Belumosudil clinical trials
Belumosudil is named as an intervention in 7 current clinical trials in our Canada, USA, Germany, France, Spain, Italy, Netherlands, Israel, China, Belgium, South Korea, Australia, UK, Turkey, Japan, Sweden, Denmark, Austria, Czechia, Norway, Poland, Portugal and Brazil registers. 5 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Sanofi (5). The most-studied condition is Chronic Graft Versus Host Disease. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Belumosudil is approved
All regulators →Of the three regulators tracked here, the first to approve Belumosudil was the US, on 16 Jul 2021. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Belumosudil patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Belumosudil, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 5 listed patents; the last listed expires 14 Jul 2042 (US 12097202).
- Latest patent on the drug substance itself: 20 Jun 2034 (US 8357693).
- Exclusivity ODE-362: Orphan drug exclusivity: treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic gvhd)…, until 16 Jul 2028.
- REZUROCK for treatment of graft-versus-host disease: until 25 Mar 2036. Union Register
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Belumosudil
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Belumosudil works
All drug targets →- Rho-associated protein kinase 2 inhibitor InhibitorTarget: ROCK2 Rho associated coiled-coil containing protein kinase 2✓ In ChEMBL and the Guide to Pharmacology
- Rho-associated protein kinase inhibitor InhibitorTarget: Rho-associated protein kinase✓ In ChEMBL and the Guide to Pharmacology
- Chronic lung allograft dysfunctionPhase 3
- Bronchiolitis obliterans syndromePhase 2
- Chronic graft versus host diseasePhase 2
- Diffuse sclerodermaPhase 2
- Idiopathic pulmonary fibrosisPhase 2
- Psoriasis vulgarisPhase 2
- Rheumatoid arthritisPhase 2
- Systemic sclerosisPhase 2
- Plasma cell myelomaPhase 1/2
- Psoriatic arthritisPhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2005186, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9558, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Belumosudil
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Belumosudil. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Belumosudil for treating chronic graft-versus-host disease after 2 or more systemic treatments in people 12 years and over NICE TA949 | Recommended | 7 Feb 2024 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Belumosudil
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: RezurockEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Belumosudil
- ChEMBL
- CHEMBL2005186
- DrugBank
- DB16703
- PubChem CID
- 11950170
- CAS number
- 911417-87-3
- FDA UNII
- 834YJF89WO
- Wikidata
- Q27269397
- Wikipedia
- Belumosudil
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Belumosudil
7 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Belumosudil in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Belumosudil. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
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
2026-525913-30-00 · Immune System Diseases
|
Phase 3 | Ongoing | Sanofi-Aventis Recherche & Developpement | Belgium, Czechia, Hungary + 19 more |
Belumosudil across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Belumosudil on the HPRA medicines list.
- REZUROCK 200 mg film-coated tabletsSanofi Winthrop Industrie · EU/1/26/2015/001-002
Supply shortages
No entry for Belumosudil in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- RezurockEMA · 24 Mar 2026 · Sanofi Winthrop Industrie
Conditions studied with Belumosudil
5 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Sanofi | 5 |
| National Institute of Allergy and Infectious Diseases (NIAID) | 1 |
| Dennis Kim | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Belumosudil trials
How many clinical trials are testing Belumosudil?
7 current trials in our Canada, USA, Germany, France, Spain, Italy, Netherlands, Israel, China, Belgium, South Korea, Australia, UK, Turkey, Japan, Sweden, Denmark, Austria, Czechia, Norway, Poland, Portugal and Brazil registers name Belumosudil (also registered as SAR445761) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Belumosudil trials recruiting patients?
Yes. 5 of the 7 trials are recruiting: 3 with sites in Canada, 3 with sites in USA, 3 with sites in Germany, 3 with sites in France, 3 with sites in Spain, 3 with sites in Italy, 3 with sites in Netherlands, 3 with sites in Israel, 2 with sites in China, 2 with sites in Belgium, 2 with sites in South Korea, 2 with sites in Australia, 1 with sites in UK, 1 with sites in Turkey, 2 with sites in Japan, 1 with sites in Sweden, 1 with sites in Denmark, 1 with sites in Austria, 1 with sites in Czechia and 2 with sites in Norway. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Belumosudil clinical trials?
Sanofi (5), National Institute of Allergy and Infectious Diseases (NIAID) (1) and Dennis Kim (1). The number in brackets is how many trials each organisation leads.
Is Belumosudil licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Belumosudil, for example REZUROCK 200 mg film-coated tablets (Sanofi Winthrop Industrie). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Belumosudil shortage?
Not in the lists we track: Belumosudil has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Belumosudil works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Belumosudil works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Belumosudil (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.