Drugs / Belumosudil
Belumosudil
also known as
KD025 · Belumosudil mesylate · KD-025 MESYLATE · REZUROCK · Rock2 inhibitor kd025 · Slx-2119 free base
Small molecule targets ROCK2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected chronic graft versus host disease 1 milestone | |||||
| Refused (EMA) | EU (EMA) | Rezurock | chronic graft versus host disease | 2025-10-17 | “negative opinion on the marketing authorisation application for Rezurock (belumosudil) for the third-line treatment of adults and pediatric patients with chronic...” sanofi.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved · conditional | EU (EMA) | Rezurock | — | 2026-03-24 | europa.eu ↗ |
| Approved | US (FDA) | REZUROCK | — | 2021-07-16 | fda.gov ↗ |
Trials 38
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT05382377 | May 2022 → May 2024 | cancer | jianming xu | Unknown | No outcome recorded |
| Phase 0 | NCT04735822 | Oct 2020 → Sep 2021 | — | Kadmon Corporation, LLC | Completed | No outcome recorded |
| Phase 19 trials | ||||||
| Phase 1 | NCT05806749 | Jul 2023 → Aug 2028 expected | chronic transplant rejection, end stage renal failure | University of California, Los Angeles | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05806567 | Jul → Oct 2022 | immune system disorder | Kadmon, a Sanofi Company | Completed | No outcome recorded |
| Phase 1 | NCT04166942 | Dec 2019 → Jun 2022 | — | Kadmon, a Sanofi Company | Completed | No outcome recorded |
| Phase 1 | NCT03907540 | Apr → May 2019 | autoimmune disease | Kadmon Corporation, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03530995 | Apr 2018 → Feb 2019 | autoimmune disease | Kadmon Corporation, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02557139 | Sep → Oct 2015 | — | Kadmon Corporation, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05918614 | Mar → Jun 2014 | immune system disorder | Kadmon, a Sanofi Company | Completed | No outcome recorded |
| Phase 1 | NCT05918588 | Nov 2013 → Mar 2014 | immune system disorder | Kadmon, a Sanofi Company | Completed | No outcome recorded |
| Phase 1 | NCT05918627 | Sep → Dec 2009 | immune system disorder | Kadmon, a Sanofi Company | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06105554 | Jan 2024 → Aug 2027 expected | plasma cell myeloma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04643002 | Jan 2021 → Sep 2027 expected | plasma cell myeloma | Sanofi | Recruiting | No outcome recorded |
| Phase 218 trials · 2 missed | ||||||
| Phase 2 | NCT07643025 | Nov 2026 → Nov 2029 expected | chronic graft versus host disease | Dennis Kim | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07116031 | Dec 2025 → Sep 2028 expected | chronic graft versus host disease | Sanofi | Recruiting | No outcome recorded |
| Phase 2 | NCT06751602 | Sep 2025 → Dec 2027 expected | chronic transplant rejection | The Methodist Hospital Research Institute | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT05567406 | Jun 2025 → Aug 2026 | chronic graft versus host disease | Kadmon, a Sanofi Company | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT07006506 | May 2025 → May 2029 expected | graft versus host disease, hematopoietic and lymphoid cell neoplasm | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06476132 | Mar 2025 → May 2027 expected | — | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 2 | NCT05922761 | May 2024 → Jun 2027 expected | chronic graft versus host disease, transplant-related bronchiolitis obliterans | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06046248 | Jan 2024 → Dec 2026 expected | chronic graft versus host disease | Northside Hospital, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT05996627 | Dec 2023 → Apr 2028 expected | chronic graft versus host disease | Fred Hutchinson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05305989 | Feb 2022 → Jun 2024 | chronic graft versus host disease | Kadmon, a Sanofi Company | Completed | No outcome recorded |
| Phase 2 | NCT04680975 | Mar 2021 → May 2022 | diffuse cutaneous systemic sclerosis | Kadmon, a Sanofi Company | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03919799 | Jun 2019 → Aug 2022 | diffuse cutaneous systemic sclerosis | Kadmon, a Sanofi Company | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT03640481 | Oct 2018 → Dec 2023 | chronic graft versus host disease | Kadmon, a Sanofi Company | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02841995 | Sep 2016 → May 2022 | chronic graft versus host disease | Kadmon, a Sanofi Company | Completed | No outcome recorded |
| Phase 2 | NCT02852967 | Sep 2016 → Feb 2019 | psoriasis | Kadmon Corporation, LLC | Completed | Missed primary |
| Phase 2 | NCT02688647 | May 2016 → Apr 2021 | idiopathic pulmonary fibrosis | Kadmon Corporation, LLC | Completed | No outcome recorded |
| Phase 2 | NCT02317627 | Dec 2014 → Mar 2016 | psoriasis | Kadmon Corporation, LLC | Completed | No outcome recorded |
| Phase 2 | NCT02106195 | Apr → Sep 2014 | psoriasis | Kadmon Corporation, LLC | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07771439 | Sep 2026 → Sep 2029 expected | chronic graft versus host disease | Sanofi | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06143891 | Jan 2024 → Sep 2028 expected | chronic graft versus host disease | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06082037 | Oct 2023 → Jan 2029 expected | transplant rejection | Sanofi | Recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07135973 | Aug 2026 → Aug 2027 expected | chronic graft versus host disease | Sanofi | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06616415 | Dec 2024 → May 2026 | chronic graft versus host disease | Sanofi | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07794514 | Oct 2026 → Apr 2030 expected | chronic graft versus host disease | First Affiliated Hospital of Zhejiang University | Recruiting | No outcome recorded |
| — | NCT06509490 | Jul 2024 overdue | — | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT07484113 Background | Jul 2026 → May 2028 expected | chronic graft versus host disease | Stanford University | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-03-31 | Sanofi | Regulatory Press Release: Sanofi’s Rezurock approved in the EU to treat chronic graft-vs-host disease sanofi.com ↗
The European Commission has granted a conditional marketing authorisation for Rezurock (belumosudil) for the treatment of chronic graft-versus-host disease (GVHD) in adults and in children aged 12 years and older with a body weight of at least 40 kg. |
| 2026-01-30 | Sanofi | Regulatory Press Release: Sanofi’s Rezurock recommended for EU approval by the CHMP to treat chronic graft-vs-host disease sanofi.com ↗
Sanofi’s Rezurock recommended for EU approval by the CHMP to treat chronic graft-vs-host disease |
| 2025-10-17 | Sanofi | Regulatory Press Release: Sanofi provides update on regulatory review in the EU for Rezurock to treat chronic graft-vs-host disease sanofi.com ↗
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion on the marketing authorisation application for Rezurock (belumosudil) for the third-line treatment of adults and pediatric patients with chronic graft-versus-host disease (cGVHD). |
| 2022-04-21 | Sanofi | Results Media Update: Rezurock® (belumosudil) patient-reported outcomes correlated with clinical response in chronic graft-versus-host disease sanofi.com ↗
Results from a pooled analysis of Rezurock ® (belumosudil) for the treatment of chronic graft-versus-host disease (cGVHD) show certain organ clinical responses correlated with clinically meaningful changes in patient-reported outcomes (PROs). |
All press releases naming this drug 4 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 42 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Belumosudil | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02106195 ↗ |
| Known as | Belumosudil mesylate | “Drug: Belumosudil mesylate” NCT05918627 ↗1“Drug: Belumosudil mesylate” NCT05918588 ↗ |
| Known as | KD-025 MESYLATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2005186 ↗ |
| Known as | KD025 | “Belumosudil (2-(3-(4-(1H-indazol-5-ylamino) quinazolin-2-yl) phenoxy)-N-isopropylacetamide-methane sulfonic acid salt), formerly also known as KD025, is an orally available...” NCT07484113 ↗10“A Phase 2, Randomized, Placebo-controlled, Double-blind, Open-label Extension Multicenter Study to Evaluate the Efficacy and Safety of Belumosudil (KD025) in Subjects With...” NCT03919799 ↗ “This is a single-center, 2-part, non-randomized, open-label study of the drug-drug interactions of belumosudil (KD025) with itraconazole, rifampicin, rabeprazole, and...” NCT03530995 ↗ “Belumosudil (KD025), an oral, selective, Rho-associated, coiled-coil-containing protein kinase 2 (ROCK2) inhibitor, is approved for third-line treatment of chronic...” PMID 40311075 ↗ Jul 2025 “This study was been conducted to evaluate the safety, tolerability, and activity of belumosudil (formerly known as KD025) in adult participants with chronic graft versus host...” NCT02841995 ↗ “administration of the drug belumosudil (KD025) will be safe and improve transplant tolerance” NCT05806749 ↗ “Bioavailability of Belumosudil (KD025) in Healthy Male Subjects” NCT02557139 ↗ |
| Known as | REZUROCK | “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...” NCT06751602 ↗ |
| Known as | Rock2 inhibitor kd025 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2005186 ↗ |
| Known as | Slx-2119 free base | ChEMBL registry synonym — accepted as the source's own label CHEMBL2005186 ↗ |
| Action | Inhibit | “Selective ROCK2 inhibition with belumosudil (KD025) may offer a novel approach to the management of chronic graft-versus-host disease (cGVHD).” PMID 33877856 ↗ Apr 2021 |
| Modality | Small molecule | “Kinase inhibitor, tablet taken orally” NCT05922761 ↗ |
| Route | Oral | “belumosudil given orally once daily” NCT02106195 ↗ |
| Target | ROCK2 | “Selective ROCK2 inhibition with belumosudil (KD025) may offer a novel approach to the management of chronic graft-versus-host disease (cGVHD).” PMID 33877856 ↗ Apr 2021 |