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
Further information
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