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Rezurock FDA Approval History

Last updated by Judith Stewart, BPharm on July 17, 2021.

FDA Approved: Yes (First approved July 16, 2021)
Brand name: Rezurock
Generic name: belumosudil
Dosage form: Tablets
Company: Kadmon Holdings, Inc.
Treatment for: Graft-versus-host disease

Rezurock (belumosudil) is a kinase inhibitor for the treatment of patients with chronic graft-versus-host disease (cGVHD).

  • Rezurock is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.
  • Rezurock works by targeting Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response and fibrotic processes.
  • Rezurock tablets are taken orally once daily with food.
  • Common adverse reactions include infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, decreased phosphate, increased gamma glutamyl transferase, decreased lymphocytes, and hypertension.

Development timeline for Rezurock

DateArticle
Jul 16, 2021Approval FDA Approves Rezurock (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD)
Apr 21, 2021Kadmon Announces Publication of Phase 2a Clinical Trial Results of Belumosudil for cGVHD in the Journal of Clinical Oncology
Mar 10, 2021Kadmon Announces U.S. FDA Has Extended the Review Period for Belumosudil in Chronic Graft-Versus-Host Disease
Nov 30, 2020Kadmon Announces FDA Acceptance of NDA for Belumosudil in Patients With Chronic Graft-Versus-Host Disease
Sep 30, 2020Kadmon Announces Submission of New Drug Application to the U.S. FDA for Belumosudil in Patients with Chronic Graft-Versus-Host Disease
May 21, 2020Kadmon Announces Positive Topline Results of Pivotal Trial of Belumosudil (KD025) in Chronic Graft-Versus-Host Disease

Further information

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