# Belumosudil

Source: https://onco.cc/drugs/belumosudil/  
OnCo record `belumosudil` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Belumosudil is a pill for chronic graft-versus-host disease, the long-term immune complication of donor stem-cell transplants used to cure blood cancers.

## Summary

Belumosudil is an oral selective inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2). By rebalancing Th17 and regulatory T-cell responses and reducing fibrotic signalling, it addresses both the inflammatory and the sclerotic components of chronic graft-versus-host disease, the long-term immune complication of donor stem-cell transplants used to cure leukaemias and MDS. In ROCKstar (2021) the overall response rate was 74% in patients with cGVHD after at least two prior lines, including responses in fibrotic organ involvement. It was approved in the US in 2021 for patients aged 12 and over, alongside ruxolitinib (REACH3) and ibrutinib, and axatilimab (anti-CSF1R) followed in 2024. Sequencing among them is unsettled. Belumosudil is part of the transplant survivorship toolkit: a pill that helps donor immune attack on the patient's own tissues without broad immunosuppression.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-24
- Tags: gap-fill; supportive
- Brand: Rezurock
- Modality: Oral ROCK2 inhibitor
- Mechanism: Selective inhibition of Rho-associated coiled-coil kinase 2 rebalances Th17/Treg responses and reduces fibrosis in chronic graft-versus-host disease.
- Approvals: US 2021: Chronic GVHD after failure of ≥2 lines of systemic therapy (age ≥12)

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Belumosudil
- ROCKstar (Blood 2021): https://doi.org/10.1182/blood.2021012021
- FDA approval summary (Clinical Cancer Research 2022): https://doi.org/10.1158/1078-0432.CCR-21-4176
- Label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=belumosudil

## Connected records

- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/), [Acute myeloid leukaemia](https://onco.cc/cancers/aml/), [Myelodysplastic syndromes / neoplasms (MDS)](https://onco.cc/cancers/mds/)
- fronts: [Recovery & Rejuvenation](https://onco.cc/fronts/rejuvenation/)
- technologies: [After ruxolitinib: belumosudil, axatilimab and ibrutinib in chronic GvHD](https://onco.cc/technologies/gvhd-belumosudil-axatilimab-ibrutinib/), [Allogeneic stem cell transplantation](https://onco.cc/technologies/allogeneic-hsct/), [Chronic graft-versus-host disease](https://onco.cc/technologies/gvhd-chronic-overview/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- companies: [Sanofi](https://onco.cc/companies/sanofi/)
- trials: [ROCKstar](https://onco.cc/trials/rockstar/)
- key papers: [Belumosudil for chronic graft-versus-host disease after 2 or more prior lines of therapy: the ROCKstar Study](https://onco.cc/key-papers/paper-rockstar-blood-2021/)
- terms: [Graft-versus-host disease (GVHD) and graft-versus-leukaemia](https://onco.cc/terms/gvhd/)

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