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Belumosudil - Kadmon Pharmaceuticals

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Drug Profile

Belumosudil - Kadmon Pharmaceuticals

Alternative Names: Belumosudil mesylate - Kadmon Pharmaceuticals; BN-101; KD-025; KD025 mesylate; ME-3208; REZUROCK; Rholistiq; SAR445761; SLX-2119

Latest Information Update: 04 Mar 2026

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At a glance

  • Originator Surface Logix
  • Developer BK Pharmaceuticals; Kadmon Pharmaceuticals; Romeck Pharma
  • Class Acetamides; Amines; Anti-inflammatories; Antifibrotics; Antineoplastics; 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

  • Marketed Graft-versus-host disease
  • Registered Lung transplant rejection
  • Phase II Idiopathic pulmonary fibrosis; Systemic scleroderma
  • Phase I Autoimmune disorders
  • Preclinical Multiple myeloma
  • Discontinued Cancer; Non-alcoholic steatohepatitis; Plaque psoriasis; Rheumatoid arthritis; Systemic lupus erythematosus

Most Recent Events

  • 17 Feb 2026 Discontinued - Phase-III for Graft-versus-host disease (In adults, In the elderly, Newly diagnosed, In adolescents, Combination therapy) in Turkey, Spain, Netherlands, Israel, France, Greece, Czech Republic, Canada, Belgium, Australia, Austria, Brazil, China, Denmark, Germany, Hong Kong, Italy, Portugal, Sweden, United Kingdom, USA and Argentina based on pre-specified futility interim analysis (PO)
  • 12 Feb 2026 Kadmon Pharmaceuticals withdraws a phase II trial prior to enrolment for Graft-versus-host disease (In adolescents, In adults, In the elderly, Treatment experienced) in USA (PO, Tablet) due to sponsors decision (NCT05567406)
  • 30 Jan 2026 The Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency (EMA) issues a positive opinion for the conditional approval of Belumosudil for Graft-versus-host disease in European Union

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