiting

Refractory

NCT07484113

Clinical

Trials by Indication[1]

Chronic Graft Versus Host Disease6 trials

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

Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host Disease

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

Show 3 more 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 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

A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK)

Recruiting· Sanofi logo

Sanofi·Phase 2·NCT07116031·37 enrolled

Systemic Sclerosis2 trials

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

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

KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis

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

Age1 trial

Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

Recruiting· Sanofi logo

Sanofi·Phase 1/2·NCT04643002·258 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

Refractory1 trial

IL6-receptor Inhibitor Iwith Belumosudil for the Treatment of Belumosudil-refractory cGVHD

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

13 more indications

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

Absorption1 trial

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

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

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

Lung Transplant Recipient1 trial

Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients

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

Bronchiolitis Obliterans1 trial

BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)

Recruiting·—·Phase 2·NCT05922761·45 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

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

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

Interaction1 trial

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

Completed·KKadmon Corporation, LLC·Phase 1·NCT03530995·73 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 — 24 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 Disease6 trials

Systemic Sclerosis2 trials

Age1 trial

Oral1 trial

Refractory1 trial

Psoriasis Vulgaris1 trial

Absorption1 trial

Efficacy and Safety1 trial

Idiopathic Pulmonary Fibrosis1 trial

Lung Transplant Recipient1 trial

Bronchiolitis Obliterans1 trial

Glucocorticoids1 trial

Psoriasis1 trial

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

Interaction1 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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