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Belumosudil - Kadmon Pharmaceuticals

Drug Profile

Belumosudil - Kadmon Pharmaceuticals

Alternative Names: Belumosudil mesylate - Kadmon Pharmaceuticals; BN-101; KD-025; KD025 mesylate; ME-3208; REZUROCK; SLX-2119

Latest Information Update: 10 Aug 2021

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At a glance

  • Originator Surface Logix
  • Developer BK Pharmaceuticals; Kadmon Pharmaceuticals
  • Class Acetamides; Amines; Anti-inflammatories; Antifibrotics; Antipsoriatics; Antirheumatics; Hepatoprotectants; Indazoles; Phenyl ethers; Quinazolines; Skin disorder therapies; Small molecules
  • Mechanism of Action Rho-associated kinase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Graft-versus-host disease; Systemic scleroderma
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Graft-versus-host disease
  • Phase II Idiopathic pulmonary fibrosis; Systemic scleroderma
  • Discontinued Non-alcoholic steatohepatitis; Plaque psoriasis; Rheumatoid arthritis; Systemic lupus erythematosus

Most Recent Events

  • 04 Aug 2021 Belumosudil contains black box warning of embryo-fetal toxicity when administered to pregnant women
  • 20 Jul 2021 PDUFA action date extended by US FDA to 30/08/2021 for NDA for Graft-versus-host disease
  • 16 Jul 2021 Registered for Graft-versus-host disease (In adolescents, In children, Treatment-experienced, In adults) in USA (PO) - First global approval (under Project Orbis and RTOR programme)
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